Protection of Stratospheric Ozone: Extension of the Laboratory and Analytical Use Exemption for Essential Class I Ozone-Depleting Substances, 66679-66682 [2014-26530]
Download as PDF
Federal Register / Vol. 79, No. 217 / Monday, November 10, 2014 / Proposed Rules
Program, Part A, General Requirements
and Applicability, and to Utah Rules
R307–110–1 and R307–110–31. In
addition, EPA is proposing approval of
the January 28, 2014 submitted SIP
revisions to Utah’s SIP Section X,
Vehicle Inspection and Maintenance
Program, Part F, Cache County, with
clarification below, and to Utah Rule
R307–110–36. EPA clarifies that with its
proposed approval of Utah’s SIP Section
X, Vehicle Inspection and Maintenance
Program, Part F, Cache County,
Appendix 2, the provisions in the
BRHD’s Regulation 2013–1, Section
9.4.6 and the diesel test procedures as
specified in BRHD’s Regulation 2013–1,
Appendix D are being proposed for
approval only for purposes of
strengthening the SIP. These provisions
are not being proposed for approval as
a diesel I/M program and are not being
assigned any SIP credit.
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IX. Statutory and Executive Order
Reviews
Under the Clean Air Act, the
Administrator is required to approve a
SIP submission that complies with the
provisions of the Act and applicable
federal regulations. 42 U.S.C. 7410(k);
40 CFR 52.02(a). Thus, in reviewing SIP
submissions, EPA’s role is to approve
state choices, provided that they meet
the criteria of the Clean Air Act.
Accordingly, this action merely
proposes to approve state law as
meeting federal requirements and does
not impose additional requirements
beyond those imposed by state law. For
that reason, this proposed action:
• Is not a ‘‘significant regulatory
action’’ subject to review by the Office
of Management and Budget under
Executive Order 12866 (58 FR 51735,
October 4, 1993);
• Does not impose an information
collection burden under the provisions
of the Paperwork Reduction Act (44
U.S.C. 3501 et seq.);
• Is certified as not having a
significant economic impact on a
substantial number of small entities
under the Regulatory Flexibility Act (5
U.S.C. 601 et seq.);
• Does not contain any unfunded
mandate or significantly or uniquely
affect small governments, as described
in the Unfunded Mandates Reform Act
of 1995 (Pub. L. 104–4);
• Does not have federalism
implications as specified in Executive
Order 13132 (64 FR 43255, August 10,
1999);
• Is not an economically significant
regulatory action based on health or
safety risks subject to Executive Order
13045 (62 FR 19885, April 23, 1997);
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• Is not a significant regulatory action
subject to Executive Order 13211 (66 FR
28355, May 22, 2001);
• Is not subject to requirements of
Section 12(d) of the National
Technology Transfer and Advancement
Act of 1995 (15 U.S.C. 272 note) because
application of those requirements would
be inconsistent with the Clean Air Act;
and
• Does not provide EPA with the
discretionary authority to address, as
appropriate, disproportionate human
health or environmental effects, using
practicable and legally permissible
methods, under Executive Order 12898
(59 FR 7629, February 16, 1994).
In addition, this proposed rule does
not have tribal implications as specified
by Executive Order 13175 (65 FR 67249,
November 9, 2000), because the SIP is
not approved to apply in Indian country
located in the state, and EPA notes that
it will not impose substantial direct
costs on tribal governments or preempt
tribal law.
List of Subjects in 40 CFR Part 52
Environmental protection, Air
pollution control, Carbon monoxide,
Intergovernmental relations, Nitrogen
dioxide, Ozone, Particulate matter,
Reporting and recordkeeping
requirements, and Volatile organic
compounds.
Authority: 42 U.S.C. 7401 et seq.
Dated: October 20, 2014.
Shaun L. McGrath,
Regional Administrator, Region 8.
[FR Doc. 2014–26630 Filed 11–7–14; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 82
[EPA–HQ–OAR–2014–0621; FRL–9918–59–
OAR]
RIN 2060–AS38
Protection of Stratospheric Ozone:
Extension of the Laboratory and
Analytical Use Exemption for Essential
Class I Ozone-Depleting Substances
Environmental Protection
Agency.
ACTION: Proposed rule.
AGENCY:
The Environmental Protection
Agency (EPA) is proposing to extend the
laboratory and analytical use exemption
for the production and import of class
I ozone-depleting substances through
December 31, 2021. This action is
proposed under the Clean Air Act in
anticipation of upcoming actions by the
SUMMARY:
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66679
Parties to the Montreal Protocol on
Substances that Deplete the Ozone
Layer. The exemption allows the
production and import of controlled
substances in the United States for
laboratory and analytical uses that have
not been already identified by EPA as
nonessential.
Comments must be submitted by
December 10, 2014.
ADDRESSES: Submit your comments,
identified by Docket ID No. EPA–HQ–
OAR–2014–0621, by one of the
following methods:
• www.regulations.gov: Follow the
on-line instructions for submitting
comments.
• Email: a-and-r-Docket@epa.gov.
• Fax: (202) 566–9744.
• Phone: (202) 566–1742.
• U.S. Mail: Docket EPA–HQ–OAR–
2014–0621, U.S. Environmental
Protection Agency, EPA Docket Center,
Air and Radiation Docket, Mail Code
28221T, 1200 Pennsylvania Avenue
NW., Washington, DC 20460.
• Hand Delivery or Courier: Docket
EPA–HQ–OAR–2014–0621, EPA Docket
Center—Public Reading Room, EPA
West Building, Room 3334, 1301
Constitution Avenue NW., Washington,
DC 20004. Such deliveries are only
accepted during the Docket’s normal
hours of operation, and special
arrangements should be made for
deliveries of boxed information.
Instructions: Direct your comments to
Docket ID No. EPA–HQ–OAR–2014–
0621. EPA’s policy is that all comments
received will be included in the public
docket without change and may be
made available online at
www.regulations.gov, including any
personal information provided, unless
the comment includes information
claimed to be Confidential Business
Information (CBI) or other information
whose disclosure is restricted by statute.
Do not submit information that you
consider to be CBI or otherwise
protected through www.regulations.gov
or email. The 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 email
comment directly to EPA without going
through www.regulations.gov your email
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
DATES:
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cannot read your comment due to
technical difficulties and cannot contact
you for clarification, EPA may not be
able to consider your comment.
Electronic files should avoid the use of
special characters, any form of
encryption, and be free of any defects or
viruses. For additional information
about EPA’s public docket visit the EPA
Docket Center homepage at https://
www.epa.gov/epahome/dockets.htm.
Docket: All documents in the docket
are listed on the www.regulations.gov
Web site. Although listed in the index,
some information is not publicly
available, e.g., confidential business
information (CBI) or other information
whose disclosure is restricted by statute.
Certain other material, such as
copyrighted material, is not placed on
the Internet and will be publicly
available only in hard copy form.
Publicly available docket materials are
available either electronically through
www.regulations.gov or in hard copy at
the Air and Radiation Docket, EPA/DC,
EPA West, Room 3334, 1301
Constitution Ave. NW., Washington,
DC. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday
through Friday, excluding legal
holidays. The telephone number for the
Public Reading Room is (202) 566–1744,
and the telephone number for the Air
and Radiation Docket is (202) 566–1742.
FOR FURTHER INFORMATION CONTACT:
Jeremy Arling by regular mail: U.S.
Environmental Protection Agency,
Stratospheric Protection Division
(6205T), 1200 Pennsylvania Avenue
NW., Washington, DC 20460; by
telephone: 202–343–9055; or by email:
arling.jeremy@epa.gov. You may also
visit the EPA’s Ozone Protection 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:
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I. General Information
A. Does this action apply to me?
Entities potentially regulated by this
action potentially include: (1)
Pharmaceutical preparations
manufacturing businesses (NAICS code
325412); (2) medical and diagnostic
laboratories (NAICS code 621511); (3)
research and development in the
physical, engineering, and life sciences
(NAICS code 54171); and (4)
environmental consulting services
(NAICS code 541620). This list is not
intended to be exhaustive, but rather to
provide a guide for readers regarding
entities likely to be regulated by this
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action. To determine whether your
facility, company, business, or
organization could be regulated by this
action, you should carefully examine
the regulations promulgated at 40 CFR
part 82, subpart A. If you have questions
regarding the applicability of this action
to a particular entity, consult the person
listed in the preceding section.
B. What should I consider when
preparing my comments?
1. Confidential Business Information.
Do not submit confidential business
information (CBI) to EPA through
www.regulations.gov or email. 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. Information so
marked will not be disclosed except in
accordance with procedures set forth in
40 CFR part 2. 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.
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 Laboratory and
Analytical Use Exemption
The Montreal Protocol on Substances
That Deplete the Ozone Layer (Montreal
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Protocol, or Protocol) is the
international agreement to reduce and
eventually eliminate the global
production and consumption 1 of ozonedepleting substances (ODS). This goal is
accomplished through adherence by
each country that is a Party to the
Montreal Protocol to phaseout
schedules for specific controlled
substances. The Protocol established
January 1, 1996, as the date by which
the production and import of most
substances classified as ‘‘class I
controlled substances’’ under the Clean
Air Act—including chlorofluorocarbons
(CFCs), carbon tetrachloride, and methyl
chloroform 2—were phased out in
developed countries, including the
United States. The Clean Air Act grants
EPA the authority to implement the
Protocol’s phaseout schedules in the
United States. Section 604 of the Clean
Air Act requires EPA to issue
regulations phasing out production and
consumption of class I ODS according to
a prescribed schedule. EPA’s phaseout
regulations for ODS are codified at 40
CFR part 82, subpart A.
The Montreal Protocol provides
exemptions that allow for the continued
import and/or production of ODS for
specific uses. For most class I ODS, the
Parties may collectively grant
exemptions to the ban on production
and import of ODS 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 should
qualify as ‘essential’ only if: (i) It is
necessary for the health, safety or is
critical for the functioning of society
(encompassing cultural and intellectual
aspects); and (ii) there are no available
technically and economically feasible
alternatives or substitutes that are
acceptable from the standpoint of
environment and health.’’
Decision X/19 under the Montreal
Protocol (taken in 1998) allowed a
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 from the United States to other
Parties to the Montreal Protocol (see section 601(6)
of the Clean Air Act).
2 Class I controlled substances are listed at 40 CFR
part 82, subpart A, Appendix A.
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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 a regulation
issued March 13, 2001 (66 FR 14760).
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 laboratory
and analytical 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 these exclusions 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 ODS under the essential
laboratory and analytical use
exemption. Decision XVIII/15 outlined
specific uses and exclusions for methyl
bromide under the exemption. EPA
incorporated specific uses of methyl
bromide in the essential laboratory and
analytical use exemption at Appendix G
to subpart A of 40 CFR part 82 on
December 27, 2007 (72 FR 73264).
In November 2009, at the 21st MOP,
the Parties in Decision XXI/6 extended
the global laboratory and analytical use
exemption through December 31, 2014.
Based on this decision, EPA amended
the regulation at 40 CFR 82.8(b) to
extend the essential laboratory and
analytical use exemption through
December 31, 2014 (76 FR 77909,
December 15, 2011). Decision XXI/6
also notes laboratory and analytical uses
of ODS for which the TEAP and its
Chemicals Technical Options
Committee (CTOC), determined that
alternative procedures exist. However,
the Parties did not exclude any of those
procedures from the exemption for
laboratory and analytical uses.
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At the July 2014 Open Ended Working
Group meeting of the Montreal Protocol,
the United States Government
submitted a draft Decision to extend the
global laboratory and analytical use
exemption through December 31, 2021.
This draft Decision is available in the
docket to this rule. The Parties will
decide whether to extend the exemption
at their next Meeting of the Parties in
November 2014.
A detailed discussion of the
laboratory and analytical uses of ODS
can be found in the regulation issued by
EPA on March 13, 2001 (66 FR 14760).
That rule also discusses how 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, due to the Appendix G
requirements for small quantity and
high purity. For example, class I ODS
must be sold in cylinders three liters or
smaller or in glass ampoules 10
milliliter or smaller. Since issuing the
original exemption, EPA has not
received information that would suggest
otherwise.
U.S. production and consumption of
ODS under the laboratory and analytical
use exemption is on a general decline,
indicating that many users have been
able to transition from ozone-depleting
substances. However, 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, EPA is proposing
to extend this exemption through
December 31, 2021.
EPA believes an extension of seven
years is warranted, as it is unlikely that
non-ODS replacements will be in place
for all laboratory and analytical uses
prior to that time. An extension of this
length would also minimize uncertainty
for stakeholders and promote
administrative efficiency. EPA
recognizes that the Parties may not agree
to extend the exemption or may agree to
an expiration date that is earlier than
December 31, 2021. In either event, EPA
will not adopt a final rule containing an
extension beyond that agreed by the
Parties.
EPA welcomes comment on a variety
of potential scenarios including no
extension or an extension shorter than
seven years. While there is uncertainty
about the length of the extension, EPA
believes it is appropriate to propose this
rule prior to action being taken by the
Parties to the Protocol to avoid a
significant gap in the availability of this
exemption. Because the Parties will not
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66681
take a Decision until November 2014,
EPA is requesting public input now so
as to be able to finalize an extension
shortly after the Meeting of the Parties.
EPA notes that if the exemption lapses,
stocks of existing class I ODS produced
or imported under the exemption can
continue to be sold by distributors and
used by laboratories as the prohibition
applies only to the production and
import of class I ODS.
EPA is also seeking comment from
standards organizations that either
continue to use ODS in their standards
or that have developed new standards.
Similarly, EPA is interested in comment
from laboratories that continue to use
ODS or that have transitioned to ozonesafe alternatives.
III. Statutory and Executive Order
Reviews
Additional information about these
statutes and Executive Orders can be
found at https://www2.epa.gov/lawsregulations/laws-and-executive-orders.
A. Executive Order 12866: Regulatory
Planning and Review and Executive
Order 13563: Improving Regulation and
Regulatory Review
This action is not a significant
regulatory action and was therefore not
submitted to the Office of Management
and Budget (OMB) for review.
B. Paperwork Reduction Act (PRA)
This action does not impose any new
information collection burden under the
PRA. OMB has previously approved the
information collection activities
contained in the existing regulations
and has assigned OMB control number
2060–0170. This action extends but
does not modify the existing exemption
from the phaseout of class I ODS.
C. Regulatory Flexibility Act
I certify that this action will not have
a significant economic impact on a
substantial number of small entities
under the RFA. In making this
determination, the impact of concern is
any significant adverse economic
impact on small entities. 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, has
no net burden or otherwise has a
positive economic effect on 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. We have therefore
concluded that this action will relieve
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regulatory burden for all directly
regulated small entities.
D. Unfunded Mandates Reform Act
This action does not contain any
unfunded mandate as described in
UMRA, 2 U.S.C. 1531–1538, and does
not significantly or uniquely affect small
governments. The action imposes no
enforceable duty on any state, local or
tribal governments or the private sector.
This action merely extends the essential
laboratory and analytical use exemption
from the 1996 and 2005 phaseouts of
class I ODS production and
consumption until December 31, 2021.
E. Executive Order 13132: Federalism
This action 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.
F. Executive Order 13175: Consultation
and Coordination With Indian Tribal
Governments
rmajette on DSK2TPTVN1PROD with PROPOSALS
This action does not have tribal
implications as specified in Executive
Order 13175. This rule does not
significantly or uniquely affect the
communities of Indian tribal
governments, nor does it impose any
enforceable duties on communities of
Indian tribal governments. This action
would extend the essential laboratory
and analytical use exemption from the
1996 and 2005 phaseouts of class I ODS
production and consumption until
December 31, 2021. Thus, Executive
Order 13175 does not apply to this
action.
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G. Executive Order 13045: Protection of
Children From Environmental Health
Risks and Safety Risks
EPA interprets Executive Order 13045
as applying only to those regulatory
actions that concern environmental
health or safety risks that the agency has
reason to believe may
disproportionately affect children, per
the definition of ‘‘covered regulatory
action’’ in section 2–202 of the
Executive Order. This action is not
subject to Executive Order 13045
because it does not concern an
environmental health risk or safety risk.
H. Executive Order 13211: Actions That
Significantly Affect Energy Supply,
Distribution, or Use
This action is not subject to Executive
Order 13211, because it is not a
significant regulatory action under
Executive Order 12866.
I. National Technology Transfer and
Advancement Act
This rulemaking does not involve
technical standards.
J. Executive Order 12898: Federal
Actions To Address Environmental
Justice in Minority
Populations and Low-Income
Populations
EPA believes the human health or
environmental risk addressed by this
action will not have potential
disproportionately high and adverse
human health or environmental effects
on minority, low-income, or indigenous
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,
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environmental impact will result from
the handling and disposal of the small
amounts of class I ODS used in such
applications.
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: October 31, 2014.
Gina McCarthy,
Administrator.
For the reasons set out in the
preamble, 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.
