29952 Federal Register / Vol. 74, No. 120 / Wednesday, June 24, 2009 / Rules and Regulations 

PART 80–REGULATION OF FUEL AND 

FUEL ADDITIVES 

■ 1. The authority citation for part 80 

continues to read as follows: 

Authority: 42 U.S.C. 7414, 7542, 7545, and 

7601(a). 

■ 2. Section 80.1129 is amended as 

follows: 

■ a. By revising paragraph (b)(1). 

■ b. By revising paragraph (b)(4). 

■ c. By revising paragraph (b)(5)(ii). 

■ d. By adding paragraph (b)(8). 

§ 80.1129 Requirements for separating 

RINs from volumes of renewable fuel. 

* * * * * 

(b) * * * 

(1) Except as provided in paragraphs 

(b)(6) and (b)(8) of this section, a party 

that is an obligated party according to 

§ 80.1106 must separate any RINs that 

have been assigned to a volume of 

renewable fuel if they own that volume. 

* * * * * 

(4) Any party that produces, imports, 

owns, sells or uses a volume of neat 

renewable fuel may separate any RINs 

that have been assigned to that volume 

of neat renewable fuel if the party 

designates the neat renewable fuel as 

motor vehicle fuel, and the neat 

renewable fuel is used as a motor 

vehicle fuel. 

(5) * * * 

(ii) This paragraph (b)(5) shall not 

apply to any party meeting the 

requirements of paragraph (b)(4) of this 

section. 

* * * * * 

(8) For a party that has received a 

small refinery exemption under 

§ 80.1141 or a small refiner exemption 

under § 80.1142, and who is not 

otherwise an obligated party, during the 

period of time that the small refinery or 

small refiner exemption is in effect the 

party may only separate RINs that have 

been assigned to volumes of renewable 

fuel that the party blends into motor 

vehicle fuel in accordance with 

paragraph (b)(2) of this section. 

* * * * * 

3. Section 80.1131 is amended by 

adding paragraph (a)(8) and removing 

paragraph (b)(4) to read as follows: 

§ 80.1131 Treatment of invalid RINs. 

(a) * * * 

(8) In the event that the same RIN is 

transferred to two or more parties, all 

such RINs will be deemed to be invalid, 

unless EPA in its sole discretion 

determines that some portion of these 

RINs is valid. 

* * * * * 

4. Section 80.1151 is amended by 

revising paragraph (b)(5) to read as 

follows: 

§ 80.1151 What are the recordkeeping 

requirements under the RFS program? 

* * * * * 

(b) * * * 

(5) Records related to the production, 

importation, ownership, sale or use of 

any volume of neat renewable fuel that 

any party designates as motor vehicle 

fuel and uses as motor vehicle fuel. 

* * * * * 

[FR Doc. E9–14849 Filed 6–23–09; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 82 

[EPA–HQ–OAR–2008–0503; FRL–8922–7] 

RIN–2060–AO77 

Protection of Stratospheric Ozone: 

Allocation of Essential Use Allowances 

for Calendar Year 2009 

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 for calendar year 

2009. Essential use allowances enable a 

person to obtain controlled Class I 

ozone depleting substances as part of an 

exemption to the regulatory ban on the 

production and import of these 

chemicals, which became effective 

January 1, 1996. EPA allocates essential 

use allowances for production and 

import of a specific quantity of Class I 

substances solely for the designated 

essential purpose. The allocation in this 

action is 63.0 metric tons of 

chlorofluorocarbons for use in metered 

dose inhalers for 2009. 

DATES: This final rule is effective June 

24, 2009. 

ADDRESSES: EPA has established a 

docket for this action under Docket ID 

No. EPA–HQ–OAR–2008–0503. 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 

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: 

Jennifer Bohman, by regular mail: U.S. 

Environmental Protection Agency, 

Stratospheric Protection Division 

(6205J), 1200 Pennsylvania Avenue, 

NW., Washington, DC, 20460; by courier 

service or overnight express: 1301 L 

Street, NW., Room 1047A, Washington 

DC, 20005; by telephone: (202) 343– 

9548; or by e-mail: 

bohman.jennifer@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 2009 

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 

VI. Effective Date of This Final Rule 

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 

Federal Register / Vol. 74, No. 120 / Wednesday, June 24, 2009 / Rules and Regulations 29953 

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. 

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. 

Eliminating the production and 

consumption of Class I ODSs is 

accomplished through adherence to 

phaseout schedules for specific Class I 

ODSs 2 which include 

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 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 metered dose inhalers (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, halon1301, 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 laboratory and 

analytical use 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 

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 take the final decisions on 

whether to approve a Party’s essential 

use nomination at their annual Meeting 

of the Parties. This nomination process 

occurs approximately two years before 

the year in which the allowances would 

be in effect. The allowances allocated 

for 2009 in this final rule were first 

nominated by the United States in 

January 2007. 

