Protection of Stratospheric Ozone: Adjusting Allowances for Class I Substances for Export to Article 5 Countries, 49395-49399 [E6-13951]
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Federal Register / Vol. 71, No. 163 / Wednesday, August 23, 2006 / Proposed Rules
40 CFR Part 82
[EPA–HQ–OAR–2005–0151, FRL–8212–5]
RIN 2060–AK45
Protection of Stratospheric Ozone:
Adjusting Allowances for Class I
Substances for Export to Article 5
Countries
Environmental Protection
Agency (EPA).
ACTION: Notice of proposed rulemaking.
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AGENCY:
SUMMARY: This proposed action amends
previous action by the Agency regarding
the allocation of Article 5 allowances
that permit production of ozonedepleting substances (ODS) that are
Class I, Group I controlled substances
solely for export to developing countries
to meet those countries’ basic domestic
needs. Specifically, this action will
remove the 2007–2009 phasedown step
for companies that manufacture CFCs–
11, –12, or –114 for export to meet the
basic domestic needs of developing
countries. The Agency is taking this
action in response to notification that
there would otherwise be a shortfall in
the availability of pharmaceutical-grade
CFCs for use in metered dose inhalers
in developing countries. In a final rule
published December 29, 2005, EPA
established initial baselines for each
company that are far more stringent
than required under the Beijing
Adjustments to the Montreal Protocol
on Substances that Deplete the Ozone
Layer (the Montreal Protocol), which set
out restrictions for production to meet
basic domestic needs. Therefore, even
without the 2007–2009 step-down
reduction, the U.S. will be at production
levels to meet basic domestic needs that
are far below those allowed under the
Beijing Adjustments. This action is
taken in accordance with the Montreal
Protocol and the Clean Air Act (CAA).
DATES: Written comments on the rule
must be received on or before
September 22, 2006. Any party
requesting a public hearing must notify
the contact person listed below by 5
p.m. eastern standard time on August
28, 2006. If a hearing is requested it will
be held on September 7, 2006 and
comments will be due to the Agency
October 10, 2006. EPA will post
information regarding a hearing, if one
is requested, on the Ozone Protection
Web site https://www.epa.gov/ozone.
Persons interested in attending a public
hearing should consult with the contact
person below regarding the location and
time of the hearing.
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Submit your comments,
identified by Docket ID No. OAR–2005–
0151, by one of the following methods:
• https://www.regulations.gov: follow
the on-line instructions for submitting
comments.
• E-mail: A-and-R-docket@epa.gov.
• Fax: 202–566–1741.
• Mail: Air Docket, Environmental
Protection Agency, Mailcode: 6102T,
1200 Pennsylvania Ave., NW.,
Washington, DC 20460.
• Hand Delivery or Courier. Deliver
your comments to: EPA Air Docket, EPA
West, 1301 Constitution Avenue, NW.,
Room B108, Mail Code 6102T,
Washington, DC 20004. Such deliveries
are only accepted during the Docket’s
normal hours of operation, and special
arrangements should be made for
deliveries of boxed information.
Instructions: Direct your comments to
Docket ID No EPA–HQ–OAR–2005–
0151 EPA’s policy is that all comments
received will be included in the public
docket without change and may be
made available online at https://
www.regulations.gov, including any
personal information provided, unless
the comment includes information
claimed to be Confidential Business
Information (CBI) or other information
whose disclosure is restricted by statute.
Do not submit information that you
consider to be CBI or otherwise
protected through www.regulations.gov
or e-mail. The https://
www.regulations.gov Web site is an
‘‘anonymous access’’ system, which
means EPA will not know your identity
or contact information unless you
provide it in the body of your comment.
If you send an e-mail comment directly
to EPA without going through
www.regulations.gov, your e-mail
address will be automatically captured
and included as part of the comment
that is placed in the public docket and
made available on the Internet. If you
submit an electronic comment, EPA
recommends that you include your
name and other contact information in
the body of your comment and with any
disk or CD–ROM you submit. If EPA
cannot read your comment due to
technical difficulties and cannot contact
you for clarification, EPA may not be
able to consider your comment.
Electronic files should avoid the use of
special characters, any form of
encryption, and be free of any defects or
viruses. For additional information
about EPA’s public docket visit the EPA
Docket Center homepage at https://
www.epa.gov/epahome/dockets.htm.
Docket: All documents in the docket
are listed in the www.regulations.gov
index. Although listed in the index,
some information is not publicly
ADDRESSES:
ENVIRONMENTAL PROTECTION
AGENCY
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available, e.g., CBI or other information
whose disclosure is restricted by statute.
Certain other material, such as
copyrighted material, will be publicly
available only in hard copy. Publicly
available docket materials are available
either electronically in
www.regulations.gov or in hard copy at
the Air Docket, EPA/DC, EPA West,
Room B102, 1301 Constitution Ave.,
NW., Washington, DC. This Docket
Facility 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:
Cindy Axinn Newberg, EPA,
Stratospheric Protection Division, Office
of Atmospheric Programs, Office of Air
and Radiation (6205J), 1200
Pennsylvania Avenue, NW.,
Washington, DC 20460, (202) 343–9729,
newberg.cindy@epa.gov.
Table of Contents
I. What Is the Legislative and Regulatory
Background of the Phaseout Regulations
for Ozone-Depleting Substances?
II. Today’s Action
III. Statutory and Executive Order Reviews
A. Executive Order No. 12866: Regulatory
Planning and Review
B. Paperwork Reduction Act
C. Regulatory Flexibility
D. Unfunded Mandates Reform Act
E. Executive Order No. 13132: Federalism
F. Executive Order No. 13175: Consultation
and Coordination With Indian Tribal
Governments
G. Executive Order No. 13045: Protection
of Children From Environmental Health
& Safety Risks
H. Executive Order No. 13211: Actions
That Significantly Affect Energy Supply,
Distribution, or Use
I. National Technology Transfer
Advancement Act
J. Congressional Review Act
I. What Is the Legislative and
Regulatory Background of the Phaseout
Regulations for Ozone-Depleting
Substances?
The current regulatory requirements
of the Stratospheric Ozone Protection
Program that limit production and
consumption of ozone-depleting
substances (ODSs) can be found at 40
CFR part 82, subpart A. The regulatory
program was originally published in the
Federal Register on August 12, 1988 (53
FR 30566), in response to the 1987
signing and subsequent ratification of
the Montreal Protocol on Substances
that Deplete the Ozone Layer (Montreal
Protocol). The U.S. was one of the
original signatories to the 1987 Montreal
Protocol and the U.S. ratified the
Protocol on April 21, 1988. Congress
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then enacted, and President Bush signed
into law, the Clean Air Act
Amendments of 1990 (CAAA of 1990),
which included Title VI on
Stratospheric Ozone Protection, codified
as 42 U.S.C. Chapter 85, Subchapter VI,
to ensure that the United States could
satisfy its obligations under the
Montreal Protocol. EPA issued new
regulations to implement this legislation
and has made several amendments to
the regulations since.
