Protection of Stratospheric Ozone: Extension of Global Laboratory and Analytical Use Exemption for Essential Class I Ozone Depleting Substances, 77048-77052 [05-24612]
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[FR Doc. 05–24606 Filed 12–28–05; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 82
[FRL–8016–7]
RIN 2060–AM56
Protection of Stratospheric Ozone:
Extension of Global Laboratory and
Analytical Use Exemption for Essential
Class I Ozone Depleting Substances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
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AGENCY:
SUMMARY: EPA is taking final action to
extend the global laboratory and
analytical use exemption for production
and import of class I ozone-depleting
substances from December 31, 2005, to
December 31, 2007, consistent with
recent actions by the Parties to the
Montreal Protocol on Substances that
Deplete the Ozone Layer. The
exemption allows persons in the United
States to produce and import controlled
substances for laboratory and analytical
uses that have not been already
identified by EPA as nonessential.
EFFECTIVE DATE: This final rule is
effective on January 1, 2006.
ADDRESSES: EPA has established a
docket for this action under Docket ID
No. OAR–2004–0064. All documents in
the docket are listed in the EDOCKET
index at https://www.epa.gov/edocket.
Although listed in the index, some
information is not publicly available,
i.e., 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 in
EDOCKET or in hard copy at the Air
Docket, EPA/DC, EPA West, Room
B102, 1301 Constitution Ave., NW.,
Washington, DC. This Docket Facility is
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open from 8:30 a.m. to 4:30 p.m.,
Monday through Friday, excluding legal
holidays. The Public Reading Room is
open from 8:30 a.m. to 4:30 p.m.,
Monday through Friday, excluding legal
holidays. The telephone number for the
Public Reading Room is (202) 566–1744,
and the telephone number for the Air
Docket is (202) 566–1742.
FOR FURTHER INFORMATION CONTACT:
Hodayah Finman, U.S. Environmental
Protection Agency, Office of Air and
Radiation, Stratospheric Protection
Division (6205J), 1200 Pennsylvania
Avenue, NW., Washington, DC 20460;
telephone number: (202) 343–9246; fax
numbers: (202) 343–2338;
finman.hodayah@epa.gov. You may also
visit the EPA’s Ozone Depletion Web
site at www.epa.gov/ozone for further
information about EPA’s Stratospheric
Ozone Protection regulations, the
science of ozone layer depletion, and
other related topics.
SUPPLEMENTARY INFORMATION: This final
rule concerns the exemption for
laboratory and analytical uses from CAA
restrictions on the consumption and
production of class I controlled
substances. In May 2005, EPA proposed
extending this exemption program from
December 31, 2005, to December 31,
2007, consistent with action taken by
the Parties to the Montreal Protocol (70
FR 25726, May 13, 2005). Today’s action
finalizes the proposed extension. In
addition, the Agency solicited comment
on clarifying the status of methyl
bromide, a class I controlled substance,
under the laboratory and analytical use
exemption program. EPA is deferring
final action on that aspect of the
proposed rule.
Section 553(d) of the Administrative
Procedure Act (APA), 5 U.S.C., Chapter
5, generally provides that rules may not
take effect earlier than 30 days after they
are published in the Federal Register.
Today’s final rule is issued under
section 307(d) of the CAA, which states:
‘‘The provisions of section 553 through
557 * * * of Title 5 shall not, except as
expressly provided in this subsection,
apply to actions to which this
subsection applies.’’ CAA section
307(d)(1). Thus, section 553(d) of the
APA does not apply to this rule. EPA
nevertheless is acting consistently with
the policies underlying APA section
553(d) in making this rule effective on
January 1, 2006 APA section 553(d)
provides an exception for any action
that grants or recognizes an exemption
or relieves a restriction. Today’s final
rule extends an exemption from the
phaseout of class I ozone-depleting
substances. Because the current
exemption expires at the end of 2005,
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EPA is making this rule effective
immediately to ensure that the
exemption will not lapse.
Table of Contents
I. Background on the Montreal Protocol and
the Global Laboratory and Analytical Use
Exemption
II. Extension of the Global Laboratory and
Analytical Use Exemption
III. Applicability of the Global Laboratory
and Analytical Use Exemption to Methyl
Bromide
IV. Statutory and Executive Order Reviews
A. Executive Order No. 12866: Regulatory
Planning and Review
B. Paperwork Reduction Act
C. Regulatory Flexibility Act
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. Background on the Montreal Protocol
and the Global Laboratory and
Analytical Use Exemption
The Montreal Protocol on Substances
that Deplete the Ozone Layer (Protocol)
is the international agreement to reduce
and eventually eliminate the production
and consumption 1 of all stratospheric
ozone-depleting substances (ODSs). The
elimination of production and
consumption of ODSs is accomplished
through adherence to phaseout
schedules for specific class I ODSs,2
including: chlorofluorocarbons (CFCs),
halons, carbon tetrachloride, and methyl
chloroform. The Clean Air Act, as
amended in 1990 and 1998, requires
EPA to promulgate regulations
implementing the Protocol’s phaseout
schedules in the United States. Those
regulations are codified at 40 CFR part
82. As of January 1, 1996, production
and import of most class I ODSs were
phased out in developed countries,
including the United States.
However, the Protocol provides
exemptions that allow for the continued
import and/or production of ODSs for
specific uses. Under the Protocol, for
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). Stockpiles
of class I ODSs produced or imported prior to the
1996 phaseout may be used for purposes not
expressly banned at 40 CFR part 82.
