49836 Federal Register / Vol. 70, No. 163 / Wednesday, August 24, 2005 / Rules and Regulations 

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).

2Class I ozone depleting substances are listed at 

40 CFR part 82, subpart A, appendix A.

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 82

[FRL–7958–2] 

RIN 2060–AM50

Protection of Stratospheric Ozone: 

Allocation of Essential Use Allowances 

for Calendar Year 2005

AGENCY: Environmental Protection 

Agency (EPA).

ACTION: Final rule.

SUMMARY: With this action, EPA is 

allocating 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 allocations total 1,820.48 

metric tons of chlorofluorocarbons for 

use in metered dose inhalers.

DATES: This final rule is effective August 

19, 2005.

ADDRESSES: Materials related to this 

rulemaking are contained in EPA Air 

Docket OAR–2004–0063. The EPA Air 

Docket is located at EPA West Building, 

Room B102, 1301 Constitution Avenue, 

NW., Washington, DC, 20460. The Air 

Docket is open from 8:30 a.m. until 4:30 

p.m. Monday through Friday. Materials 

related to previous EPA actions on the 

essential use program are contained in 

EPA Air Docket No. A–93–39.

FOR FURTHER INFORMATION CONTACT:

Hodayah Finman by regular mail: U.S. 

Environmental Protection Agency, 

Stratospheric Protection Division 

(6205J), 1200 Pennsylvania Avenue, 

NW., Washington, DC, 20460; by 

telephone: 202–343–9246; by fax: 202–

343–2338; or by email: 

finman.hodayah@epa.gov.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. General Information 

How Can I Get Copies of Related 

Information? 

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. Response to Comments 

A. EPA Should Not Allocate Essential Use 

Allowances Generally 

B. EPA Should Not Allocate Essential Use 

Allowances for Production of Albuterol 

MDIs 

C. Aventis Pharmaceuticals Requested 

Additional CFCs for 2005

D. Effect of Montreal Protocol Decisions 

E. EPA Must Reevaluate FDA’s 

Determinations Regarding Essential Use 

Allowance Volumes 

F. EPA May Not Allocate Allowances to 

Companies That Fail to Demonstrate 

Research and Development of 

Alternatives 

G. EPA Must Reduce Allocations of 

Essential Use Allowances by the Amount 

That CFC Stockpiles Exceed a One-Year 

Supply 

H. EPA Must Comply With the Act’s 

Requirements for Notice and Comment 

Rulemaking 

I. The Increase in Armstrong’s Proposed 

Allocation Was Not Supported by 

Publicly Available Information 

IV. 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 

J. Congressional Review Act 

VI. Judicial Review 

VII. Effective Date of This Final Rule

I. General Information 

How Can I Get Copies of Related 

Information? 

1. Docket 

EPA has established an official public 

docket for this action at Air Docket ID 

No. OAR–2004–0063. The official 

public docket consists of the documents 

specifically referenced in this action 

and other information related to this 

action. Hard copies of documents 

related to previous essential use 

allocation rulemakings and other 

actions may be found in EPA Air Docket 

ID No. A–93–39. The public docket does 

not include Confidential Business 

Information (CBI) or other information 

whose disclosure is restricted by statute. 

The public docket is available for 

viewing at the Air and Radiation Docket 

in the EPA Docket Center, (EPA/DC) 

EPA West, Room B102, 1301 

Constitution Ave., NW., Washington, 

DC. The EPA Docket Center 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 Reading Room is (202) 

566–1741, and the telephone number for 

the Air and Radiation Docket is (202) 

566–1742. EPA may charge a reasonable 

fee for copying docket materials.

2. Electronic Access 

An electronic version of the public 

docket is available through EPA’s 

electronic public docket and comment 

system, ‘‘EPA Dockets.’’ You may use 

EPA Dockets at http://www.epa.gov/

edocket/ to view public comments, 

access the index listing of the contents 

of the official public docket, and to 

access those documents in the public 

docket that are available electronically. 

Once in the system, select ‘‘search,’’ 

then key in the appropriate docket 

identification number. 

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 an international agreement aimed at 

reducing and eliminating the 

production and consumption 1 of 

stratospheric ozone depleting 

substances (ODSs). The elimination of 

production and consumption of class I 

ODSs is accomplished through 

adherence to phaseout schedules for 

specific class I ODSs,2 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 

Federal Register / Vol. 70, No. 163 / Wednesday, August 24, 2005 / Rules and Regulations 49837

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. 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.’’ Under 

the Act, this exemption was available 

only until January 1, 2005. Prior to that 

date, EPA issued methyl chloroform 

allowances to the U.S. Space Shuttle 

and Titan Rocket programs. 

(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 (MDIs), 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 

use allowances for halon, because in 

most cases alternatives are available and 

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 XV/8, 

additionally allows a general exemption 

for laboratory and analytical uses 

through December 31, 2007. 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 will 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 (TEAP) 

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 MDIs, EPA requests 

information from manufacturers about 

the number and type of MDIs 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 MDIs in the coming 

calendar year. Based on FDA’s 

determination, 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 will 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. 

EPA published a proposed rule on 

December 22, 2004 (69 FR 76655) that 

would have allocated a total of 1,524.58 

metric tons of allowances. EPA 

subsequently determined that the 

amount proposed to be allocated to one 

company, Armstrong Pharmaceuticals, 

was incorrect. Specifically, EPA had 

proposed to allocate to Armstrong 29 

metric tons, but the amount should have 

been 270.90 metric tons. EPA published 

a supplemental proposal on February 

23, 2005 (70 FR 8753) to correct the 

error, which increased the total amount 

of proposed allowances to 1,766.48 

metric tons. Today’s rule finalizes both 

the proposed rule and the supplemental 

proposed rule. 

III. Response to Comments

EPA received eight sets of comments 

from six individual commenters on the 

proposed rule and the supplemental 

proposed rule, four of which were late 

comments. One commenter objected to 

the granting of essential use status 

generally. One commenter requested 

additional allowances for 2005. The 

other four commenters presented 

arguments related to the obligations of 

the United States under the Montreal 

Protocol and the requirements of the 

Clean Air Act with respect to the 

proposed allocations. The comments are 

addressed in more detail below. 

A. EPA Should Not Allocate Essential 

Use Allowances Generally 

One commenter opposed exempting 

Class I substances for any purpose, 

including asthma medication, because 

non-ozone depleting alternatives have 

been developed (OAR–2004–0063–

0006). EPA disagrees with this 

comment. Section 604 of the Act directs 

49838 Federal Register / Vol. 70, No. 163 / Wednesday, August 24, 2005 / Rules and Regulations 

EPA to authorize production of CFCs for 

essential MDIs if FDA, in consultation 

with EPA, determines such production 

to be necessary. FDA has found the use 

of ozone-depleting substances to be 

essential in certain metered dose 

inhalers for the treatment of asthma and 

chronic pulmonary disease (see 21 CFR 

2.125(e)). As established by final rule on 

July 24, 2002 (67 FR 48370), FDA will 

determine through rulemaking when an 

MDI is no longer essential due to the 

availability of safe and effective 

alternatives. 

The same commenter also stated, 

‘‘[A]ll of the information these polluting 

companies submit should be open to the 

public.’’ The information submitted was 

claimed as confidential. That 

information is being treated in 

accordance with EPA’s regulations on 

confidential business information at 40 

CFR 2.201 through 2.311. 

B. EPA Should Not Allocate Essential 

Use Allowances for Production of 

Albuterol MDIs 

One commenter wrote that EPA 

should not allocate essential use 

allowances for use in CFC albuterol 

MDIs because they are ‘‘non-essential’’ 

and the allocations would be 

‘‘inconsistent with Decisions of the 

Parties to the Montreal Protocol’’ (OAR–

2004–0063–0012). The commenter 

referenced a letter sent by the Natural 

Resources Defense Council (NRDC) to 

EPA on May 13, 2004, that addressed 

the inclusion of CFCs for albuterol MDIs 

in the United States’ 2006 essential use 

nomination. EPA responded with a 

letter dated July 12, 2004, in which we 

said, ‘‘Until FDA issues a final rule to 

delist albuterol MDIs (with an identified 

effective date) in accordance with its 

own regulations and the Administrative 

Procedures Act, it is premature and 

contrary to law for EPA unilaterally to 

conclude that CFC albuterol MDIs are in 

fact no longer essential in the United 

States and to remove this essential use 

from the U.S. nomination for 2006.’’ 

These letters have been placed in EPA 

Docket no. OAR–2004–0063. FDA since 

announced its decision that CFC 

albuterol MDIs will no longer be 

essential after December 31, 2008 (70 FR 

17168, April 4, 2005). Thus, FDA 

continues to regard CFC albuterol MDIs 

as essential for the current control 

period. EPA is therefore allocating 

essential use allowances for CFC 

albuterol MDIs in this final rule. 

C. Aventis Pharmaceuticals Requested 

Additional CFCs for 2005

Aventis Pharmaceuticals submitted to 

the docket a request for additional 

allowances in the amount of 60 metric 

tons, which if allocated would bring the 

company’s total allocation for 2005 to 

117 metric tons. A portion of the 

additional CFCs would be used for 

products exported outside the United 

States. EPA and FDA considered this 

request and determined to grant 

additional allowances for MDI products 

marketed in the United States; the 

relevant correspondence has been 

placed in EPA Docket no. OAR–2004–

0063.

EPA is not granting additional 

allowances to Aventis for production of 

CFC MDIs that would be sold outside 

the United States. Under section 

604(d)(2) of the Act, EPA authorizes 

production of class I substances ‘‘if such 

authorization is determined by the 

Commissioner in consultation with the 

Administrator, to be necessary for use in 

medical devices.’’ EPA and FDA have 

concluded that they currently lack 

sufficient information about whether the 

MDIs in question have been declared 

essential in those counties by their 

public health authority, whether they 

could otherwise be considered essential, 

or whether production of CFCs for these 

MDIs is necessary. FDA is thus unable 

to render a determination on those 

issues. Without such determinations, 

EPA is not allocating allowances for 

those MDIs. 

