Document ID: EPA-HQ-OAR-2007-0384-0012
Agency: epa
Document Type: Rule
Title: Protection of Stratospheric Ozone: Extension of Global Laboratory and Analytical Use Exemption for Essential Class I Ozone-Depleting Substances
Posted Date: 2007-12-27T05:00Z

[Federal Register: December 27, 2007 (Volume 72, Number 247)]
[Rules and Regulations]               
[Page 73264-73269]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27de07-9]                         

[[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.

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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 http://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 
http://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 http://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.
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    \1\ ``Consumption'' is defined as the amount of a substance 
produced in the United States, plus the amount imported into the 
United States, minus the amount exported to Parties to the Montreal 
Protocol (see Section 601(6) of the Clean Air Act). 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