25780 Federal Register / Vol. 75, No. 89 / Monday, May 10, 2010 / Rules and Regulations 

substantial number of small entities 

under the Regulatory Flexibility Act (5 

U.S.C. 601 et seq.); 

• Does not contain any unfunded 

mandate or significantly or uniquely 

affect small governments, as described 

in the Unfunded Mandates Reform Act 

of 1995 (Pub. L. 104–4); 

• Does not have Federalism 

implications as specified in Executive 

Order 13132 (64 FR 43255, August 10, 

1999); 

• Is not an economically significant 

regulatory action based on health or 

safety risks subject to Executive Order 

13045 (62 FR 19885, April 23, 1997); 

• Is not a significant regulatory action 

subject to Executive Order 13211 (66 FR 

28355, May 22, 2001); 

• Is not subject to requirements of 

Section 12(d) of the National 

Technology Transfer and Advancement 

Act of 1995 (15 U.S.C. 272 note) because 

application of those requirements would 

be inconsistent with the Clean Air Act; 

and 

• Does not provide EPA with the 

discretionary authority to address, as 

appropriate, disproportionate human 

health or environmental effects, using 

practicable and legally permissible 

methods, under Executive Order 12898 

(59 FR 7629, February 16, 1994). 

In addition, these rules do not have 

tribal implications as specified by 

Executive Order 13175 (65 FR 67249, 

November 9, 2000), because the SIP is 

not approved to apply in Indian country 

located in the State, and EPA notes that 

it will not impose substantial direct 

costs on tribal governments or preempt 

tribal law. 

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. EPA will submit a 

report containing this action and other 

required information to the U.S. Senate, 

the U.S. House of Representatives, and 

the Comptroller General of the United 

States prior to publication of the rule in 

the Federal Register. A major rule 

cannot take effect until 60 days after it 

is published in the Federal Register. 

This action is not a ‘‘major rule’’ as 

defined by 5 U.S.C. 804(2). 

Under section 307(b)(1) of the Clean 

Air Act, petitions for judicial review of 

this action must be filed in the United 

States Court of Appeals for the 

appropriate circuit by July 9, 2010. 

Filing a petition for reconsideration by 

the Administrator of this final rule does 

not affect the finality of this action for 

the purposes of judicial review nor does 

it extend the time within which a 

petition for judicial review may be filed, 

and shall not postpone the effectiveness 

of such rule or action. Parties with 

objections to this direct final rule are 

encouraged to file a comment in 

response to the parallel notice of 

proposed rulemaking for this action 

published in the Proposed Rules section 

of today’s Federal Register, rather than 

file an immediate petition for judicial 

review of this direct final rule, so that 

EPA can withdraw this direct final rule 

and address the comment in the 

proposed rulemaking. This action may 

not be challenged later in proceedings to 

enforce its requirements (see section 

307(b)(2)). 

List of Subjects in 40 CFR Part 52 

Environmental protection, Air 

pollution control, Incorporation by 

reference, Intergovernmental relations, 

Nitrogen dioxide, Ozone, Reporting and 

recordkeeping requirements. 

Dated: April 1, 2010. 

Jared Blumenfeld, 

Regional Administrator, Region IX. 

■ Part 52, Chapter I, Title 40 of the Code 

of Federal Regulations is amended as 

follows: 

PART 52 [AMENDED] 

■ 1. The authority citation for Part 52 

continues to read as follows: 

Authority: 42 U.S.C. 7401 et seq. 

Subpart F—California 

■ 2. Section 52.220, is amended by 

adding paragraph (c)(377) (i)(B) to read 

as follows: 

§ 52.220 Identification of plan. 

* * * * * 

(c) * * * 

(377) * * * 

(i) * * * 

(B) Yolo Solano Air Quality 

Management District. 

(1) Rule 2.37, ‘‘Natural Gas-Fired 

Water Heaters and Small Boilers,’’ 

revised on April 8, 2009. 

