Source: https://www.federalregister.gov/documents/2011/07/15/2011-17905/protection-of-stratospheric-ozone-extension-of-global-laboratory-and-analytical-use-exemption-for
Timestamp: 2017-08-23 01:09:16
Document Index: 144909173

Matched Legal Cases: ['art 82', 'Art. 2', 'Art. 2', 'Art. 2', 'Art. 2', 'Art. 2', 'art 82', 'art 82', 'art 82', '§\u200982', 'art 82', 'art 82', 'art 82', 'art 9']

Written comments on this proposed rule must be received by the EPA Docket on or before September 13, 2011.
41747-41751 (5 pages)
FRL-9439-3
https://www.federalregister.gov/d/2011-17905 https://www.federalregister.gov/d/2011-17905
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 Start Printed Page 41748Parties 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 21st Meeting of the Parties [MOP] to the Montreal Protocol). EPA is not proposing to add these procedures at this time.
Submit your comments, identified by Docket ID No. EPA-HQ-OAR-2010-0672, by one of the following methods:
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.
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.
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-Start Printed Page 41749depleting 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.
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 § 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.
(i) of hydrocarbons (oil and grease) in water or soil
(iii) when recording infrared and nuclear magnetic resonance (NMR) spectra, including hydroxyl index
(i) liquid chromatography (HPLC) of drugs and pesticides
(ii) gas chromatography of organic chemicals such as steroids
(iii) adsorption chromatography of organic chemicals
(iii) specific weight of cementStart Printed Page 41750
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.
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.
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.
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.
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.
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.Start Printed Page 41751
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.
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.
[FR Doc. 2011-17905 Filed 7-14-11; 8:45 am]