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 

29954 Federal Register / Vol. 74, No. 120 / Wednesday, June 24, 2009 / Rules and Regulations 

may allocate essential use allowances in 

quantities that together are less than 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 2009, the Parties authorized 

the United States to allocate up to 282 

metric tons (MT) of CFCs for essential 

uses. In a notice of proposed rulemaking 

published in the Federal Register on 

January 16, 2009 (74 FR 2954), EPA 

proposed to allocate 63.0 MT of CFCs 

for the production of MDIs for the 

calendar year 2009. In this final rule, 

EPA is allocating 63.0 MT of CFCs for 

the production of MDIs for calendar 

year 2009. 

II. Essential Use Allowances for 

Medical Devices 

The following is a step-by-step list of 

actions EPA and FDA have taken to 

implement the exemption for medical 

devices found at section 604(d)(2) of the 

Act for the 2009 calendar year. 

1. On January 16, 2008, EPA sent 

letters to MDI manufacturers requesting 

the following information under section 

114 of the Act (‘‘114 letters’’): 

a. The MDI product where CFCs will 

be used. 

b. The number of units of each MDI 

product produced from 1/1/07 to 12/31/ 

07. 

c. The number of units anticipated to 

be produced in 2008. 

d. The number of units anticipated to 

be produced in 2009. 

e. The gross target fill weight per unit 

(grams). 

f. Total amount of CFCs to be 

contained in the MDI product for 2009. 

g. The additional amount of CFCs 

necessary for production. 

h. The total CFC request per MDI 

product for 2009. 

The letters from EPA are available for 

review in the Air Docket ID No. EPA– 

HQ–OAR–2008–0503. 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 2008, as 

required by 40 CFR 82.13(u), EPA 

received annual reporting 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 pre-1996 and post-1996 CFCs). 

The data submitted from the MDI 

manufacturers is available for review in 

the Air Docket ID No. EPA–HQ–OAR– 

2008–0503. 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 February 13, 2008, 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 2009. This letter is available for 

review in Air Docket ID No. EPA–HQ– 

OAR–2008–0503. 

4. On April 28, 2008, FDA sent a letter 

to EPA stating the amount of CFCs 

determined by the Commissioner to be 

necessary for each MDI company in 

2009. FDA’s letter informed EPA that it 

had determined that 88.0 MT of CFCs 

were necessary for use in medical 

devices in the year 2009. This letter is 

available for review in the Air Docket ID 

No. EPA–HQ–OAR–2008–0503. 

5. On August 12, 2008, FDA sent a 

letter to EPA revising its April 28, 2008 

essential use determination. FDA’s 

revised letter informed EPA that it had 

determined that 63.0 MT of CFCs were 

necessary for use in medical devices for 

the year 2009. In its letter, FDA stated 

that ‘‘The amount of CFCs 

recommended in our April 28, 2008 

letter was based on information 

available then, that led to assumptions 

that are now outdated.’’ This letter is 

available for review in the Air Docket ID 

No. EPA–HQ–OAR–2008–0503. 

With respect to the 2009 

determination, FDA stated, ‘‘FDA’s 

determination for the allocation of CFCs 

is lower than the total amount requested 

by sponsors. In reaching this 

determination, we took into account the 

sponsors’ production of MDIs that used 

CFCs as a propellant in 2007, their 

estimated production in 2008, their 

estimated production in 2009, their 

anticipated essential-use allocations in 

2008, their current (as of December 31, 

2007) stockpile levels, and any 

intercompany transfers of CFCs. Finally, 

FDA based its determination for 2009 on 

an estimate of the quantity of CFCs that 

would allow manufacturers to have a 

12-month stockpile at the end of 2009, 

in accordance with 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 2008 (72 FR 

32269, June 12, 2007); 

• All manufacturers will procure the 

full quantity of CFCs allocated to them 

for 2008; 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. 

For calendar year 2009, FDA’s 

determination aggregates the amounts of 

CFC–11, –12, or –114 being allocated to 

the MDI manufacturer. In its letter FDA 

stated, ‘‘As has generally been our 

practice, FDA is aggregating the 

amounts for CFCs, and is providing 

recommendations on the total amounts 

of CFCs necessary to protect the public 

health. FDA expects manufacturers to 

maintain an appropriate balance of 

CFCs necessary to produce their CFC 

MDIs.’’ 

6. In accordance with FDA’s 

determination, EPA proposed to allocate 

63.0 MT of CFCs for the production of 

MDIs for the calendar year 2009 in a 

proposed rulemaking published on 

January 16, 2009 (74 FR 2954). 