(2) Rule 2.42, ‘‘Nitric Acid 

Production,’’ adopted on May 13, 2009. 

* * * * * 

[FR Doc. 2010–10943 Filed 5–7–10; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 82 

[EPA–HQ–OAR–2009–0566; FRL–9147–8] 

RIN–2060–AP59 

Protection of Stratospheric Ozone: 

Allocation of Essential Use Allowances 

for Calendar Year 2010 

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 ozonedepleting substances (ODSs) for 

calendar year 2010. Essential use 

allowances enable a person to obtain 

controlled Class I ODSs through an 

exemption to the regulatory ban on the 

production and import of these 

chemicals, which became effective as of 

January 1, 1996. EPA allocates essential 

use allowances for production or import 

of a specific quantity of Class I 

substances solely for the designated 

essential purpose. The allocation in this 

action is 30.0 metric tons (MT) of 

chlorofluorocarbons (CFCs) for use in 

metered dose inhalers (MDIs) for 2010. 

DATES: This final rule is effective May 

10, 2010. 

ADDRESSES: EPA has established a 

docket for this action under Docket ID 

No. EPA–HQ–OAR–2009–0566. All 

documents in the docket are listed on 

the http://www.regulations.gov Web 

site. Although listed in the index, some 

information is not publicly available, 

e.g., confidential business information 

(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 through 

http://www.regulations.gov or in hard 

copy at the Air Docket, EPA/DC, EPA 

West, Room 3334, 1301 Constitution 

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

Docket Facility is open from 8:30 a.m. 

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

excluding legal holidays. 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 the Air Docket is (202) 566– 

1742. 

FOR FURTHER INFORMATION CONTACT: 

Jeremy Arling, by regular mail: U.S. 


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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. 

3See Section 614(b) of the Act. EPA’s regulations 

implementing the essential use provisions of the 

Act and the Protocol are located in 40 CFR part 82. 

Environmental Protection Agency, 

Stratospheric Protection Division 

(6205J), 1200 Pennsylvania Avenue, 

NW., Washington, DC 20460; by courier 

service or overnight express: 1301 L 

Street, NW., Room 1047A, Washington, 

DC 20005; by telephone: (202) 343– 

9055; or by e-mail: 

arling.jeremy@epa.gov. 

SUPPLEMENTARY INFORMATION: 

Table of Contents 

I. 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? 

II. Essential Use Allowances for Medical 

Devices 

III. Response to Comments 

IV. Allocation of Essential Use Allowances 

for Calendar Year 2010 

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. Executive Order 12898: Federal Actions 

To Address Environmental Justice in 

Minority Populations and Low-Income 

Populations 

K. Congressional Review Act 

I. Basis for Allocating Essential Use 

Allowances 

A. What are essential use allowances? 

Essential use allowances are 

allowances to produce or import certain 

ozone depleting substances (ODSs) in 

the U.S. for purposes that have been 

deemed ‘‘essential’’ by the U.S. 

Government and by the Parties to the 

Montreal Protocol on Substances that 

Deplete the Ozone Layer (Montreal 

Protocol). 

The Montreal Protocol is the 

international agreement aimed at 

reducing and eliminating the 

production and consumption 1 of ODSs. 

The elimination of production and 

consumption of Class I ODSs is 

accomplished through adherence to 

phaseout schedules for specific Class I 

ODSs,2 which include 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 Montreal Protocol and 

the Clean Air Act (the Act) provide 

exemptions that allow for the continued 

import and/or production of Class I 

ODSs for specific uses. Under the 

Montreal 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 

Montreal 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 phaseout 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 

section 604(d)(1) of 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 MDIs that use CFCs as propellant for 

the treatment of asthma and chronic 

obstructive pulmonary disease. 

(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 

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. 

