Protection of Stratospheric Ozone: Extension of Global Laboratory and Analytical Use Exemption for Essential Class I Ozone-Depleting Substances, 73264-73269 [E7-25091]
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Federal Register / Vol. 72, No. 247 / Thursday, December 27, 2007 / Rules and Regulations
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 82
[EPA–HQ–OAR–2007–0384; FRL–8510–9 ]
RIN 2060–AO28
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 the
production and import of class I ozonedepleting substances through December
31, 2011, consistent with the 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. The final rule also extends
the applicability of the global laboratory
and analytical use exemption to the
production and import of methyl
bromide for specific laboratory uses.
Finally, this action eliminates the
testing of organic matter in coal from the
global laboratory and analytical use
exemption.
DATES: This final rule is effective on
December 27, 2007.
ADDRESSES: EPA has established a
docket for this action identified under
Docket ID No. EPA–HQ–OAR–2007–
0384. All documents in the docket are
listed on the https://www.regulations.gov
site. 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, is not placed on
the Internet and will be publicly
available only in hard copy form.
Publicly available docket materials are
available only through
www.regulations.gov or in hard copy. To
obtain copies of materials in hard copy,
please call the EPA Docket Center at
(202) 564–1744 between the hours of
8:30 a.m.–4:30 p.m. E.S.T., Monday–
Friday, excluding legal holidays, to
schedule an appointment. The EPA
Docket Center’s Public Reading Room
address is EPA/DC, EPA West, Room
3334, 1301 Constitution Ave., NW.,
Washington, DC 20004.
FOR FURTHER INFORMATION CONTACT:
Staci Gatica by regular mail: U.S.
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Environmental Protection Agency,
Stratospheric Protection Division
(6205J), 1200 Pennsylvania Avenue,
NW., Washington, DC, 20460; by courier
service or overnight express: 1301 L
Street, NW., Washington DC 20005,
Workstation 1047B, by telephone: 202–
343–9469; or by e-mail:
gatica.staci@epa.gov. You may also visit
the EPA’s Ozone Depletion Web site at
www.epa.gov/ozone/strathome.html for
further information about EPA’s
Stratospheric Ozone Protection
regulations, the science of ozone layer
depletion, and other related topics.
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. EPA
is issuing this final rule under section
307(d) of the Clean Air Act, which
states: ‘‘The provisions of section 553
through 557 * * * of Title 5 shall not,
except as expressly provided in this
section, 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 is
nevertheless acting consistently with
the policies underlying APA section
553(d) in making this rule effective on
January 1, 2008. APA section 553(d)
authorizes an earlier effective date ‘‘as
otherwise provided by the agency upon
good cause found and published with
the rule.’’ Because, absent today’s
action, the exemption from the phaseout
of Class I substances used for laboratory
and analytical uses will expire as of the
end of 2007, it is important to assure
that today’s action will take effect at the
beginning of 2008.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Background on the Montreal Protocol and
the Global Laboratory and Analytical Use
Exemption
II. This Action
A. Extension of the Global Laboratory and
Analytical Use Exemption
B. Applicability of the Global Laboratory
and Analytical Use Exemption to Methyl
Bromide
C. Eliminating the Testing of Organic
Matter in Coal From the Global
Exemption for Laboratory and Analytical
Use
D. Minor Technical Corrections
III. Statutory and Executive Order Reviews
A. Executive Order 12866: Regulatory
Planning and Review
B. Paperwork Reduction Act
C. Regulatory Flexibility Act
D. Unfunded Mandates Reform Act
E. Executive Order 13132: Federalism
F. Executive Order 13175: Consultation
and Coordination With Indian Tribal
Governments
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G. Executive Order 13045: Protection of
Children from Environmental Health
Risks and Safety Risks
H. Executive Order 13211: Actions that
Significantly Affect Energy Supply,
Distribution, or Use
I. National Technology Transfer and
Advancement Act
J. Executive Order 12898: Federal Actions
to Address Environmental Justice in
Minority Populations and Low-Income
Populations
K. Congressional Review Act
I. Background on the Montreal Protocol
and the Global Laboratory and
Analytical Use Exemption
The Montreal Protocol on Substances
that Deplete the Ozone Layer (Montreal
Protocol) is the international agreement
to reduce and eventually eliminate the
production and consumption 1 of all
ozone-depleting substances (ODSs). The
elimination of production and
consumption of ODSs has been
accomplished through adherence to
phaseout schedules for specific ODSs.
Section 604 of the Clean Air Act, as
amended in 1990 and 1998, requires
EPA to promulgate regulations
implementing the Montreal Protocol’s
phaseout schedules in the United States.
Those regulations are codified at 40 CFR
Part 82, Subpart A. As of January 1,
1996, production and import of most
class I ODSs—including
chlorofluorocarbons (CFCs), halons,
carbon tetrachloride, and methyl
chloroform 2—were phased out in
developed countries, including the
United States.
However, the Montreal Protocol
provides exemptions that allow for the
continued import and/or production of
ODSs for specific uses. Under the
Montreal Protocol, for 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),
hydrobromofluorocarbons (Art. 2G), and
chlorobromomethane (Art. 2I). As
defined by Decision IV/25 of the Parties,
1 ‘‘Consumption’’ is defined as the amount of a
substance produced in the United States, plus the
amount imported into the United States, minus the
amount exported to Parties to the Montreal Protocol
(see Section 601(6) of the Clean Air Act).
2 Class I ozone depleting substances are listed at
40 CFR Part 82, Subpart A, Appendix A.
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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 (taken in 1998) allowed
a general exemption for essential
laboratory and analytical uses through
December 31, 2005. EPA codified this
exemption 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 requested the
Montreal Protocol’s Technology and
Economic Assessment Panel (TEAP), a
group of technical experts from various
Parties, to report annually to the Parties
to the Montreal Protocol on procedures
that could be performed without the use
of controlled substances. It further
stated that at future Meetings of the
Parties (MOPs), the Parties would
decide whether such procedures should
no longer be eligible for exemptions.
Based on the TEAP’s recommendation,
the Parties to the Montreal 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).
At the 18th MOP the Parties
acknowledged the need for methyl
bromide for laboratory and analytical
procedures, and added methyl bromide
to the approved ODSs under the
essential laboratory and analytical use
exemption. Decision XVIII/15 outlines
specific uses and exclusions for methyl
bromide under the exemption. Section
II. B of this preamble provides further
discussion of the inclusion of methyl
bromide in the essential laboratory and
analytical use exemption.