2 Class I ozone depleting substances are listed at
40 CFR part 82, subpart A, appendix A.
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most class I ODSs, the Parties may
collectively grant exemptions to the ban
on production and import of ODSs for
uses that they determine to be
‘‘essential.’’ For example, with respect
to CFCs, Article 2A(4) provides that the
phaseout will apply ‘‘save to the extent
that the Parties decide to permit the
level of production or consumption that
is necessary to satisfy uses agreed by
them to be essential.’’ Similar language
appears in the control provisions for
halons (Art. 2B), carbon tetrachloride
(Art. 2D), methyl chloroform (Art. 2E),
hydrobromochlorofluorocarbons (Art.
2G), and bromochloromethane (Art. 2I).
As defined by Decision IV/25 of the
Parties, use of a controlled substance is
essential only if (1) it is necessary for
the health, safety or is critical for the
functioning of society (encompassing
cultural and intellectual aspects), and
(2) there are no available technically
and economically feasible alternatives
or substitutes that are acceptable from
the standpoint of environment and
health.
Decision X/19 under the Protocol
(taken in 1998) allowed a general
exemption for essential laboratory and
analytical uses through December 31,
2005. EPA included this exemption in
our regulations at 40 CFR part 82,
subpart A. While the Clean Air Act does
not specifically provide for this
exemption, EPA determined that an
exemption for essential laboratory and
analytical uses was allowable under the
Act as a de minimis exemption. EPA
addressed the de minimis exemption in
the final rule of March 13, 2001 (66 FR
14760–14770).
Decision X/19 also asked the
Protocol’s Technology and Economic
Assessment Panel (TEAP), a group of
technical experts from member
countries, to report annually on
procedures that could be performed
without the use of controlled substances
and stated that at future meetings the
Parties would decide whether such
procedures should no longer be eligible
for exemptions. Based on the TEAP’s
recommendation, the Parties to the
Protocol decided in 1999 (Decision XI/
15) that the general exemption no longer
applied to the following uses: Testing of
oil and grease, and total petroleum
hydrocarbons in water; testing of tar in
road-paving materials; and forensic
finger-printing. EPA incorporated this
exclusion at Appendix G to Subpart A
of 40 CFR part 82 on February 11, 2002
(67 FR 6352).
Subsequently, in its May 2003
progress report the TEAP noted, ‘‘No
new non-ODS methods have been
forthcoming which would enable the
TEAP to recommend the elimination of
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further uses of controlled substances for
analytical and laboratory uses’’ (p. 106,
see Air Docket OAR–2004–0064). Based
on this statement, and in consideration
of the pending cessation of the
laboratory use exemption in 2005, the
European Community proposed an
extension of the exemption that would
allow further time for development of
non-ODS methods. At their fifteenth
Meeting in November 2003, the Parties
adopted the proposal in Decision XV/8,
which extended the global exemption
for laboratory and analytical uses to
December 31, 2007.
EPA’s regulations regarding this
exemption at 40 CFR 82.8(b) currently
state, ‘‘A global exemption for class I
controlled substances for essential
laboratory and analytical uses shall be
in effect through December 31, 2005
subject to the restrictions in appendix G
of this subpart, and subject to the
record-keeping and reporting
requirements at § 82.13(u) though (x).
There is no amount specified for this
exemption.’’ Because certain laboratory
procedures continue to require the use
of class I substances in the United
States, and because non-ODS
replacements for the class I substances
have not been identified for all uses,
EPA is revising 40 CFR 82.8(b) to reflect
the extension of the exemption to 2007
consistent with Decision XV/8. For a
more detailed discussion of the reasons
for the exemption, refer to the March 13,
2001, Federal Register notice.
II. Extension of the Global Laboratory
and Analytical Use Exemption
With today’s action, EPA is extending
the laboratory and analytical use
exemption from December 31, 2005, to
December 31, 2007. This exemption
allows for production and import of
certain ODSs to meet laboratory and
analytical needs.
EPA received three sets of comments
on the proposed rule (70 FR 25726), two
of which did not support extending the
exemption and one late comment which
did support extending the exemption.
One commenter indicated that as long
as there is an exemption program,
industry will not have an incentive to
seek alternatives. EPA believes that the
time-limited nature of the exemption
program, first through 2005 and now
through 2007, does provide industry
with an incentive to continue to explore
alternatives. The Agency notes that
many of the exempted uses are for niche
applications or for experimental work of
importance to society. For example,
some federal and state laws, including
regulations issued under the Clean Air
Act and the Clean Water Act, require
testing of the water, soil, or air to
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77049
measure compliance with
environmental standards. A pure
sample of an ODS may be necessary to
properly calibrate the testing equipment
and effectively monitor the presence of
chemicals of interest in the
environment. A fuller description of
laboratory and analytical uses may be
found in EPA’s 2001 rulemaking on the
topic (66 FR 14760) and in the
comments in the accompanying paper
docket #A–93–39.
Furthermore, EPA notes that total
consumption (defined as production
plus imports minus exports) for
laboratory uses is small relative to
baseline and has declined over time.
The amount of phased-out class I
substances being supplied to
laboratories under this exemption
decreased each year since 1997 to reach
the level of eight metric tons in 2001
(approximately one-quarter the amount
supplied in 1997), according to EPA’s
tracking system for ODSs.
Another commenter expressed
concern that the exemption would be
phased out ‘‘eventually’’ as described in
the proposal and suggested that the
exemption should last only another two
years. In today’s action, EPA is
extending the laboratory and analytical
use exemption by two years recognizing,
however, that after December 2007 there
still may be a need for this exemption.
Should the Parties to the Montreal
Protocol take a decision to further
extend the exemption beyond 2007,
EPA will seek comment on a new
timeframe for the exemption.
