[Federal Register Volume 79, Number 217 (Monday, November 10, 2014)]
[Proposed Rules]
[Pages 66679-66682]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-26530]



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 

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: [email protected].
     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 http://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: [email protected]. 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.


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 
     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 
    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 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

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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

    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 

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,

    For the reasons set out in the preamble, 40 CFR part 82 is proposed 
to be amended as follows:


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 

Sec.  82.8  Grant of essential use allowances and critical use 

* * * * *
    (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 
* * * * *
[FR Doc. 2014-26530 Filed 11-7-14; 8:45 am]