2. Section 82.8 is amended by revising
paragraph (b) to read as follows:
■
§ 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, 2021,
subject to the restrictions in appendix G
of this subpart, and subject to the
recordkeeping and reporting
requirements at § 82.13(u) through (x).
There is no amount specified for this
exemption.
*
*
*
*
*
[FR Doc. 2014–26530 Filed 11–7–14; 8:45 am]
BILLING CODE 6560–50–P
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Agencies
[Federal Register Volume 79, Number 217 (Monday, November 10, 2014)]
[Proposed Rules]
[Pages 66679-66682]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-26530]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 82
[EPA-HQ-OAR-2014-0621; FRL-9918-59-OAR]
RIN 2060-AS38
Protection of Stratospheric Ozone: Extension of the Laboratory
and Analytical Use Exemption for Essential Class I Ozone-Depleting
Substances
AGENCY: Environmental Protection Agency.
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: The Environmental Protection Agency (EPA) is proposing to
extend the laboratory and analytical use exemption for the production
and import of class I ozone-depleting substances through December 31,
2021. This action is proposed under the Clean Air Act in anticipation
of upcoming actions by the Parties to the Montreal Protocol on
Substances that Deplete the Ozone Layer. The exemption allows the
production and import of controlled substances in the United States for
laboratory and analytical uses that have not been already identified by
EPA as nonessential.
DATES: Comments must be submitted by December 10, 2014.
ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
OAR-2014-0621, by one of the following methods:
www.regulations.gov: Follow the on-line instructions for
submitting comments.
Email: a-and-r-Docket@epa.gov.
Fax: (202) 566-9744.
Phone: (202) 566-1742.
U.S. Mail: Docket EPA-HQ-OAR-2014-0621, U.S. Environmental
Protection Agency, EPA Docket Center, Air and Radiation Docket, Mail
Code 28221T, 1200 Pennsylvania Avenue NW., Washington, DC 20460.
Hand Delivery or Courier: Docket EPA-HQ-OAR-2014-0621, EPA
Docket Center--Public Reading Room, EPA West Building, Room 3334, 1301
Constitution Avenue NW., Washington, DC 20004. Such deliveries are only
accepted during the Docket's normal hours of operation, and special
arrangements should be made for deliveries of boxed information.
Instructions: Direct your comments to Docket ID No. EPA-HQ-OAR-
2014-0621. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
www.regulations.gov, including any personal information provided,
unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through www.regulations.gov or email. The
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 email comment
directly to EPA without going through www.regulations.gov your email
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
[[Page 66680]]
cannot read your comment due to technical difficulties and cannot
contact you for clarification, EPA may not be able to consider your
comment. Electronic files should avoid the use of special characters,
any form of encryption, and be free of any defects or viruses. For
additional information about EPA's public docket visit the EPA Docket
Center homepage at https://www.epa.gov/epahome/dockets.htm.
Docket: All documents in the docket are listed on the
www.regulations.gov Web site. Although listed in the index, some
information is not publicly available, e.g., confidential business
information (CBI) or other information whose disclosure is restricted
by statute. Certain other material, such as copyrighted material, is
not placed on the Internet and will be publicly available only in hard
copy form. Publicly available docket materials are available either
electronically through www.regulations.gov or in hard copy at the Air
and Radiation Docket, EPA/DC, EPA West, Room 3334, 1301 Constitution
Ave. NW., Washington, DC. The Public Reading Room is open from 8:30
a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Public Reading Room is (202) 566-1744, and the
telephone number for the Air and Radiation Docket is (202) 566-1742.
FOR FURTHER INFORMATION CONTACT: Jeremy Arling by regular mail: U.S.
Environmental Protection Agency, Stratospheric Protection Division
(6205T), 1200 Pennsylvania Avenue NW., Washington, DC 20460; by
telephone: 202-343-9055; or by email: arling.jeremy@epa.gov. You may
also visit the EPA's Ozone Protection 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:
I. General Information
A. Does this action apply to me?
Entities potentially regulated by this action potentially include:
(1) Pharmaceutical preparations manufacturing businesses (NAICS code
325412); (2) medical and diagnostic laboratories (NAICS code 621511);
(3) research and development in the physical, engineering, and life
sciences (NAICS code 54171); and (4) environmental consulting services
(NAICS code 541620). This list is not intended to be exhaustive, but
rather to provide a guide for readers regarding entities likely to be
regulated by this action. To determine whether your facility, company,
business, or organization could be regulated by this action, you should
carefully examine the regulations promulgated at 40 CFR part 82,
subpart A. If you have questions regarding the applicability of this
action to a particular entity, consult the person listed in the
preceding section.