7. In this final rule, EPA is allocating 

63.0 MT of CFCs for the production of 

MDIs for calendar year 2009. 

III. Response to Comments 

EPA received comments from two 

entities on the proposed rule. 

One commenter supported the 

proposed rule and opposed limiting the 

use of ODSs in MDIs. The commenter 

noted that lower cost CFC MDIs are a 

benefit for low-income individuals. 

EPA believes that only a limited 

amount of production or import of CFCs 

for use in MDIs is necessary in 2009. 

Section 604 of the Clean Air Act directs 

EPA to authorize the production of 

CFCs for essential MDIs if FDA, in 

consultation with EPA, determines such 

production to be necessary. FDA, in 

consultation with EPA, has determined 

that 63.0 MT of CFCs are necessary to 

meet the demand for 2009 MDI 

manufacturing. Therefore, this action 

allocates 63.0 MT of CFCs for use in 

MDIs in 2009. 

EPA and FDA understand that 

patients may incur additional costs to 

purchase inhalers as the market 

transitions to CFC-free alternatives, such 

Federal Register / Vol. 74, No. 120 / Wednesday, June 24, 2009 / Rules and Regulations 29955 

as HFA MDIs. For example, patients 

covered by medical insurance may 

encounter higher co-payments to 

purchase HFA MDIs, which are brand 

name products. However, patient 

assistance programs exist to assist 

patients with the increased costs. For 

low-income patients, these programs 

include free and/or discounted 

medicines. To assist patients facing 

higher co-pays associated with the 

increased costs of the HFA MDIs, 

programs such as coupons and 

discounted HFA MDIs are being made 

available through physicians’ offices, at 

pharmacies, and at individual 

manufacturers’ Web sites. 

In a related rulemaking, FDA 

responded to a similar comment 

regarding the cost of CFC-free 

alternatives, stating, ‘‘Considering the 

availability of programs providing lowcost or free prescription drugs that 

would allow low-income, elderly, and 

uninsured individuals to purchase 

alternative MDIs, and the availability of 

physician samples, we believe that 

patients will be adequately served by 

alternative MDIs’’ (73 FR 69532). 

A second commenter supported the 

proposed rule but believes that the US 

Government should take actions to limit 

the amount of CFCs needed for use in 

MDIs in the future. The commenter 

believes that the U.S. Government 

should set up procedures or guidelines 

to encourage MDI manufacturers to 

develop CFC-free MDIs. The commenter 

also asked whether the global laboratory 

and analytical use exemption would 

extend to the future use of MDIs. 

EPA notes that the transition to 

ozone-safe alternatives is well underway 

and that, for example, the allocation of 

essential use allowances for CFC-based 

MDIs significantly decreased from over 

3,000 MT in 2000 to 63.0 MT in 2009. 

In this action, EPA is only allocating 

essential use allowances to one 

manufacturer of CFC–MDIs. 

FDA has found the use of ODSs to be 

essential in a limited number of medical 

products, including certain metered 

dose inhalers for the treatment of 

asthma and chronic obstructive 

pulmonary disease (see 21 CFR 

2.125(e)(1) and (e)(2)). When a specific 

medical product meets the criteria for 

removal of the essential use designation, 

FDA initiates rulemakings that remove 

the essential use designations for MDIs 

in a manner that is protective of public 

health. Specifically, FDA published a 

final rule in 2008 that removes the 

essential use designation for 

epinephrine used in MDIs as of 

December 31, 2011 (73 FR 69532). 

Further, FDA published a proposed rule 

in 2007 that proposes removing the 

essential use designations for 

flunisolide, triamcinolone, 

metaproterenol, pirbuterol, albuterol 

and ipratropium in combination, 

cromolyn, and nedocromil used in MDIs 

as of December 31, 2009 (72 FR 32030). 

With respect to the comment that EPA 

should encourage MDI manufacturers to 

develop CFC-free MDIs, EPA agrees that 

companies that apply for essential use 

allocations should demonstrate ongoing 

research and development of 

alternatives to CFC MDIs. Decision VIII/ 

10, taken in 1997, provides for 

applicants to submit information on the 

status of research and development into 

alternatives, and Decision XIX/13, taken 

in September 2007, provides for 

applicants to submit related information 

describing their progress in 

transitioning to CFC-free formulations. 

Since 1997, EPA has requested that 

applicants provide this information 

with their applications for CFC essential 

use nominations. The MDI manufacturer 

that is receiving an essential use 

allocation has submitted information to 

EPA pertaining to its research and 

development efforts. 

Finally, the global laboratory and 

analytical exemption allows the 

continued production and import of 

small amounts of class I ODSs for use 

in essential laboratory and analytical 

methods. 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. 