The requirements contained in the
final rules published in the Federal
Register on December 20, 1994 (59 FR
65478) and May 10, 1995 (60 FR 24970)
establish an Allowance Program. The
Allowance Program and its history are
described in the notice of proposed
rulemaking published in the Federal
Register on November 10, 1994 (59 FR
56276). The control and the phaseout of
the production and consumption of
Class I ODSs as required under the
Protocol and the CAA are accomplished
through the Allowance Program.
In developing the Allowance Program,
we collected information on the
amounts of ODSs produced, imported,
exported, transformed and destroyed
within the U.S. for specific baseline
years for specific chemicals. This
information was used to establish the
U.S. production and consumption
ceilings for these chemicals. The data
were also used to assign companyspecific production and import rights to
companies that were in most cases
producing or importing during the
specific year of data collection. These
production or import rights are called
‘‘allowances.’’ Due to the complete
phaseout of many ODSs, the quantities
of allowances granted to companies for
those chemicals were gradually reduced
and eventually eliminated. Production
allowances and consumption
allowances no longer exist for any ODSs
that are Class I controlled substances.
All production or consumption of Class
I controlled substances is prohibited
under the Montreal Protocol and the
CAA, except for a few narrow
exemptions.
In the context of the regulatory
program, the use of the term
‘‘consumption’’ may be misleading.
Consumption does not mean the ‘‘use’’
of a controlled substance, but rather is
defined as the formula: production +
imports¥exports, of controlled
substances (Article 1 of the Protocol and
Section 601 of the CAA). Class I
controlled substances that were
produced or imported through the
expenditure of allowances prior to their
phaseout date may continue to be used
by industry and the public after their
phaseout date except where the
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regulations include explicit use
restrictions. Use of such substances may
be subject to other regulatory
limitations.
The specific names and chemical
formulas for the Class I controlled
substances are in Appendix A and
Appendix F in Subpart A of 40 CFR Part
82. The specific names and chemical
formulas for the Class II controlled
substances are in Appendix B and
Appendix F in Subpart A.
Although the regulations phased out
the production and consumption of
Class I controlled substances, a very
limited number of exemptions exist,
consistent with U.S. obligations under
the Montreal Protocol. The regulations
allow for the manufacture of phased-out
Class I controlled substances provided
the substances are either transformed or
destroyed. They also allow limited
manufacture if the substances are (1)
exported to meet the basic domestic
needs of countries operating under
Article 5 of the Montreal Protocol or (2)
produced for essential or critical uses as
authorized by the Montreal Protocol and
the regulations. Limited exceptions to
the ban on the import of phased-out
Class I controlled substances also exist
if the substances are: (1) Previously
used, (2) imported for essential or
critical uses as authorized by the
Montreal Protocol and the regulations,
(3) imported for destruction or
transformation only, or (4) a
transhipment or (5) a heel (a small
amount of controlled substance
remaining in a container after it is
discharged or off-loaded) (40 CFR 82.4).
On December 29, 2005, EPA
published a final rule in the Federal
Register (70 FR 77042) concerning
production of specific Class I controlled
substances for export to meet the basic
domestic needs of developing countries
(‘‘Article 5’’ countries). It established a
new Article 5 allowance baseline for
Class I controlled substances,
established a schedule for phased
reductions in such allowances, and
extended the time allowed for Article 5
production for methyl bromide. Article
5 allowances are solely for production
to meet the basic domestic needs of
developing countries referred to in the
Protocol as ‘‘Article 5’’ parties. This
action amends the schedule for phased
reductions in Article 5 allowances for
companies that produce and export
Class I, Group I substances to meet the
basic domestic needs of Article 5
countries.
II. Today’s Action
Under the Montreal Protocol,
industrialized countries and developing
countries have different schedules for
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phasing out the production and import
of ODSs. Developing countries operating
under Article 5, paragraph 1 of the
Montreal Protocol in most cases have
additional time in which to phase out
ODSs. The Parties to the Montreal
Protocol recognized that it would be
inadvisable for developing countries to
spend their scarce resources to build
new ODS manufacturing facilities to
meet their basic domestic needs as
industrialized countries phase out. The
Parties therefore decided to permit a
small amount of production in
industrialized countries, in addition to
the amounts permitted under those
countries’ phaseout schedules, for
export to meet the basic domestic needs
of developing countries.
The adjustments to the Montreal
Protocol adopted by the Parties at their
11th meeting in Beijing required Parties
that manufacture ODSs for basic
domestic needs to establish baselines for
such production, calculated based on
the average quantity of the ODS
exported to Article 5 countries over a
specified range of years. The
adjustments also instituted a reduction
schedule for Article 5 manufacture
which reflects the reduction schedule in
place for developing country ODS
consumption. The Beijing Adjustments
underscore the Parties’ concern that
global oversupply of certain Class I
ODSs is interfering with the transition
to alternatives. The oversupply of these
ODSs results in low prices that make it
difficult for non-ozone-depleting
alternatives to compete in the
marketplace. Businesses and
individuals thus lack an economic
incentive to transition to alternatives.
The Beijing baseline calculation was
designed to overcome this problem with
respect to Article 5 countries by
reducing supply to those countries. The
price of these ODSs should rise to
reflect the decrease in supply.
In response to the Beijing
Adjustments, EPA published a final rule
in the Federal Register on December 29,
2005 (70 FR 77042). The Beijing
Adjustments to the Protocol, Article 2A,
paragraphs 4–7 state that an
industrialized Party’s allowable
production of CFCs–11, –12, –113, –114,
and –115, referred to under the Clean
Air Act as Class I, Group I substances,
to meet the basic domestic needs of
Article 5 Parties shall be measured
against ‘‘the annual average of its
production of [these substances] for
basic domestic needs for the period
1995 to 1997 inclusive.’’ EPA’s
December 29, 2005 action was far more
stringent than the requirements set forth
in Beijing. The Agency established a
baseline for Class I, Group I substances
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using the more recent export data from
the years 2000–2003, years in which
there were far fewer exports. Therefore,
instead of establishing an aggregate
baseline for Class I, Group I substances
of 9,951 metric tons—reflecting the
1995–1997 average called for by the
Beijing Adjustments—EPA’s December
29, 2005 final rule established a more
stringent baseline of 345 metric tons,
reflecting export data from 2000–2003,
believing that more recent export data
represented a truer picture of the actual
basic domestic needs for these
chemicals in developing countries and
would thereby address the concerns
regarding global oversupply of CFCs.
After publication of the December 29,
2005 final rule, EPA was informed that
although there is a global oversupply of
CFCs in general, there are not sufficient
supplies of pharmaceutical-grade CFCs
available for use in metered dose
inhalers in developing countries.
Pharmaceutical-grade CFCs are more
pure than a typical batch of CFCs and
have to meet stringent specifications set
out by regulatory authorities if they are
to be used in medical devices.
Developed countries like the United
States have already reached their
phaseout date for the production and
consumption of CFCs. Under the
Montreal Protocol, once a Party has
reached the phaseout date for CFCs it is
allowed to apply for an essential use
exemption, which permits the Party to
consume limited amounts of CFCs for
essential uses such as certain metered
dose inhalers. Developing countries do
not phase out their CFC consumption
until 2010 and do not have access to an
essential use exemption until that time.
