Document ID: EPA-HQ-OAR-2010-0672-0001
Agency: epa
Document Type: Proposed Rule
Title: Protection of Stratospheric Ozone: Extension of Global Laboratory and Analytical Use Exemption for Essential Class I Ozone-Depleting Substances
Posted Date: 2011-07-15T04:00Z

[Federal Register Volume 76, Number 136 (Friday, July 15, 2011)]
[Proposed Rules]
[Pages 41747-41751]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-17905]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 82

[EPA-HQ-OAR-2010-0672; FRL-9439-3]
RIN 2060-AQ39

Protection of Stratospheric Ozone: Extension of Global Laboratory 
and Analytical Use Exemption for Essential Class I Ozone-Depleting 
Substances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing to extend the global laboratory and 
analytical use exemption for the production and import of Class I 
ozone-depleting substances through December 31, 2014, consistent with 
the recent actions by the

[[Page 41748]]

Parties to the Montreal Protocol on Substances that Deplete the Ozone 
Layer. The exemption allows persons in the United States to produce and 
import controlled substances for laboratory and analytical uses that 
have not been already identified by EPA as nonessential. EPA is also 
seeking comment on adding to the list of procedures that are excluded 
from the exemption uses that are noted in Decision XXI/6 (from the 
21\st\ Meeting of the Parties [MOP] to the Montreal Protocol). EPA is 
not proposing to add these procedures at this time.

DATES: Written comments on this proposed rule must be received by the 
EPA Docket on or before September 13, 2011.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
OAR-2010-0672, by one of the following methods:
     http://www.regulations.gov: Follow the on-line 
instructions for submitting comments.
     E-mail: a-and-r-Docket@epa.gov.
     Fax: 202-566-1741.
     Mail: Docket EPA-HQ-OAR-2010-0672, Air and Radiation 
Docket and Information Center, U.S. Environmental Protection Agency, 
Mail code: 6102T, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
     Hand Delivery: Docket EPA-HQ-OAR-2010-0672, Air and 
Radiation Docket at EPA West, 1301 Constitution Avenue, NW., Room B108, 
Washington, DC 20460. Such deliveries are only accepted during the 
Docket's normal hours of operation, and special arrangements should be 
made for deliveries of boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-OAR-
2010-0672. EPA's policy is that all comments received will be included 
in the public docket without change and may be made available online at 
http://www.regulations.gov, including any personal information 
provided, unless the comment includes information claimed to be 
Confidential Business Information (CBI) or other information whose 
disclosure is restricted by statute. Do not submit information that you 
consider to be CBI or otherwise protected through http://www.regulations.gov or e-mail. The http://www.regulations.gov Web site 
is an ``anonymous access'' system, which means EPA will not know your 
identity or contact information unless you provide it in the body of 
your comment. If you send an e-mail comment directly to EPA without 
going through www.regulations.gov, your e-mail address will be 
automatically captured and included as part of the comment that is 
placed in the public docket and made available on the Internet. If you 
submit an electronic comment, EPA recommends that you include your name 
and other contact information in the body of your comment and with any 
disk or CD-ROM you submit. If EPA cannot read your comment due to 
technical difficulties and cannot contact you for clarification, EPA 
may not be able to consider your comment. Electronic files should avoid 
the use of special characters, any form of encryption, and be free of 
any defects or viruses. For additional information about EPA's public 
docket, visit the EPA Docket Center homepage at http://www.epa.gov/epahome/dockets.htm.

FOR FURTHER INFORMATION CONTACT: Ifeyinwa Davis by regular mail: U.S. 
Environmental Protection Agency, Stratospheric Protection Division 
(6205J), 1200 Pennsylvania Avenue, NW., Washington, DC 20460; by 
courier service or overnight express: 1301 L Street, NW., Workstation 
1027N, Washington, DC 20005; by telephone: 202-343-9234; or by e-mail: 
davis.ifeyinwa@epa.gov. You may also visit the EPA's Ozone Protection 
Web site at http://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:

Table of Contents

I. General Information
    A. What should I consider when preparing my comments?
II. Extension of the Global Laboratory and Analytical Use Exemption
III. Statutory and Executive Order Reviews
    A. Executive Order 12866: Regulatory Planning and Review and 
Executive Order 13563: Improving Regulation and Regulatory Review
    B. Paperwork Reduction Act
    C. Regulatory Flexibility Act
    D. Unfunded Mandates Reform Act
    E. Executive Order 13132: Federalism
    F. Executive Order 13175: Consultation and Coordination With 
Indian Tribal Governments
    G. Executive Order 13045: Protection of Children From 
Environmental Health Risks and Safety Risks
    H. Executive Order 13211: Actions That Significantly Affect 
Energy Supply, Distribution, or Use
    I. National Technology Transfer and Advancement Act
    J. Executive Order 12898: Federal Actions To Address 
Environmental Justice in Minority Populations and Low-Income 
Populations

I. General Information

A. What should I consider when preparing my comments?

    1. Confidential Business Information. Do not submit confidential 
business information (CBI) to EPA through http://www.regulations.gov or 
e-mail. Clearly mark the part or all of the information that you claim 
to be CBI. For CBI information in a disk or CD-ROM that you mail to 
EPA, mark the outside of the disk or CD-ROM as CBI and then identify 
electronically within the disk or CD-ROM the specific information that 
is claimed as CBI. In addition to one complete version of the comment 
that includes information claimed as CBI, a copy of the comment that 
does not contain the information claimed as CBI must be submitted for 
inclusion in the public docket. Information so marked will not be 
disclosed except in accordance with procedures set forth in 40 CFR part 
2.
    2. Tips for Preparing Your Comments. When submitting comments, 
remember to:
     Identify the rulemaking by docket number and other 
identifying information (subject heading, Federal Register date, and 
page number).
     Follow directions--The agency may ask you to respond to 
specific questions or organize comments by referencing a Code of 
Federal Regulations (CFR) part or section number.
     Explain why you agree or disagree; suggest alternatives 
and substitute language for your requested changes.
     Describe any assumptions and provide any technical 
information and/or data that you used.
     If you estimate potential costs or burdens, explain how 
you arrived at your estimate in sufficient detail to allow for it to be 
reproduced.
     Provide specific examples to illustrate your concerns, and 
suggest alternatives.
     Explain your views as clearly as possible, avoiding the 
use of profanity or personal threats.
     Make sure to submit your comments by the comment period 
deadline identified.

II. Extension of the Global Laboratory and Analytical Use Exemption

    The Montreal Protocol on Substances that Deplete the Ozone Layer 
(Montreal Protocol) is the international agreement to reduce and 
eventually eliminate the production and consumption\1\ of ozone-

[[Page 41749]]

depleting substances (ODS). The elimination of production and 
consumption of ODSs is accomplished through adherence to phaseout 
schedules for specific controlled substances. Section 604 of the Clean 
Air Act requires EPA to promulgate regulations phasing out production 
and consumption of Class I ODS according to a prescribed schedule. EPA 
has accelerated this phaseout schedule pursuant to Section 606 of the 
Clean Air Act, which requires the Agency to promulgate an accelerated 
phaseout schedule in response to Montreal Protocol modifications that 
accelerate the international phaseout. EPA's phaseout regulations for 
ODS are codified at 40 CFR part 82, subpart A. As of January 1, 1996, 
production and import of most Class I controlled substances--including 
chlorofluorocarbons (CFCs), halons, carbon tetrachloride, and methyl 
chloroform\2\--were phased out in developed countries, including the 
United States.
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    \1\ ``Consumption'' is defined as the amount of a substance 
produced in the United States, plus the amount imported into the 
United States, minus the amount exported 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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    However, the Montreal Protocol provides exemptions that allow for 
the continued import and/or production of ODSs for specific uses. Under 
the Montreal Protocol, for most Class I ODSs, the Parties may 
collectively grant exemptions to the ban on production and import of 
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 is essential only if (1) it is 
necessary for the health, safety or is critical for the functioning of 
society (encompassing cultural and intellectual aspects), and (2) there 
are no available technically and economically feasible alternatives or 
substitutes that are acceptable from the standpoint of environment and 
health.
    Decision X/19 (taken in 1998) allowed a general exemption for 
essential laboratory and analytical uses through December 31, 2005. EPA 
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 the final rule of 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 this 
exclusion 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 approved ODSs 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. Decision XXI/6 lists laboratory and analytical uses 
of ODSs for which the TEAP and its Chemicals Technical Options 
Committee (CTOC), determined that alternative procedures exist. 
However, the Parties did not exclude any additional procedures from the 
exemption for laboratory and analytical uses. The Parties asked the 
TEAP and the CTOC to continue to consider possible alternatives and 
report back to the Parties.
    EPA's regulations regarding this exemption at 40 CFR 82.8(b) 
currently state, ``A global exemption for Class I controlled substances 
for essential laboratory and analytical uses shall be in effect through 
December 31, 2011, 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.'' Because certain laboratory procedures continue to require 
the use of Class I substances in the United States, because non-ODS 
replacements for the Class I substances have not been identified for 
all uses, and because the Parties, via Decision XXI/6, extended this 
exemption through December 31, 2014, EPA is proposing to revise 40 CFR 
82.8(b) to reflect the extension of the exemption to December 31, 2014. 
For a more detailed discussion of the reasons for the exemption, refer 
to the March 13, 2001, final rule (66 FR 14760). As discussed in the 
March 2001 rule, 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.
    EPA is seeking comment on adding to the list of procedures that are 
excluded from the exemption under 40 CFR part 82, appendix G. EPA is 
not proposing to add these procedures at this time. The following uses 
are noted in Decision XXI/6 as being laboratory and analytical 
procedures for which the TEAP and its CTOC have concluded that 
alternatives exist.

(a) Analyses in which the ODS is used as a solvent for spectroscopic 
measurements:
    (i) of hydrocarbons (oil and grease) in water or soil
    (ii) of simethicone (polydimethylsiloxane)
    (iii) when recording infrared and nuclear magnetic resonance 
(NMR) spectra, including hydroxyl index
(b) Analyses in which the ODS is used as a solvent for 
electrochemical methods of analysis of:
    (i) cyanocobalamin
    (ii) bromine index
(c) Analyses involving selective solubility in the ODS of:
    (i) cascarosides
    (ii) thyroid extracts
    (iii) polymers
(d) Analyses in which the ODS is used to preconcentrate the analyte, 
for:
    (i) liquid chromatography (HPLC) of drugs and pesticides
    (ii) gas chromatography of organic chemicals such as steroids
    (iii) adsorption chromatography of organic chemicals
(e) Titration of iodine with thiosulfate (iodometric analyses) for 
determination of:
    (i) iodine
    (ii) copper
    (iii) arsenic
    (iv) sulphur
(f) Iodine and bromine index measurements (titrations)
(g) Miscellaneous analyses, namely
    (i) stiffness of leather
    (ii) jellification point
    (iii) specific weight of cement

[[Page 41750]]

    (iv) gas mask cartridge breakthrough
(h) Use of ODS as a solvent in organic chemical reactions
    (i) O- and N-difluoromethylation
(i) General use as laboratory solvent, namely
    (i) washing of NMR tubes
    (ii) removal of greases from glassware

EPA is seeking comment on whether alternative procedures exist in the 
United States for each of these laboratory applications. EPA notes that 
unlike the procedures already listed in Appendix G to 40 CFR part 82, 
the list developed by the TEAP and its CTOC has not been adopted by the 
Parties to the Montreal Protocol. Commenters should be aware that if 
EPA were to add these procedures to the list of procedures that are 
excluded from the exemption in Appendix G, then no further production 
or import of ODS for these laboratory procedures would be permitted. In 
the supply chain, ODS distributors would not be able to obtain 
quantities for those purposes.

    EPA is seeking comments on today's proposal and the alternative 
approach described above, noting that the path forward for the general 
exemption for laboratory and analytical procedures under the Montreal 
Protocol is not clear. The Parties to the Montreal Protocol could 
decide between now and December 31, 2014, to exclude additional 
procedures from the general exemption; to replace the general exemption 
with a list of specifically approved procedures; or not to extend the 
exemption beyond December 31, 2014.

III. Statutory and Executive Order Reviews

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'' under the 
terms of Executive Order (EO) 12866 (58 FR 51735, October 4, 1993) and 
is therefore not subject to review under Executive Order 12866 and 
13563 (76 FR 3821, January 21, 2011).

B. Paperwork Reduction Act

    This action does not impose any new information collection burden. 
This action extends the existing global laboratory and analytical use 
exemption allowing the production and import of Class I ozone-depleting 
substances until December 31, 2014. The Office of Management and Budget 
(OMB) has previously approved the information collection requirements 
contained in the existing regulations at 40 CFR 82.8(a) under the 
provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. and 
has assigned OMB control number 2060-0170. The OMB control numbers for 
EPA's regulations in 40 CFR part 82 are listed in 40 CFR part 9.

C. Regulatory Flexibility Act

    The RFA generally requires an agency to prepare a regulatory 
flexibility analysis of any rule subject to notice and comment 
rulemaking requirements under the Administrative Procedure Act or any 
other statute unless the agency certifies that the rule will not have a 
significant economic impact on a substantial number of small entities. 
Small entities include small businesses, small organizations, and small 
governmental jurisdictions.
    For purposes of assessing the impact of today's proposed rule on 
small entities, small entity is defined as: (1) Pharmaceutical 
preparations manufacturing businesses (NAICS code 325412) that have 
fewer than 750 employees; (2) a small governmental jurisdiction that is 
a government of a city, county, town, school district or special 
district with a population of less than 50,000; and (3) a small 
organization that is any not-for-profit enterprise which is 
independently owned and operated and is not dominant its field.
    After considering the economic impacts of today's proposed rule on 
small entities, I certify that this action will not have a significant 
economic impact on a substantial number of small entities. In 
determining whether a rule has a significant economic impact on a 
substantial number of small entities, the impact of concern is any 
significant adverse economic impact on small entities, since the 
primary purpose of the regulatory flexibility analyses is to identify 
and address regulatory alternatives ``which minimize any significant 
economic impact of the rule on small entities.'' 5 U.S.C. 603 and 604. 
Thus, an agency may certify that a rule will not have a significant 
economic impact on a substantial number of small entities if the rule 
relieves regulatory burden, or otherwise has a positive economic effect 
on all of the small entities subject to the rule.
    This action, once finalized, will provide an otherwise unavailable 
benefit to those companies that obtain ozone-depleting substances under 
the essential laboratory and analytical use exemption. We have 
therefore concluded that today's proposed rule will relieve regulatory 
burden for all small entities. We continue to be interested in the 
potential impact of the proposed rule on small entities and welcome 
comments on issues related to such impacts.