The commenter continues to express
concern that the exemption benefits
companies at the expense of children
and other members of the public. As
described above, this exemption
services the research and analytical
community who are often engaged in
work to protect the public. The
laboratory and analytical exemption was
agreed to by the Parties to the Montreal
Protocol in Decisions X/19 and XV/8 as
part of the careful balancing intrinsic in
any public policy discussion. As
discussed in the March 2001 notice, the
controls in place for laboratory and
analytical uses provide adequate
assurance that very little, if any,
environmental damage will result from
the handling and disposal of the small
amounts of class I ODSs used in such
applications. Therefore, EPA does not
anticipate significant environmental
impacts on the ozone layer as a result
of today’s action.
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III. Applicability of the Global
Laboratory and Analytical Use
Exemption to Methyl Bromide
As of January 1, 2005, production and
import of methyl bromide is no longer
allowed in the United States, except for
limited exemptions (40 CFR 82.4(d)).
Methyl bromide is a class I controlled
substance used chiefly as a fumigant for
soil treatment and pest control. In the
proposed rule, EPA sought comment on
whether the global laboratory exemption
should include methyl bromide and also
sought information on laboratory and
analytical processes that involve the use
of small quantities of methyl bromide.
EPA only received one comment and it
was general in nature. The commenter
indicated that she did not support any
exemptions for methyl bromide.
Recognizing that further discussion of
whether the global laboratory exemption
should include methyl bromide may
occur at a future meeting of the Parties
to the Montreal Protocol, EPA is
deferring final action on this aspect of
the proposed rule.
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IV. Statutory and Executive Order
Reviews
A. Executive Order 12866: Regulatory
Planning and Review
Under Executive Order 12866 (58 FR
51735 (October 4, 1993)), the Agency
must determine whether the regulatory
action is ‘‘significant’’ and therefore
subject to OMB review and the
requirements of the Executive Order.
The Order defines ‘‘significant
regulatory action’’ as one that is likely
to result in a rule that may: (1) Have an
annual effect on the economy of $100
million or more or adversely affect in a
material way the economy, a sector of
the economy, productivity, competition,
jobs, the environment, public health or
safety, or State, local, or tribal
governments or communities; (2) create
a serious inconsistency or otherwise
interfere with an action taken or
planned by another agency; (3)
materially alter the budgetary impact of
entitlements, grants, user fees, or loan
programs or the rights and obligations of
recipients thereof; or (4) raise novel
legal or policy issues arising out of legal
mandates, the President’s priorities, or
the principles set forth in the Executive
Order.
It has been determined that this rule
is not a ‘‘significant regulatory action’’
under the terms of Executive Order
12866 and is therefore not subject to
OMB review.
B. Paperwork Reduction Act
This action does not impose any new
information collection burden because
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EPA is not creating new information or
reporting requirements. However, the
Office of Management and Budget
(OMB) has previously approved the
information collection requirements
contained in the existing regulations, as
part of the final rule promulgated by the
Agency on May 10, 1995, 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 in 40
CFR are listed in 40 CFR part 9.
C. Regulatory Flexibility Act
EPA has determined that it is not
necessary to prepare a regulatory
flexibility analysis in connection with
this final rule.
For purposes of assessing the impact
of today’s rule on small entities, the
term small entities is defined as: (1) A
Pharmaceutical preparations
manufacturing business (NAICS code
325412); (2) a small governmental
jurisdiction that is a government of a
city, county, town, school district or
special district with a population of less
than 50,000; and (3) a small
organization that is any not-for-profit
enterprise which is independently
owned and operated and is not
dominant in its field.
After considering the economic
impacts of today’s final rule on small
entities, EPA has concluded that this
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action will not have a significant
economic impact on a substantial
number of small entities. In determining
whether a rule has a significant
economic impact on a substantial
number of small entities, the impact of
concern is any significant adverse
economic impact on small entities,
since the primary purpose of the
regulatory flexibility analyses is to
identify and address regulatory
alternatives ‘‘which minimize any
significant economic impact of the
proposed rule on small entities.’’ 5
U.S.C. 603 and 604. Thus, an agency
may conclude that a rule will not have
a significant economic impact on a
substantial number of small entities if
the rule relieves regulatory burden, or
otherwise has a positive economic effect
on all of the small entities subject to the
rule.’’
This rule provides an otherwise
unavailable benefit to those companies
that obtain ozone depleting substances
under the essential laboratory and
analytical use exemption. Today’s
action will extend the Global Laboratory
and Analytical Use Exemption (The Lab
Exemption) from its current expiration
date of December 31, 2005 to December
31, 2007. The Lab Exemption allows
companies to produce CFCs and other
Class I ozone depleting substances
(ODS), that are otherwise phased out,
for use of very small quantities of ODS
in laboratory settings. We have therefore
concluded that today’s final rule will
relieve regulatory burden for all small
entities.
D. Unfunded Mandates Reform Act
Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA), Public
Law 104–4, establishes requirements for
Federal agencies to assess the effects of
their regulatory actions on State, local,
and tribal governments and the private
sector. Under section 202 of the UMRA,
EPA generally must prepare a written
statement, including a cost-benefit
analysis, for proposed and final rules
with ‘‘Federal mandates’’ that may
result in expenditures to State, local,
and tribal governments, in the aggregate,
or to the private sector, of $100 million
or more in any one year. Before
promulgating an EPA rule for which a
written statement is needed, section 205
of the UMRA generally requires EPA to
identify and consider a reasonable
number of regulatory alternatives and
adopt the least costly, most 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
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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.
