[Federal Register: May 10, 2010 (Volume 75, Number 89)]
[Rules and Regulations]
[Page 25780-25784]
[DOCID:fr10my10-10]

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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.

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SUMMARY: With this action, EPA is allocating essential use allowances
for import and production of Class I ozone-depleting 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<PHONE_NUMBER>, and the telephone number for the Air
Docket is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Jeremy Arling, 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:<PHONE_NUMBER>; or by e-mail:
<EMAIL_ADDRESS>
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.
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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).
    \2\ Class I ozone depleting substances are listed at 40 CFR part
82, subpart A, appendix A.
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    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:
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    \3\ See 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.
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    (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

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 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-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

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
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 (i) Metered Dose Inhalers (for oral inhalation) for Treatment of Asthma
                and Chronic Obstructive Pulmonary Disease
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                                                           2010 Quantity
              Company                     Chemical         (metric tons)
------------------------------------------------------------------------
Armstrong.........................  CFC-11 or...........            30.0
                                    CFC-12 or...........
                                    CFC-114.............
------------------------------------------------------------------------

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.

    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.

0
40 CFR Part 82 is amended as follows:

PART 82--PROTECTION OF STRATOSPHERIC OZONE

0
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

0
2. Section 82.8 is amended by revising the table in paragraph (a) to
read as follows:

Sec.  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
-------------------------------------------------------------------------
                                                           2010 Quantity
              Company                     Chemical         (metric tons)
------------------------------------------------------------------------
Armstrong.........................  CFC-11 or CFC-12 or             30.0
                                     CFC-114..
------------------------------------------------------------------------

* * * * *
[FR Doc. 2010-10926 Filed 5-7-10; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 87, Number 124 (Wednesday, June 29, 2022)]
[Notices]
[Pages 38809-38810]
[FR Doc No: 2022-13886]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Docket No. FAA-2022-0455]

Agency Information Collection Activities: Requests for Comments;
Clearance of a Renewed Approval of Information Collection:
Certification of Airmen for the Operation of Light-Sport Aircraft

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice and request for comments.

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SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FAA
invites public comments about our intention to request Office of
Management and Budget (OMB) approval to renew an information
collection. The Federal Register Notice with a 60-day comment period
soliciting comments on the following collection of information was
published on June 6, 2022. The information to be collected is necessary
to ensure compliance with regulations governing the training and
certification of light-sport pilots and instructors.

DATES: Written comments should be submitted by July 29, 2022.

ADDRESSES: Written comments and recommendations for the proposed
information collection should be sent within 30 days of publication of
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function.

FOR FURTHER INFORMATION CONTACT: Craig Holmes by email at:
[email protected]; phone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including (a) Whether the proposed
collection of information is necessary for FAA's performance; (b) the
accuracy of the estimated burden; (c) ways for FAA to enhance the
quality, utility and clarity of the information collection; and (d)
ways that the burden could be minimized without reducing the quality of
the collected information.
    OMB Control Number: 2120-0690.
    Title: Certification of Airmen for the Operation of Light-Sport
Aircraft.
    Form Numbers: 8710-11.
    Type of Review: Renewal.
    Background: The Federal Register Notice with a 60-day comment
period soliciting comments on the following

collection of information was published on June 6, 2022 (87 FR 20497).
This information collection requires applicants for certification as
sport pilots to complete FAA form 8710-11, log training, take and pass
a knowledge test, and requires organizations to develop and maintain
training courses for sport pilots. The total of sport pilot applicants
is estimated to be 500, with a burden of 734 hours. In addition,
applications for certification as sport pilot instructors are required
to take and pass a knowledge test, submit to a flight review, and
purchase a training course. This affects an estimated 40 applicants,
with a total annual burden of 33 hours.
    Respondents: Sport Pilots and Certificated Flight Instructors.
    Frequency: On occasion.
    Estimated Average Burden per Response: 10 minutes.
    Estimated Total Annual Burden: 767 hours.