An additional essential use exemption 

under the Montreal Protocol, as agreed 

in Decision X/19, is the 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 exemption 

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 

exemption at Appendix G to Subpart A 

of 40 CFR part 82 on February 11, 2002 

(67 FR 6352). In a December 29, 2005, 

final rule, EPA extended the general 

exemption for laboratory and analytical 

uses through December 31, 2007 (70 FR 

77048), in accordance with Decision 

XV/8 of the Parties to the Protocol. At 

the 19th Meeting of the Parties in 

September 2007, the Parties agreed to 

extend the global laboratory and 

analytical use exemption through 

December 31, 2011, in Decision XIX/18. 

In a December 27, 2007, final 


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rulemaking EPA took action to (1) 

extend the laboratory and analytical use 

exemption from December 31, 2007, to 

December 31, 2011, for specific 

laboratory uses, (2) apply the laboratory 

and analytical use exemption to the 

production and import of methyl 

bromide, and (3) eliminate the testing of 

organic matter in coal from the 

laboratory and analytical use exemption 

(72 FR 73264). 

C. What is the process for allocating 

essential use allowances? 

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 Parties. The 

Parties make the final decisions on 

whether to approve a Party’s essential 

use nomination at their annual meeting. 

This nomination process occurs 

approximately two years before the year 

in which the allowances would be in 

effect. The allowances proposed for 

allocation for 2010 were first nominated 

by the United States in January 2008. 

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 Montreal 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 2010, the Parties authorized 

the United States to allocate up to 92 

MT of CFCs for essential uses. 

II. 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 2010 

calendar year. 

1. On January 7, 2009, EPA sent 

letters to MDI manufacturers requesting 

the following information under section 

114 of the Act (‘‘114 letters’’): 

• The MDI product in which CFCs 

will be used. 

• The number of units of each MDI 

product produced from 1/1/08 to 12/31/ 

08. 

• The number of units anticipated to 

be produced in 2009. 

• The number of units anticipated to 

be produced in 2010. 

• The gross target fill weight per unit 

(grams). 

• Total amount of CFCs to be 

contained in the MDI product for 2010. 

• The additional amount of CFCs 

necessary for production. 

• The total CFC request per MDI 

product for 2010. 

The 114 letters are available for review 

in the Air Docket ID No. EPA–HQ– 

OAR–2009–0566. The companies 

requested that their responses be treated 

as confidential business information; for 

this reason, EPA has placed the 

responses in the confidential portion of 

the docket. 

2. At the end of January 2009, as 

required by 40 CFR 82.13(u), EPA 

received information from MDI 

manufacturers that included such data 

as the type and quantity of CFCs held 

at the end of the year (i.e. stocks of pre1996 and post-1996 CFCs). The data 

submitted from the MDI manufacturers 

is available for review in the Air Docket 

ID No. EPA–HQ–OAR–2009–0566. The 

companies requested that their 

individual responses be treated as 

confidential business information; for 

this reason, EPA has placed the 

individual responses in the confidential 

portion of the docket. 

3. On April 1, 2009, EPA sent FDA the 

information MDI manufacturers 

provided in response to the 114 letters 

and information required by 40 CFR 

82.13(u) with a letter requesting that 

FDA make a determination regarding 

the amount of CFCs necessary for MDIs 

for calendar year 2010. This letter is 

available for review in Air Docket ID 

No. EPA–HQ–OAR–2009–0566. 

4. On July 10, 2009, FDA sent a letter 

to EPA stating the amount of CFCs 

determined by the Commissioner to be 

necessary for each MDI company in 

2010. This letter is available for review 

in the Air Docket ID No. EPA–HQ– 

OAR–2009–0566. FDA’s letter informed 

EPA that it had determined that 30.0 

MT of CFCs were necessary for use in 

medical devices in the year 2010. 

With respect to the 2010 

determination, FDA stated, ‘‘Our 

determination for the allocation of CFCs 

is lower than the total amount requested 

by manufacturers. In reaching this 

estimate, we took into account the 

sponsors’ production of MDIs that used 

CFCs as a propellant in 2008, their 

estimated production in 2009, their 

estimated production in 2010, their 

anticipated essential-use allocations in 

2009, and their current (as of December 

31, 2008) stockpile levels. Our 

determination took into account any 

transferred CFCs as well as pre-1996 

CFC amounts. Finally, we based our 

determination for 2010 on an estimate of 

the quantity of CFCs that would allow 

manufacturers to have adequate 

stockpiles at the end of 2010 consistent 

with the principles in paragraph 3 of 

Decision XVI/12 and paragraph 2 of 

Decision XVII/5.’’ 

The letter stated that in making its 

determination, FDA made the following 

assumptions: 

• All manufacturers will receive the 

full essential-use allocation proposed by 

EPA for calendar year 2009 (74 FR 2954, 

January 16, 2009); 

• All manufacturers will procure the 

full quantity of CFCs allocated to them 

for 2009; and 

• No bulk CFCs currently held by, or 

allocated to, any manufacturer will be 

exported from the United States. 

EPA has confirmed with FDA that this 

determination is consistent with 

Decision XVII/5, including language on 

stocks that states that Parties ‘‘shall take 

into account pre- and post-1996 stocks 

of controlled substances as described in 

paragraph 1(b) of Decision IV/25, such 

that no more than a one-year operational 

supply is maintained by that 

manufacturer.’’ Allowing manufacturers 

to maintain up to a one-year operational 

supply accounts for unexpected 

variability in the demand for MDI 

products or other unexpected 

occurrences in the market and therefore 

ensures that MDI manufacturers are able 

to produce their essential use MDIs. 

5. In accordance with FDA’s 

determination, EPA proposed to allocate 

30.0 MT of CFCs for the production of 

MDIs for the calendar year 2010 in a 

proposed rulemaking published on 

December 11, 2009 (74 FR 65719). 

6. In this final rule, EPA is allocating 

30.0 MT of CFCs for the production of 

MDIs for calendar year 2010. 

III. Response to Comments 

EPA received one significant 

comment on the proposed rule. The 

commenter opposed exemptions from 

the regulatory phaseout of CFCs. The 

commenter stated that five years should 

be the maximum number of years for 

granting exemptions. 

Under section 604(d) of the Act, ‘‘to 

the extent such action is consistent with 

the Montreal Protocol,’’ EPA is 

authorized to allow the production of 

limited quantities of Class I ODSs for 

use in medical devices ‘‘if such 

authorization is determined by the 

Commissioner [of the Food and Drug 


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Federal Register / Vol. 75, No. 89 / Monday, May 10, 2010 / Rules and Regulations 25783 

Administration], in consultation with 

the Administrator [of EPA] to be 

necessary for use in medical devices.’’ 

The Act does not specify or limit the 

number of years for which EPA might 

grant essential use allowances for the 

production or import of CFCs for use in 

medical devices. [Does the Protocol 

have a time limit on this point? Should 

address that here too.] 

EPA describes above the actions and 

decision factors used to allocate 

essential use allowances. EPA believes 

the research and analysis supporting 

this final action is sound and that the 

allocation of CFCs for the continued 

manufacture of MDIs is necessary. EPA 

notes that the Montreal Protocol’s 

Medical Technical Options Committee 

also recognized the necessity of 

allocating essential use allowances for 

CFCs for use in MDIs in 2010 by 

supporting the U.S. nomination. 

IV. Allocation of Essential Use 

Allowances for Calendar Year 2010 

With this action, EPA is allocating 

essential use allowances for calendar 

year 2010 to the entity 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 ALLOWANCES FOR CALENDAR YEAR 2010 

(i) Metered Dose Inhalers (for oral inhalation) 

for Treatment of Asthma and Chronic Obstructive Pulmonary Disease 

Company Chemical 2010 Quantity 

(metric tons) 

Armstrong ... CFC–11 or ...