Today’s rule contains no Federal
mandates (under the regulatory
provisions of Title II of the UMRA) for
State, local, or tribal governments or the
private sector, since it merely extends
the availability of an already available
exemption to the ban on production and
import of class I ODSs. For the same
reason, EPA has determined that this
rule contains no regulatory
requirements that might significantly or
uniquely affect small governments.
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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 final rule does not have
federalism implications. It will not have
substantial direct effects on the States,
on the relationship between the national
government and the States, or on the
distribution of power and
responsibilities among the various
levels of government, as specified in
Executive Order 13132. Today’s rule
affects only the companies that produce
or import class I ozone-depleting
substances for laboratory or analytical
uses. Thus, Executive Order 13132 does
not apply to this rule.
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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 final rule does not
have tribal implications, as specified in
Executive Order No. 13175. Today’s
final rule does not significantly or
uniquely affect the communities of
Indian tribal governments. The final
rule does not impose any enforceable
duties on communities of Indian tribal
governments. Thus, Executive Order No.
13175 does not apply to this final rule.
G. Executive Order No. 13045:
Protection of Children From
Environmental Health & Safety Risks
Executive Order No. 13045:
‘‘Protection of Children from
Environmental Health Risks and Safety
Risks’’ (62 FR 19885, April 23, 1997)
applies to any rule that: (1) Is
determined to be ‘‘economically
significant’’ as defined under Executive
Order 12866, and (2) concerns an
environmental health 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 Executive Order 12866, we
nonetheless have reason to believe that
the 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,
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77051
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. The public is invited to submit or
identify peer-reviewed studies and data,
of which EPA may not be aware, that
assessed results of early life sun
exposure.
However, as discussed in the March
13, 2001, Federal Register notice, the
laboratory and analytical applications
addressed in today’s proposed rule
involve extremely controlled use and
disposal of all chemicals, including any
ODS. As a result, emissions of ODS into
the atmosphere are negligible. In light of
the conditions already applied to the
global exemption by appendix G to
subpart A of 40 CFR part 82, EPA
believes that any additional controls on
laboratory uses would provide little, if
any, benefit.
H. Executive Order No. 13211: Actions
That Significantly Affect Energy Supply,
Distribution, or Use
This 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
As noted in the proposed rule, section
12(d) of the National Technology
Transfer and Advancement Act of 1995
(‘‘NTTAA’’), Public Law. No. 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
E:\FR\FM\29DER1.SGM
29DER1
77052
Federal Register / Vol. 70, No. 249 / Thursday, December 29, 2005 / Rules and Regulations
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
action does not involve technical
standards. Therefore, EPA did not
consider the use of any voluntary
consensus standards.
J. Congressional Review Act
The Congressional Review Act, 5
U.S.C. 801 et seq., as added by the Small
Business Regulatory Enforcement
Fairness Act of 1996, generally provides
that before a rule may take effect, the
agency promulgating the rule must
submit a rule report, which includes a
copy of the rule, to each House of the
Congress and to the Comptroller General
of the United States. 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 is not a ‘‘major rule’’ as
defined by 5 U.S.C. 804(2). This rule
will be effective on January 1, 2006.
List of Subjects in 40 CFR Part 82
Environmental protection,
Administrative practice and procedures,
Air pollution control, Chemicals,
Exports, Imports, Ozone, Production,
Reporting and recordkeeping
requirements, Treaties.
Dated: December 22, 2005.
Stephen L. Johnson,
Administrator.
I
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:
I
Authority: 42 U.S.C. 7414, 7601, 7671–
7671q.
Subpart A—Production and
Consumption Controls
2. Section 82.8 is amended by revising
paragraph (b) to read as follows:
sroberts on PROD1PC70 with RULES
§ 82.8 Grant of essential use allowances
and critical use allowances.
*
*
*
*
*
(b) A global exemption for class I
controlled substances for essential
laboratory and analytical uses shall be
in effect through December 31, 2007,
subject to the restrictions in appendix G
19:06 Dec 28, 2005
On July
19, 2005, the Commission released
Telecommunications Relay Services and
Speech-to-Speech Services for
Individuals with Hearing and Speech
Disabilities, Order (Two-Line Captioned
Telephone Order), CG Docket No. 03–
123, FCC 05–141, which was published
in the Federal Register on September
14, 2005 (70 FR 54294), concluding that
two-line captioned telephone service is
a type of TRS eligible for compensation
from the Interstate TRS Fund, effective
Synopsis
In the Two-line Captioned Telephone
Order, the Commission concluded that
two-line captioned telephone service is
a form of TRS eligible for compensation
from the Fund. Two-line Captioned
Telephone Order, 20 FCC Rcd at 13199,
paragraph 10. See generally
Telecommunications Relay Services,
and Speech-to-Speech Services for
Individuals with Hearing and Speech
Disabilities, CC Docket No. 98–67,
Declaratory Ruling, 18 FCC Rcd 16121
[FR Doc. 05–24612 Filed 12–28–05; 8:45 am]
BILLING CODE 6560–50–P
FEDERAL COMMUNICATIONS
COMMISSION
47 CFR Part 64
[CG Docket No. 03–123; DA 05–3138]
Telecommunications Relay Services
and Speech-to-Speech Services for
Individuals With Hearing and Speech
Disabilities
Federal Communications
Commission.
ACTION: Final rule; approval of
allocation factor.
AGENCY:
SUPPLEMENTARY INFORMATION:
I
VerDate Aug<31>2005
SUMMARY: In this document, the
Commission adopts the Interstate
Telecommunications Relay Services
(TRS) Fund administrator’s (the
National Exchange Carrier Association,
Inc. (NECA)), proposed interstate
allocation factor of 11 percent for
determining the number of inbound
two-line captioned telephone minutes
compensable from the Interstate TRS
Fund. Also, in this document, the
Commission concludes that NECA
correctly calculated the factor as
directed by the Two-Line Captioned
Telephone Order. Therefore, the
Commission directs NECA to
compensate providers of inbound twoline captioned telephone calls from the
Interstate TRS Fund pursuant to the 11
percent interstate allocation factor
retroactively to the effective date of the
Two-Line Captioned Telephone Order.
DATES: Effective December 2, 2005.
FOR FURTHER INFORMATION CONTACT:
Thomas Chandler, Consumer &
Governmental Affairs Bureau, Disability
Rights Office at (202) 418–1475 (voice),
(202) 418–0597 (TTY), or e-mail at
Thomas.Chandler@fcc.gov.
October 14, 2005. On August 2, 2005,
NECA submitted a proposed interstate
allocation factor of 11 percent for
inbound two-line captioned telephone
minutes. This is a summary of the
Commission’s Order, DA 05–3138,
adopted December 1, 2005, released
December 2, 2005 in CG Docket 03–123,
adopting NECA’s proposed interstate
allocation factor of 11 percent and
directing NECA to compensate
providers of inbound two-line captioned
telephone calls from the Interstate TRS
Fund pursuant to the 11 percent
interstate allocation factor retroactively
for the period October 14, 2005 through
June 30, 2006. The Order does not
contain new or modified information
collections requirements subject to the
Paperwork Reduction Act of 1995
(PRA), Public Law 104–13. In addition,
it does not contain any new or modified
‘‘information collection burden for
small business concerns with fewer than
25 employees,’’ pursuant to the Small
Business Paperwork Relief Act of 2002,
Public Law 107–198, see 44 U.S.C. 3506
(c)(4). The full text of the Order and
copies of any subsequently filed
documents in this matter will be
available for public inspection and
copying during regular business hours
at the FCC Reference Information
Center, Portals II, 445 12th Street, SW.,
Room CY–A257, Washington, DC 20554.
The Order and copies of subsequently
filed documents in this matter may also
be purchased from the Commission’s
duplicating contractor at Portals II, 445
12th Street, SW., Room CY–B402,
Washington, DC 20554. Customers may
contact the Commission duplicating
contractor at their Web site https://
www.bcpiweb.com or call 1–800–378–
3160. To request materials in accessible
formats for people with disabilities
(Braille, large print, electronic files,
audio format), send an e-mail to
fcc504@fcc.gov or call the Consumer &
Governmental Affairs Bureau at (202)
418–0530 (voice), (202) 418–0432
(TTY). The Order can also be
downloaded in Word or Portable
Document Format (PDF) at: https://
www.fcc.gov/cgb/dro.
of this subpart, and subject to the record
keeping and reporting requirements at
§ 82.13(u) through (x). There is no
amount specified for this exemption.
*
*
*
*
*
Jkt 208001
PO 00000
Frm 00082
Fmt 4700
Sfmt 4700
E:\FR\FM\29DER1.SGM
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]]>Agencies
[Federal Register Volume 70, Number 249 (Thursday, December 29, 2005)]
[Rules and Regulations]
[Pages 77048-77052]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-24612]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 82
[FRL-8016-7]
RIN 2060-AM56
Protection of Stratospheric Ozone: Extension of Global Laboratory
and Analytical Use Exemption for Essential Class I Ozone Depleting
Substances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: EPA is taking final action to extend the global laboratory and
analytical use exemption for production and import of class I ozone-
depleting substances from December 31, 2005, to December 31, 2007,
consistent with recent actions by the Parties to the Montreal Protocol
on Substances that Deplete the Ozone Layer. The exemption allows
persons in the United States to produce and import controlled
substances for laboratory and analytical uses that have not been
already identified by EPA as nonessential.
EFFECTIVE DATE: This final rule is effective on January 1, 2006.
ADDRESSES: EPA has established a docket for this action under Docket ID
No. OAR-2004-0064. All documents in the docket are listed in the
EDOCKET index at https://www.epa.gov/edocket. Although listed in the
index, some information is not publicly available, i.e., 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 in
EDOCKET 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 Public Reading Room is open from 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding legal holidays. The telephone
number for the Public Reading Room is (202) 566-1744, and the telephone
number for the Air Docket is (202) 566-1742.
FOR FURTHER INFORMATION CONTACT: Hodayah Finman, U.S. Environmental
Protection Agency, Office of Air and Radiation, Stratospheric
Protection Division (6205J), 1200 Pennsylvania Avenue, NW., Washington,
DC 20460; telephone number: (202) 343-9246; fax numbers: (202) 343-
2338; finman.hodayah@epa.gov. You may also visit the EPA's Ozone
Depletion Web site at www.epa.gov/ozone for further information about
EPA's Stratospheric Ozone Protection regulations, the science of ozone
layer depletion, and other related topics.
SUPPLEMENTARY INFORMATION: This final rule concerns the exemption for
laboratory and analytical uses from CAA restrictions on the consumption
and production of class I controlled substances. In May 2005, EPA
proposed extending this exemption program from December 31, 2005, to
December 31, 2007, consistent with action taken by the Parties to the
Montreal Protocol (70 FR 25726, May 13, 2005). Today's action finalizes
the proposed extension. In addition, the Agency solicited comment on
clarifying the status of methyl bromide, a class I controlled
substance, under the laboratory and analytical use exemption program.
EPA is deferring final action on that aspect of the proposed rule.
