Protection of Stratospheric Ozone: Extension of the Laboratory and Analytical Use Exemption for Essential Class I Ozone-Depleting Substances, 3885-3888 [2015-01295]
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Federal Register / Vol. 80, No. 16 / Monday, January 26, 2015 / Rules and Regulations
EPA APPROVED NEW MEXICO REGULATIONS—Continued
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into the SIP:
G. ‘‘Carbon dioxide’’
M. ‘‘Greenhouse gas’’
O. ‘‘Hydrofluorocarbons’’
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[FR Doc. 2015–00774 Filed 1–23–15; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 82
[EPA–HQ–OAR–2014–0621; FRL–9921–52–
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.
Final rule.
ACTION:
This rule extends the
laboratory and analytical use exemption
for the production and import of class
I ozone-depleting substances through
December 31, 2021. The Environmental
Protection Agency (EPA) is taking this
action under the Clean Air Act,
consistent with a recent decision of 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.
SUMMARY:
DATES:
This rule is effective January 26,
2015.
EPA has established a
docket for this action under Docket ID
No. EPA–HQ–OAR–2014–0621. 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.
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ADDRESSES:
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Certain other material, such as
copyrighted material, is not placed on
the Internet and is 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
20004. 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: 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)(1) 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.’’ 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
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making this rule effective on January 26,
2015. APA section 553(d) allows an
effective date less than 30 days after
publication for a rule that ‘‘that grants
or recognizes an exemption or relieves
a restriction.’’ 5 U.S.C. 553(d)(1). Since
today’s action grants an exemption for
limited laboratory and analytical uses
from the general prohibition on
production or import of Class I ozone
depleting substances after their
phaseout dates, EPA is making this
action effective immediately upon
publication.
I. General Information
A. Does this action apply to me?
Entities potentially regulated by this
action 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.
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
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production and consumption 1 of ozonedepleting substances (ODS). This goal is
accomplished through adherence by
each country that is a Party to the
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 (CAA or Act)—
including chlorofluorocarbons (CFCs),
carbon tetrachloride, and methyl
chloroform 2—were to be 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
general exemption for essential
laboratory and analytical uses through
December 31, 2005. EPA codified this
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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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.
In November 2014, the Parties in
Decision XXVI/5 extended the global
laboratory and analytical use exemption
through December 31, 2021. This final
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rule extends the laboratory and
analytical use exemption found in 40
CFR 82.8(b) to match the recent
international decision.
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
milliliters or smaller. Since issuing the
original exemption, EPA has not
received information that would suggest
a significant environmental effect from
this exemption.
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 extending
this exemption through December 31,
2021.
EPA received one substantive
comment in response to the proposed
rule, which was supportive of extending
the exemption through December 31,
2021. The commenter, a manufacturer of
ozone-depleting substances used as
solvents under the exemption, agreed
that non-ODS replacements for class I
substances have not been identified, and
stated that the low volume of usage of
these chemicals and their exclusive use
in professionally managed analytical
laboratories means there is very low risk
that environmental damage will occur.
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. Decision XXVI/5
encourages parties to continue to
investigate the possibility of replacing
ozone-depleting substances in
laboratory and analytical uses. EPA did
not receive comments from standards
organizations that continue to use ODS
in their standards or from laboratories
that have transitioned to ozone-safe
alternatives. EPA intends to continue to
work to investigate barriers to
transitioning from ozone-depleting
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E. Executive Order 13132: Federalism
substances to alternatives for this
limited use.
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
regulatory burden for all directly
regulated small entities.
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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.
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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
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. Thus, Executive
Order 13175 does not apply to this
action.
G. Executive Order 13045: Protection of
Children From Environmental Health
Risks and Safety Risks
This action is not subject to Executive
Order 13045 because it is not
economically significant as defined in
Executive Order 12866, and because
EPA does not believe the environmental
health or safety risks addressed by this
action present a disproportionate risk to
children. A discussion of this action’s
health and risk effects are contained in
the direct final rule establishing the De
Minimis Exemption for Laboratory
Essential Uses (66 FR 14760; March 13,
2001). 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.
H. Executive Order 13211: Actions That
Significantly Affect Energy Supply,
Distribution, or Use
3887
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.
K. Congressional Review Act (CRA)
This action is subject to the CRA, and
EPA will submit a rule report to each
House of the Congress and to the
Comptroller General of the United
States. The CRA allows the issuing
agency to make a rule effective sooner
than otherwise provided by the CRA if
the agency makes a good cause finding
that notice and comment rulemaking
procedures are impracticable,
unnecessary or contrary to the public
interest (5 U.S.C. 808(2)). The EPA has
made a good cause finding for this rule
as discussed in the Supplementary
Information section of the preamble,
including the basis for that finding.
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: January 16, 2015.
Gina McCarthy,
Administrator.