Therefore, the Agency’s previous
conclusion that there is an oversupply
of CFCs was not correct with regard to
pharmaceutical-grade CFCs. Because the
essential use exemption will not be
available to developing countries until
2010, there is a need for developed
countries to supply CFCs to meet this
demand between 2007 and 2009 under
the provisions for basic domestic needs
identified in the Montreal Protocol and
EPA regulations.
The number of facilities that are rated
for pharmaceutical-grade CFC
production is limited. One company
that owns such a facility in the U.S. had
previously sourced the developing
country demand for pharmaceuticalgrade CFCs from a facility in Europe
which, as of 2006, is no longer in
operation. Since EPA’s December 29,
2005 final rule set baselines for CFC
production for basic domestic needs
that are far below the requirements of
the Beijing Adjustments, the Agency
could allow for a moderate increase in
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the amount of CFC production to meet
domestic needs in order to make up the
potential shortfall in pharmaceuticalgrade CFC production for developing
countries, while still exceeding
compliance with the U.S.’s Montreal
Protocol obligations.
The Montreal Protocol encourages
industrial rationalization to minimize
the number of sources that produce
ozone-depleting substances. The closure
of plants in Europe and in developing
countries as part of their phase out
plans is consistent with this
environmental goal. However, EPA
recognizes the compelling public health
rationale for continued manufacture of
certain CFC-containing metered dose
inhalers (MDIs). In fact, on April 11,
2006, EPA published a proposed rule in
the Federal Register to allow for the
manufacture of CFCs for use in metered
dose inhalers in the United States for
the year 2006, nearly ten years after our
phaseout of CFCs (71 FR 18262).
Therefore, the Agency is proposing to
remove the next phasedown step for
companies that manufacture Class I,
Group I substances from the phaseout
schedule for Article 5 allowances
effective January 1, 2007. Since the
Agency’s December 29, 2005 final rule
established very low baselines for these
substances, the U.S. will still exceed
compliance with the Beijing
Adjustments even without a step-down
to 15% of baseline. A step-down to 15%
of the baseline established by the
Beijing Adjustments (which is based on
1995–1997 export data) would result in
an allowable production level of 1,493
metric tons. By comparison, EPA’s
proposed approach, which uses the
more stringent regulatory baseline based
on 2000–2003 export data but maintains
the 50% step-down level through 2009,
results in an allowable production level
of only 173 metric tons.
As a result of the action described in
this proposed rulemaking, companies
that manufacture Class I, Group I
substances will have their Article 5
production frozen at the 2006 reduction
level of 50% of baseline for the
remaining years of the Article 5
reduction schedule, specifically years
2007–2009. EPA reviewed data
provided on the volume of
pharmaceutical-grade CFCs produced to
meet basic domestic needs over the
years 2000–2005 and consulted with
other governments to confirm whether
they did project a need for
pharmaceutical-grade CFCs between
2007 and 2009. In removing the next
step-down requirement from our
domestic regulation, EPA will allow
companies to manufacture at their 2006
level, which will be sufficient to meet
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the need for pharmaceutical-grade CFCs
based on the data reviewed by the
Agency.
III. Statutory and Executive Order
Reviews
A. Executive Order No. 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.
B. Paperwork Reduction Act
This proposed action does not impose
any new information collection burden.
However, the Office of Management and
Budget (OMB) has previously approved
the information collection requirements
contained in the existing regulations, 40
CFR Part 82, under the provisions of the
Paperwork Reduction Act, 44 U.S.C.
3501 et seq. and has assigned OMB
control number 2060–0170, EPA ICR
number 1432. A copy of the OMBapproved Information Collection
Request (ICR) may be obtained from
Susan Auby, Collection Strategies
Division; U.S. Environmental Protection
Agency (2822T); 1200 Pennsylvania
Ave., NW., Washington, DC 20460 or by
calling (202) 566–1672.
Burden means the total time, effort, or
financial resources expended by persons
to generate, maintain, retain, or disclose
or provide information to or for a
Federal agency. This includes the time
needed to review instructions; develop,
acquire, install, and utilize technology
and systems for the purposes of
collecting, validating, and verifying
information, processing and
maintaining information, and disclosing
and providing information; adjust the
existing ways to comply with any
previously applicable instructions and
requirements; train personnel to be able
to respond to a collection of
information; search data sources;
complete and review the collection of
information; and transmit or otherwise
disclose the information.
An Agency may not conduct or
sponsor, and a person is not required to
respond to, a collection of information
unless it displays a currently valid OMB
control number. The OMB control
numbers for EPA’s regulations are listed
in 40 CFR Part 9 and 48 CFR Chapter
15.
C. Regulatory Flexibility Act
EPA has determined that it is not
necessary to prepare a regulatory
flexibility analysis in connection with
this proposed rule. For purposes of
assessing the impacts of today’s rule on
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small entities, small entity is defined as:
(1) A small business that is identified by
the North American Industry
Classification System (NAICS) Code in
the Table below; (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.
NAICS
code
Category
1. Chemical and Allied Products, NEC ...................................................................................................
After considering the economic
impacts of this proposed rule on small
entities, EPA has concluded that this
action will not have a significant
economic impact on a substantial
number of small entities. This proposed
rule will not impose any requirements
on small entities, as it regulates large
corporations that produce, import, or
export Class I controlled substances.
There are no small entities in this
regulated industry.
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D. Unfunded Mandates Reform Act
Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA), Public
Law 104–4, establishes requirements for
Federal agencies to assess the effects of
their regulatory actions on State, local,
and tribal governments and the private
sector. Under section 202 of the UMRA,
EPA generally must prepare a written
statement, including a cost-benefit
analysis, for proposed and final rules
with ‘‘Federal mandates’’ that may
result in expenditures to State, local,
and tribal governments, in the aggregate,
or to the private sector, of $100 million
or more in any one year. Before
promulgating an EPA rule for which a
written statement is needed, section 205
of the UMRA generally requires EPA to
identify and consider a reasonable
number of regulatory alternatives and
adopt the least costly, most costeffective, or least burdensome
alternative that achieves the objectives
of the rule. The provisions of section
205 do not apply when they are
inconsistent with applicable law.
Moreover, section 205 allows EPA to
adopt an alternative other than the least
costly, most cost-effective, or least
burdensome alternative if the
Administrator publishes with the final
rule an explanation why that alternative
was not adopted. Before EPA establishes
any regulatory requirements that may
significantly or uniquely affect small
governments, including tribal
governments, it must have developed
under section 203 of the UMRA a small
government agency plan. The plan must
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provide for notifying potentially
affected small governments, enabling
officials of affected small governments
to have meaningful and timely input in
the development of EPA regulatory
proposals with significant Federal
intergovernmental mandates, and
informing, educating, and advising
small governments on compliance with
the regulatory requirements.
EPA has determined that this
proposed rule does not contain a
Federal mandate that may result in
expenditures of $100 million or more
for State, local, and tribal governments,
in the aggregate, or the private sector in
any one year. Thus, today’s rule is not
subject to the requirements of sections
202 and 205 of the UMRA. Further, EPA
has determined that this proposed rule
contains no regulatory requirements that
might significantly or uniquely affect
small governments because it does not
impose any requirements on any State,
local, or tribal government.