CFC–12 or 

CFC–114. 

30.0 

V. Statutory and Executive Order 

Reviews 

A. Executive Order 12866: Regulatory 

Planning and Review 

This action is not a ‘‘significant 

regulatory action’’ under the terms of 

Executive Order (EO) 12866 (58 FR 

51735, October 4, 1993) and is therefore 

not subject to review under the EO. 

EPA prepared an analysis of the 

potential costs and benefits related to 

this action. This analysis is contained in 

the Agency’s Regulatory Impact 

Analysis (RIA) for the entire Title VI 

phaseout program (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). 

A copy of the analysis is available in the 

docket for this action and the analysis 

is briefly summarized here. The RIA 

examined the projected economic costs 

of a complete phaseout of consumption 

of ozone-depleting 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 

MDIs. 

B. Paperwork Reduction Act 

This action does not impose any new 

information collection burden. The 

recordkeeping and reporting 

requirements included in this action are 

already included in an existing 

information collection burden and this 

action does not make any changes that 

would affect the burden. The Office of 

Management and Budget (OMB) has 

previously approved the information 

collection requirements contained in the 

existing regulations at 40 CFR 82.8(a) 

under the provisions of the Paperwork 

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

and has assigned OMB control number 

2060–0170. The OMB control numbers 

for EPA’s regulations in 40 CFR are 

listed in 40 CFR part 9. 

C. Regulatory Flexibility Act 

The Regulatory Flexibility Act 

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 final rule on small entities, 

small entity is defined as: (1) A small 

business that is primarily engaged in 

pharmaceutical preparations 

manufacturing as defined by NAICS 

code 325412 with 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-for-profit 

enterprise which is independently 

owned and operated and is not 

dominant its field. 

After considering the economic 

impacts of today’s final 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 final action will provide an 

otherwise unavailable benefit to those 

companies that are receiving essential 

use allowances by creating an 

exemption to the regulatory phaseout of 

chlorofluorocarbons. EPA therefore 

concluded that today’s final rule will 

relieve regulatory burden for all small 

entities. EPA solicited comments on the 

potential impact of the proposed rule on 

small entities. EPA did not receive 

comments related to the potential 

impact of the proposed rule on small 

entities. 

D. Unfunded Mandates Reform Act 

This action contains no Federal 

mandates under the provisions of Title 

II of the Unfunded Mandates Reform 

Act of 1995 (UMRA), 2 U.S.C. 1531– 

1538 for State, local, or Tribal 

governments or the private sector. The 

action imposes no enforceable duty on 

any State, local or Tribal governments or 

the private sector. This action does not 

impose any new requirements on any 

entities. Therefore, this action is not 

subject to the requirements of sections 

202 and 205 of the UMRA. This action 

is also not subject to the requirements 

of section 203 of UMRA because it 

contains no regulatory requirements that 

might significantly or uniquely affect 

small governments because this rule 

merely allocates essential use 

allowances to entities under an 

exemption to the ban on production and 

import of Class I ODSs. 

E. Executive Order 13132: Federalism 

This action 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. This action 

merely allocates essential use 

allowances to entities under an 

exemption to the ban on production and 

import of Class I ODSs. Thus, Executive 

Order 13132 does not apply to this rule. 


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In the spirit of Executive Order 13132, 

and consistent with EPA policy to 

promote communications between EPA 

and State and local governments, EPA 

specifically solicited comment on the 

proposed action from State and local 

officials. 

F. Executive Order 13175: Consultation 

and Coordination With Indian Tribal 

Governments 

This action does not have Tribal 

implications, as specified in Executive 

Order 13175 (65 FR 67249, November 9, 

2000). This action merely allocates 

essential use allowances to entities 

under an exemption to the ban on 

production and import of Class I ODSs. 

This action does not impose substantial 

direct compliance costs on Indian Tribal 

governments. Thus, Executive Order 

13175 does not apply to this action. 

