
[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]


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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.

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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

[[Page 3886]]

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 http://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