Following publication of the proposed 

rule in the Federal Register and the 

request by Aventis for increased 

allowances, EPA was notified that 

Aventis sold certain of its assets related 

to MDI production to Inyx USA. 

Therefore, today’s action assigns the 

allowances proposed for Aventis, 

including the additional allowances, to 

Inyx. 

EPA received separate but similar sets 

of comments from the International 

Pharmaceutical Aerosol Consortium 

(IPAC), NRDC, the U.S. Stakeholders 

Group on MDI Transition, and 

GlaxoSmithKline (GSK), a 

pharmaceutical company and member 

of IPAC. EPA’s responses to these 

comments are grouped below in 

accordance with the major points made 

by the commenters. In many instances 

EPA references the GSK comments 

because they were both representative of 

and more detailed than other comments. 

D. Effect of Montreal Protocol Decisions 

GSK commented that ‘‘EPA’s statutory 

obligation to fully implement the 

provisions of the Montreal Protocol 

includes decisions by the Parties to the 

Protocol’’ (OAR–2004–0063–0008, p. 2). 

EPA previously discussed the relevance 

of Decisions of the Parties 69 FR 76984–

76985. Today’s action is fully consistent 

with the Montreal Protocol and the 

Decisions of the Parties bolster, rather 

than detract from, EPA’s interpretation 

and application of the Protocol’s 

essential use provisions. 

E. EPA Must Reevaluate FDA’s 

Determinations Regarding Essential Use 

Allowance Volumes 

GSK argued that EPA must adhere to 

Montreal Protocol Decisions and 

commented, ‘‘The fact that FDA has 

recommended [certain allocation] levels 

does not absolve EPA from evaluating 

consistency with Protocol decisions at 

the time it makes * * * allocations’’ 

(OAR–2004–0063–0008, p. 3). GSK also 

argued that EPA may not rely on the 

levels authorized by the Parties to the 

Protocol, but must reapply relevant 

Decisions in its rulemaking process to 

ensure consistency with the Protocol. 

EPA understands today’s rulemaking 

to be fully consistent with the relevant 

Protocol Decisions and with its 

obligations under the Protocol and 

Federal law. As explained elsewhere in 

this section of the preamble, most of the 

Decisions cited by GSK specifically 

reference the nomination process, not 

the allocation process. EPA accordingly 

reviews those Decisions in preparing the 

nomination. 

F. EPA May Not Allocate Allowances to 

Companies That Fail To Demonstrate 

Research and Development of 

Alternatives 

GSK argued that Decisions VIII/10, 

XV/5, and IV/25 require EPA to deny 

allowances to companies that did not 

submit research and development 

information. GSK stated that it is 

‘‘highly likely’’ that not all companies 

that requested allowances have 

submitted such information, and 

suggested that the U.S. nomination may 

have been non-responsive on this point 

(OAR–2004–0063–0008, p. 8). 

EPA disagrees with the commenter’s 

interpretation of Decision VIII/10 and its 

effort to establish links between this 

Decision and others. Decision VIII/10 

provides that Parties ‘‘will request 

companies applying for MDI essentialuse exemptions to demonstrate ongoing 

research and development of 

alternatives to CFC MDIs with all due 

diligence’’ as well as to report in 

confidence on resources and progress in 

alternatives development. In accordance 

with this Decision, since 1997 EPA has 

requested applicants to provide this 

information when submitting requests 

for CFC essential use nominations. (67 

FR 66148, October 30, 2002). Thus, 

EPA’s interpretation is consistent with 

this Decision.

Contrary to GSK’s suggestion, 

Decision VIII/10 does not require any 

Federal Register / Vol. 70, No. 163 / Wednesday, August 24, 2005 / Rules and Regulations 49839

action to be taken at the allocation stage. 

Instead, it states only that Parties ‘‘will 

request’’ information on research and 

development from companies. In 

addition, Decision VIII/10 does not state 

how to use the information. It does not 

require the United States to report to the 

Parties on research and development, 

either in connection with essential use 

nominations or otherwise. Nor does it 

serve as a basis for denying an essential 

use allowance request. See, for example, 

67 FR 6355, February 11, 2002. 

GSK commented that EPA should not 

allocate allowances to companies that 

do not plan to replace their CFC MDI 

product with a non-CFC alternative and 

are not conducting research to develop 

new products (OAR–2004–0063–0008, 

p. 9). Decision VIII/10, however, does 

not say that all applicants must 

demonstrate ongoing research and 

development, regardless of the 

circumstances. EPA interprets the 

Parties’ intent in taking Decision VIII/10 

to be, as stated on its face, ‘‘to promote 

industry’s participation on a smooth 

and efficient transition away from CFC 

based MDIs’’ generally. Granting 

allowances for a CFC MDI product, if 

the product is listed as essential and 

production of CFCs is determined by the 

Commissioner of FDA to be necessary 

under section 604(d)(2) of the Act, 

allows industry and patients to continue 

to make and use needed products while 

non-CFC alternatives are developed. 

This is consistent with the Decision 

VIII/10 standard of ‘‘due diligence.’’