Section 553(d) of the Administrative Procedure Act (APA), 5 U.S.C.,
Chapter 5, generally provides that rules may not take effect earlier
than 30 days after they are published in the Federal Register. Today's
final rule is issued under section 307(d) of the CAA, which states:
``The provisions of section 553 through 557 * * * of Title 5 shall not,
except as expressly provided in this subsection, apply to actions to
which this subsection applies.'' CAA section 307(d)(1). Thus, section
553(d) of the APA does not apply to this rule. EPA nevertheless is
acting consistently with the policies underlying APA section 553(d) in
making this rule effective on January 1, 2006 APA section 553(d)
provides an exception for any action that grants or recognizes an
exemption or relieves a restriction. Today's final rule extends an
exemption from the phaseout of class I ozone-depleting substances.
Because the current exemption expires at the end of 2005, EPA is making
this rule effective immediately to ensure that the exemption will not
lapse.
Table of Contents
I. Background on the Montreal Protocol and the Global Laboratory and
Analytical Use Exemption
II. Extension of the Global Laboratory and Analytical Use Exemption
III. Applicability of the Global Laboratory and Analytical Use
Exemption to Methyl Bromide
IV. Statutory and Executive Order Reviews
A. Executive Order No. 12866: Regulatory Planning and Review
B. Paperwork Reduction Act
C. Regulatory Flexibility Act
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. Background on the Montreal Protocol and the Global Laboratory and
Analytical Use Exemption
The Montreal Protocol on Substances that Deplete the Ozone Layer
(Protocol) is the international agreement to reduce and eventually
eliminate the production and consumption \1\ of all stratospheric
ozone-depleting substances (ODSs). The elimination of production and
consumption of ODSs is accomplished through adherence to phaseout
schedules for specific class I ODSs,\2\ including: chlorofluorocarbons
(CFCs), halons, carbon tetrachloride, and methyl chloroform. The Clean
Air Act, as amended in 1990 and 1998, requires EPA to promulgate
regulations implementing the Protocol's phaseout schedules in the
United States. Those regulations are codified at 40 CFR part 82. As of
January 1, 1996, production and import of most class I ODSs were phased
out in developed countries, including the United States.
---------------------------------------------------------------------------
\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). Stockpiles of
class I ODSs produced or imported prior to the 1996 phaseout may be
used for purposes not expressly banned at 40 CFR part 82.
\2\ Class I ozone depleting substances are listed at 40 CFR part
82, subpart A, appendix A.
---------------------------------------------------------------------------
However, the Protocol provides exemptions that allow for the
continued import and/or production of ODSs for specific uses. Under the
Protocol, for
[[Page 77049]]
most class I ODSs, the Parties may collectively grant exemptions to the
ban on production and import of ODSs for uses that they determine to be
``essential.'' For example, with respect to CFCs, Article 2A(4)
provides that the phaseout will apply ``save to the extent that the
Parties decide to permit the level of production or consumption that is
necessary to satisfy uses agreed by them to be essential.'' Similar
language appears in the control provisions for halons (Art. 2B), carbon
tetrachloride (Art. 2D), methyl chloroform (Art. 2E),
hydrobromochlorofluorocarbons (Art. 2G), and bromochloromethane (Art.
2I). As defined by Decision IV/25 of the Parties, use of a controlled
substance is essential only if (1) it is necessary for the health,
safety or is critical for the functioning of society (encompassing
cultural and intellectual aspects), and (2) there are no available
technically and economically feasible alternatives or substitutes that
are acceptable from the standpoint of environment and health.
Decision X/19 under the Protocol (taken in 1998) allowed a general
exemption for essential laboratory and analytical uses through December
31, 2005. EPA included this exemption in our regulations at 40 CFR part
82, subpart A. While the Clean Air Act does not specifically provide
for this exemption, EPA determined that an exemption for essential
laboratory and analytical uses was allowable under the Act as a de
minimis exemption. EPA addressed the de minimis exemption in the final
rule of March 13, 2001 (66 FR 14760-14770).
Decision X/19 also asked the Protocol's Technology and Economic
Assessment Panel (TEAP), a group of technical experts from member
countries, to report annually on procedures that could be performed
without the use of controlled substances and stated that at future
meetings the Parties would decide whether such procedures should no
longer be eligible for exemptions. Based on the TEAP's recommendation,
the Parties to the Protocol decided in 1999 (Decision XI/15) that the
general exemption no longer applied to the following uses: Testing of
oil and grease, and total petroleum hydrocarbons in water; testing of
tar in road-paving materials; and forensic finger-printing. EPA
incorporated this exclusion at Appendix G to Subpart A of 40 CFR part
82 on February 11, 2002 (67 FR 6352).
Subsequently, in its May 2003 progress report the TEAP noted, ``No
new non-ODS methods have been forthcoming which would enable the TEAP
to recommend the elimination of further uses of controlled substances
for analytical and laboratory uses'' (p. 106, see Air Docket OAR-2004-
0064). Based on this statement, and in consideration of the pending
cessation of the laboratory use exemption in 2005, the European
Community proposed an extension of the exemption that would allow
further time for development of non-ODS methods. At their fifteenth
Meeting in November 2003, the Parties adopted the proposal in Decision
XV/8, which extended the global exemption for laboratory and analytical
uses to December 31, 2007.