    Issued in Washington, DC, on June 24, 2022.
Dwayne C. Morris,
Project Manager, Flight Standards Service, General Aviation and
Commercial Division.
[FR Doc. 2022-13886 Filed 6-28-22; 8:45 am]
BILLING CODE 4910-13-P


Attachment C

Consultations Between the US EPA and Respondents to the Information Collection Request: “Pesticide Registration Fee Waivers”; OMB Control No.: 2070-0167	EPA ICR No.: 2147.04

Company Name:  Walter G. Legge Company, Inc.

Name of person consulted:  Liz Bauer

Date: 12/10/09

Q: When preparing your waiver request did you consult the Questions and Answers on the EPA website (http://www.epa.gov/pesticides/fees/questions/waivers.htm)?

A:  Yes

Q: If yes, did you find it helpful and informative?

A:  Not necessary.  Hard to find it on the web and, once found it was hard to understand and was redundant.

Q: What improvements or clarifications would you like to see?

A:   Link directly to small businesses on the pesticides web site.  Reduce the number of steps to complete a small business waiver request and provide a direct link to pay.gov.  EPA not always prompt in returning phone calls when there are questions.

Q: Are you aware of the industry generated form?

A:  could not find it.

Q: Would you use the industry generated form (http://www.cspa.org/pdf/waiver.pdf)?   If no, why not?

After receiving a copy of the form from EPA, used it.

Labor Rates:

Q: Would you say the following labor rates are accurate?

$109.82 /hr management; $60.39 /hr technical staff; $35.89 /hr clerical

Management prepares small business waiver request.  Approx. $100/hr

•The agency methodology for estimating the cost and burden associated with the paperwork involved with preparing your waiver request is the following

Management: reading and comprehending the regulations, planning activities to submit the waiver request: 10 hrs; Subsequent submissions: 2 hrs

Prepares application – 3 hours provided EPA does not need to be contacted for questions.

Technical:  locating and preparing copies of taxes, audits, payroll account statements, any market analysis, etc.?  40 hrs; Subsequent submissions 40 hrs

No technical support in preparing application.

Clerical: preparing the submission 10 hrs; Subsequent submissions 10 hrs

No clerical support used.

Q: Did we miss anything?

Comments:

Attachment C.1

Consultations conducted for the renewal of the Pesticide Registration Fee Waivers; OMB Control No.: 2070-0167	EPA ICR No.: 2147.04

Company Name:  Falcon Lab LLC

Name of person consulted:  Terry Pizzarello, COO

Date: December 14, 2009

Q: When preparing your waiver request did you consult the Questions and Answers on the EPA website?

A:  Yes

Q: If yes, did you find it helpful and informative?

A:  Yes

Q: What improvements or clarifications would you like to see?

A:   No suggestions at this time.

Q: Are you aware of the industry generated form?

A:  yes

Q: Would you use the industry generated form?   If no, why not?

Yes

Labor Rates:

Q: Would you say the following labor rates are accurate?

$109.82 /hr management; $60.39 /hr technical staff; $35.89 /hr clerical

Do not know – family owned company.

•The agency methodology for estimating the cost and burden associated with the paperwork involved with preparing your waiver request is the following

Management: reading and comprehending the regulations, planning activities to submit the waiver request: 10 hrs; Subsequent submissions: 2 hrs

Management prepares the small business fee waiver request.   2.0 hours for an initial submission during a maintenance fee cycle.  Subsequent application in the same year -   0.75 hours

Technical:  locating and preparing copies of taxes, audits, payroll account statements, any market analysis, etc.?  40 hrs; Subsequent submissions 40 hrs

Clerical: preparing the submission 10 hrs; Subsequent submissions 10 hrs

Q: Did we miss anything?

 No

Comments:

Attachment C.2

Consultations conducted for the renewal of the Pesticide Registration Fee Waivers; OMB Control No.: 2070-0167	EPA ICR No.: 2147.04

Company Name:  Mason Chemical Company

Name of person consulted: Elizabeth Tannehill

Date: December 14, 2009

Q: When preparing your waiver request did you consult the Questions and Answers on the EPA website?

A:  Not any more, very familiar with them.

Q: If yes, did you find it helpful and informative?