Companies may elect to drop their 

CFC products and withdraw from the 

essential use program over time in 

accordance with their business plans. 

EPA has seen at least two instances in 

which companies—Sciarra Laboratories 

and PLIVA—withdrew from the 

essential use program (by no longer 

requesting essential use allowances) 

without ultimately reformulating their 

products in a non-CFC version, leaving 

the need for their products to be filled 

by other essential MDIs or alternatives. 

This process is consistent with the goal 

of promoting a ‘‘smooth and efficient 

transition.’’ EPA has placed in Docket 

no. OAR–2004–0063 Federal Register

notices from 2001 and 2002 indicating 

Sciarra’s withdrawal from the program, 

as well as the Federal Register notice 

from 2004 indicating the last year in 

which PLIVA received allowances 

(PLIVA is not included in today’s rule). 

Additionally, EPA has docketed the U.S. 

response to Decision XIV/5, sent to the 

Ozone Secretariat on February 23, 2005, 

in which the U.S. identified all CFC and 

non-CFC inhalers sold domestically. 

GSK stated that ‘‘it is not reasonable 

to conclude that because a parent 

company has presented information to 

demonstrate its compliance with 

Decision VIII/10, that such compliance 

automatically applies to that company’s 

subsidiaries. * * * EPA has not 

provided any information by which the 

public can reasonably conclude that 

Schering-Plough has shared the fruits of 

[its] collaboration with its subsidiary, 

Warrick Pharmaceuticals’’ (OAR–2004–

0063–0008, p. 11). GSK also stated that 

EPA must deny allocations to Schering 

for Warrick’s product based on 

Schering’s alleged failure to submit 

information on Warrick’s research and 

development efforts. However, as noted 

above, Decision VIII/10 calls for 

countries to request information from 

companies regarding research and 

development, and does not speak to the 

issue of denying petitions. Furthermore, 

the decision does not indicate whether 

the Parties had any specific intent 

regarding parent-subsidiary 

collaborations. Given the underlying 

purpose of the Decision to encourage 

research and development by the 

industry as a whole and the lack of 

formal corporate distinctions in the 

Protocol, EPA disagrees with GSK’s 

construction. 

GSK also incorrectly concludes that 

Decision XV/5 establishes that ‘‘EPA 

* * * allocations must be assessed for 

each active ingredient and each 

intended market’’ (OAR–2004–0063–

0008, p. 10). In Decision XV/5, the 

Parties agreed: ‘‘To request that Parties 

* * * when submitting their 

nominations for essential-use 

exemptions for CFCs for metered-dose 

inhalers, specify, for each nominated 

use, the active ingredients, the intended 

market for sale or distribution and the 

quantity of CFCs required.’’ Decision 

XV/5(2). This Decision refers 

specifically to the nomination process. 

It does not address research and 

development reporting, nor does it 

affect EPA’s authority with regard to the 

granting of essential use allowances on 

that ground. 

Finally, GSK’s citation of Decision IV/

25 is also inapposite. GSK stated that if 

a company’s efforts to research and 

develop alternatives, to collaborate with 

others, and to share such information 

with its subsidiaries are ‘‘insufficient,’’ 

then it has not taken ‘‘all economically 

feasible steps * * * to minimize the 

essential use’’ in accordance with 

Decision IV/25(1)(b)(i) (OAR–2004–

0063–0008, pp. 10–11). EPA disagrees 

with the commenter’s suggestion of a 

direct relationship between Decisions 

IV/25 and VIII/10. Decision VIII/10 does 

not make reference to Decision IV/25. 

Also, GSK’s proposed construction is 

unreasonable due to the practical 

difficulties associated with determining 

whether an individual company’s 

research and development efforts 

constitute ‘‘all economically feasible 

steps’’ for that company. Such a 

determination could require detailed 

knowledge of the company’s financial 

status and business plans, as well as an 

understanding of the economic 

importance of the company’s MDI 

products relative to other products 

manufactured by the company. 

Moreover, Paragraph 1(b)(i) of 

Decision IV/25 speaks to minimization 

of particular essential uses, not to 

general research and development. EPA 

has received information from 

applicants regarding their efforts to 

minimize the essential use and 

associated emissions. The United States 

reports to the Parties on these efforts in 

the annual essential use nomination. 

The essential use nomination for 2005 

(pp. 12–13), for example, listed several 

waste minimization strategies employed 

in the manufacture of MDIs (see Docket 

OAR–2004–0063). Information 

submitted by individual companies in 

connection with annual essential use 

nominations has been claimed as 

confidential and is being treated in 

accordance with EPA’s regulations on 

confidential business information a 40 

CFR 2.201 through 2.311. 