B. What should I consider when preparing my comments?
1. Confidential Business Information. Do not submit confidential
business information (CBI) to EPA through www.regulations.gov or email.
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. Information so marked will not be disclosed except
in accordance with procedures set forth in 40 CFR part 2. 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.
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 Laboratory and Analytical Use Exemption
The Montreal Protocol on Substances That Deplete the Ozone Layer
(Montreal Protocol, or Protocol) is the international agreement to
reduce and eventually eliminate the global production and consumption
\1\ of ozone-depleting substances (ODS). This goal is accomplished
through adherence by each country that is a Party to the Montreal
Protocol to phaseout schedules for specific controlled substances. The
Protocol established January 1, 1996, as the date by which the
production and import of most substances classified as ``class I
controlled substances'' under the Clean Air Act--including
chlorofluorocarbons (CFCs), carbon tetrachloride, and methyl chloroform
\2\--were phased out in developed countries, including the United
States. The Clean Air Act grants EPA the authority to implement the
Protocol's phaseout schedules in the United States. Section 604 of the
Clean Air Act requires EPA to issue regulations phasing out production
and consumption of class I ODS according to a prescribed schedule.
EPA's phaseout regulations for ODS are codified at 40 CFR part 82,
subpart A.
---------------------------------------------------------------------------
\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 from the United States to
other Parties to the Montreal Protocol (see section 601(6) of the
Clean Air Act).
\2\ Class I controlled substances are listed at 40 CFR part 82,
subpart A, Appendix A.
---------------------------------------------------------------------------
The Montreal Protocol provides exemptions that allow for the
continued import and/or production of ODS for specific uses. For most
class I ODS, the Parties may collectively grant exemptions to the ban
on production and import of ODS 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 should qualify as `essential' only if: (i) It is necessary
for the health, safety or is critical for the functioning of society
(encompassing cultural and intellectual aspects); and (ii) there are no
available technically and economically feasible alternatives or
substitutes that are acceptable from the standpoint of environment and
health.''
Decision X/19 under the Montreal Protocol (taken in 1998) allowed a
[[Page 66681]]
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 a
regulation issued March 13, 2001 (66 FR 14760).
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 laboratory and analytical 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 these
exclusions 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 ODS under the essential laboratory and analytical use
exemption. Decision XVIII/15 outlined specific uses and exclusions for
methyl bromide under the exemption. EPA incorporated specific uses of
methyl bromide in the essential laboratory and analytical use exemption
at Appendix G to subpart A of 40 CFR part 82 on December 27, 2007 (72
FR 73264).
In November 2009, at the 21st MOP, the Parties in Decision XXI/6
extended the global laboratory and analytical use exemption through
December 31, 2014. Based on this decision, EPA amended the regulation
at 40 CFR 82.8(b) to extend the essential laboratory and analytical use
exemption through December 31, 2014 (76 FR 77909, December 15, 2011).
Decision XXI/6 also notes laboratory and analytical uses of ODS for
which the TEAP and its Chemicals Technical Options Committee (CTOC),
determined that alternative procedures exist. However, the Parties did
not exclude any of those procedures from the exemption for laboratory
and analytical uses.
At the July 2014 Open Ended Working Group meeting of the Montreal
Protocol, the United States Government submitted a draft Decision to
extend the global laboratory and analytical use exemption through
December 31, 2021. This draft Decision is available in the docket to
this rule. The Parties will decide whether to extend the exemption at
their next Meeting of the Parties in November 2014.
A detailed discussion of the laboratory and analytical uses of ODS
can be found in the regulation issued by EPA on March 13, 2001 (66 FR
14760). That rule also discusses how 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,
due to the Appendix G requirements for small quantity and high purity.
For example, class I ODS must be sold in cylinders three liters or
smaller or in glass ampoules 10 milliliter or smaller. Since issuing
the original exemption, EPA has not received information that would
suggest otherwise.
U.S. production and consumption of ODS under the laboratory and
analytical use exemption is on a general decline, indicating that many
users have been able to transition from ozone-depleting substances.
However, 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, EPA
is proposing to extend this exemption through December 31, 2021.