E. Executive Order No. 13132:
Federalism
Executive Order 13132, entitled
‘‘Federalism’’ (64 FR 43255, August 10,
1999), requires EPA to develop an
accountable process to ensure
‘‘meaningful and timely input by State
and local officials in the development of
regulatory policies that have federalism
implications.’’ ‘‘Policies that have
federalism implications’’ is defined in
the Executive Order to include
regulations that have ‘‘substantial direct
effects on the States, on the relationship
between the national government and
the States, or on the distribution of
power and responsibilities among the
various levels of government.’’
This proposed rule does not have
federalism implications. It will not have
substantial direct effects on the States,
on the relationship between the national
government and the States, or on the
distribution of power and
responsibilities among the various
levels of government, as specified in
Executive Order 13132. This proposed
rule is expected to primarily affect
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422690
SIC code
SIC small business size standard (in number of
employees or
millions of
dollars)
5169
100
producers and exporters of Class I,
Group I controlled substances. Thus,
Executive Order 13132 does not apply
to this proposed rule.
F. Executive Order No. 13175:
Consultation and Coordination With
Indian Tribal Governments
Executive Order No. 13175, entitled
‘‘Consultation and Coordination with
Indian Tribal Governments’’ (65 FR
67249, November 9, 2000), requires EPA
to develop an accountable process to
ensure ‘‘meaningful and timely input by
tribal officials in the development of
regulatory policies that have tribal
implications.’’ This proposed rule does
not have tribal implications, as specified
in Executive Order No. 13175, because
it does not significantly or uniquely
affect the communities of Indian tribal
governments. The proposed rule does
not impose any enforceable duties on
communities of Indian tribal
governments. Thus, Executive Order No.
13175 does not apply to this proposed
rule.
G. Executive Order No. 13045:
Protection of Children From
Environmental Health & Safety Risks
Executive Order 13045: ‘‘Protection of
Children from Environmental Health
Risks and Safety Risks’’ (62 FR 19885,
April 23, 1997) applies to any rule that:
(1) Is determined to be ‘‘economically
significant’’ under E.O. 12866, and (2)
concerns an environmental health or
safety risk that EPA has reason to
believe may have a disproportionate
effect on children. If the regulatory
action meets both criteria, the Agency
must evaluate the environmental health
or safety effects of the planned rule on
children, and explain why the planned
regulation is preferable to other
potentially effective and reasonably
feasible alternatives considered by the
Agency.
While this proposed rule is not
subject to the Executive Order because
it is not economically significant as
defined in E.O. 12866, we nonetheless
have reason to believe that the
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environmental health or safety risk
addressed by this action may have a
disproportionate effect on children.
Depletion of stratospheric ozone results
in greater transmission of the sun’s
ultraviolet (UV) radiation to the earth’s
surface. The following studies describe
the effects on children of excessive
exposure to UV radiation: (1)
Westerdahl J, Olsson H, Ingvar C. ‘‘At
what age do sunburn episodes play a
crucial role for the development of
malignant melanoma,’’ Eur J Cancer
1994; 30A:1647–54; (2) Elwood JM,
Jopson J. ‘‘Melanoma and sun exposure:
an overview of published studies,’’ Int
J Cancer 1997; 73:198–203; (3)
Armstrong BK. ‘‘Melanoma: childhood
or lifelong sun exposure,’’ In: Grobb JJ,
Stern RS, Mackie RM, Weinstock WA,
eds. ‘‘Epidemiology, causes and
prevention of skin diseases,’’ 1st ed.
London, England: Blackwell Science,
1997:63–6; (4) Whiteman D., Green A.
‘‘Melanoma and Sunburn,’’ Cancer
Causes Control, 1994; 5:564–72; (5)
Kricker A, Armstrong, BK, English, DR,
Heenan, PJ. ‘‘Does intermittent sun
exposure cause basal cell carcinoma? A
case control study in Western
Australia,’’ Int J Cancer 1995; 60:489–
94; (6) Gallagher, RP, Hill, GB, Bajdik,
CD, et al. ‘‘Sunlight exposure,
pigmentary factors, and risk of
nonmelanocytic skin cancer I, Basal cell
carcinoma,’’ Arch Dermatol 1995;
131:157–63; (7) Armstrong, BK. ‘‘How
sun exposure causes skin cancer: an
epidemiological perspective,’’
Prevention of Skin Cancer. 2004; 89–
116.
Allowing continuing U.S. production
to meet developing countries’ basic
domestic needs, including their need for
pharmaceutical-grade CFCs, avoids the
need for those countries to install new
ODS manufacturing facilities. The
amount of CFCs that will be released to
the atmosphere should remain the same
regardless of the manufacturing
location. In addition, avoiding the
installation of new capacity is one
means of ensuring that production
levels continue to decline. Thus, this
proposed rule is not expected to
increase the impacts on children’s
health from stratospheric ozone
depletion.
H. Executive Order No. 13211: Actions
That Significantly Affect Energy Supply,
Distribution, or Use
This proposed rule is not a
‘‘significant energy action’’ as defined in
Executive Order No. 13211, ‘‘Actions
Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use’’ (66 FR 28355 (May
22, 2001)) because it is not a significant
VerDate Aug<31>2005
15:59 Aug 22, 2006
Jkt 208001
regulatory action under Executive Order
12866.
I. National Technology Transfer
Advancement Act
Section 12(d) of the National
Technology Transfer and Advancement
Act of 1995 (‘‘NTTAA’’), Public Law.
104–113, Section 12(d) (15 U.S.C. 272
note) directs EPA to use voluntary
consensus standards in its regulatory
activities unless to do so would be
inconsistent with applicable law or
otherwise impractical. Voluntary
consensus standards are technical
standards (e.g., materials specifications,
test methods, sampling procedures, and
business practices) that are developed or
adopted by voluntary consensus
standards bodies. The NTTAA directs
EPA to provide Congress, through OMB,
explanations when the Agency decides
not to use available and applicable
voluntary consensus standards. This
proposed rule does not involve
technical standards. Therefore, EPA did
not consider the use of any voluntary
consensus standards.
Class I substances in
group I
(in percent)
Control
period
2013 ..........
2014 ..........
2015 ..........
*
*
Class I substances in
group VI
(In percent)
0
0
0
*
*
80
80
0
*
[FR Doc. E6–13951 Filed 8–22–06; 8:45 am]
BILLING CODE 6560–50–P
DEPARTMENT OF TRANSPORTATION
Maritime Administration
46 CFR Part 296
[Docket No. MARAD–2006–23804]
RIN 2133–AB68
Maintenance and Repair
Reimbursement Pilot Program
Maritime Administration, DOT.
Notice of opening of reply
comment period.
AGENCY:
ACTION:
List of Subjects in 40 CFR Part 82
Environmental protection.
SUMMARY: The Maritime Administration
(MARAD) is amending its regulations
governing its pilot program for the
Dated: August 17, 2006.
reimbursement of costs of qualified
Stephen L. Johnson,
maintenance and repair (M&R) of
Administrator.
Maritime Security Program (MSP)
40 CFR part 82 is amended as follows: vessels performed in United States
shipyards. Under Public Law 109–163,
PART 82—PROTECTION OF
the Secretary of Transportation, acting
STRATOSPHERIC OZONE
through the Maritime Administrator, is
1. The authority citation for part 82
directed to implement regulations that,
continues to read as follows:
among other things, replace MARAD’s
voluntary M&R reimbursement program
Authority: 42 U.S.C. 7414, 7601, 7671–
with a mandatory system.
7671q.
The notice of proposed rulemaking for
2. Section 82.11 is amended by
this action was published in the Federal
revising paragraph (a)(3) to read as
Register on February 8, 2006 (71 FR
follows:
6438). Several of the comments received
argued that MARAD lacks authority to
§ 82.11 Exports of Class I controlled
substances to Article 5 Parties.
unilaterally add to existing MSP
agreements the added obligation on the
(a) * * *
(3) Phased Reduction Schedule for
part of the MSP contractor to enter into
Article 5 Allowances allocated in
an M&R Pilot Program agreement. In
§ 82.11. For each control period
order to have a full airing of this
specified in the following table, each
fundamental issue, MARAD is hereby
person is granted the specified
giving notice that we have decided to
percentage of the baseline Article 5
open a reply comment period for this
allowances apportioned under § 82.11.
rulemaking. Reply comments may
address the issue highlighted above or
Class I subClass I subany other issue raised in the original set
Control
stances in
stances in
of comments received in this docket.
period
group I
group VI
DATES: Reply comments are due
(in percent)
(In percent)
September 22, 2006.
2006 ..........
50
80
ADDRESSES: You may submit reply
2007 ..........
50
80
2008 ..........
50
80 comments [identified by DOT DMS
2009 ..........
50
80 Docket Number MARAD 2006–23804]
2010 ..........
0
80 by any of the following methods:
• Web site: https://dms.dot.gov.
2011 ..........
0
80
2012 ..........
0
80 Follow the instructions for submitting
PO 00000
Frm 00015
Fmt 4702
Sfmt 4702
E:\FR\FM\23AUP1.SGM
23AUP1
Agencies
[Federal Register Volume 71, Number 163 (Wednesday, August 23, 2006)]
[Proposed Rules]
[Pages 49395-49399]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-13951]
[[Page 49395]]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 82
[EPA-HQ-OAR-2005-0151, FRL-8212-5]
RIN 2060-AK45
Protection of Stratospheric Ozone: Adjusting Allowances for Class
I Substances for Export to Article 5 Countries
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice of proposed rulemaking.
-----------------------------------------------------------------------
SUMMARY: This proposed action amends previous action by the Agency
regarding the allocation of Article 5 allowances that permit production
of ozone-depleting substances (ODS) that are Class I, Group I
controlled substances solely for export to developing countries to meet
those countries' basic domestic needs. Specifically, this action will
remove the 2007-2009 phasedown step for companies that manufacture
CFCs-11, -12, or -114 for export to meet the basic domestic needs of
developing countries. The Agency is taking this action in response to
notification that there would otherwise be a shortfall in the
availability of pharmaceutical-grade CFCs for use in metered dose
inhalers in developing countries. In a final rule published December
29, 2005, EPA established initial baselines for each company that are
far more stringent than required under the Beijing Adjustments to the
Montreal Protocol on Substances that Deplete the Ozone Layer (the
Montreal Protocol), which set out restrictions for production to meet
basic domestic needs. Therefore, even without the 2007-2009 step-down
reduction, the U.S. will be at production levels to meet basic domestic
needs that are far below those allowed under the Beijing Adjustments.
This action is taken in accordance with the Montreal Protocol and the
Clean Air Act (CAA).
DATES: Written comments on the rule must be received on or before
September 22, 2006. Any party requesting a public hearing must notify
the contact person listed below by 5 p.m. eastern standard time on
August 28, 2006. If a hearing is requested it will be held on September
7, 2006 and comments will be due to the Agency October 10, 2006. EPA
will post information regarding a hearing, if one is requested, on the
Ozone Protection Web site https://www.epa.gov/ozone. Persons interested
in attending a public hearing should consult with the contact person
below regarding the location and time of the hearing.
ADDRESSES: Submit your comments, identified by Docket ID No. OAR-2005-
0151, by one of the following methods:
https://www.regulations.gov: follow the on-line
instructions for submitting comments.
E-mail: A-and-R-docket@epa.gov.
Fax: 202-566-1741.
Mail: Air Docket, Environmental Protection Agency,
Mailcode: 6102T, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
Hand Delivery or Courier. Deliver your comments to: EPA
Air Docket, EPA West, 1301 Constitution Avenue, NW., Room B108, Mail
Code 6102T, Washington, DC 20004. Such deliveries are only accepted
during the Docket's normal hours of operation, and special arrangements
should be made for deliveries of boxed information.
Instructions: Direct your comments to Docket ID No EPA-HQ-OAR-2005-
0151 EPA's policy is that all comments received will be included in the
public docket without change and may be made available online at http:/
/www.regulations.gov, including any personal information provided,
unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through www.regulations.gov or e-mail.
The https://www.regulations.gov Web site is an ``anonymous access''
system, which means EPA will not know your identity or contact
information unless you provide it in the body of your comment. If you
send an e-mail comment directly to EPA without going through
www.regulations.gov, your e-mail address will be automatically captured
and included as part of the comment that is placed in the public docket
and made available on the Internet. If you submit an electronic
comment, EPA recommends that you include your name and other contact
information in the body of your comment and with any disk or CD-ROM you
submit. If EPA cannot read your comment due to technical difficulties
and cannot contact you for clarification, EPA may not be able to
consider your comment. Electronic files should avoid the use of special
characters, any form of encryption, and be free of any defects or
viruses. For additional information about EPA's public docket visit the
EPA Docket Center homepage at https://www.epa.gov/epahome/dockets.htm.
Docket: All documents in the docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in www.regulations.gov or in hard copy at the Air Docket, EPA/DC, EPA
West, Room B102, 1301 Constitution Ave., NW., Washington, DC. This
Docket Facility 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: Cindy Axinn Newberg, EPA,
Stratospheric Protection Division, Office of Atmospheric Programs,
Office of Air and Radiation (6205J), 1200 Pennsylvania Avenue, NW.,
Washington, DC 20460, (202) 343-9729, newberg.cindy@epa.gov.
Table of Contents
I. What Is the Legislative and Regulatory Background of the Phaseout
Regulations for Ozone-Depleting Substances?
II. Today's Action
III. Statutory and Executive Order Reviews
A. Executive Order No. 12866: Regulatory Planning and Review
B. Paperwork Reduction Act
C. Regulatory Flexibility
D. Unfunded Mandates Reform Act
E. Executive Order No. 13132: Federalism
F. Executive Order No. 13175: Consultation and Coordination With
Indian Tribal Governments
G. Executive Order No. 13045: Protection of Children From
Environmental Health & Safety Risks
H. Executive Order No. 13211: Actions That Significantly Affect
Energy Supply, Distribution, or Use
I. National Technology Transfer Advancement Act
J. Congressional Review Act
I. What Is the Legislative and Regulatory Background of the Phaseout
Regulations for Ozone-Depleting Substances?
The current regulatory requirements of the Stratospheric Ozone
Protection Program that limit production and consumption of ozone-
depleting substances (ODSs) can be found at 40 CFR part 82, subpart A.
The regulatory program was originally published in the Federal Register
on August 12, 1988 (53 FR 30566), in response to the 1987 signing and
subsequent ratification of the Montreal Protocol on Substances that
Deplete the Ozone Layer (Montreal Protocol). The U.S. was one of the
original signatories to the 1987 Montreal Protocol and the U.S.
ratified the Protocol on April 21, 1988. Congress
[[Page 49396]]
then enacted, and President Bush signed into law, the Clean Air Act
Amendments of 1990 (CAAA of 1990), which included Title VI on
Stratospheric Ozone Protection, codified as 42 U.S.C. Chapter 85,
Subchapter VI, to ensure that the United States could satisfy its
obligations under the Montreal Protocol. EPA issued new regulations to
implement this legislation and has made several amendments to the
regulations since.
The requirements contained in the final rules published in the
Federal Register on December 20, 1994 (59 FR 65478) and May 10, 1995
(60 FR 24970) establish an Allowance Program. The Allowance Program and
its history are described in the notice of proposed rulemaking
published in the Federal Register on November 10, 1994 (59 FR 56276).
The control and the phaseout of the production and consumption of Class
I ODSs as required under the Protocol and the CAA are accomplished
through the Allowance Program.
In developing the Allowance Program, we collected information on
the amounts of ODSs produced, imported, exported, transformed and
destroyed within the U.S. for specific baseline years for specific
chemicals. This information was used to establish the U.S. production
and consumption ceilings for these chemicals. The data were also used
to assign company-specific production and import rights to companies
that were in most cases producing or importing during the specific year
of data collection. These production or import rights are called
``allowances.'' Due to the complete phaseout of many ODSs, the
quantities of allowances granted to companies for those chemicals were
gradually reduced and eventually eliminated. Production allowances and
consumption allowances no longer exist for any ODSs that are Class I
controlled substances. All production or consumption of Class I
controlled substances is prohibited under the Montreal Protocol and the
CAA, except for a few narrow exemptions.
In the context of the regulatory program, the use of the term
``consumption'' may be misleading. Consumption does not mean the
``use'' of a controlled substance, but rather is defined as the
formula: production + imports-exports, of controlled substances
(Article 1 of the Protocol and Section 601 of the CAA). Class I
controlled substances that were produced or imported through the
expenditure of allowances prior to their phaseout date may continue to
be used by industry and the public after their phaseout date except
where the regulations include explicit use restrictions. Use of such
substances may be subject to other regulatory limitations.
The specific names and chemical formulas for the Class I controlled
substances are in Appendix A and Appendix F in Subpart A of 40 CFR Part
82. The specific names and chemical formulas for the Class II
controlled substances are in Appendix B and Appendix F in Subpart A.
Although the regulations phased out the production and consumption
of Class I controlled substances, a very limited number of exemptions
exist, consistent with U.S. obligations under the Montreal Protocol.
The regulations allow for the manufacture of phased-out Class I
controlled substances provided the substances are either transformed or
destroyed. They also allow limited manufacture if the substances are
(1) exported to meet the basic domestic needs of countries operating
under Article 5 of the Montreal Protocol or (2) produced for essential
or critical uses as authorized by the Montreal Protocol and the
regulations. Limited exceptions to the ban on the import of phased-out
Class I controlled substances also exist if the substances are: (1)
Previously used, (2) imported for essential or critical uses as
authorized by the Montreal Protocol and the regulations, (3) imported
for destruction or transformation only, or (4) a transhipment or (5) a
heel (a small amount of controlled substance remaining in a container
after it is discharged or off-loaded) (40 CFR 82.4).
On December 29, 2005, EPA published a final rule in the Federal
Register (70 FR 77042) concerning production of specific Class I
controlled substances for export to meet the basic domestic needs of
developing countries (``Article 5'' countries). It established a new
Article 5 allowance baseline for Class I controlled substances,
established a schedule for phased reductions in such allowances, and
extended the time allowed for Article 5 production for methyl bromide.
Article 5 allowances are solely for production to meet the basic
domestic needs of developing countries referred to in the Protocol as
``Article 5'' parties. This action amends the schedule for phased
reductions in Article 5 allowances for companies that produce and
export Class I, Group I substances to meet the basic domestic needs of
Article 5 countries.
II. Today's Action
Under the Montreal Protocol, industrialized countries and
developing countries have different schedules for phasing out the
production and import of ODSs. Developing countries operating under
Article 5, paragraph 1 of the Montreal Protocol in most cases have
additional time in which to phase out ODSs. The Parties to the Montreal
Protocol recognized that it would be inadvisable for developing
countries to spend their scarce resources to build new ODS
manufacturing facilities to meet their basic domestic needs as
industrialized countries phase out. The Parties therefore decided to
permit a small amount of production in industrialized countries, in
addition to the amounts permitted under those countries' phaseout
schedules, for export to meet the basic domestic needs of developing
countries.
The adjustments to the Montreal Protocol adopted by the Parties at
their 11th meeting in Beijing required Parties that manufacture ODSs
for basic domestic needs to establish baselines for such production,
calculated based on the average quantity of the ODS exported to Article
5 countries over a specified range of years. The adjustments also
instituted a reduction schedule for Article 5 manufacture which
reflects the reduction schedule in place for developing country ODS
consumption. The Beijing Adjustments underscore the Parties' concern
that global oversupply of certain Class I ODSs is interfering with the
transition to alternatives. The oversupply of these ODSs results in low
prices that make it difficult for non-ozone-depleting alternatives to
compete in the marketplace. Businesses and individuals thus lack an
economic incentive to transition to alternatives. The Beijing baseline
calculation was designed to overcome this problem with respect to
Article 5 countries by reducing supply to those countries. The price of
these ODSs should rise to reflect the decrease in supply.
In response to the Beijing Adjustments, EPA published a final rule
in the Federal Register on December 29, 2005 (70 FR 77042). The Beijing
Adjustments to the Protocol, Article 2A, paragraphs 4-7 state that an
industrialized Party's allowable production of CFCs-11, -12, -113, -
114, and -115, referred to under the Clean Air Act as Class I, Group I
substances, to meet the basic domestic needs of Article 5 Parties shall
be measured against ``the annual average of its production of [these
substances] for basic domestic needs for the period 1995 to 1997
inclusive.'' EPA's December 29, 2005 action was far more stringent than
the requirements set forth in Beijing. The Agency established a
baseline for Class I, Group I substances
[[Page 49397]]
using the more recent export data from the years 2000-2003, years in
which there were far fewer exports. Therefore, instead of establishing
an aggregate baseline for Class I, Group I substances of 9,951 metric
tons--reflecting the 1995-1997 average called for by the Beijing
Adjustments--EPA's December 29, 2005 final rule established a more
stringent baseline of 345 metric tons, reflecting export data from
2000-2003, believing that more recent export data represented a truer
picture of the actual basic domestic needs for these chemicals in
developing countries and would thereby address the concerns regarding
global oversupply of CFCs.