G. EPA Must Reduce Allocations of 

Essential Use Allowances by the 

Amount That CFC Stockpiles Exceed a 

One-Year Supply 

Commenters argued that because 

Decision XVI/12 states that countries 

should pursue ‘‘the objective of 

maintaining no more than one year’s 

operational supply [of CFCs],’’ and 

because Decision IV/25 states that 

production and consumption should be 

permitted only if ‘‘the controlled 

substance is not available in sufficient 

quantity and quality from existing 

stocks,’’ that EPA must reduce 

allocations if stockpiles of CFCs amount 

to more than a one-year supply. GSK 

also argued that section 604(d)(2) of the 

Clean Air Act reinforces this 

requirement by allowing the 

Administrator to authorize new 

production of class I substances for 

medical devices only if ‘‘such action is 

consistent with the Montreal Protocol’’ 

(OAR–2004–0063–0008, p. 13).

EPA believes that this argument 

misreads the Decisions in question and 

that today’s action is fully consistent 

with those Decisions and the Protocol. 

At the last Meeting of the Parties in 

November 2004, the Parties specifically 

negotiated and addressed in text the 

issue of stockpiles for CFC MDIs. They 

concluded in Decision XVI/12 that 

49840 Federal Register / Vol. 70, No. 163 / Wednesday, August 24, 2005 / Rules and Regulations 

‘‘Parties, when preparing essential use 

nominations for CFCs, should give due 

consideration to existing stocks * * * 

with the objective of maintaining no 

more than one year’s operational 

supply.’’ First, by its very terms, the 

Decision only applies prospectively, 

when countries make a nomination, not 

during any later domestic allocation 

process. 

Second, Decision XVI/12 did not exist 

at the time of the 2005 U.S. nomination. 

The first nomination subject to Decision 

XVI/12, which the United States 

delivered to the Parties on February 2, 

2005, stated, ‘‘The USEPA monitors 

reserves through information provided 

by companies that receive essential use 

allowances. In putting forward our 2007 

essential use exemption nomination, the 

United States carefully reviewed the 

size of company reserves, bearing in 

mind that information on reserves at the 

end of 2003 or 2004 is not a reliable 

indicator of the amounts that will be 

held, and their distribution at the 

beginning of 2007. Bearing in mind this 

uncertainty, the United States has given 

due consideration to the existence of 

stocks in accordance with Decision XVI/

12’’ (p. 16). Thus, the United States has 

acted in conformance with Decision 

XVI/12. 

Third, Decision XVI/12 only sets an 

objective of a one-year operational 

supply. It does not establish an absolute 

limitation. Giving ‘‘due consideration’’ 

to the level of stocks at the time of 

nomination does not necessarily equate 

to adjusting the U.S. nomination if the 

stockpile data at that point in time 

indicate a supply greater than one year’s 

worth. The commenters cited data 

regarding on-hand CFC supplies at the 

beginning of 2004. To the extent the 

commenters’ concern is based on this 

data, EPA directs their attention to the 

more recent report filed with the Ozone 

Secretariat on February 23, 2005 (see 

Docket No. OAR–2004–0063). 

GSK noted that Decision XVI/2 

expressly references Decision IV/25. 

However, Decision IV/25 does not alter 

the plain meaning of Decision XVI/12, 

and indeed it could not, having been 

decided by the Parties twelve years 

before they decided Decision XVI/12. 

GSK also stated that Decision IV/25 

independently requires EPA to reduce 

allocations to the extent that stockpiles 

are ‘‘excessive.’’ This statement assumes 

that the Decision’s language could only 

apply to individual Parties, ignores its 

hortatory nature, and overlooks the fact 

that the Parties specifically chose, in 

Decision XVI/12, to address the 

stockpile topic by setting an ‘‘objective’’ 

and by referring to the nomination, not 

to any domestic allocation process. 

GSK also referred to Decision XV/5(2), 

in which the Parties decided, among 

other things, ‘‘[t]o request that Parties 

* * * when submitting their 

nominations for essential-use 

exemptions for CFCs for metered-dose 

inhalers, specify, for each nominated 

use, the active ingredients * * * and 

the quantity of CFCs required.’’ GSK 

stated that the combined effect of 

Decisions IV/25 and XV/5 is that EPA 

must, ‘‘[i]n most cases * * * assess 

stockpiles on a company-specific basis’’ 

(OAR–2004–0063–0008, p. 13). As a 

consequence, GSK argued, EPA must 

consider both available stockpiles in the 

aggregate and as held by individual 

companies. If a single company holds 

stockpiles greater than one year’s 

operational supply, then according to 

the commenter EPA must reduce the 

amount of that company’s allocation. 

GSK has incorrectly interpreted a 

Decision that explicitly refers to 

individual Parties’ nominations as 

referring to individual Parties’ licensing 

processes. The United States acted in 

accordance with Decision XV/5, which 

was taken in November 2003, by 

submitting the requested information in 

a letter to the TEAP co-chairs (dated 

April 21, 2004) in connection with the 

2006 essential use nomination. The 

United States also sent updated 

information to the TEAP co-chairs on 

February 23, 2005, in connection with 

the 2007 essential use nomination. 

Decision XV/5, whether considered 

alone or together with Decision IV/25, 

does not require the United States to 

take any action other than to submit the 

requested information as part of its 

essential use nomination. GSK did not 

explain the assertion that the two 

Decisions, taken together, provide more 

direction than either provides on its 

face, nor is there any indication of a 

direct relationship between the two 

Decisions. Decision XV/5 does not make 

reference to Decision IV/25. 