Most recently in September 2007, at
the 19th MOP, the Parties in Decision
XIX/18 extended the global laboratory
and analytical use exemption through
December 31, 2011. Decision XIX/18
also eliminates the testing of organic
matter in coal from the global
exemption for laboratory and analytical
uses of controlled substances and
requests the Technology and Economic
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Assessment Panel (TEAP) and its
Chemical Technical Options Committee
(CTOC) to provide, by the Twenty-first
Meeting of the Parties, a list of
laboratory analytical uses of ozonedepleting substances, indicating those
for which alternatives exist and
therefore no longer need exemption for
use of class I ODS (p. 43, Air Docket
EPA–HQ–OAR–2007–0384).
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, 2007
subject to the restrictions in appendix G
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.’’
Because certain laboratory procedures
continue to require the use of class I
substances in the United States, because
non-ODS replacements for the class I
substances have not been identified for
all uses, and because the Parties, via
Decision XIX/18, extended this
exemption through December 31, 2011,
EPA is revising 40 CFR 82.8(b) to reflect
the extension of the exemption to
December 31, 2011. For a more detailed
discussion of the reasons for the
exemption, refer to the March 13, 2001,
final rule (66 FR 14760). As discussed
in the March 2001 rule, 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 ODS used
in such applications. In addition, the
2006 CTOC Assessment Report shows a
general decrease from 2002 through
2005 in the amount of phased-out class
I substances being supplied to
laboratories under this exemption (p.
33, EPA–HQ–OAR–2007–0384).
EPA proposed to extend the date
through December 31, 2015 but clearly
explained that at the time the proposed
rule was issued the Parties had not yet
taken a decision regarding extension of
the global laboratory and analytical use
exemption and that the final rule would
reflect the date decided by the Parties at
the 18th MOP.
II. This Action
Today, EPA takes final action to (1)
extend the laboratory and analytical use
exemption from December 31, 2007, to
December 31, 2011, for specific
laboratory uses, (2) apply the laboratory
and analytical use exemption to the
production and import of methyl
bromide, (3) eliminate the testing of
organic matter in coal from the
laboratory and analytical use
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exemption, and (4) make technical
corrections to regulatory text.
A. Extension of the Global Laboratory
and Analytical Use Exemption
EPA received three comments on the
proposed rule (72 FR 52332). Two
comments supported the proposal. A
third commenter provided general
comments stating that chemicals that
deplete the ozone should not be used
any longer and questioned whether any
use of such chemicals is essential. As
discussed above, the Montreal Protocol
specifically provides for exemptions for
essential uses, and Decisions of the
Parties—including Decision XIX/18
taken in 2007, specifically provide for
an exemption for global laboratory and
analytical uses. EPA notes that uses
addressed under this exemption are
typically 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 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 March 2001 final rule
(66 FR 14760).
B. Applicability of the Global Laboratory
and Analytical Use Exemption to
Methyl Bromide
As of January 1, 2005, production and
import of methyl bromide has been
phased out 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. EPA
created a system of allowances to permit
continued production and import of
methyl bromide for critical uses after
January 1, 2005 (see 69 FR 76982,
December 23, 2004). This critical use
exemption does not include provisions
for continued production of methyl
bromide to supply laboratories.
However, the phaseout of methyl
bromide production and import does
not currently restrict inventories of
methyl bromide produced prior to
January 1, 2005, from being used for
laboratory and analytical applications,
as described in the December 23, 2004
final rule.
Methyl bromide (also known as
bromomethane) has laboratory uses, for
example, as a chemical intermediate
and methylating agent. EPA regulations
allow for methyl bromide to be
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produced after the January 1, 2005,
phaseout date if production is covered
by ‘‘unexpended critical use
allowances’’ (40 CFR 82.4(b)(1)). The
regulations also provide for a ‘‘global
exemption for class I controlled
substances for essential laboratory and
analytical uses,’’ subject to the
restrictions in Appendix G (40 CFR
82.4(n)(1)(iii), 82.8(b)). EPA did not
address the issue of whether the lab use
exemption should apply to methyl
bromide when promulgating the initial
exemption, but EPA did propose to
include methyl bromide in the 2005
rulemaking that extended the exemption
through December 31, 2007 (see 70 FR
25727). EPA received one comment on
the proposed inclusion of methyl
bromide and it was general in nature.
Nonetheless, EPA recognized that
further discussion of whether the global
laboratory exemption should include
methyl bromide might occur at a future
MOP and deferred final action on the
issue.
In November of 2006, during the 18th
Meeting of the Parties to the Montreal
Protocol, the Parties included methyl
bromide in the essential laboratory and
analytical use exemption via Decision
XVIII/15. Specifically, Decision XVIII/
15 allows methyl bromide to be used:
(1) As a reference or standard (a) to
calibrate equipment which uses methyl
bromide; (b) to monitor methyl bromide
emission levels; (c) to determine methyl
bromide residue levels in goods, plants,
and commodities; (2) in laboratory
toxicological studies; (3) to compare the
efficacy of methyl bromide and its
alternatives inside a laboratory; and (4)
as a laboratory agent which is destroyed
in a chemical reaction in the manner of
feedstock. Furthermore, Decision XVIII/
15 specifically notes that the Montreal
Protocol’s technical review bodies were
not in favor of classifying field trials
using methyl bromide as essential
laboratory and analytical uses and
indicates that Parties wishing to carry
out such field trials could submit
critical use nominations for that
purpose (p. 43, EPA–HQ–OAR–2007–
0384).
EPA sought comment on whether the
global laboratory and analytical use
exemption should specifically include
methyl bromide. The three comments
received were general in nature and did
not discuss methyl bromide specifically.
Because EPA did not receive any
adverse comment regarding the
inclusion of methyl bromide in the
laboratory and analytical use
exemption, the Agency is extending the
exemption to the methyl bromide uses
listed in the proposed rule.
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C. Eliminating the Testing of Organic
Matter in Coal From the Global
Exemption for Laboratory and
Analytical Use
Decision X/19, paragraph 2, requests
the Technology and Economic
Assessment Panel (TEAP), a group of
technical experts from various Parties,
to report annually on the development
and availability of laboratory and
analytical procedures that can be
performed without using class I
controlled substances and that Parties,
in subsequent decisions, would decide
whether such procedures would no
longer be eligible for exemptions.
Decision XIX/18 eliminates the testing
of organic matter in coal from the global
laboratory and analytical use
exemption.
In the proposed rule, EPA indicated
its overall intention to mirror in this
final rule, the decisions taken at the
19th MOP in September of 2007.
Therefore, this action eliminates the
testing of organic matter in coal from the
global laboratory and analytical use
exemption. EPA highly regards
technical recommendations made by the
TEAP and routinely amends domestic
regulations to mirror decisions taken by
the Parties based on TEAP
recommendations.
D. Minor Technical Corrections
EPA proposed to revise three
paragraphs in the reporting
requirements at 40 CFR 82.13 to correct
two sets of minor typographical errors.
EPA received no specific comments on
these corrections, and is finalizing them
today.
The first set addresses incorrect
paragraph references. Under 40 CFR
82.13(v), distributors of laboratory
supplies who purchased controlled
substances under the essential global
laboratory and analytical use exemption
must report on a quarterly basis the
quantity of each controlled substance
purchased by each laboratory customer
whose certification was previously
provided to the distributor, and refers to
the provisions of paragraph (y). The
reference to paragraph (y) is erroneous
and should instead be a reference to
paragraph (w), which describes annual
certifications provided by laboratory
customers. Paragraph (v) also refers to
§ 82.4(z), but should actually reference
§ 82.13(x).
Similarly, § 82.13(x) (applicable to
distributors who only sell controlled
substances as reference standards for
calibrating laboratory analytical
equipment) incorrectly refers to
paragraph (y) and should instead refer
to paragraph (w). Further, the reference
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to reports required under paragraph (x)
should be corrected to refer to reports
required under (v).
The second set of corrections
addresses the inaccurate terminology
that is used to refer to the essential
laboratory and analytical use
exemption. In § 82.13(v), (w), and (x),
the exemption is referred to as the
‘‘global laboratory essential-use
exemption.’’ This is not consistent with
the rest of the regulation. EPA is
replacing the reference to ‘‘global
laboratory essential-use exemption’’
with the term ‘‘global essential
laboratory and analytical use
exemption,’’ in § 82.13(v), (w), and (x).
EPA received no specific comments on
these corrections.
III. Statutory and Executive Order
Reviews
A. Executive Order 12866: Regulatory
Planning and Review
This final 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 final action does not propose any
new information collection burden. The
recordkeeping and reporting
requirements included in this action are
already included in an existing
information collection burden analysis
and this action does not propose any
changes that would affect the burden.
The Office of Management and Budget
(OMB) has previously approved the
information collection requirements
contained in the existing regulations at
40 CFR 82.8(a) under the provisions of
the Paperwork Reduction Act, 44 U.S.C.
3501, et seq. and has assigned OMB
control number 2060–0170, EPA ICR
number 1432.25. 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
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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 part 82 are listed in 40 CFR part 9.
C. Regulatory Flexibility Act
The RFA generally requires an agency
to prepare a regulatory flexibility
analysis of any rule subject to notice
and comment rulemaking requirements
under the Administrative Procedure Act
or any other statute unless the agency
certifies that the rule will not have a
significant economic impact on a
substantial number of small entities.
Small entities include small businesses,
small organizations, and small
governmental jurisdictions.
For purposes of assessing the impact
of today’s final rule on small entities,
small entity is defined as: (1)
Pharmaceutical preparations
manufacturing businesses (NAICS code
325412) that have less than 750
employees; (2) a small governmental
jurisdiction that is a government of a
city, county, town, school district or
special district with a population of less
than 50,000; and (3) a small
organization that is any not-for-profit
enterprise which is independently
owned and operated and is not
dominant in its field.
After considering the economic
impacts of today’s final rule on small
entities, I certify that this action will not
have a significant economic impact on
a substantial number of small entities.
In determining whether a rule has a
significant economic impact on a
substantial number of small entities, the
impact of concern is any significant
adverse economic impact on small
entities, since the primary purpose of
the regulatory flexibility analyses is to
identify and address regulatory
alternatives ‘‘which minimize any
significant economic impact of the rule
on small entities.’’ 5 U.S.C. 603 and 604.
Thus, an agency may certify that a rule
will not have a significant economic
impact on a substantial number of small
entities if the rule relieves regulatory
burden, or otherwise has a positive
economic effect on all of the small
entities subject to the rule.
This action provides an otherwise
unavailable benefit to those companies
that obtain ozone-depleting substances
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under the essential laboratory and
analytical use exemption. Therefore
today’s action will relieve regulatory
burden for all small entities.
D. Unfunded Mandates Reform Act
Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA), Pub.L.
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 a small government
agency plan under section 203 of the
UMRA. 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 final 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 provides
an essential laboratory and analytical
use exemption from the 1996 and 2005
phaseouts of class I ODSs (including
methyl bromide). Similarly, EPA has
determined that this rule contains no
regulatory requirements that might
significantly or uniquely affect small
governments, because this rule merely
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73267
extends the essential laboratory and
analytical use exemption.
E. Executive Order 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. Thus, Executive
Order 13132 does not apply to this rule.
F. Executive Order 13175: Consultation
and Coordination With Indian Tribal
Governments
Executive Order 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 13175 as it merely
provides an essential laboratory and
analytical use exemption from the 1996
and 2005 phaseouts of class I ODSs
(including methyl bromide). Thus,
Executive Order 13175 does not apply
to this rule.
G. Executive Order 13045: Protection of
Children From Environmental Health
Risks and 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
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regulation is preferable to other
potentially effective and reasonably
feasible alternatives considered by the
Agency.
EPA interprets E.O. 13045 as applying
only to those regulatory actions that are
based on health or safety risks, such as
the analysis required under section 5–
501 of the Order has the potential to
influence the regulation. This final rule
is not subject to E.O. 13045 as it merely
provides an essential laboratory and
analytical use exemption from the 1996
and 2005 phaseouts of class I ODSs
(including methyl bromide).
H. Executive Order 13211: Actions That
Significantly Affect Energy Supply,
Distribution, or Use
This final rule is not subject to
Executive Order 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. The rule merely provides an
essential laboratory and analytical use
exemption from the 1996 and 2005
phaseouts of class I ODSs (including
methyl bromide).
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I. National Technology Transfer and
Advancement Act
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 by voluntary consensus
standards bodies. The NTTAA directs
EPA to provide Congress, through OMB,
explanations when the Agency decides
not to use available and applicable
voluntary consensus standards. This
final rule does not involve technical
standards. Therefore, EPA did not
consider the use of any voluntary
consensus standards.
J. Executive Order 12898: Federal
Actions To Address Environmental
Justice in Minority Populations and
Low-Income Populations
Executive Order (EO) 12898 (59 FR
7629 (Feb. 16, 1994)) establishes federal
executive policy on environmental
justice. Its main provision directs
federal agencies, to the greatest extent
practicable and permitted by law, to
make environmental justice part of their
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mission by identifying and addressing,
as appropriate, disproportionately high
and adverse human health or
environmental effects of their programs,
policies, and activities on minority
populations and low-income
populations in the United States.
EPA has determined that this final
rule will not have disproportionately
high and adverse human health or
environmental effects on minority or
low-income populations because it does
not affect the level of protection
provided to human health or the
environment. The controls in place for
laboratory and analytical uses provide
adequate assurance that very little, if
any, environmental impact will result
from the handling and disposal of the
small amounts of class I ODS used in
such applications.
Furthermore, the 2006 CTOC
Assessment Report shows a general
decrease from 2002 through 2005 in the
amount of phased-out class I substances
being supplied to laboratories under this
exemption.
K. Congressional Review Act
The Congressional Review Act, 5
U.S.C. 801, et seq., as added by the
Small Business Regulatory Enforcement
Fairness Act of 1996, generally provides
that before a rule may take effect, the
agency promulgating the rule must
submit a rule report, which includes a
copy of the rule, to each House of the
Congress and to the Comptroller General
of the United States. EPA will submit a
report containing this rule and other
required information to the U.S. Senate,
the U.S. House of Representatives, and
the Comptroller General of the United
States prior to publication of the rule in
the Federal Register. A major rule
cannot take effect until 60 days after it
is published in the Federal Register.
This action is not a ‘‘major rule’’ as
defined by 5 U.S.C. 804(2). This rule
will be effective December 27, 2007.
List of Subjects in 40 CFR Part 82
Environmental protection,
Administrative practice and procedure,
Air pollution control, Chemicals,
Chlorofluorocarbons, Imports, Methyl
chloroform, Ozone, Reporting and
recordkeeping requirements.
Dated: December 19, 2007.
Stephen L. Johnson,
Administrator.
For the reasons set out in the
preamble, 40 CFR Part 82 is amended as
follows:
I
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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:
I
§ 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, 2011,
subject to the restrictions in appendix G
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.
*
*
*
*
*
I 3. Section 82.13 is amended by
revising paragraphs (v), (w) introductory
text, and (x) to read as follows:
§ 82.13 Recordkeeping and reporting
requirements for class I controlled
substances.
*
*
*
*
*
(v) Any distributor of laboratory
supplies who purchased controlled
substances under the global essential
laboratory and analytical use exemption
must submit quarterly (except
distributors following procedures in
paragraph (x) of this section) the
quantity of each controlled substance
purchased by each laboratory customer
whose certification was previously
provided to the distributor pursuant to
paragraph (w) of this section.
(w) A laboratory customer purchasing
a controlled substance under the global
essential laboratory and analytical use
exemption must provide the producer,
importer or distributor with a one-timeper-year certification for each controlled
substance that the substance will only
be used for essential laboratory and
analytical uses (defined at appendix G
of this subpart) and not be resold or
used in manufacturing.
*
*
*
*
*
(x) Any distributor of laboratory
supplies who purchased class I
controlled substances under the global
essential laboratory and analytical use
exemption, and who only sells the class
I controlled substances as reference
standards for calibrating laboratory
analytical equipment, may write a letter
to the Administrator requesting
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permission to submit the reports
required under paragraph (v) of this
section annually rather than quarterly.
The Administrator will review the
request and issue a notification of
permission to file annual reports if, in
the Administrator’s judgment, the
distributor meets the requirements of
this paragraph. Upon receipt of a
notification of extension from the
Administrator, the distributor must
submit annually the quantity of each
controlled substance purchased by each
laboratory customer whose certification
was previously provided to the
distributor pursuant to paragraph (w) of
this section.
*
*
*
*
*
4. Appendix G to subpart A of part 82
is amended by adding item paragraph 1.
(d) and by adding paragraph 5. to read
as follows:
I
Appendix G to Subpart A of Part 82—
UNEP Recommendations for Conditions
Applied to Exemptions and Essential
Laboratory and Analytical Uses
1. * * *
d. Testing of organic matter in coal.
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*
*
*
*
*
5. Pursuant to Decision XVIII/15 of the
Parties to the Montreal Protocol, methyl
bromide is exempted for the following
approved essential laboratory and analytical
purposes listed in following items (a) through
(d). Use of methyl bromide for field trials is
not an approved use under the global
laboratory and analytical use exemption. The
provisions of Appendix G, paragraphs (1),
(2), (3), and (4), regarding purity, mixing,
container, and reporting requirements for
other exempt ODSs, also apply to the use of
methyl bromide under this exemption.
a. Methyl bromide is exempted as an
approved essential laboratory and analytical
use as a reference or standard to calibrate
equipment which uses methyl bromide, to
monitor methyl bromide emission levels, or
to determine methyl bromide residue levels
in goods, plants and commodities;
b. Methyl bromide is exempted as an
approved essential laboratory and analytical
when used in laboratory toxicological
studies;
c. Methyl bromide is exempted as an
approved essential laboratory and analytical
use to compare the efficacy of methyl
bromide and its alternatives inside a
laboratory; and
d. Methyl bromide is exempted as an
approved essential laboratory and analytical
use as a laboratory agent which is destroyed
in a chemical reaction in the manner of
feedstock.
[FR Doc. E7–25091 Filed 12–26–07; 8:45 am]
BILLING CODE 6560–50–P
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DEPARTMENT OF COMMERCE
National Oceanic and Atmospheric
Administration
50 CFR Part 622
[Docket No. 001005281–0369–02]
RIN 0648–XE53
Fisheries of the Caribbean, Gulf of
Mexico, and South Atlantic; Coastal
Migratory Pelagic Resources of the
Gulf of Mexico and South Atlantic; Trip
Limit Reduction
National Marine Fisheries
Service (NMFS), National Oceanic and
Atmospheric Administration (NOAA),
Commerce.
ACTION: Temporary rule; trip limit
reduction.
AGENCY:
SUMMARY: NMFS reduces the trip limit
in the commercial hook-and-line fishery
for king mackerel in the northern
Florida west coast subzone to 500 lb
(227 kg) of king mackerel per day in or
from the exclusive economic zone
(EEZ). This trip limit reduction is
necessary to protect the Gulf king
mackerel resource.
DATES: This rule is effective 12:01 a.m.,
local time, December 27, 2007, through
June 30, 2008, unless changed by further
notification in the Federal Register.
FOR FURTHER INFORMATION CONTACT:
Susan Gerhart, telephone 727–824–
5305, fax 727–824–5308, e-mail
susan.gerhart@noaa.gov.
SUPPLEMENTARY INFORMATION: The
fishery for coastal migratory pelagic fish
(king mackerel, Spanish mackerel, cero,
cobia, little tunny, and, in the Gulf of
Mexico only, dolphin and bluefish) is
managed under the Fishery
Management Plan for the Coastal
Migratory Pelagic Resources of the Gulf
of Mexico and South Atlantic (FMP).