For the reasons set out in the
preamble, 40 CFR part 82 is amended as
follows:
PART 82—PROTECTION OF
STRATOSPHERIC OZONE
1. The authority citation for part 82
continues to read as follows:
■
This action is not subject to Executive
Order 13211, because it is not a
significant regulatory action under
Executive Order 12866.
Authority: 42 U.S.C. 7414, 7601, 7671–
7671q.
I. National Technology Transfer and
Advancement Act
§ 82.8 Grant of essential use allowances
and critical use allowances.
This rulemaking does not involve
technical standards.
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2. Amend § 82.8 by revising paragraph
(b) to read as follows:
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(b) A global exemption for class I
controlled substances for essential
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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.
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[FR Doc. 2015–01295 Filed 1–23–15; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 271
[EPA–R04–RCRA–2014–0710; FRL–9921–
90–Region 4]
Georgia: Final Authorization of State
Hazardous Waste Management
Program Revisions
Environmental Protection
Agency (EPA).
ACTION: Direct final rule.
AGENCY:
Georgia has applied to the
Environmental Protection Agency (EPA)
for final authorization of changes to its
hazardous waste program under the
Resource Conservation and Recovery
Act (RCRA). EPA has determined that
these changes satisfy all requirements
needed to qualify for final authorization,
and is authorizing the State’s changes
through this direct final rule. In the
‘‘Proposed Rules’’ section of today’s
Federal Register, EPA is also publishing
a separate document that serves as the
proposal to authorize these changes.
EPA believes this action is not
controversial and does not expect
comments that oppose it. Unless EPA
receives written comments that oppose
this authorization during the comment
period, the decision to authorize
Georgia’s changes to its hazardous waste
program will take effect. If EPA receives
comments that oppose this action, EPA
will publish a document in the Federal
Register withdrawing today’s direct
final rule before it takes effect, and the
separate document published in today’s
‘‘Proposed Rules’’ section of this
Federal Register will serve as the
proposal to authorize the changes.
DATES: This final authorization will
become effective on March 27, 2015
unless EPA receives adverse written
comment by February 25, 2015. If EPA
receives such comment, EPA will
publish a timely withdrawal of this
direct final rule in the Federal Register
and inform the public that this
authorization will not take effect.
ADDRESSES: Submit your comments,
identified by Docket ID No. EPA–R04–
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SUMMARY:
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RCRA–2014–0710, by one of the
following methods:
• Federal eRulemaking Portal:
www.regulations.gov. Follow the on-line
instructions for submitting comments.
• Email: gleaton.gwen@epa.gov.
• Fax: (404) 562–9964 (prior to
faxing, please notify the EPA contact
listed below).
• Mail: Send written comments to
Gwendolyn Gleaton, Permits and State
Programs Section, RCRA Programs and
Materials Management Branch, RCRA
Division, U.S. Environmental Protection
Agency, Atlanta Federal Center, 61
Forsyth Street SW., Atlanta, Georgia
30303–8960.
• Hand Delivery or Courier: Deliver
your comments to Gwendolyn Gleaton,
Permits and State Programs Section,
RCRA Programs and Materials
Management Branch, RCRA Division,
U.S. Environmental Protection Agency,
Atlanta Federal Center, 61 Forsyth
Street SW., Atlanta, Georgia 30303–
8960. Such deliveries are only accepted
during the Regional Office’s normal
hours of operation, and special
arrangements should be made for
deliveries of boxed information.
Instructions: EPA must receive your
comments by February 25, 2015. Direct
your comments to Docket ID No. EPA–
R04–RCRA–2014–0710. 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 publicly 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
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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
www.epa.gov/epahome/dockets.htm).
Docket: All documents in the docket
are listed in the 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
www.regulations.gov, or in hard copy.
You may view and copy Georgia’s
application and associated publicly
available materials from 8:00 a.m. to
4:00 p.m. at the following locations:
EPA, Region 4, RCRA Division, Atlanta
Federal Center, 61 Forsyth Street SW.,
Atlanta, Georgia 30303–8960; telephone
number: (404) 562–8500; and the
Georgia Department of Natural
Resources, Environmental Protection
Division, 2 Martin Luther King Jr. Drive,
Suite 1154 East Tower, Atlanta, Georgia
30334–4910; telephone number: (404)
656–2833. Interested persons wanting to
examine these documents should make
an appointment with the office at least
a week in advance.
FOR FURTHER INFORMATION CONTACT:
Gwendolyn Gleaton, Permits and State
Programs Section, RCRA Programs and
Materials Management Branch, RCRA
Division, U.S. Environmental Protection
Agency, Atlanta Federal Center, 61
Forsyth Street SW., Atlanta, Georgia
30303–8960; telephone number: (404)
562–8500; fax number: (404) 562–9964;
email address: gleaton.gwen@epa.gov.