G. Executive Order 13045: Protection of 

Children From Environmental Health 

Risks and Safety Risks 

EPA interprets EO 13045 as applying 

to those regulatory actions that concern 

health or safety risks, such that the 

analysis required under section 5–501 of 

the Order has the potential to influence 

the regulation. This final rule is not 

subject to EO 13045 because it 

implements Section 604(d)(2) of the 

Clean Air Act which states that the 

Agency shall authorize essential use 

exemptions should the Food and Drug 

Administration determine that such 

exemptions are necessary. 

H. Executive Order 13211: Actions That 

Significantly Affect Energy Supply, 

Distribution, or Use 

This action is not a ‘‘significant energy 

action’’ as defined in Executive Order 

13211 (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. This 

action merely allocates essential use 

allowances to entities under an 

exemption to the ban on production and 

import of Class I ODSs. 

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, 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 

final rule does not involve technical 

standards. Therefore, EPA did not 

consider the use of any voluntary 

consensus standards. 

J. Executive Order 12898: Federal 

Actions To Address Environmental 

Justice in Minority Populations and 

Low-Income Populations 

Executive Order (EO) 12898 (59 FR 

7629 (Feb. 16, 1994)) establishes Federal 

executive policy on environmental 

justice. Its main provision directs 

Federal agencies, to the greatest extent 

practicable and permitted by law, to 

make environmental justice part of their 

mission by identifying and addressing, 

as appropriate, disproportionately high 

and adverse human health or 

environmental effects of their programs, 

policies, and activities on minority 

populations and low-income 

populations in the United States. 

EPA has determined that this rule will 

not have disproportionately high and 

adverse human health or environmental 

effects on minority or low-income 

populations, because it affects the level 

of environmental protection equally for 

all affected populations without having 

any disproportionately high and adverse 

human health or environmental effects 

on any population, including any 

minority or low-income population. 

Any ozone depletion that results from 

this rule will impact all affected 

populations equally because ozone 

depletion is a global environmental 

problem with environmental and 

human effects that are, in general, 

equally distributed across geographical 

regions. 

K. 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. EPA will submit a 

report containing this rule and other 

required information to the U.S. Senate, 

the U.S. House of Representatives, and 

the Comptroller General of the United 

States prior to publication of the rule in 

the Federal Register. A major rule 

cannot take effect until 60 days after it 

is published in the Federal Register. 

This action not a ‘‘major rule’’ as defined 

by 5 U.S.C. 804(2). This rule will be 

effective May 10, 2010. 

List of Subjects in 40 CFR Part 82 

Environmental protection, 

Administrative practice and procedure, 

Air pollution control, Chemicals, 

Chlorofluorocarbons, Imports, Methyl 

Chloroform, Ozone, Reporting and 

recordkeeping requirements. 

Dated: April 29, 2010. 

Lisa P. Jackson, 

Administrator. 

■ 40 CFR Part 82 is amended as follows: 

PART 82—PROTECTION OF 

STRATOSPHERIC OZONE 

■ 1. The authority citation for part 82 

continues to read as follows: 

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

7671q. 

Subpart A—Production and 

Consumption Controls 

■ 2. Section 82.8 is amended by revising 

the table in paragraph (a) to read as 

follows: 

§ 82.8 Grant of essential use allowances 

and critical use allowances. 

(a) * * * 

TABLE I—ESSENTIAL USE ALLOWANCES FOR CALENDAR YEAR 2010 

(i) Metered Dose Inhalers (for oral inhalation) 

for Treatment of Asthma and Chronic Obstructive Pulmonary Disease 

Company Chemical 2010 Quantity 

(metric tons) 

Armstrong ... CFC–11 or 

CFC–12 or 

CFC–114..

30.0 

* * * * * 

[FR Doc. 2010–10926 Filed 5–7–10; 8:45 am] 

BILLING CODE 6560–50–P 


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