A:

Q: What improvements or clarifications would you like to see?

A:  None

Q: Are you aware of the industry generated form?

A: use the voluntary industry generated form

Q: Would you use the industry generated form?   If no, why not?

Use the form

Labor Rates:

Q: Would you say the following labor rates are accurate?

$109.82 /hr management; $60.39 /hr technical staff; $35.89 /hr clerical

•The agency methodology for estimating the cost and burden associated with the paperwork involved with preparing your waiver request is the following

Management: reading and comprehending the regulations, planning activities to submit the waiver request: 10 hrs; Subsequent submissions: 2 hrs

Management prepares the application – 4 hours for initial application per maintenance fee cycle, subsequent application within a maintenance fee cycle  – less than 1 hour.  Agency estimated labor rate for management is reasonable.

Technical:  locating and preparing copies of taxes, audits, payroll account statements, any market analysis, etc.?  40 hrs; Subsequent submissions 40 hrs

Clerical: preparing the submission 10 hrs; Subsequent submissions 10 hrs

Q: Did we miss anything?

Attachment C.3

Consultations conducted for the renewal of the Pesticide Registration Fee Waivers; OMB Control No.: 2070-0167	EPA ICR No.: 2147.04

Company Name: Phoenix Environmental Care LLC

Name of person consulted: Sherry Hutcheson

Date: 12/15/09

Q: When preparing your waiver request did you consult the Questions and Answers on the EPA website (http://www.epa.gov/pesticides/fees/questions/waivers.htm)?

A: No

Q: If yes, did you find it helpful and informative?

A:

Q: What improvements or clarifications would you like to see?

A:

Q: Are you aware of the industry generated form (http://www.cspa.org/pdf/waiver.pdf)?

A:

Q: Would you use the industry generated form? yes

  If no, why not?

Labor Rates:

Q: Would you say the following labor rates are accurate? Yes

$109.82 /hr management; $60.39 /hr technical staff; $35.89 /hr clerical

•The agency methodology for estimating the cost and burden associated with the paperwork involved with preparing your waiver request is the following

Management: reading and comprehending the regulations, planning activities to submit the waiver request: 7 hrs; Subsequent submissions: 2 hrs

Technical:  locating and preparing copies of taxes, audits, payroll account statements, any market analysis, etc.?  24 hrs; Subsequent submissions 4 hrs

Clerical: preparing the submission  6 hrs; Subsequent submissions 6 hrs

Q: Did we miss anything? No

Comments:

Attachment C.4

Consultations conducted for the renewal of the Pesticide Registration Fee Waivers; OMB Control No.: 2070-0167	EPA ICR No.: 2147.04

Company Name: Canada Inc.

Name of person consulted:   William Stoneman, consultant

Date: December 14, 2009

Q: When preparing your waiver request did you consult the Questions and Answers on the EPA website?

A:  Yes

Q: If yes, did you find it helpful and informative?

A:  Yes

Q: What improvements or clarifications would you like to see?

A:   post the name of the contact on the guidance web page

Q: Are you aware of the industry generated form?

A: yes

Q: Would you use the industry generated form?   If no, why not?

Used it once, prefer to send a letter answering questions.

Labor Rates:

Q: Would you say the following labor rates are accurate?

$109.82 /hr management; $60.39 /hr technical staff; $35.89 /hr clerical

Management rate is reasonable.  Neither technical nor clerical staff involved in waiver request preparation.

•The agency methodology for estimating the cost and burden associated with the paperwork involved with preparing your waiver request is the following

Management: reading and comprehending the regulations, planning activities to submit the waiver request: 10 hrs; Subsequent submissions: 2 hrs

Management (both consultant and Canada, Inc.) did all of the work on the small business fee waiver request.  3 hours spent to prepare an initial application.

Technical:  locating and preparing copies of taxes, audits, payroll account statements, any market analysis, etc.?  40 hrs; Subsequent submissions 40 hrs

Clerical: preparing the submission 10 hrs; Subsequent submissions 10 hrs

Q: Did we miss anything?

No

Comments: