Protection of Stratospheric Ozone: Extension of Global Laboratory and
Analytical Use Exemption for Essential Class I Ozone-Depleting Substances
[Federal Register: September 13, 2007 (Volume 72, Number 177)]
[Proposed Rules]
[Page 52332-52337]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13se07-21]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 82
[EPA-HQ-OAR-2007-0384; FRL-8467-3]
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: Proposed rule.
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SUMMARY: EPA is proposing to extend the global laboratory and
analytical use exemption for production and import of class I ozone-
depleting substances beyond December 31, 2007, contingent upon and
consistent with future anticipated 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. EPA also is proposing
to add, for specific laboratory uses, the applicability of the
laboratory and analytical use exemption to production and import of
methyl bromide.
DATES: Written comments on this proposed rule must be received by the
EPA Docket on or before November 13, 2007.
ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
OAR-2007-0384, by one of the following methods:
• http://www.regulations.gov. Follow the on-line
instructions for submitting comments.
• E-mail: A-and-R-docket@epa.gov.
• Fax: 202-343-2338, attn: Staci Gatica.
• Mail: Air Docket, Environmental Protection Agency,
Mailcode 6102T, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
• Hand Delivery or Courier: Deliver your comments to: EPA
Air Docket, EPA West 1301 Constitution Avenue, NW., Room B108, Mail
Code 6102T, Washington, DC 20460. Such deliveries are only accepted
during the Docket's normal hours of operation, and special arrangements
should be made for deliveries of boxed information.
Instructions: Direct your comments to Docket ID No. EPA-HQ-OAR -
2007-0384. EPA's policy is that all comments received by the docket
will be included in the public docket without change and may be made
available online at http://www.regulations.gov, including any personal
information provided, unless the comment includes information claimed
to be Confidential Business Information (CBI) or other information
whose disclosure is restricted by statute. Do not submit information
through http://www.regulations.gov or e-mail that you consider to be CBI
or otherwise protected. If you would like the Agency to consider comments
that include CBI, EPA recommends that you submit the comments to the
docket that exclude the CBI portion but that you provide a complete
version of your comments, including the CBI, to the person listed under
ADDRESSES above. The http://www.regulations.gov Web site is an ``anonymous
access'' system, which means EPA will not know your identity or contact
information unless you provide it in the body of your comment. If you
send an e-mail comment directly to EPA without going through http://
www.regulations.gov your e-mail address will be automatically captured
and included as part of the comment that is placed in the public docket
and made available on the Internet. If you submit an electronic
comment, EPA recommends that you include your name and other contact
information in the body of your comment and with any disk or CD-ROM you
submit. If EPA cannot read your comment due to technical difficulties
and cannot contact you for clarification, EPA may not be able to
consider your comment. Electronic files should avoid the use of special
characters, any form of encryption, and be free of any defects or
viruses. For additional information about EPA's public docket visit the
EPA Docket Center homepage at http://www.epa.gov/epahome/dockets.htm.
Docket: All documents in the docket are listed in the
http://www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in http://www.regulations.gov or in hard copy at the Air Docket, EPA/DC,
EPA West, Room B102, 1301 Constitution Ave., NW., Washington, DC. This
Docket Facility is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is (202) 566-1744, and the telephone number for the Air
Docket is (202) 566-1742.
FOR FURTHER INFORMATION CONTACT: 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.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. General Information
A. What should I consider when preparing my comments?
II. Extension of the Global Laboratory and Analytical Use Exemption
III. Applicability of the Global Laboratory and Analytical Use
Exemption to Methyl Bromide
IV. Minor Technical Corrections
V. Statutory and Executive Order Reviews
A. Executive Order 12866: Regulatory Planning and Review
B. Paperwork Reduction Act
C. Regulatory Flexibility Act
D. Unfunded Mandates Reform Act
E. Executive Order 13132: Federalism
F. Executive Order 13175: Consultation and Coordination With
Indian Tribal Governments
G. Executive Order 13045: Protection of Children From
Environmental Health Risks and Safety Risks
[[Page 52333]]
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
I. General Information
A. What should I consider when preparing my comments?
1. Confidential Business Information. Do not submit this
information to EPA through http://www.regulations.gov or e-mail. Clearly mark
the part or all of the information that you claim to be CBI. For CBI
information in a disk or CD-ROM that you mail to EPA, mark the outside
of the disk or CD-ROM as CBI and then identify electronically within
the disk or CD-ROM the specific information that is claimed as CBI. In
addition to one complete version of the comment that includes
information claimed as CBI, a copy of the comment that does not contain
the information claimed as CBI must be submitted for inclusion in the
public docket. Information so marked will not be disclosed except in
accordance with procedures set forth in 40 CFR Part 2.
2. Tips for Preparing Your Comments. When submitting comments,
remember to:
• Identify the rulemaking by docket number and other identifying
information (subject heading, Federal Register date and page number).
• Follow directions--The agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
• Explain why you agree or disagree; suggest alternatives
and substitute language for your requested changes.
• Describe any assumptions and provide any technical
information and/or data that you used.
• If you estimate potential costs or burdens, explain how you arrived
at your estimate in sufficient detail to allow for it to be reproduced.
• Provide specific examples to illustrate your concerns, and
suggest alternatives.
• Explain your views as clearly as possible, avoiding the
use of profanity or personal threats.
• Make sure to submit your comments by the comment period
deadline identified.
II. Extension of 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
stratospheric 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).
\2\ Class I ozone depleting substances are listed at 40 CFR part
82 subpart A, appendix A.
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However, the Montreal Protocol 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, 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
included this exemption in our regulations at 40 CFR part 82, subpart
A. While the Clean Air Act does not specifically provide for this
exemption, EPA determined that an exemption for essential laboratory
and analytical uses was allowable under the Act as a de minimis
exemption. EPA addressed the de minimis exemption in the final rule of
March 13, 2001 (66 FR 14760-14770).
Decision X/19 also 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).
Most recently, in its 2006 Assessment Report, the Chemicals
Technical Options Committee (CTOC) (a subgroup that reports to the
TEAP), explained that while it was brought to their attention that some
opportunities for substitution exist, there has been only slow progress
in replacing ODSs that are being used in laboratory and analytical
procedures with substances that are less harmful to the ozone layer (p.
31, Air Docket EPA-HQ-OAR-2007-0384). The TEAP has not recommended any
additional procedures to exclude from the exemption for existing
approved ODSs. Members of the CTOC will continue to monitor possible
alternatives and report back to the Parties.
However, at the Eighteenth 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 III of this
preamble provides further discussion of the inclusion of methyl bromide
in the essential laboratory and analytical use exemption.
Based on (1) The CTOC's recognition that new non-ODS methods are
not available for existing exempted laboratory and analytical uses and
(2) the recent decision by the Parties to include methyl bromide under
the exemption, EPA believes it is very likely that the Parties plan to
extend the
[[Page 52334]]
existing exemption, which is currently set to expire on December 31,
2007. EPA expects this decision to be made during the nineteenth MOP in
September 2007, as the current agenda includes the discussion to extend
the essential laboratory and analytical use exemption.
Anticipating extension of the essential laboratory and analytical
use exemption, EPA is proposing in this rulemaking to extend the
applicability of the exemption beyond December 31, 2007. Specifically,
EPA is proposing to extend the exemption through December 31, 2015;
however, based on comments and the anticipated Decision by the Parties
to the Protocol, EPA would amend the date in the final rule to be
consistent with the Parties' Decision if a date other than December 31,
2015 is chosen. Until a Decision is adopted by the Parties the Agency
does not know exactly what date will be decided upon by the Parties.
EPA considered proposing an extension date of 2009, since the previous
extension for this exemption was two years, from December 31, 2005
through December 31, 2007. But based on recent discussions by technical
experts, such as the CTOC (p. 31, Air Docket EPA-HQ-OAR-2007-0384), EPA
believes that the exemption for essential laboratory and analytical
uses will be necessary for some time longer than two years and that the
Parties may decide upon an extension beyond two years. Therefore, EPA
is proposing to extend the exemption through December 31, 2015 based on
when it may be reasonable to assume that an exemption would no longer
be necessary. EPA intends to finalize this rulemaking using the actual
extension date decided upon by the Parties to ensure consistency,
noting that the Parties will have considered the most recent technical
review and analysis conducted by the CTOC and the TEAP. Furthermore,
the overall finalization of the rule is contingent upon the Parties'
extension of the exemption under the Montreal Protocol. EPA is
interested in any comments the public may have on the proposed
extension date, including our rationale for finalizing a date different
from the proposed date of December 31, 2015, based on the anticipated
future decision by the Parties of the Montreal Protocol.