After publication of the December 29, 2005 final rule, EPA was
informed that although there is a global oversupply of CFCs in general,
there are not sufficient supplies of pharmaceutical-grade CFCs
available for use in metered dose inhalers in developing countries.
Pharmaceutical-grade CFCs are more pure than a typical batch of CFCs
and have to meet stringent specifications set out by regulatory
authorities if they are to be used in medical devices. Developed
countries like the United States have already reached their phaseout
date for the production and consumption of CFCs. Under the Montreal
Protocol, once a Party has reached the phaseout date for CFCs it is
allowed to apply for an essential use exemption, which permits the
Party to consume limited amounts of CFCs for essential uses such as
certain metered dose inhalers. Developing countries do not phase out
their CFC consumption until 2010 and do not have access to an essential
use exemption until that time. Therefore, the Agency's previous
conclusion that there is an oversupply of CFCs was not correct with
regard to pharmaceutical-grade CFCs. Because the essential use
exemption will not be available to developing countries until 2010,
there is a need for developed countries to supply CFCs to meet this
demand between 2007 and 2009 under the provisions for basic domestic
needs identified in the Montreal Protocol and EPA regulations.
The number of facilities that are rated for pharmaceutical-grade
CFC production is limited. One company that owns such a facility in the
U.S. had previously sourced the developing country demand for
pharmaceutical-grade CFCs from a facility in Europe which, as of 2006,
is no longer in operation. Since EPA's December 29, 2005 final rule set
baselines for CFC production for basic domestic needs that are far
below the requirements of the Beijing Adjustments, the Agency could
allow for a moderate increase in the amount of CFC production to meet
domestic needs in order to make up the potential shortfall in
pharmaceutical-grade CFC production for developing countries, while
still exceeding compliance with the U.S.'s Montreal Protocol
obligations.
The Montreal Protocol encourages industrial rationalization to
minimize the number of sources that produce ozone-depleting substances.
The closure of plants in Europe and in developing countries as part of
their phase out plans is consistent with this environmental goal.
However, EPA recognizes the compelling public health rationale for
continued manufacture of certain CFC-containing metered dose inhalers
(MDIs). In fact, on April 11, 2006, EPA published a proposed rule in
the Federal Register to allow for the manufacture of CFCs for use in
metered dose inhalers in the United States for the year 2006, nearly
ten years after our phaseout of CFCs (71 FR 18262).
Therefore, the Agency is proposing to remove the next phasedown
step for companies that manufacture Class I, Group I substances from
the phaseout schedule for Article 5 allowances effective January 1,
2007. Since the Agency's December 29, 2005 final rule established very
low baselines for these substances, the U.S. will still exceed
compliance with the Beijing Adjustments even without a step-down to 15%
of baseline. A step-down to 15% of the baseline established by the
Beijing Adjustments (which is based on 1995-1997 export data) would
result in an allowable production level of 1,493 metric tons. By
comparison, EPA's proposed approach, which uses the more stringent
regulatory baseline based on 2000-2003 export data but maintains the
50% step-down level through 2009, results in an allowable production
level of only 173 metric tons.
As a result of the action described in this proposed rulemaking,
companies that manufacture Class I, Group I substances will have their
Article 5 production frozen at the 2006 reduction level of 50% of
baseline for the remaining years of the Article 5 reduction schedule,
specifically years 2007-2009. EPA reviewed data provided on the volume
of pharmaceutical-grade CFCs produced to meet basic domestic needs over
the years 2000-2005 and consulted with other governments to confirm
whether they did project a need for pharmaceutical-grade CFCs between
2007 and 2009. In removing the next step-down requirement from our
domestic regulation, EPA will allow companies to manufacture at their
2006 level, which will be sufficient to meet the need for
pharmaceutical-grade CFCs based on the data reviewed by the Agency.
III. Statutory and Executive Order Reviews
A. Executive Order No. 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.
B. Paperwork Reduction Act
This proposed action does not impose any new information collection
burden. However, the Office of Management and Budget (OMB) has
previously approved the information collection requirements contained
in the existing regulations, 40 CFR Part 82, under the provisions of
the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. and has assigned
OMB control number 2060-0170, EPA ICR number 1432. A copy of the OMB-
approved Information Collection Request (ICR) may be obtained from
Susan Auby, Collection Strategies Division; U.S. Environmental
Protection Agency (2822T); 1200 Pennsylvania Ave., NW., Washington, DC
20460 or by calling (202) 566-1672.
Burden means the total time, effort, or financial resources
expended by persons to generate, maintain, retain, or disclose or
provide information to or for a Federal agency. This includes the time
needed to review instructions; develop, acquire, install, and utilize
technology and systems for the purposes of collecting, validating, and
verifying information, processing and maintaining information, and
disclosing and providing information; adjust the existing ways to
comply with any previously applicable instructions and requirements;
train personnel to be able to respond to a collection of information;
search data sources; complete and review the collection of information;
and transmit or otherwise disclose the information.
An Agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid OMB control number. The OMB control numbers for EPA's
regulations are listed in 40 CFR Part 9 and 48 CFR Chapter 15.
C. Regulatory Flexibility Act
EPA has determined that it is not necessary to prepare a regulatory
flexibility analysis in connection with this proposed rule. For
purposes of assessing the impacts of today's rule on
[[Page 49398]]
small entities, small entity is defined as: (1) A small business that
is identified by the North American Industry Classification System
(NAICS) Code in the Table below; (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.
------------------------------------------------------------------------
SIC small
business size
standard (in
Category NAICS SIC code number of
code employees or
millions of
dollars)
------------------------------------------------------------------------
1. Chemical and Allied Products, 422690 5169 100
NEC............................
------------------------------------------------------------------------
After considering the economic impacts of this proposed rule on
small entities, EPA has concluded that this action will not have a
significant economic impact on a substantial number of small entities.
This proposed rule will not impose any requirements on small entities,
as it regulates large corporations that produce, import, or export
Class I controlled substances. There are no small entities in this
regulated industry.
D. Unfunded Mandates Reform Act
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public
Law 104-4, establishes requirements for Federal agencies to assess the
effects of their regulatory actions on State, local, and tribal
governments and the private sector. Under section 202 of the UMRA, EPA
generally must prepare a written statement, including a cost-benefit
analysis, for proposed and final rules with ``Federal mandates'' that
may result in expenditures to State, local, and tribal governments, in
the aggregate, or to the private sector, of $100 million or more in any
one year. Before promulgating an EPA rule for which a written statement
is needed, section 205 of the UMRA generally requires EPA to identify
and consider a reasonable number of regulatory alternatives and adopt
the least costly, most cost-effective, or least burdensome alternative
that achieves the objectives of the rule. The provisions of section 205
do not apply when they are inconsistent with applicable law. Moreover,
section 205 allows EPA to adopt an alternative other than the least
costly, most cost-effective, or least burdensome alternative if the
Administrator publishes with the final rule an explanation why that
alternative was not adopted. Before EPA establishes any regulatory
requirements that may significantly or uniquely affect small
governments, including tribal governments, it must have developed under
section 203 of the UMRA a small government agency plan. The plan must
provide for notifying potentially affected small governments, enabling
officials of affected small governments to have meaningful and timely
input in the development of EPA regulatory proposals with significant
Federal intergovernmental mandates, and informing, educating, and
advising small governments on compliance with the regulatory
requirements.
