Document ID: EPA-HQ-OAR-2010-0672-0017
Agency: epa
Document Type: Rule
Title: Protection of Stratospheric Ozone: Extension of the Laboratory and Analytical Use Exemption for Essential Class I Ozone-Depleting Substances
Posted Date: 2011-12-15T05:00Z

[Federal Register Volume 76, Number 241 (Thursday, December 15, 2011)]
[Rules and Regulations]
[Pages 77909-77913]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-32179]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 82

[EPA-HQ-OAR-2010-0672; FRL-9507-6]
RIN 2060-AQ39

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

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA is extending the laboratory and analytical use exemption 
for the production and import of Class I ozone-depleting substances 
through December 31, 2014. This action is taken under the Clean Air Act 
consistent with the recent 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: This action is effective on December 15, 2011.

ADDRESSES: EPA has established a docket for this action under Docket ID 
No. EPA-HQ-OAR-2010-0672. 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., 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 http://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 
(6205J), 1200 Pennsylvania Avenue NW., Washington, DC 20460; by courier 
service or overnight express: 1301 L Street NW., Washington, DC 20005; 
by telephone: (202) 343-9055; or by email: arling.jeremy@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: Section 553(d) of the Administrative 
Procedure Act (APA), 5 U.S.C. Chapter 5, generally

[[Page 77910]]

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 
December 15, 2011. APA section 553(d) allows an effective date less 
than 30 days after publication ``as otherwise provided by the agency 
for good cause found and published with the rule.'' As explained below, 
EPA finds that there is good cause for this rule to become effective on 
December 15, 2011, even though this results in an effective date fewer 
than 30 days from the date of publication in the Federal Register. The 
purpose of the 30-day waiting period prescribed in APA section 553(d) 
is to give affected parties a reasonable time to adjust their behavior 
and prepare before the final rule takes effect. This final rule extends 
an exemption from the phaseout of class I ozone depleting substances 
for limited laboratory and analytical uses that is set to expire on 
December 31, 2011. A shorter effective date in such circumstances is 
consistent with the purposes of APA section 553(d), which provides an 
exception for any action that grants or recognizes an exemption or 
relieves a restriction. Accordingly, we find good cause exists to make 
this rule effective December 15, 2011.

Table of Contents

I. Extension of the Laboratory and Analytical Use Exemption
II. 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
    K. Congressional Review Act

I. 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 Class I controlled substances--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 promulgate 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 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 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 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 also notes 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 of those procedures from the 
exemption for laboratory and analytical uses. The Parties asked the 
TEAP and the CTOC to continue to consider

[[Page 77911]]

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 proposed to revise 40 CFR 
82.8(b) to reflect the extension of the exemption to December 31, 2014. 
The EPA received two comments in total on the proposed rule, including 
the proposal to adopt the Parties' extension, one from a corporation 
(the company commenter) and one from a laboratory. The company 
commenter supported the proposed extension of the global laboratory use 
exemption through December 31, 2014, while the other commenter 
supported the extension insofar as it applied to the use of carbon 
tetrachloride. For a more detailed discussion of the reasons for the 
exemption, refer to the regulation issued March 13, 2001 (66 FR 14760). 
That rule 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. In the 
decade since EPA issued the exemption, EPA and has not received 
information that would suggest otherwise.
    In the proposed rule, EPA also sought comment on adding to the list 
of procedures that are excluded from the exemption under 40 CFR part 
82, appendix G. EPA did not propose 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;
    (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 sought comment on whether alternative procedures exist in the 
United States for each of these laboratory applications. EPA received 
comments from the same two commenters noted above regarding the use of 
carbon tetrachloride (CTC), which is an ODS, in analyses under section 
(a)(iii) of Decision XXI/6, which analyses are described above. Due to 
its unique properties (e.g. lack of carbon-hydrogen bonds, small but 
non-zero solubility), the commenters stated that CTC is used as a 
solvent in certain analytical measurements.
    The company commenter stated that the procedures listed in section 
(a)(iii) of Decision XXI/6 are standard spectroscopic procedures for 
which CTC is not required. Therefore, the commenter does not oppose the 
exclusion of those procedures from the exemption. The commenter did 
describe its own current use of the chemical for a proprietary method 
of hydroxyl analysis that does not fall under the analysis listed in 
section (a)(iii) and for which CTC would still be required.
    The laboratory commenter also discussed CTC's unique properties and 
commented that the continued use of CTC as a solvent is essential for 
some of the uses listed in section (a)(iii) of Decision XXI/6. It 
interpreted the Decision language quoted above as proposed regulatory 
language and requested that the following line be added to the 
potential exclusion that appears in paragraph (a)(iii) of the Decision: 
``Research applications for which there are no effective alternate 
solvents for carbon tetrachloride are not prohibited.''
    EPA did not propose to remove any of these procedures from the list 
of exempted uses of ODS and is not taking action in this final rule. 
However, EPA continues to be interested in laboratory uses of ODS for 
which there are no effective alternatives since this issue continues to 
be discussed by the Parties to the Protocol.

II. 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 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.

[[Page 77912]]

    For purposes of assessing the impact of today's rule on small 
entities, small entity is defined as: (1) A small business as defined 
by the Small Business Administration's regulations at 13 CFR 121.201; 
(2) pharmaceutical preparations manufacturing businesses (NAICS code 
325412) that have fewer than 750 employees; (3) 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 
(4) a small organization that is any not-for-profit enterprise which is 
independently owned and operated and is not dominant in its field.
    After considering the economic impacts of today's 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 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 today's rule will relieve regulatory burden for all small 
entities.

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 solicited 
comment on this 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 solicited comment 
on this action from tribal officials.

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 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 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 rule does not 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 
rule does not involve technical standards. Therefore, EPA did not 
consider 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 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.

[[Page 77913]]

K. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and to the Comptroller General of the 
United States. EPA will submit a report containing this rule and other 
required information to the U.S. Senate, the U.S. House of 
Representatives, and the Comptroller General of the United States prior 
to publication of the rule in the Federal Register. A ``major rule,'' 
as defined by 5 U.S.C. 804(2), cannot take effect until 60 days after 
it is published in the Federal Register. This action is not a ``major 
rule.'' This rule will be effective January 1, 2012.

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: December 9, 2011.
Lisa P. Jackson,
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. 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. 2011-32179 Filed 12-14-11; 8:45 am]
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