The FMP was prepared by the Gulf of
Mexico and South Atlantic Fishery
Management Councils and is
implemented under the authority of the
Magnuson-Stevens Fishery
Conservation and Management Act
(Magnuson-Stevens Act) by regulations
at 50 CFR part 622.
On April 27, 2000, NMFS
implemented the final rule (65 FR
16336, March 28, 2000) that divided the
Florida west coast subzone of the
eastern zone into northern and southern
subzones, and established their separate
quotas. The quota for the northern
Florida west coast subzone is 168,750 lb
(76,544 kg)(50 CFR
622.42(c)(1)(i)(A)(2)(ii)).
In accordance with 50 CFR
622.44(a)(2)(ii)(B)(2), from the date that
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73269
75 percent of the northern Florida west
coast subzone’s quota has been
harvested until a closure of the
subzone’s fishery has been effected or
the fishing year ends, king mackerel in
or from the EEZ may be possessed on
board or landed from a permitted vessel
in amounts not exceeding 500 lb (227
kg) per day.
NMFS has determined that 75 percent
of the quota for Gulf group king
mackerel from the northern Florida west
coast subzone has been reached.
Accordingly, a 500–lb (227–kg) trip
limit applies to vessels in the
commercial fishery for king mackerel in
or from the EEZ in the northern Florida
west coast subzone effective 12:01 a.m.,
local time, December 27, 2007. The 500–
lb (227–kg) trip limit will remain in
effect until the fishery closes or until the
end of the current fishing year (June 30,
2008), whichever occurs first.
The Florida west coast subzone is that
part of the eastern zone south and west
of 25°20.4′ N. lat. (a line directly east
from the Miami-Dade County, FL
boundary). The Florida west coast
subzone is further divided into northern
and southern subzones. The northern
subzone is that part of the Florida west
coast subzone that is between 26°19.8′
N. lat. (a line directly west from the Lee/
Collier County, FL boundary) and
87°31′06″; W. long. (a line directly south
from the Alabama/Florida boundary).
Classification
This action responds to the best
available information recently obtained
from the fishery. The Assistant
Administrator for Fisheries, NOAA,
finds good cause to waive the
requirement to provide prior notice and
opportunity for public comment
pursuant to the authority set forth at 5
U.S.C. 553(b)(B) as such prior notice
and opportunity for public comment is
unnecessary and contrary to the public
interest. Such procedures would be
unnecessary because the rule itself
already has been subject to notice and
comment, and all that remains is to
notify the public of the closure, if
warranted.
NMFS also finds good cause that the
implementation of this action cannot be
delayed for 30 days. There is a need to
implement this measure in a timely
fashion to prevent an overrun of the
commercial quota of Gulf king mackerel
in the northern Florida west coast
subzone, given the capacity of the
fishing fleet to harvest the quota
quickly. Any delay in implementing this
action would be contrary to the
Magnuson-Stevens Act and the FMP.
Accordingly, under 5 U.S.C. 553(d), a
delay in the effective date is waived.
E:\FR\FM\27DER1.SGM
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]]>Agencies
[Federal Register Volume 72, Number 247 (Thursday, December 27, 2007)]
[Rules and Regulations]
[Pages 73264-73269]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-25091]
[[Page 73264]]
=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 82
[EPA-HQ-OAR-2007-0384; FRL-8510-9 ]
RIN 2060-AO28
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 the production and import of class I
ozone-depleting substances through December 31, 2011, consistent with
the 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. The final rule also extends the applicability of
the global laboratory and analytical use exemption to the production
and import of methyl bromide for specific laboratory uses. Finally,
this action eliminates the testing of organic matter in coal from the
global laboratory and analytical use exemption.
DATES: This final rule is effective on December 27, 2007.
ADDRESSES: EPA has established a docket for this action identified
under Docket ID No. EPA-HQ-OAR-2007-0384. All documents in the docket
are listed on the https://www.regulations.gov site. 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, is not placed on the
Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available only through
www.regulations.gov or in hard copy. To obtain copies of materials in
hard copy, please call the EPA Docket Center at (202) 564-1744 between
the hours of 8:30 a.m.-4:30 p.m. E.S.T., Monday-Friday, excluding legal
holidays, to schedule an appointment. The EPA Docket Center's Public
Reading Room address is EPA/DC, EPA West, Room 3334, 1301 Constitution
Ave., NW., Washington, DC 20004.
FOR FURTHER INFORMATION CONTACT: Staci Gatica by regular mail: U.S.
Environmental Protection Agency, Stratospheric Protection Division
(6205J), 1200 Pennsylvania Avenue, NW., Washington, DC, 20460; by
courier service or overnight express: 1301 L Street, NW., Washington DC
20005, Workstation 1047B, by telephone: 202-343-9469; or by e-mail:
gatica.staci@epa.gov. You may also visit the EPA's Ozone Depletion Web
site at www.epa.gov/ozone/strathome.html for further information about
EPA's Stratospheric Ozone Protection regulations, the science of ozone
layer depletion, and other related topics.
SUPPLEMENTARY INFORMATION: 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. EPA is issuing this final rule under section
307(d) of the Clean Air Act, which states: ``The provisions of section
553 through 557 * * * of Title 5 shall not, except as expressly
provided in this section, 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 is nevertheless acting consistently with
the policies underlying APA section 553(d) in making this rule
effective on January 1, 2008. APA section 553(d) authorizes an earlier
effective date ``as otherwise provided by the agency upon good cause
found and published with the rule.'' Because, absent today's action,
the exemption from the phaseout of Class I substances used for
laboratory and analytical uses will expire as of the end of 2007, it is
important to assure that today's action will take effect at the
beginning of 2008.