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 EPA anticipates the Parties will extend this
exemption under the Montreal Protocol, EPA is proposing to revise 40
CFR 82.8(b) to reflect the extension of the exemption to December 31,
2015. For a more detailed discussion of the reasons for the exemption,
refer to the March 13, 2001, Federal Register notice. As discussed in
the March 2001 notice, the controls in place for laboratory and
analytical uses provide adequate assurance that very little, if any,
environmental damage will result from the handling and disposal of the
small amounts of class I 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).
III. 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 disallowed 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
76981, December 23, 2004). This 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 Framework rule (69 FR 76982).
Methyl bromide (also known as bromomethane) does have laboratory
uses, for example, as a chemical intermediate and methylating agent.
EPA regulations allow for methyl bromide to be produced after the
January 1, 2005, phaseout date if production is covered by ``essential
use allowances or exemptions.'' (40 CFR 82.4(b)(1)) The regulations
list the laboratory and analytical use exemption as a ``global
exemption for class I controlled substances,'' subject to the
restrictions in appendix G (40 CFR 82.4(n)(1)(iii), 82.8(b)). EPA did
not originally address the issue of whether the exemption should apply
to methyl bromide, 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 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, the Decision XVIII/15 allows methyl bromide 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; (4) as a laboratory agent which is destroyed in a chemical
reaction in the manner of feedstock. Furthermore, Decision XVIII/15
specifically disallows classifying field trials using methyl bromide as
essential laboratory and analytical uses and indicates that entities
wishing to carry out such field trials could submit critical use
nominations for that purpose (p. 43, EPA-HQ-OAR-2007-0384).
Furthermore, we believe that extending the essential laboratory and
analytical uses exemption to include methyl bromide is fully consistent
with allowing this exemption under the Clean Air Act as a de minimis
exemption. EPA addressed the de minimis exemption in a final rule dated
March 13, 2001 (66 FR 14760-14770). EPA believes only a very small
amount of methyl bromide will produced under the laboratory and
analytical use exemption. To date, very few companies have approached
EPA about extending the laboratory and analytical use exemption to
include methyl bromide. EPA does not believe that there is a large
demand for methyl bromide for laboratory and analytical uses, and there
is no indication that there has been significant use of the pre-
phaseout inventories (that is, methyl bromide
[[Page 52335]]
produced prior to January 1, 2005) for such uses.
One interested company provided EPA with an estimate of annual
methyl bromide sales for laboratory and analytical use, if allowed
under the current exemption. That company anticipated only 0.14 metric
tons in sales. Considering that 27 metric tons of ODSs were produced in
2005 and reported to the UNEP under the current laboratory and
analytical use exemption, and considering that EPA has no reason to
believe that large amounts of methyl bromide will be demanded and
produced under the laboratory and analytical exemption, EPA, in
accordance with Decision XVIII/15, proposes to add language regarding
methyl bromide inclusion under the global laboratory exemption rule in
Appendix G to Subpart A of Part 82. EPA is seeking public comment on
the proposed inclusion of methyl bromide in the essential laboratory
and analytical use exemption.
IV. Minor Technical Correction
EPA is proposing to revise three paragraphs in the reporting
requirements at Sec. 82.13 to correct two sets of minor typographical
errors. The first set addresses incorrect paragraph references. Under
Sec. 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 be a reference to paragraph (w), which
describes annual certifications provided by laboratory customers. The
same paragraph (Sec. 82.13(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
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 proposes to replace the
reference to ``global laboratory essential-use exemption'' with
``global essential laboratory and analytical use exemption'' found in
Sec. 82.13(v), (w), and (x).
EPA seeks comment on these proposed corrections.
V. Statutory and Executive Order Reviews
A. Executive Order 12866: Regulatory Planning and Review
This action is not a ``significant regulatory action'' under the
terms of Executive Order (EO) 12866 (58 FR 51735, October 4, 1993) and
is therefore not subject to review under the EO.
B. Paperwork Reduction Act
This 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 and
this action does not propose any changes that would affect the burden.
However, 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 previously applicable instructions and requirements;
train personnel to be able to respond to a collection of information;
search data sources; complete and review the collection of information;
and transmit or otherwise disclose the information.