SUPPLEMENTARY INFORMATION:
A. Why are revisions to State programs
necessary?
States which have received final
authorization from EPA under RCRA
section 3006(b), 42 U.S.C. 6926(b), must
maintain a hazardous waste program
that is equivalent to, consistent with,
and no less stringent than the Federal
program. As the Federal program
changes, States must change their
programs and ask EPA to authorize the
changes. Changes to State programs may
be necessary when Federal or State
statutory or regulatory authority is
modified or when certain other changes
occur. Most commonly, States must
change their programs because of
changes to EPA’s regulations in 40 Code
of Federal Regulations (CFR) parts 124,
260 through 268, 270, 273, and 279.
New Federal requirements and
prohibitions imposed by Federal
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]]>Agencies
[Federal Register Volume 80, Number 16 (Monday, January 26, 2015)]
[Rules and Regulations]
[Pages 3885-3888]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-01295]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 82
[EPA-HQ-OAR-2014-0621; FRL-9921-52-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: Final rule.
-----------------------------------------------------------------------
SUMMARY: This rule extends the laboratory and analytical use exemption
for the production and import of class I ozone-depleting substances
through December 31, 2021. The Environmental Protection Agency (EPA) is
taking this action under the Clean Air Act, consistent with a recent
decision of 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: This rule is effective January 26, 2015.
ADDRESSES: EPA has established a docket for this action under Docket ID
No. EPA-HQ-OAR-2014-0621. 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 is 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 20004. 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: 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)(1) 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.'' 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 26, 2015.
APA section 553(d) allows an effective date less than 30 days after
publication for a rule that ``that grants or recognizes an exemption or
relieves a restriction.'' 5 U.S.C. 553(d)(1). Since today's action
grants an exemption for limited laboratory and analytical uses from the
general prohibition on production or import of Class I ozone depleting
substances after their phaseout dates, EPA is making this action
effective immediately upon publication.
I. General Information
A. Does this action apply to me?
Entities potentially regulated by this action 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.
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
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production and consumption \1\ of ozone-depleting substances (ODS).
This goal is accomplished through adherence by each country that is a
Party to the 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 (CAA or
Act)--including chlorofluorocarbons (CFCs), carbon tetrachloride, and
methyl chloroform \2\--were to be 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.
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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 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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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
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.
In November 2014, the Parties in Decision XXVI/5 extended the
global laboratory and analytical use exemption through December 31,
2021. This final rule extends the laboratory and analytical use
exemption found in 40 CFR 82.8(b) to match the recent international
decision.
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 milliliters or smaller. Since issuing
the original exemption, EPA has not received information that would
suggest a significant environmental effect from this exemption.
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 extending this exemption through December 31, 2021.
EPA received one substantive comment in response to the proposed
rule, which was supportive of extending the exemption through December
31, 2021. The commenter, a manufacturer of ozone-depleting substances
used as solvents under the exemption, agreed that non-ODS replacements
for class I substances have not been identified, and stated that the
low volume of usage of these chemicals and their exclusive use in
professionally managed analytical laboratories means there is very low
risk that environmental damage will occur.
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. Decision XXVI/5 encourages
parties to continue to investigate the possibility of replacing ozone-
depleting substances in laboratory and analytical uses. EPA did not
receive comments from standards organizations that continue to use ODS
in their standards or from laboratories that have transitioned to
ozone-safe alternatives. EPA intends to continue to work to investigate
barriers to transitioning from ozone-depleting
[[Page 3887]]
substances to alternatives for this limited use.
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 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 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. Thus, Executive Order 13175
does not apply to this action.
G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks
This action is not subject to Executive Order 13045 because it is
not economically significant as defined in Executive Order 12866, and
because EPA does not believe the environmental health or safety risks
addressed by this action present a disproportionate risk to children. A
discussion of this action's health and risk effects are contained in
the direct final rule establishing the De Minimis Exemption for
Laboratory Essential Uses (66 FR 14760; March 13, 2001). 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.
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.
K. Congressional Review Act (CRA)
This action is subject to the CRA, and EPA will submit a rule
report to each House of the Congress and to the Comptroller General of
the United States. The CRA allows the issuing agency to make a rule
effective sooner than otherwise provided by the CRA if the agency makes
a good cause finding that notice and comment rulemaking procedures are
impracticable, unnecessary or contrary to the public interest (5 U.S.C.
808(2)). The EPA has made a good cause finding for this rule as
discussed in the Supplementary Information section of the preamble,
including the basis for that finding.
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: January 16, 2015.
Gina McCarthy,
Administrator.
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.
0
2. Amend Sec. 82.8 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
[[Page 3888]]
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. 2015-01295 Filed 1-23-15; 8:45 am]
BILLING CODE 6560-50-P