Table of Contents
I. Background on the Montreal Protocol and the Global Laboratory and
Analytical Use Exemption
II. This Action
A. Extension of the Global Laboratory and Analytical Use
Exemption
B. Applicability of the Global Laboratory and Analytical Use
Exemption to Methyl Bromide
C. Eliminating the Testing of Organic Matter in Coal From the
Global Exemption for Laboratory and Analytical Use
D. Minor Technical Corrections
III. Statutory and Executive Order Reviews
A. Executive Order 12866: Regulatory Planning and Review
B. Paperwork Reduction Act
C. Regulatory Flexibility Act
D. Unfunded Mandates Reform Act
E. Executive Order 13132: Federalism
F. Executive Order 13175: Consultation and Coordination With
Indian Tribal Governments
G. Executive Order 13045: Protection of Children from
Environmental Health Risks and Safety Risks
H. Executive Order 13211: Actions that Significantly Affect
Energy Supply, Distribution, or Use
I. National Technology Transfer and Advancement Act
J. Executive Order 12898: Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations
K. Congressional Review Act
I. Background on the Montreal Protocol and the Global Laboratory and
Analytical Use Exemption
The Montreal Protocol on Substances that Deplete the Ozone Layer
(Montreal Protocol) is the international agreement to reduce and
eventually eliminate the production and consumption \1\ of all ozone-
depleting substances (ODSs). The elimination of production and
consumption of ODSs has been accomplished through adherence to phaseout
schedules for specific ODSs. Section 604 of the Clean Air Act, as
amended in 1990 and 1998, requires EPA to promulgate regulations
implementing the Montreal Protocol's phaseout schedules in the United
States. Those regulations are codified at 40 CFR Part 82, Subpart A. As
of January 1, 1996, production and import of most class I ODSs--
including chlorofluorocarbons (CFCs), halons, carbon tetrachloride, and
methyl chloroform \2\--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). 1
\2\ Class I ozone depleting substances are listed at 40 CFR Part
82, Subpart A, Appendix A.
---------------------------------------------------------------------------
However, the Montreal Protocol provides exemptions that allow for
the continued import and/or production of ODSs for specific uses. Under
the Montreal Protocol, for 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), hydrobromofluorocarbons (Art. 2G), and
chlorobromomethane (Art. 2I). As defined by Decision IV/25 of the
Parties,
[[Page 73265]]
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 (taken in 1998) allowed a general exemption for
essential laboratory and analytical uses through December 31, 2005. EPA
codified this exemption 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 requested the Montreal Protocol's Technology and
Economic Assessment Panel (TEAP), a group of technical experts from
various Parties, to report annually to the Parties to the Montreal
Protocol on procedures that could be performed without the use of
controlled substances. It further stated that at future Meetings of the
Parties (MOPs), the Parties would decide whether such procedures should
no longer be eligible for exemptions. Based on the TEAP's
recommendation, the Parties to the Montreal 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).
At the 18th MOP the Parties acknowledged the need for methyl
bromide for laboratory and analytical procedures, and added methyl
bromide to the approved ODSs under the essential laboratory and
analytical use exemption. Decision XVIII/15 outlines specific uses and
exclusions for methyl bromide under the exemption. Section II. B of
this preamble provides further discussion of the inclusion of methyl
bromide in the essential laboratory and analytical use exemption.
Most recently in September 2007, at the 19th MOP, the Parties in
Decision XIX/18 extended the global laboratory and analytical use
exemption through December 31, 2011. Decision XIX/18 also eliminates
the testing of organic matter in coal from the global exemption for
laboratory and analytical uses of controlled substances and requests
the Technology and Economic Assessment Panel (TEAP) and its Chemical
Technical Options Committee (CTOC) to provide, by the Twenty-first
Meeting of the Parties, a list of laboratory analytical uses of ozone-
depleting substances, indicating those for which alternatives exist and
therefore no longer need exemption for use of class I ODS (p. 43, Air
Docket EPA-HQ-OAR-2007-0384).
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, 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.'' Because certain laboratory procedures continue to require
the use of class I substances in the United States, because non-ODS
replacements for the class I substances have not been identified for
all uses, and because the Parties, via Decision XIX/18, extended this
exemption through December 31, 2011, EPA is revising 40 CFR 82.8(b) to
reflect the extension of the exemption to December 31, 2011. For a more
detailed discussion of the reasons for the exemption, refer to the
March 13, 2001, final rule (66 FR 14760). As discussed in the March
2001 rule, 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 ODS used in such applications. In addition, the 2006 CTOC
Assessment Report shows a general decrease from 2002 through 2005 in
the amount of phased-out class I substances being supplied to
laboratories under this exemption (p. 33, EPA-HQ-OAR-2007-0384).
EPA proposed to extend the date through December 31, 2015 but
clearly explained that at the time the proposed rule was issued the
Parties had not yet taken a decision regarding extension of the global
laboratory and analytical use exemption and that the final rule would
reflect the date decided by the Parties at the 18th MOP.
II. This Action
Today, EPA takes final action to (1) extend the laboratory and
analytical use exemption from December 31, 2007, to December 31, 2011,
for specific laboratory uses, (2) apply the laboratory and analytical
use exemption to the production and import of methyl bromide, (3)
eliminate the testing of organic matter in coal from the laboratory and
analytical use exemption, and (4) make technical corrections to
regulatory text.
A. Extension of the Global Laboratory and Analytical Use Exemption
EPA received three comments on the proposed rule (72 FR 52332). Two
comments supported the proposal. A third commenter provided general
comments stating that chemicals that deplete the ozone should not be
used any longer and questioned whether any use of such chemicals is
essential. As discussed above, the Montreal Protocol specifically
provides for exemptions for essential uses, and Decisions of the
Parties--including Decision XIX/18 taken in 2007, specifically provide
for an exemption for global laboratory and analytical uses. EPA notes
that uses addressed under this exemption are typically 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
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 March 2001 final rule (66 FR
14760).
B. Applicability of the Global Laboratory and Analytical Use Exemption
to Methyl Bromide
As of January 1, 2005, production and import of methyl bromide has
been phased out 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. EPA created
a system of allowances to permit continued production and import of
methyl bromide for critical uses after January 1, 2005 (see 69 FR
76982, December 23, 2004). This critical use exemption does not include
provisions for continued production of methyl bromide to supply
laboratories. However, the phaseout of methyl bromide production and
import does not currently restrict inventories of methyl bromide
produced prior to January 1, 2005, from being used for laboratory and
analytical applications, as described in the December 23, 2004 final
rule.
Methyl bromide (also known as bromomethane) has laboratory uses,
for example, as a chemical intermediate and methylating agent. EPA
regulations allow for methyl bromide to be
[[Page 73266]]
produced after the January 1, 2005, phaseout date if production is
covered by ``unexpended critical use allowances'' (40 CFR 82.4(b)(1)).
The regulations also provide for a ``global exemption for class I
controlled substances for essential laboratory and analytical uses,''
subject to the restrictions in Appendix G (40 CFR 82.4(n)(1)(iii),
82.8(b)). EPA did not address the issue of whether the lab use
exemption should apply to methyl bromide when promulgating the initial
exemption, but EPA did propose to include methyl bromide in the 2005
rulemaking that extended the exemption through December 31, 2007 (see
70 FR 25727). EPA received one comment on the proposed inclusion of
methyl bromide and it was general in nature. Nonetheless, EPA
recognized that further discussion of whether the global laboratory
exemption should include methyl bromide might occur at a future MOP and
deferred final action on the issue.