EPA's regulations regarding this exemption at 40 CFR 82.8(b)
currently state, ``A global exemption for class I controlled substances
for essential laboratory and analytical uses shall be in effect through
December 31, 2005 subject to the restrictions in appendix G of this
subpart, and subject to the record-keeping and reporting requirements
at Sec. 82.13(u) though (x). There is no amount specified for this
exemption.'' Because certain laboratory procedures continue to require
the use of class I substances in the United States, and because non-ODS
replacements for the class I substances have not been identified for
all uses, EPA is revising 40 CFR 82.8(b) to reflect the extension of
the exemption to 2007 consistent with Decision XV/8. For a more
detailed discussion of the reasons for the exemption, refer to the
March 13, 2001, Federal Register notice.
II. Extension of the Global Laboratory and Analytical Use Exemption
With today's action, EPA is extending the laboratory and analytical
use exemption from December 31, 2005, to December 31, 2007. This
exemption allows for production and import of certain ODSs to meet
laboratory and analytical needs.
EPA received three sets of comments on the proposed rule (70 FR
25726), two of which did not support extending the exemption and one
late comment which did support extending the exemption. One commenter
indicated that as long as there is an exemption program, industry will
not have an incentive to seek alternatives. EPA believes that the time-
limited nature of the exemption program, first through 2005 and now
through 2007, does provide industry with an incentive to continue to
explore alternatives. The Agency notes that many of the exempted uses
are for niche applications or for experimental work of importance to
society. For example, some federal and state laws, including
regulations issued under the Clean Air Act and the Clean Water Act,
require testing of the water, soil, or air to measure compliance with
environmental standards. A pure sample of an ODS may be necessary to
properly calibrate the testing equipment and effectively monitor the
presence of chemicals of interest in the environment. A fuller
description of laboratory and analytical uses may be found in EPA's
2001 rulemaking on the topic (66 FR 14760) and in the comments in the
accompanying paper docket A-93-39.
Furthermore, EPA notes that total consumption (defined as
production plus imports minus exports) for laboratory uses is small
relative to baseline and has declined over time. The amount of phased-
out class I substances being supplied to laboratories under this
exemption decreased each year since 1997 to reach the level of eight
metric tons in 2001 (approximately one-quarter the amount supplied in
1997), according to EPA's tracking system for ODSs.
Another commenter expressed concern that the exemption would be
phased out ``eventually'' as described in the proposal and suggested
that the exemption should last only another two years. In today's
action, EPA is extending the laboratory and analytical use exemption by
two years recognizing, however, that after December 2007 there still
may be a need for this exemption. Should the Parties to the Montreal
Protocol take a decision to further extend the exemption beyond 2007,
EPA will seek comment on a new timeframe for the exemption.
The commenter continues to express concern that the exemption
benefits companies at the expense of children and other members of the
public. As described above, this exemption services the research and
analytical community who are often engaged in work to protect the
public. The laboratory and analytical exemption was agreed to by the
Parties to the Montreal Protocol in Decisions X/19 and XV/8 as part of
the careful balancing intrinsic in any public policy discussion. As
discussed in the March 2001 notice, the controls in place for
laboratory and analytical uses provide adequate assurance that very
little, if any, environmental damage will result from the handling and
disposal of the small amounts of class I ODSs used in such
applications. Therefore, EPA does not anticipate significant
environmental impacts on the ozone layer as a result of today's action.
[[Page 77050]]
III. Applicability of the Global Laboratory and Analytical Use
Exemption to Methyl Bromide
As of January 1, 2005, production and import of methyl bromide is
no longer allowed in the United States, except for limited exemptions
(40 CFR 82.4(d)). Methyl bromide is a class I controlled substance used
chiefly as a fumigant for soil treatment and pest control. In the
proposed rule, EPA sought comment on whether the global laboratory
exemption should include methyl bromide and also sought information on
laboratory and analytical processes that involve the use of small
quantities of methyl bromide. EPA only received one comment and it was
general in nature. The commenter indicated that she did not support any
exemptions for methyl bromide. Recognizing that further discussion of
whether the global laboratory exemption should include methyl bromide
may occur at a future meeting of the Parties to the Montreal Protocol,
EPA is deferring final action on this aspect of the proposed rule.
IV. Statutory and Executive Order Reviews
A. Executive Order 12866: Regulatory Planning and Review
Under Executive Order 12866 (58 FR 51735 (October 4, 1993)), the
Agency must determine whether the regulatory action is ``significant''
and therefore subject to OMB review and the requirements of the
Executive Order. The Order defines ``significant regulatory action'' as
one that is likely to result in a rule that may: (1) Have an annual
effect on the economy of $100 million or more or adversely affect in a
material way the economy, a sector of the economy, productivity,
competition, jobs, the environment, public health or safety, or State,
local, or tribal governments or communities; (2) create a serious
inconsistency or otherwise interfere with an action taken or planned by
another agency; (3) materially alter the budgetary impact of
entitlements, grants, user fees, or loan programs or the rights and
obligations of recipients thereof; or (4) raise novel legal or policy
issues arising out of legal mandates, the President's priorities, or
the principles set forth in the Executive Order.
It has been determined that this rule is not a ``significant
regulatory action'' under the terms of Executive Order 12866 and is
therefore not subject to OMB review.
B. Paperwork Reduction Act
This action does not impose any new information collection burden
because EPA is not creating new information or reporting requirements.
However, the Office of Management and Budget (OMB) has previously
approved the information collection requirements contained in the
existing regulations, as part of the final rule promulgated by the
Agency on May 10, 1995, 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 in 40 CFR are listed in 40 CFR part 9.
C. Regulatory Flexibility Act
EPA has determined that it is not necessary to prepare a regulatory
flexibility analysis in connection with this final rule.