Furthermore, the U.S. nomination for 

2005 had already been submitted at the 

time the Parties took Decision XV/5 and 

thus Decision XV/5 did not apply to that 

nomination because it post-dated it.

Another commenter quoted the May 

2004 TEAP Report (see Docket no. 

OAR–2004–0063) to the effect that 

‘‘individual companies may hold a 

substantial and, perhaps, 

disproportionate amount’’ of a Party’s 

stockpile (OAR–2004–0063–0011, p. 2). 

EPA does not agree with this commenter 

that the statements in the TEAP report—

a document that has never been 

formally adopted by the United States—

regarding individual holdings mean that 

Decision XVI/12 must or should be read 

as relating to individual holdings. The 

TEAP only serves as an advisory body 

to the Parties to inform their decision 

making. It is not a directive body. 

Moreover, the natural reading of 

Decision XVI/12 is that each Party’s 

objective should be to maintain no more 

than one year’s (aggregate) supply. 

Paragraph 3 of that Decision states that 

‘‘Parties * * * should give due 

consideration to existing stocks * * * 

with the objective of maintaining no 

more than one year’s operational 

supply.’’ The ‘‘Parties’’ are the subject of 

the sentence and are thus the entities to 

which the phrase ‘‘objective of 

maintaining no more than one year’s 

operational supply’’ pertains. 

H. EPA Must Comply With the Act’s 

Requirements for Notice and Comment 

Rulemaking 

GSK stated that EPA, in our 

supplemental proposal to correct 

Armstrong’s allocation, failed to comply 

with section 307(d) of the Act. Section 

307(d)(3) directs EPA to make available, 

among other items, the factual data on 

which a proposed rule is based and the 

methodology used in obtaining and 

analyzing those data. GSK stated that 

the supplemental proposal was based on 

information that had not been placed in 

the docket, and also that the 

supplemental proposal was not justified 

based on information that EPA had 

made public. GSK also stated, ‘‘Even if 

it were correct that a requesting 

company has sufficient information to 

comment on its own proposed 

allocation, neither EPA nor FDA have 

[sic] provided any basis for a different 

interested party to meaningfully 

comment on that allocation’’ (OAR–

2004–0063–0016, p. 3). 

As stated above, the information on 

which FDA, in consultation with EPA, 

based the proposed allocations was 

claimed confidential by the submitting 

companies, including Armstrong 

Pharmaceuticals. As a consequence, 

EPA has treated this information in 

accordance with our regulations on 

confidential business information at 40 

CFR 2.201 through 2.311. EPA has 

entered placeholder documents in the 

public portion of the docket to indicate 

the documents that we placed in the 

confidential portion. 

With respect to the methodology used 

to determine the proposed allocations, 

EPA described the process for allocating 

essential use allowances in the 

preamble to the proposed rule 

published on December 22, 2004 (69 FR 

76657). Section 604(d)(2) of the Act 

directs the Agency to authorize 

production of class I substances ‘‘if such 

authorization is determined by the 

Commissioner, in consultation with the 

Federal Register / Vol. 70, No. 163 / Wednesday, August 24, 2005 / Rules and Regulations 49841

Administrator, to be necessary for use in 

medical devices.’’ EPA entered the 

Acting Commissioner’s letter of 

determination (OAR–2004–0063–0005), 

as well as the FDA’s subsequent letter 

of correction (OAR–2004–0063–0010), 

into the public docket for comment. 

EPA also explained in the preamble of 

the supplemental proposal that the 

allocation originally proposed for 

Armstrong Pharmaceuticals was based 

on an error, and the purpose of the 

supplemental notice was to correct the 

error. Portions of the correspondence 

regarding the nature of the error have 

been placed in the confidential portion 

of the docket due to concerns regarding 

disclosure of information claimed as 

confidential. A placeholder has been 

entered in the public portion of the 

docket with respect to this information. 

EPA thus has made public the most 

information possible given our 

obligations regarding the treatment of 

information claimed as confidential. 

Therefore, EPA has acted in accordance 

with section 307(d) of the Act with 

respect to making public the basis and 

methodology for our proposed 

allocations. EPA has also acted in 

accordance with section 604(d)(2) of the 

Act. EPA does not have discretion to 

refuse to authorize production that is 

consistent with the Montreal Protocol 

and that has been determined to be 

necessary by FDA in consultation with 

EPA.

I. The Increase in Armstrong’s Proposed 

Allocation Was Not Supported by 

Publicly Available Information 

GSK stated that the corrected 

allocation proposed for Armstrong 

Pharmaceuticals in the supplemental 

notice was too high and ‘‘cannot be 

supported under the CAA or the 

Montreal Protocol’’ (OAR–2004–0063–

0016, p. 6). This commenter argued that 

Armstrong’s actual MDI production in 

recent years, according to publicly 

available data, was far less than would 

warrant the amount of CFC production 

allowances that Armstrong would 

receive according to the supplemental 

proposed rule. Also, GSK stated that 

Armstrong ‘‘must be holding huge 

stockpiles of CFCs—at least sufficient to 

supply its production for more than a 

year,’’ and that by allocating additional 

allowances to Armstrong in 2005 EPA 

would violate the terms of the Montreal 

Protocol (OAR–2004–0063–0016, p. 5). 