In November of 2006, during the 18th Meeting of the Parties to the
Montreal Protocol, the Parties included methyl bromide in the essential
laboratory and analytical use exemption via Decision XVIII/15.
Specifically, Decision XVIII/15 allows methyl bromide to be used: (1)
As a reference or standard (a) to calibrate equipment which uses methyl
bromide; (b) to monitor methyl bromide emission levels; (c) to
determine methyl bromide residue levels in goods, plants, and
commodities; (2) in laboratory toxicological studies; (3) to compare
the efficacy of methyl bromide and its alternatives inside a
laboratory; and (4) as a laboratory agent which is destroyed in a
chemical reaction in the manner of feedstock. Furthermore, Decision
XVIII/15 specifically notes that the Montreal Protocol's technical
review bodies were not in favor of classifying field trials using
methyl bromide as essential laboratory and analytical uses and
indicates that Parties wishing to carry out such field trials could
submit critical use nominations for that purpose (p. 43, EPA-HQ-OAR-
2007-0384).
EPA sought comment on whether the global laboratory and analytical
use exemption should specifically include methyl bromide. The three
comments received were general in nature and did not discuss methyl
bromide specifically. Because EPA did not receive any adverse comment
regarding the inclusion of methyl bromide in the laboratory and
analytical use exemption, the Agency is extending the exemption to the
methyl bromide uses listed in the proposed rule.
C. Eliminating the Testing of Organic Matter in Coal From the Global
Exemption for Laboratory and Analytical Use
Decision X/19, paragraph 2, requests the Technology and Economic
Assessment Panel (TEAP), a group of technical experts from various
Parties, to report annually on the development and availability of
laboratory and analytical procedures that can be performed without
using class I controlled substances and that Parties, in subsequent
decisions, would decide whether such procedures would no longer be
eligible for exemptions. Decision XIX/18 eliminates the testing of
organic matter in coal from the global laboratory and analytical use
exemption.
In the proposed rule, EPA indicated its overall intention to mirror
in this final rule, the decisions taken at the 19th MOP in September of
2007. Therefore, this action eliminates the testing of organic matter
in coal from the global laboratory and analytical use exemption. EPA
highly regards technical recommendations made by the TEAP and routinely
amends domestic regulations to mirror decisions taken by the Parties
based on TEAP recommendations.
D. Minor Technical Corrections
EPA proposed to revise three paragraphs in the reporting
requirements at 40 CFR 82.13 to correct two sets of minor typographical
errors. EPA received no specific comments on these corrections, and is
finalizing them today.
The first set addresses incorrect paragraph references. Under 40
CFR 82.13(v), distributors of laboratory supplies who purchased
controlled substances under the essential global laboratory and
analytical use exemption must report on a quarterly basis the quantity
of each controlled substance purchased by each laboratory customer
whose certification was previously provided to the distributor, and
refers to the provisions of paragraph (y). The reference to paragraph
(y) is erroneous and should instead be a reference to paragraph (w),
which describes annual certifications provided by laboratory customers.
Paragraph (v) also refers to Sec. 82.4(z), but should actually
reference Sec. 82.13(x).
Similarly, Sec. 82.13(x) (applicable to distributors who only sell
controlled substances as reference standards for calibrating laboratory
analytical equipment) incorrectly refers to paragraph (y) and should
instead refer to paragraph (w). Further, the reference to reports
required under paragraph (x) should be corrected to refer to reports
required under (v).
The second set of corrections addresses the inaccurate terminology
that is used to refer to the essential laboratory and analytical use
exemption. In Sec. 82.13(v), (w), and (x), the exemption is referred
to as the ``global laboratory essential-use exemption.'' This is not
consistent with the rest of the regulation. EPA is replacing the
reference to ``global laboratory essential-use exemption'' with the
term ``global essential laboratory and analytical use exemption,'' in
Sec. 82.13(v), (w), and (x). EPA received no specific comments on
these corrections.
III. Statutory and Executive Order Reviews
A. Executive Order 12866: Regulatory Planning and Review
This final 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 final action does not propose any new information collection
burden. The recordkeeping and reporting requirements included in this
action are already included in an existing information collection
burden analysis and this action does not propose any changes that would
affect the burden. The Office of Management and Budget (OMB) has
previously approved the information collection requirements contained
in the existing regulations at 40 CFR 82.8(a) under the provisions of
the Paperwork Reduction Act, 44 U.S.C. 3501, et seq. and has assigned
OMB control number 2060-0170, EPA ICR number 1432.25. 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
[[Page 73267]]
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 part 82 are listed in 40 CFR part 9.
C. Regulatory Flexibility Act
The RFA generally requires an agency to prepare a regulatory
flexibility analysis of any rule subject to notice and comment
rulemaking requirements under the Administrative Procedure Act or any
other statute unless the agency certifies that the rule will not have a
significant economic impact on a substantial number of small entities.
Small entities include small businesses, small organizations, and small
governmental jurisdictions.
For purposes of assessing the impact of today's final rule on small
entities, small entity is defined as: (1) Pharmaceutical preparations
manufacturing businesses (NAICS code 325412) that have less than 750
employees; (2) a small governmental jurisdiction that is a government
of a city, county, town, school district or special district with a
population of less than 50,000; and (3) a small organization that is
any not-for-profit enterprise which is independently owned and operated
and is not dominant in its field.
After considering the economic impacts of today's final rule on
small entities, I certify that this action will not have a significant
economic impact on a substantial number of small entities. In
determining whether a rule has a significant economic impact on a
substantial number of small entities, the impact of concern is any
significant adverse economic impact on small entities, since the
primary purpose of the regulatory flexibility analyses is to identify
and address regulatory alternatives ``which minimize any significant
economic impact of the rule on small entities.'' 5 U.S.C. 603 and 604.
Thus, an agency may certify that a rule will not have a significant
economic impact on a substantial number of small entities if the rule
relieves regulatory burden, or otherwise has a positive economic effect
on all of the small entities subject to the rule.
This action provides an otherwise unavailable benefit to those
companies that obtain ozone-depleting substances under the essential
laboratory and analytical use exemption. Therefore today's action will
relieve regulatory burden for all small entities.
D. Unfunded Mandates Reform Act
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Pub.L.
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 a small government agency plan
under section 203 of the UMRA. 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 final 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 provides an
essential laboratory and analytical use exemption from the 1996 and
2005 phaseouts of class I ODSs (including methyl bromide). Similarly,
EPA has determined that this rule contains no regulatory requirements
that might significantly or uniquely affect small governments, because
this rule merely extends the essential laboratory and analytical use
exemption.