The use of CFCs in MDIs is not a 

laboratory or analytical use. Therefore, 

the use of CFCs in MDIs would not 

qualify under the global laboratory and 

analytical use exemption. 

IV. Allocation of Essential Use 

Allowances for Calendar Year 2009 

With this action, EPA is allocating 

essential use allowances for calendar 

year 2009 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 2009 

Company Chemical 2009 quantity 

(metric tons) 

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

Armstrong ................................................. CFC–11 or CFC–12 or CFC–114 ................................................................................ 63.0 

V. Statutory and Executive Order 

Reviews 

A. Executive Order 12866: Regulatory 

Planning and Review 

Under Executive Order (EO) 12866 

(58 FR 51735, October 4, 1993), this 

action is a ‘‘significant regulatory 

action’’ because it raises novel legal or 

policy issues. Accordingly, EPA 

submitted this action to the Office of 

Management and Budget (OMB) for 

review under EO 12866 and any 

changes made in response to OMB 

recommendations have been 

documented in the docket for this 

action. 

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 ozonedepleting 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. However, the 

Office of Management and Budget 

(OMB) has previously approved the 

information collection requirements 

29956 Federal Register / Vol. 74, No. 120 / Wednesday, June 24, 2009 / Rules and Regulations 

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 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 in its field. 

After considering the economic 

impacts of today’s 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 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. We have therefore 

concluded that today’s 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 is 

deregulatory and does not impose any 

new requirements on any entities. 

Therefore, this action is not subject to 

the requirements of sections 202 and 

205 of 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 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, titled 

‘‘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 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 

This action does not have tribal 

implications, as specified in Executive 

Order 13175 (65 FR 67249, November 9, 

2000). This action does not have tribal 

implications because it does not have 

substantial direct effects on one or more 

Indian tribes, on the relationship 

between the Federal Government and 

Indian tribes, or on the distribution of 

power and responsibilities between the 

Federal Government and Indian tribes. 

Thus, Executive Order 13175 does not 

apply to this action. EPA solicited 

comment on the proposed rule from 

tribal officials. EPA did not receive any 

comments from tribal officials on the 

proposed rule. 

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 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 rule does not have any adverse 

energy effects because it merely 

allocates essential use allowances to 

entities manufacturing metered dose 

inhalers as 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 

rule does not involve technical 

standards. Therefore, EPA did not 

consider the use of any voluntary 

consensus standards. 

Federal Register / Vol. 74, No. 120 / Wednesday, June 24, 2009 / Rules and Regulations 29957 

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 concluded that it is not 

practicable to determine whether there 

would be disproportionately high and 

adverse human health or environmental 

effects on minority and/or low income 

populations from this rule. EPA 

believes, however, that this action 

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. 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 

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 June 24, 2009. 

VI. 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. This 

final rule is issued under section 307(d) 

of the CAA, which does not include a 

30-day effective-date period 

requirement, and which precludes the 

application of section 553(d). CAA 

section 307(d)(1) (‘‘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.’’) EPA is 

making this final rule effective June 24, 

2009, and believes that this is consistent 

with the policies underlying APA 

section 553(d). Specifically, APA 

section 553(d) provides an exception for 

any action that grants or recognizes an 

exemption or relieves a restriction. 

Because this 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 

Environmental protection, 

Administrative practice and procedure, 

Air pollution control, Chemicals, 

Chlorofluorocarbons, Imports, Methyl 

Chloroform, Ozone, Reporting and 

recordkeeping requirements. 

Dated: June 18, 2009. 

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 

table I 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 2009 

Company Chemical 2009 quantity 

(metric tons) 

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

Armstrong ................................................. CFC–11 or CFC–12 or CFC–114 ................................................................................ 63.0 

* * * * * 

[FR Doc. E9–14862 Filed 6–23–09; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 161 

[EPA–HQ–OPP–2004–0387; FRL–8418–5] 

Data Requirements for Antimicrobial 

Pesticides; Technical Amendment 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule; technical 

amendment. 

SUMMARY: EPA is issuing this technical 

amendment to clarify that the data 

requirements for pesticide registration 

in 40 CFR part 161 are applicable only 

to antimicrobial pesticides. 

DATES: This technical amendment is 

effective June 24, 2009. 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2004–0387. All documents in the 

docket are listed in the docket index 

available in http://www.regulations.gov. 

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 in the electronic docket at 

http://www.regulations.gov, or, if only 

available in hard copy, at the OPP 

Regulatory Public Docket in Rm. S– 

4400, One Potomac Yard (South Bldg.), 

2777 S. Crystal Dr., Arlington, VA. The 

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

to 4 p.m., Monday through Friday,