Because Armstrong has claimed its 

2005 essential use allowance 

documentation as confidential, EPA is 

unable to respond to the points made by 

the commenter specifically with regard 

to Armstrong’s proposed allocation. 

However, GSK made several 

assumptions that EPA may respond to 

in general terms. First, GSK assumed 

that a company uses all of the 

allowances it is allocated in a given 

year. This is not the case, as evidenced 

by the U.S. Accounting Framework, 

which since 2001 has shown that the 

amount authorized has consistently 

exceeded the amount actually acquired 

(Accounting Frameworks for 2001–2004 

have been placed in Docket no. OAR–

2004–0063). In the 2004 Accounting 

Framework, for example, the United 

States reported 964 metric tons of CFCs 

authorized but not acquired. This fact 

reflects an important aspect of the 

essential use program: Both the U.S. 

nomination and the subsequent 

allocation rule issued for a given year 

involve projections, and there is 

unavoidably some uncertainty 

associated with projections of demand 

for CFC MDIs. In the interest of ensuring 

public access to essential MDIs, EPA 

believes it is safer for public health to 

risk allocating more allowances than 

may be used than to allocate too few 

and risk a shortage. 

Second, GSK assumed that a company 

would be able to generate a large 

stockpile of essential use CFCs by using 

all of its allowances to produce or 

import CFCs without actually using 

those CFCs to manufacture MDIs during 

the same control period. However, a 

company engaging in this practice 

would reveal itself in its reporting to 

EPA in accordance with regulations at 

40 CFR 82.13(u). EPA’s examination of 

the data from this reporting has led it to 

conclude that stocks are on a downward 

trend in recent years. EPA expects 

companies to manage their allowances 

in good faith consistent with the goals 

of the essential use program. 

The proposition that any company 

has accrued stores of essential use CFCs 

many times in excess of its annual usage 

is contradicted by the Accounting 

Framework. Since 2001, the amount of 

CFCs that the United States reported to 

the Ozone Secretariat as on-hand at the 

end of the year (Column L of the 

Accounting Framework) has decreased 

every year, from 1,910 metric tons in 

2001 to 1,521 metric tons in 2004. 

Excessive stockpiling of CFCs by one or 

more companies would be reflected in 

the Accounting Framework as an 

increase in on-hand CFCs. 

Third, the commenter assumed that a 

company’s allocations must be based on 

the company’s prior record of 

production. If a company’s projected 

need for CFCs is higher than past usage, 

the commenter suggests, then EPA 

should not authorize additional CFCs. It 

is true that a company’s prior usage of 

CFCs is relevant to EPA’s proposed 

allocations, which is why EPA’s 

February 24, 2004, letter to MDI 

manufacturers required them to include 

in their essential use applications prioryear production data (OAR–2004–0063–

0002). Nevertheless, past production 

alone is an insufficient basis for 

allocating allowances in light of the fact 

that market conditions may change, and 

a company may increase or decrease its 

levels of production accordingly. Thus, 

EPA’s February 24, 2004, letter also 

requested information regarding 

anticipated needs during 2005. For this 

reason and the other reasons explained 

above, EPA disagrees with the 

conclusions reached by the commenter 

with regard to the proposed allocation 

for Armstrong. 

IV. Allocation of Essential Use 

Allowances for Calendar Year 2005

With today’s action, EPA is allocating 

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.

TABLE I.—ESSENTIAL USE ALLOCATION FOR CALENDAR YEAR 2005 

Company Chemical Quantity

(metric tons) 

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 ........... 270.90 

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

Inyx USA, Ltd.3 .......................................................................................................... CFC–11 or CFC–12 or CFC–114 ........... 111 

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

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

49842 Federal Register / Vol. 70, No. 163 / Wednesday, August 24, 2005 / Rules and Regulations 

3As explained in section III.C of the preamble, 

allowances allocated to Aventis in the proposed 

rule are being allocated to Inyx in today’s final rule.

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

Company Chemical Quantity

(metric tons) 

Wyeth Pharmaceuticals ............................................................................................. 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, it has been determined 

that this regulatory action is a 

‘‘significant regulatory action’’ because 

it raises novel legal or policy issues. As 

such, this action was submitted to OMB 

for Executive Order 12866 review. 

Changes made in response to OMB 

suggestions or recommendations will be 

documented in the public record. 

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 final 

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 final 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 final 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. OMB previously approved 

the information collection requirements 

contained in the final rule promulgated 

on May 10, 1995, and assigned OMB 

control number 2060–0170 (EPA ICR 

No. 1432.21). 

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 

EPA has determined that it is not 

necessary to prepare a regulatory 

flexibility analysis in connection with 

this final rule. EPA has also determined 

that this rule will not have a significant 

economic impact on a substantial 

number of small entities. For purposes 

of assessing the impact of today’s rule 

on small entities, small entities are 

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 that is independently 

owned and operated and is not 

dominant in its field. 