E. Executive Order 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. Thus, Executive Order 13132 does
not apply to this rule.
F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments
Executive Order 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 13175 as it merely
provides an essential laboratory and analytical use exemption from the
1996 and 2005 phaseouts of class I ODSs (including methyl bromide).
Thus, Executive Order 13175 does not apply to this rule.
G. Executive Order 13045: Protection of Children From Environmental
Health Risks and 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
[[Page 73268]]
regulation is preferable to other potentially effective and reasonably
feasible alternatives considered by the Agency.
EPA interprets E.O. 13045 as applying only to those regulatory
actions that are based on health or safety risks, such as the analysis
required under section 5-501 of the Order has the potential to
influence the regulation. This final rule is not subject to E.O. 13045
as it merely provides an essential laboratory and analytical use
exemption from the 1996 and 2005 phaseouts of class I ODSs (including
methyl bromide).
H. Executive Order 13211: Actions That Significantly Affect Energy
Supply, Distribution, or Use
This final rule is not subject to Executive Order 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. The rule
merely provides an essential laboratory and analytical use exemption
from the 1996 and 2005 phaseouts of class I ODSs (including methyl
bromide).
I. National Technology Transfer and Advancement Act
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 by voluntary consensus standards bodies. The NTTAA directs EPA
to provide Congress, through OMB, explanations when the Agency decides
not to use available and applicable voluntary consensus standards. This
final rule does not involve technical standards. Therefore, EPA did not
consider the use of any voluntary consensus standards.
J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations
Executive Order (EO) 12898 (59 FR 7629 (Feb. 16, 1994)) establishes
federal executive policy on environmental justice. Its main provision
directs federal agencies, to the greatest extent practicable and
permitted by law, to make environmental justice part of their mission
by identifying and addressing, as appropriate, disproportionately high
and adverse human health or environmental effects of their programs,
policies, and activities on minority populations and low-income
populations in the United States.
EPA has determined that this final rule will not have
disproportionately high and adverse human health or environmental
effects on minority or low-income populations because it does not
affect the level of protection provided to human health or the
environment. The controls in place for laboratory and analytical uses
provide adequate assurance that very little, if any, environmental
impact will result from the handling and disposal of the small amounts
of class I ODS used in such applications.
Furthermore, the 2006 CTOC Assessment Report shows a general
decrease from 2002 through 2005 in the amount of phased-out class I
substances being supplied to laboratories under this exemption.
K. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801, et seq., as added by
the Small Business Regulatory Enforcement Fairness Act of 1996,
generally provides that before a rule may take effect, the agency
promulgating the rule must submit a rule report, which includes a copy
of the rule, to each House of the Congress and to the Comptroller
General of the United States. EPA will submit a report containing this
rule and other required information to the U.S. Senate, the U.S. House
of Representatives, and the Comptroller General of the United States
prior to publication of the rule in the Federal Register. A major rule
cannot take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2). This rule will be effective December 27, 2007.
List of Subjects in 40 CFR Part 82
Environmental protection, Administrative practice and procedure,
Air pollution control, Chemicals, Chlorofluorocarbons, Imports, Methyl
chloroform, Ozone, Reporting and recordkeeping requirements.
Dated: December 19, 2007.
Stephen L. Johnson,
Administrator.
0
For the reasons set out in the preamble, 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, 2011, 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.
* * * * *
0
3. Section 82.13 is amended by revising paragraphs (v), (w)
introductory text, and (x) to read as follows:
Sec. 82.13 Recordkeeping and reporting requirements for class I
controlled substances.
* * * * *
(v) Any distributor of laboratory supplies who purchased controlled
substances under the global essential laboratory and analytical use
exemption must submit quarterly (except distributors following
procedures in paragraph (x) of this section) the quantity of each
controlled substance purchased by each laboratory customer whose
certification was previously provided to the distributor pursuant to
paragraph (w) of this section.
(w) A laboratory customer purchasing a controlled substance under
the global essential laboratory and analytical use exemption must
provide the producer, importer or distributor with a one-time-per-year
certification for each controlled substance that the substance will
only be used for essential laboratory and analytical uses (defined at
appendix G of this subpart) and not be resold or used in manufacturing.
* * * * *
(x) Any distributor of laboratory supplies who purchased class I
controlled substances under the global essential laboratory and
analytical use exemption, and who only sells the class I controlled
substances as reference standards for calibrating laboratory analytical
equipment, may write a letter to the Administrator requesting
[[Page 73269]]
permission to submit the reports required under paragraph (v) of this
section annually rather than quarterly. The Administrator will review
the request and issue a notification of permission to file annual
reports if, in the Administrator's judgment, the distributor meets the
requirements of this paragraph. Upon receipt of a notification of
extension from the Administrator, the distributor must submit annually
the quantity of each controlled substance purchased by each laboratory
customer whose certification was previously provided to the distributor
pursuant to paragraph (w) of this section.
* * * * *
0
4. Appendix G to subpart A of part 82 is amended by adding item
paragraph 1. (d) and by adding paragraph 5. to read as follows:
Appendix G to Subpart A of Part 82--UNEP Recommendations for Conditions
Applied to Exemptions and Essential Laboratory and Analytical Uses
1. * * *
d. Testing of organic matter in coal.
* * * * *
5. Pursuant to Decision XVIII/15 of the Parties to the Montreal
Protocol, methyl bromide is exempted for the following approved
essential laboratory and analytical purposes listed in following
items (a) through (d). Use of methyl bromide for field trials is not
an approved use under the global laboratory and analytical use
exemption. The provisions of Appendix G, paragraphs (1), (2), (3),
and (4), regarding purity, mixing, container, and reporting
requirements for other exempt ODSs, also apply to the use of methyl
bromide under this exemption.
a. Methyl bromide is exempted as an approved essential
laboratory and analytical use as a reference or standard to
calibrate equipment which uses methyl bromide, to monitor methyl
bromide emission levels, or to determine methyl bromide residue
levels in goods, plants and commodities;
b. Methyl bromide is exempted as an approved essential
laboratory and analytical when used in laboratory toxicological
studies;
c. Methyl bromide is exempted as an approved essential
laboratory and analytical use to compare the efficacy of methyl
bromide and its alternatives inside a laboratory; and
d. Methyl bromide is exempted as an approved essential
laboratory and analytical use as a laboratory agent which is
destroyed in a chemical reaction in the manner of feedstock.
[FR Doc. E7-25091 Filed 12-26-07; 8:45 am]
BILLING CODE 6560-50-P