An agency may not conduct or sponsor, and a person is not required
to respond to a collection of information unless it displays a
currently valid OMB control number. The OMB control numbers for EPA's
regulations in 40 CFR are listed in 40 CFR part 9.
C. Regulatory Flexibility Act
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 proposed 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 proposed 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, once finalized, will provide an otherwise unavailable
benefit to those companies that obtain ozone-depleting substances under
the essential laboratory and analytical use exemption. We have
therefore concluded that today's proposed rule will relieve regulatory
burden for all small entities. We continue to be interested in the
potential impact of the proposed rule on small entities and welcome
comments on issues related to such impacts.
[[Page 52336]]
D. Unfunded Mandates Reform Act
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public
Law 104-4, establishes requirements for Federal agencies to assess the
effects of their regulatory actions on State, local, and tribal
governments and the private sector. Under section 202 of the UMRA, EPA
generally must prepare a written statement, including a cost-benefit
analysis, for proposed and final rules with ``Federal mandates'' that
may result in expenditures to State, local, and tribal governments, in
the aggregate, or to the private sector, of $100 million or more in any
one year.
Before promulgating an EPA rule for which a written statement is
needed, section 205 of the UMRA generally requires EPA to identify and
consider a reasonable number of regulatory alternatives and adopt the
least costly, most cost-effective, or least burdensome alternative that
achieves the objectives of the rule. The provisions of section 205 do
not apply when they are inconsistent with applicable law. Moreover,
section 205 allows EPA to adopt an alternative other than the least
costly, most cost-effective, or least burdensome alternative, if the
Administrator publishes with the final rule an explanation why that
alternative was not adopted.
Before EPA establishes any regulatory requirements that may
significantly or uniquely affect small governments, including tribal
governments, it must have developed 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 proposed 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 phase outs 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 proposed rule does not have federalism implications. It will
not have substantial direct effects on the States, on the relationship
between the national government and the States, or on the distribution
of power and responsibilities among the various levels of government,
as specified in Executive Order 13132. 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'' (59 FR 22951, November 9, 2000),
requires EPA to develop an accountable process to ensure ``meaningful
and timely input by tribal officials in the development of regulatory
policies that have tribal implications.'' This proposed rule does not
have tribal implications, as specified in Executive Order 13175.
Today's proposed rule affects only the companies that requested
essential use allowances. 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 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 proposed rule is not subject to E.O.
13045 because it implements Section 604(d)(2) of the Clean Air Act
which states that the Agency shall authorize essential use exemptions
should the Food and Drug Administration determine that such exemptions
are necessary.
H. Executive Order 13211: Actions That Significantly Affect Energy
Supply, Distribution, or Use
This proposed rule is not subject to Executive Order 13211, Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use (66 Fed. Reg. 28355, May 22, 2001) because it is
not likely to have a significant adverse effect on the supply,
distribution, or use of energy. The rule affects only the
pharmaceutical companies that requested essential use allowances.
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
proposed 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
[[Page 52337]]
environmental effects of their programs, policies, and activities on
minority populations and low-income populations in the United States.
EPA has determined that this proposed 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
damage 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.
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: September 7, 2007.
Stephen L. Johnson,
Administrator.
40 CFR part 82 is proposed to be amended as follows:
PART 82--PROTECTION OF STRATOSPHERIC OZONE
1. The authority citation for part 82 continues to read as follows:
Authority: 42 U.S.C. 7414, 7601, 7671-7671q.
Subpart A--Production and Consumption Controls
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, 2015, 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.
* * * * *
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.
The certification must also include:
* * * * *
(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
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
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
* * * * *
5. Pursuant to Decision XVIII/15 of the Parties to the Montreal
Protocol, effective November 2006, Methyl Bromide is exempted for
the following approved essential laboratory and analytical purposes:
a. As a reference standard to calibrate equipment which uses
methyl bromide, to monitor methyl bromide emission levels, to
determine methyl bromide residue levels in goods, plants and commodities;
b. In laboratory toxicological studies;
c. To compare the efficacy of methyl bromide and its
alternatives inside a laboratory; and
d. As a laboratory agent which is destroyed in a chemical
reaction in the manner of feedstock.
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.
[FR Doc. E7-18095 Filed 9-12-07; 8:45 am]
BILLING CODE 6560-50-P
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