EPA has determined that this proposed rule does not contain a
Federal mandate that may result in expenditures of $100 million or more
for State, local, and tribal governments, in the aggregate, or the
private sector in any one year. Thus, today's rule is not subject to
the requirements of sections 202 and 205 of the UMRA. Further, EPA has
determined that this proposed rule contains no regulatory requirements
that might significantly or uniquely affect small governments because
it does not impose any requirements on any State, local, or tribal
government.
E. Executive Order No. 13132: Federalism
Executive Order 13132, entitled ``Federalism'' (64 FR 43255, August
10, 1999), requires EPA to develop an accountable process to ensure
``meaningful and timely input by State and local officials in the
development of regulatory policies that have federalism implications.''
``Policies that have federalism implications'' is defined in the
Executive Order to include regulations that have ``substantial direct
effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.''
This proposed rule does not have federalism implications. It will
not have substantial direct effects on the States, on the relationship
between the national government and the States, or on the distribution
of power and responsibilities among the various levels of government,
as specified in Executive Order 13132. This proposed rule is expected
to primarily affect producers and exporters of Class I, Group I
controlled substances. Thus, Executive Order 13132 does not apply to
this proposed rule.
F. Executive Order No. 13175: Consultation and Coordination With Indian
Tribal Governments
Executive Order No. 13175, entitled ``Consultation and Coordination
with Indian Tribal Governments'' (65 FR 67249, November 9, 2000),
requires EPA to develop an accountable process to ensure ``meaningful
and timely input by tribal officials in the development of regulatory
policies that have tribal implications.'' This proposed rule does not
have tribal implications, as specified in Executive Order No. 13175,
because it does not significantly or uniquely affect the communities of
Indian tribal governments. The proposed rule does not impose any
enforceable duties on communities of Indian tribal governments. Thus,
Executive Order No. 13175 does not apply to this proposed rule.
G. Executive Order No. 13045: Protection of Children From Environmental
Health & Safety Risks
Executive Order 13045: ``Protection of Children from Environmental
Health Risks and Safety Risks'' (62 FR 19885, April 23, 1997) applies
to any rule that: (1) Is determined to be ``economically significant''
under E.O. 12866, and (2) concerns an environmental health or safety
risk that EPA has reason to believe may have a disproportionate effect
on children. If the regulatory action meets both criteria, the Agency
must evaluate the environmental health or safety effects of the planned
rule on children, and explain why the planned regulation is preferable
to other potentially effective and reasonably feasible alternatives
considered by the Agency.
While this proposed rule is not subject to the Executive Order
because it is not economically significant as defined in E.O. 12866, we
nonetheless have reason to believe that the
[[Page 49399]]
environmental health or safety risk addressed by this action may have a
disproportionate effect on children. Depletion of stratospheric ozone
results in greater transmission of the sun's ultraviolet (UV) radiation
to the earth's surface. The following studies describe the effects on
children of excessive exposure to UV radiation: (1) Westerdahl J,
Olsson H, Ingvar C. ``At what age do sunburn episodes play a crucial
role for the development of malignant melanoma,'' Eur J Cancer 1994;
30A:1647-54; (2) Elwood JM, Jopson J. ``Melanoma and sun exposure: an
overview of published studies,'' Int J Cancer 1997; 73:198-203; (3)
Armstrong BK. ``Melanoma: childhood or lifelong sun exposure,'' In:
Grobb JJ, Stern RS, Mackie RM, Weinstock WA, eds. ``Epidemiology,
causes and prevention of skin diseases,'' 1st ed. London, England:
Blackwell Science, 1997:63-6; (4) Whiteman D., Green A. ``Melanoma and
Sunburn,'' Cancer Causes Control, 1994; 5:564-72; (5) Kricker A,
Armstrong, BK, English, DR, Heenan, PJ. ``Does intermittent sun
exposure cause basal cell carcinoma? A case control study in Western
Australia,'' Int J Cancer 1995; 60:489-94; (6) Gallagher, RP, Hill, GB,
Bajdik, CD, et al. ``Sunlight exposure, pigmentary factors, and risk of
nonmelanocytic skin cancer I, Basal cell carcinoma,'' Arch Dermatol
1995; 131:157-63; (7) Armstrong, BK. ``How sun exposure causes skin
cancer: an epidemiological perspective,'' Prevention of Skin Cancer.
2004; 89-116.
Allowing continuing U.S. production to meet developing countries'
basic domestic needs, including their need for pharmaceutical-grade
CFCs, avoids the need for those countries to install new ODS
manufacturing facilities. The amount of CFCs that will be released to
the atmosphere should remain the same regardless of the manufacturing
location. In addition, avoiding the installation of new capacity is one
means of ensuring that production levels continue to decline. Thus,
this proposed rule is not expected to increase the impacts on
children's health from stratospheric ozone depletion.
H. Executive Order No. 13211: Actions That Significantly Affect Energy
Supply, Distribution, or Use
This proposed rule is not a ``significant energy action'' as
defined in Executive Order No. 13211, ``Actions Concerning Regulations
That Significantly Affect Energy Supply, Distribution, or Use'' (66 FR
28355 (May 22, 2001)) because it is not a significant regulatory action
under Executive Order 12866.
I. National Technology Transfer Advancement Act
Section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (``NTTAA''), Public Law. 104-113, Section 12(d) (15 U.S.C.
272 note) directs EPA to use voluntary consensus standards in its
regulatory activities unless to do so would be inconsistent with
applicable law or otherwise impractical. Voluntary consensus standards
are technical standards (e.g., materials specifications, test methods,
sampling procedures, and business practices) that are developed or
adopted by voluntary consensus standards bodies. The NTTAA directs EPA
to provide Congress, through OMB, explanations when the Agency decides
not to use available and applicable voluntary consensus standards. This
proposed rule does not involve technical standards. Therefore, EPA did
not consider the use of any voluntary consensus standards.
List of Subjects in 40 CFR Part 82
Environmental protection.
Dated: August 17, 2006.
Stephen L. Johnson,
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.
2. Section 82.11 is amended by revising paragraph (a)(3) to read as
follows:
Sec. 82.11 Exports of Class I controlled substances to Article 5
Parties.
(a) * * *
(3) Phased Reduction Schedule for Article 5 Allowances allocated in
Sec. 82.11. For each control period specified in the following table,
each person is granted the specified percentage of the baseline Article
5 allowances apportioned under Sec. 82.11.
------------------------------------------------------------------------
Class I Class I
substances in substances in
Control period group I (in group VI (In
percent) percent)
------------------------------------------------------------------------
2006.................................... 50 80
2007.................................... 50 80
2008.................................... 50 80
2009.................................... 50 80
2010.................................... 0 80
2011.................................... 0 80
2012.................................... 0 80
2013.................................... 0 80
2014.................................... 0 80
2015.................................... 0 0
------------------------------------------------------------------------
* * * * *
[FR Doc. E6-13951 Filed 8-22-06; 8:45 am]
BILLING CODE 6560-50-P