For purposes of assessing the impact of today's rule on small
entities, the term small entities is defined as: (1) A Pharmaceutical
preparations manufacturing business (NAICS code 325412); (2) a small
governmental jurisdiction that is a government of a city, county, town,
school district or special district with a population of less than
50,000; and (3) a small organization that is any not-for-profit
enterprise which is independently owned and operated and is not
dominant in its field.
After considering the economic impacts of today's final rule on
small entities, EPA has concluded that this action will not have a
significant economic impact on a substantial number of small entities.
In determining whether a rule has a significant economic impact on a
substantial number of small entities, the impact of concern is any
significant adverse economic impact on small entities, since the
primary purpose of the regulatory flexibility analyses is to identify
and address regulatory alternatives ``which minimize any significant
economic impact of the proposed rule on small entities.'' 5 U.S.C. 603
and 604. Thus, an agency may conclude that a rule will not have a
significant economic impact on a substantial number of small entities
if the rule relieves regulatory burden, or otherwise has a positive
economic effect on all of the small entities subject to the rule.''
This rule provides an otherwise unavailable benefit to those
companies that obtain ozone depleting substances under the essential
laboratory and analytical use exemption. Today's action will extend the
Global Laboratory and Analytical Use Exemption (The Lab Exemption) from
its current expiration date of December 31, 2005 to December 31, 2007.
The Lab Exemption allows companies to produce CFCs and other Class I
ozone depleting substances (ODS), that are otherwise phased out, for
use of very small quantities of ODS in laboratory settings. We have
therefore concluded that today's final rule will relieve regulatory
burden for all small entities.
D. Unfunded Mandates Reform Act
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public
Law 104-4, establishes requirements for Federal agencies to assess the
effects of their regulatory actions on State, local, and tribal
governments and the private sector. Under section 202 of the UMRA, EPA
generally must prepare a written statement, including a cost-benefit
analysis, for proposed and final rules with ``Federal mandates'' that
may result in expenditures to State, local, and tribal governments, in
the aggregate, or to the private sector, of $100 million or more in any
one year. Before promulgating an EPA rule for which a written statement
is needed, section 205 of the UMRA generally requires EPA to identify
and consider a reasonable number of regulatory alternatives and adopt
the least costly, most cost-effective or least burdensome alternative
that achieves the objectives of the rule. The provisions of section 205
do not apply when they are inconsistent with applicable law. Moreover,
section 205 allows EPA to adopt an alternative other
[[Page 77051]]
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.
Today's rule contains no Federal mandates (under the regulatory
provisions of Title II of the UMRA) for State, local, or tribal
governments or the private sector, since it merely extends the
availability of an already available exemption to the ban on production
and import of class I ODSs. For the same reason, EPA has determined
that this rule contains no regulatory requirements that might
significantly or uniquely affect small governments.
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 final rule does not have federalism implications. It will not
have substantial direct effects on the States, on the relationship
between the national government and the States, or on the distribution
of power and responsibilities among the various levels of government,
as specified in Executive Order 13132. Today's rule affects only the
companies that produce or import class I ozone-depleting substances for
laboratory or analytical uses. Thus, Executive Order 13132 does not
apply to this 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 final rule does not have
tribal implications, as specified in Executive Order No. 13175. Today's
final rule does not significantly or uniquely affect the communities of
Indian tribal governments. The final rule does not impose any
enforceable duties on communities of Indian tribal governments. Thus,
Executive Order No. 13175 does not apply to this final rule.
G. Executive Order No. 13045: Protection of Children From Environmental
Health & Safety Risks
Executive Order No. 13045: ``Protection of Children from
Environmental Health Risks and Safety Risks'' (62 FR 19885, April 23,
1997) applies to any rule that: (1) Is determined to be ``economically
significant'' as defined under Executive Order 12866, and (2) concerns
an environmental health 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 Executive
Order 12866, we nonetheless have reason to believe that the
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. The public is invited to submit or identify
peer-reviewed studies and data, of which EPA may not be aware, that
assessed results of early life sun exposure.
However, as discussed in the March 13, 2001, Federal Register
notice, the laboratory and analytical applications addressed in today's
proposed rule involve extremely controlled use and disposal of all
chemicals, including any ODS. As a result, emissions of ODS into the
atmosphere are negligible. In light of the conditions already applied
to the global exemption by appendix G to subpart A of 40 CFR part 82,
EPA believes that any additional controls on laboratory uses would
provide little, if any, benefit.
H. Executive Order No. 13211: Actions That Significantly Affect Energy
Supply, Distribution, or Use
This 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
As noted in the proposed rule, section 12(d) of the National
Technology Transfer and Advancement Act of 1995 (``NTTAA''), Public
Law. No. 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
[[Page 77052]]
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
action does not involve technical standards. Therefore, EPA did not
consider the use of any voluntary consensus standards.
J. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. 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 is not a ``major rule'' as defined by 5 U.S.C.
804(2). This rule will be effective on January 1, 2006.
List of Subjects in 40 CFR Part 82
Environmental protection, Administrative practice and procedures,
Air pollution control, Chemicals, Exports, Imports, Ozone, Production,
Reporting and recordkeeping requirements, Treaties.
Dated: December 22, 2005.
Stephen L. Johnson,
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 paragraph (b) to read as
follows:
Sec. 82.8 Grant of essential use allowances and critical use
allowances.
* * * * *
(b) A global exemption for class I controlled substances for
essential laboratory and analytical uses shall be in effect through
December 31, 2007, subject to the restrictions in appendix G of this
subpart, and subject to the record keeping and reporting requirements
at Sec. 82.13(u) through (x). There is no amount specified for this
exemption.
* * * * *
[FR Doc. 05-24612 Filed 12-28-05; 8:45 am]
BILLING CODE 6560-50-P