EPA believes an extension of seven years is warranted, as it is
unlikely that non-ODS replacements will be in place for all laboratory
and analytical uses prior to that time. An extension of this length
would also minimize uncertainty for stakeholders and promote
administrative efficiency. EPA recognizes that the Parties may not
agree to extend the exemption or may agree to an expiration date that
is earlier than December 31, 2021. In either event, EPA will not adopt
a final rule containing an extension beyond that agreed by the Parties.
EPA welcomes comment on a variety of potential scenarios including
no extension or an extension shorter than seven years. While there is
uncertainty about the length of the extension, EPA believes it is
appropriate to propose this rule prior to action being taken by the
Parties to the Protocol to avoid a significant gap in the availability
of this exemption. Because the Parties will not take a Decision until
November 2014, EPA is requesting public input now so as to be able to
finalize an extension shortly after the Meeting of the Parties. EPA
notes that if the exemption lapses, stocks of existing class I ODS
produced or imported under the exemption can continue to be sold by
distributors and used by laboratories as the prohibition applies only
to the production and import of class I ODS.
EPA is also seeking comment from standards organizations that
either continue to use ODS in their standards or that have developed
new standards. Similarly, EPA is interested in comment from
laboratories that continue to use ODS or that have transitioned to
ozone-safe alternatives.
III. Statutory and Executive Order Reviews
Additional information about these statutes and Executive Orders
can be found at https://www2.epa.gov/laws-regulations/laws-and-executive-orders.
A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulation and Regulatory Review
This action is not a significant regulatory action and was
therefore not submitted to the Office of Management and Budget (OMB)
for review.
B. Paperwork Reduction Act (PRA)
This action does not impose any new information collection burden
under the PRA. OMB has previously approved the information collection
activities contained in the existing regulations and has assigned OMB
control number 2060-0170. This action extends but does not modify the
existing exemption from the phaseout of class I ODS.
C. Regulatory Flexibility Act
I certify that this action will not have a significant economic
impact on a substantial number of small entities under the RFA. In
making this determination, the impact of concern is any significant
adverse economic impact on small entities. 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, has no
net burden or otherwise has a positive economic effect on 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.
We have therefore concluded that this action will relieve
[[Page 66682]]
regulatory burden for all directly regulated small entities.
D. Unfunded Mandates Reform Act
This action does not contain any unfunded mandate as described in
UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect
small governments. The action imposes no enforceable duty on any state,
local or tribal governments or the private sector. This action merely
extends the essential laboratory and analytical use exemption from the
1996 and 2005 phaseouts of class I ODS production and consumption until
December 31, 2021.
E. Executive Order 13132: Federalism
This action 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.
F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments
This action does not have tribal implications as specified in
Executive Order 13175. This rule does not significantly or uniquely
affect the communities of Indian tribal governments, nor does it impose
any enforceable duties on communities of Indian tribal governments.
This action would extend the essential laboratory and analytical use
exemption from the 1996 and 2005 phaseouts of class I ODS production
and consumption until December 31, 2021. Thus, Executive Order 13175
does not apply to this action.
G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks
EPA interprets Executive Order 13045 as applying only to those
regulatory actions that concern environmental health or safety risks
that the agency has reason to believe may disproportionately affect
children, per the definition of ``covered regulatory action'' in
section 2-202 of the Executive Order. This action is not subject to
Executive Order 13045 because it does not concern an environmental
health risk or safety risk.
H. Executive Order 13211: Actions That Significantly Affect Energy
Supply, Distribution, or Use
This action is not subject to Executive Order 13211, because it is
not a significant regulatory action under Executive Order 12866.
I. National Technology Transfer and Advancement Act
This rulemaking does not involve technical standards.
J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority
Populations and Low-Income Populations
EPA believes the human health or environmental risk addressed by
this action will not have potential disproportionately high and adverse
human health or environmental effects on minority, low-income, or
indigenous 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.
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: October 31, 2014.
Gina McCarthy,
Administrator.
For the reasons set out in the preamble, 40 CFR part 82 is proposed
to be 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.
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, 2021, subject to the restrictions in appendix G of this
subpart, and subject to the recordkeeping and reporting requirements at
Sec. 82.13(u) through (x). There is no amount specified for this
exemption.
* * * * *
[FR Doc. 2014-26530 Filed 11-7-14; 8:45 am]
BILLING CODE 6560-50-P