Source: https://regulations.justia.com/regulations/fedreg/2014/11/10/2014-26530.html
Timestamp: 2020-04-02 23:16:34
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Matched Legal Cases: ['art 52', 'art 82', 'art 82', 'art 2', 'art 82', 'Art. 2', 'Art. 2', 'Art. 2', 'Art. 2', 'Art. 2', 'art 82', 'art 82', 'art 82', 'art 82', 'art 82', 'art 82', 'ART 82', 'art 82', '§ 82', '§ 82', 'art 82', 'art 2', 'art 82', 'art 82', 'Art. 2', 'Art. 2', 'Art. 2', 'Art. 2', 'Art. 2', 'art 82', 'art 82', 'art 82', 'art 82']

Protection of Stratospheric Ozone: Extension of the Laboratory and Analytical Use Exemption for Essential Class I Ozone-Depleting Substances, 66679-66682 [2014-26530] :: Environmental Protection Agency :: Regulation Tracker :: Justia
Justia Regulation Tracker Environmental Protection Agency Protection of Stratospheric Ozone: Extension of the Laboratory and Analytical Use Exemption for Essential Class I Ozone-Depleting Substances, 66679-66682 [2014-26530]
Protection of Stratospheric Ozone: Extension of the Laboratory and Analytical Use Exemption for Essential Class I Ozone-Depleting Substances, 66679-66682 [2014-26530]
Download as PDF Federal Register / Vol. 79, No. 217 / Monday, November 10, 2014 / Proposed Rules Program, Part A, General Requirements and Applicability, and to Utah Rules R307–110–1 and R307–110–31. In addition, EPA is proposing approval of the January 28, 2014 submitted SIP revisions to Utah’s SIP Section X, Vehicle Inspection and Maintenance Program, Part F, Cache County, with clarification below, and to Utah Rule R307–110–36. EPA clarifies that with its proposed approval of Utah’s SIP Section X, Vehicle Inspection and Maintenance Program, Part F, Cache County, Appendix 2, the provisions in the BRHD’s Regulation 2013–1, Section 9.4.6 and the diesel test procedures as specified in BRHD’s Regulation 2013–1, Appendix D are being proposed for approval only for purposes of strengthening the SIP. These provisions are not being proposed for approval as a diesel I/M program and are not being assigned any SIP credit. rmajette on DSK2TPTVN1PROD with PROPOSALS IX. Statutory and Executive Order Reviews Under the Clean Air Act, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA’s role is to approve state choices, provided that they meet the criteria of the Clean Air Act. Accordingly, this action merely proposes to approve state law as meeting federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this proposed action: • Is not a ‘‘significant regulatory action’’ subject to review by the Office of Management and Budget under Executive Order 12866 (58 FR 51735, October 4, 1993); • Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.); • Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.); • Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104–4); • Does not have federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999); • Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997); VerDate Sep<11>2014 14:44 Nov 07, 2014 Jkt 235001 • Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001); • Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the Clean Air Act; and • Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994). In addition, this proposed rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because the SIP is not approved to apply in Indian country located in the state, and EPA notes that it will not impose substantial direct costs on tribal governments or preempt tribal law. List of Subjects in 40 CFR Part 52 Environmental protection, Air pollution control, Carbon monoxide, Intergovernmental relations, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements, and Volatile organic compounds. Authority: 42 U.S.C. 7401 et seq. Dated: October 20, 2014. Shaun L. McGrath, Regional Administrator, Region 8. [FR Doc. 2014–26630 Filed 11–7–14; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY 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 Substances Environmental Protection Agency. ACTION: Proposed rule. AGENCY: 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 SUMMARY: PO 00000 Frm 00021 Fmt 4702 Sfmt 4702 66679 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. 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: a-and-r-Docket@epa.gov. • 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 DATES: E:\FR\FM\10NOP1.SGM 10NOP1 66680 Federal Register / Vol. 79, No. 217 / Monday, November 10, 2014 / Proposed Rules 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: 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: rmajette on DSK2TPTVN1PROD with PROPOSALS 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 VerDate Sep<11>2014 14:44 Nov 07, 2014 Jkt 235001 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 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 Laboratory and Analytical Use Exemption The Montreal Protocol on Substances That Deplete the Ozone Layer (Montreal PO 00000 Frm 00022 Fmt 4702 Sfmt 4702 Protocol, or Protocol) is the international agreement to reduce and eventually eliminate the global production and consumption 1 of ozonedepleting 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. 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 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. E:\FR\FM\10NOP1.SGM 10NOP1 rmajette on DSK2TPTVN1PROD with PROPOSALS Federal Register / Vol. 79, No. 217 / Monday, November 10, 2014 / Proposed Rules 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. VerDate Sep<11>2014 14:44 Nov 07, 2014 Jkt 235001 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 PO 00000 Frm 00023 Fmt 4702 Sfmt 4702 66681 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 ozonesafe alternatives. III. Statutory and Executive Order Reviews Additional information about these statutes and Executive Orders can be found at http://www2.epa.gov/lawsregulations/laws-and-executive-orders. A. Executive Order 12866: Regulatory Planning and Review and Executive Order 13563: Improving Regulation and Regulatory Review This action is not a significant regulatory action and was therefore not submitted to the Office of Management and Budget (OMB) for review. B. Paperwork Reduction Act (PRA) This action does not impose any new information collection burden under the PRA. OMB has previously approved the information collection activities contained in the existing regulations and has assigned OMB control number 2060–0170. This action extends but does not modify the existing exemption from the phaseout of class I ODS. C. Regulatory Flexibility Act I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. In making this determination, the impact of concern is any significant adverse economic impact on small entities. An agency may certify that a rule will not have a significant economic impact on a substantial number of small entities if the rule relieves regulatory burden, has no net burden or otherwise has a positive economic effect on the small entities subject to the rule. This action provides an otherwise unavailable benefit to those companies that obtain ozone-depleting substances under the essential laboratory and analytical use exemption. We have therefore concluded that this action will relieve E:\FR\FM\10NOP1.SGM 10NOP1 66682 Federal Register / Vol. 79, No. 217 / Monday, November 10, 2014 / Proposed Rules 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 rmajette on DSK2TPTVN1PROD with PROPOSALS 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. VerDate Sep<11>2014 14:44 Nov 07, 2014 Jkt 235001 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, PO 00000 Frm 00024 Fmt 4702 Sfmt 9990 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: October 31, 2014. Gina McCarthy, 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: ■ § 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, 2021, subject to the restrictions in appendix G of this subpart, and subject to the recordkeeping and reporting requirements at § 82.13(u) through (x). There is no amount specified for this exemption. * * * * * [FR Doc. 2014–26530 Filed 11–7–14; 8:45 am] BILLING CODE 6560–50–P E:\FR\FM\10NOP1.SGM 10NOP1
[Pages 66679-66682]
[FR Doc No: 2014-26530]
[EPA-HQ-OAR-2014-0621; FRL-9918-59-OAR]
RIN 2060-AS38
Protection of Stratospheric Ozone: Extension of the Laboratory
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
EPA as nonessential.
DATES: Comments must be submitted by December 10, 2014.
OAR-2014-0621, by one of the following methods:
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
2014-0621. EPA's policy is that all comments received will be included
Docket: All documents in the docket are listed on the
and Radiation Docket, EPA/DC, EPA West, Room 3334, 1301 Constitution
Ave. NW., Washington, DC. The Public Reading Room is open from 8:30
FOR FURTHER INFORMATION CONTACT: Jeremy Arling by regular mail: U.S.
(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
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
1. Confidential Business Information. Do not submit confidential
business information (CBI) to EPA through www.regulations.gov or email.
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
identifying information (subject heading, Federal Register date, and
II. Extension of the Laboratory and Analytical Use Exemption
(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,
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
(encompassing cultural and intellectual aspects); and (ii) there are no
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).
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 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
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.
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.
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
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
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.
that the agency has reason to believe may disproportionately affect
Justice in Minority
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
For the reasons set out in the preamble, 40 CFR part 82 is proposed
Authority:  42 U.S.C. 7414, 7601, 7671-7671q.
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]