D. Unfunded Mandates Reform Act

    This action contains no Federal mandates under the provisions of 
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), 2 U.S.C. 
1531-1538 for State, local, or tribal governments or the private 
sector. 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 until December 31, 2014. Therefore, this 
action is not subject to the requirements of sections 202 or 205 of the 
UMRA. This action is also not subject to the requirements of section 
203 of UMRA because it contains no regulatory requirements that might 
significantly or uniquely affect small governments.

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, as 
specified in Executive Order 13132. This action merely extends the 
essential laboratory and analytical use exemption from the 1996 and 
2005 phaseouts of Class I ODS until December 31, 2014. Thus, Executive 
Order 13132 does not apply to this action. In the spirit of Executive 
Order 13132, and consistent with EPA policy to promote communications 
between EPA and State and local governments, EPA specifically solicits 
comment on this proposed action from State and local officials.

F. Executive Order 13175: Consultation and Coordination With Indian 
Tribal Governments

    This action does not have tribal implications, as specified in 
Executive Order 13175 (65 FR 67249, November 9, 2000). 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 merely extends the essential 
laboratory and analytical use exemption from the 1996 and 2005 
phaseouts of Class I ODS until December 31, 2014. Thus, Executive Order 
13175 does not apply to this action. EPA specifically solicits 
additional comment on this proposed action from tribal officials.

[[Page 41751]]

G. Executive Order 13045: Protection of Children From Environmental 
Health Risks and Safety Risks

    EPA interprets EO 13045 (62 FR 19885, April 23, 1997) as applying 
only to those regulatory actions that concern health or safety risks, 
such that the analysis required under section 5-501 of the EO has the 
potential to influence the regulation. This action is not subject to EO 
13045 because it does not establish an environmental standard intended 
to mitigate health or safety risks.

H. Executive Order 13211: Actions That Significantly Affect Energy 
Supply, Distribution, or Use

    This proposed rule is not a ``significant energy action'' as 
defined in Executive Order 13211, ``Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use'' (66 FR 28355 
(May 22, 2001)) because it is not likely to have a significant adverse 
effect on the supply, distribution, or use of energy. This proposed 
rule does not pertain to any segment of the energy production economy 
nor does it regulate any manner of energy use. Therefore, we have 
concluded that this proposed rule is not likely to have any adverse 
energy effects.

I. National Technology Transfer and Advancement Act

    Section 12(d) of the National Technology Transfer and Advancement 
Act of 1995 (``NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 
note) directs EPA to use voluntary consensus standards in its 
regulatory activities unless to do so would be inconsistent with 
applicable law or otherwise impractical. Voluntary consensus standards 
are technical standards (e.g., materials specifications, test methods, 
sampling procedures, and business practices) that are developed or 
adopted by voluntary consensus standards bodies. The NTTAA directs EPA 
to provide Congress, through OMB, explanations when the Agency decides 
not to use available and applicable voluntary consensus standards. This 
proposed rule does not involve technical standards. Therefore, EPA is 
not considering the use of any voluntary consensus standards.

J. Executive Order 12898: Federal Actions To Address Environmental 
Justice in Minority Populations and Low-Income Populations

    Executive Order (EO) 12898 (59 FR 7629 (Feb. 16, 1994)) establishes 
federal executive policy on environmental justice. Its main provision 
directs federal agencies, to the greatest extent practicable and 
permitted by law, to make environmental justice part of their mission 
by identifying and addressing, as appropriate, disproportionately high 
and adverse human health or environmental effects of their programs, 
policies, and activities on minority populations and low-income 
populations in the United States.
    EPA has determined that this proposed rule will not have 
disproportionately high and adverse human health or environmental 
effects on minority or low-income populations because it will 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: July 8, 2011.
Lisa P. Jackson,
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:

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, 2014, 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. 2011-17905 Filed 7-14-11; 8:45 am]
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