After considering the economic 

impacts of today’s final rule on small 

entities, EPA has concluded 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 

proposed rule on small entities.’’ 5 

U.S.C. 603 and 604. Thus, an agency 

may conclude 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 

that are receiving essential use 

Federal Register / Vol. 70, No. 163 / Wednesday, August 24, 2005 / Rules and Regulations 49843

allowances. We have therefore 

concluded that today’s final rule will 

relieve regulatory burden for all small 

entities. 

D. 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 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 phaseout 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 final 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. 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 final 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 Executive 

Order 12866, and (2) concerns an 

environmental health and safety risk 

that EPA has reason to believe may have 

a disproportionate effect on children. If 

the regulatory action meets both criteria, 

the Agency must evaluate the 

environmental health or safety effects of 

the planned rule on children, and 

explain why the planned regulation is 

preferable to other potentially effective 

and reasonably feasible alternatives 

considered by the Agency. EPA 

interprets Executive Order 13045 as 

applying only to those regulatory 

actions that are based on health or safety 

risks, such that the analysis required 

under section 5–501 of the Order has 

the potential to influence the regulation. 

This rule is not subject to Executive 

Order 13045 because it implements the 

phaseout schedule and exemptions 

established by Congress in Title VI of 

the Clean Air Act. 

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 

FR 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 this regulatory 

activities unless to do so would be 

inconsistent with applicable law or 

otherwise impractical. Voluntary 

consensus standards are technical 

standards (e.g., materials specifications, 

test methods, sampling procedures, and 

business practices) that are developed or 

adopted by voluntary consensus 

standards bodies. The NTTAA directs 

EPA to provide Congress, through OMB, 

explanations when the Agency decides 

not to use available and applicable 

voluntary consensus standards. This 

final rule does not involve technical 

standards. Therefore, EPA did not 

consider the use of any voluntary 

consensus standards. 

J. Congressional Review Act 

The Congressional Review Act, 5 

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

Business Regulatory Enforcement 

Fairness Act of 1996, generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report, which includes a 

copy of the rule, to each House of the 

Congress and to the Comptroller General 

of the United States. Therefore, EPA 

will submit a report containing this rule 

and other required information to the 

U.S. Senate, the U.S. House of 

Representatives, and the Comptroller 

49844 Federal Register / Vol. 70, No. 163 / Wednesday, August 24, 2005 / Rules and Regulations 

General of the United States prior to 

publication of the rule in the Federal 

Register. This rule is not a ‘‘major rule’’ 

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

will be effective August 19, 2005. 

VI. Judicial Review 

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

EPA finds that these regulations are of 

national applicability. Accordingly, 

judicial review of the action is available 

only by the filing of a petition for review 

in the United States Court of Appeals 

for the District of Columbia Circuit 

within sixty days of publication of the 

action in the Federal Register. Under 

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

this rule may not be challenged later in 

judicial proceedings brought to enforce 

those requirements. 

VII. Effective Date of This Final Rule 

Section 553(d) of the Administrative 

Procedures Act (APA) generally 

provides that rules may not take effect 

earlier than 30 days after they are 

published in the Federal Register. 

Today’s final rule is issued under 

section 307(d) of the CAA, which states, 

‘‘The provisions of section 553 through 

557 * * * of Title 5 shall not, except as 

expressly provided in this subsection, 

apply to actions to which this 

subsection applies.’’ Thus, section 

553(d) of the APA does not apply to this 

rule. EPA nevertheless is acting 

consistently with the policies 

underlying APA section 553(d) in 

making this rule effective August 19, 

2005. APA section 553(d) provides an 

exception for any action that grants or 

recognizes an exemption or relieves a 

restriction. Because today’s action 

grants an exemption to the phaseout of 

production and consumption of CFCs, 

EPA is making this action effective 

immediately to ensure continued 

availability of CFCs for medical devices.

List of Subjects in 40 CFR Part 82

Administrative practice and 

procedure, Air pollution control, 

Chemicals, Environmental protection, 

Exports, Imports, Reporting and 

recordkeeping requirements.

Dated: August 17, 2005. 

Stephen L. Johnson, 

Administrator.

n 40 CFR part 82 is amended as follows:

PART 82—PROTECTION OF 

STRATOSPHERIC OZONE

n 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

n 2. Section 82.8 is amended by revising 

the table in paragraph (a) to read as 

follows:

§ 82.8 Grant of essential use and critical 

use allowances. 

(a) * * *

TABLE I.—ESSENTIAL USE ALLOCATION FOR CALENDAR YEAR 2005 

Company Chemical Quantity

(metric tons) 

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 ........... 270.90 

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

Inyx USA, Ltd ............................................................................................................ CFC–11 or CFC–12 or CFC–114 ........... 111 

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 Pharmaceuticals ............................................................................................. CFC–11 or CFC–12 or CFC–114 ........... 73.40 

* * * * *

[FR Doc. 05–16809 Filed 8–23–05; 8:45 am] 

BILLING CODE 6560–50–P