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Federal Register / Vol. 86, No. 160 / Monday, August 23, 2021 / Rules and Regulations December 31, 2021, time restriction, allowing for continued production and import of class I ODS in the United States after that date for laboratory and analytical uses that have not been identified by EPA as nonessential.
During the public comment period for the proposed rulemaking, which ended on October 6, 2020, EPA received a total of two comments which are publicly available in the docket. Both comments were in support of our proposed action;
one comment noted that the proposed action was a costand time-effective revision, and the other comment supported the notion that laboratories could continue to obtain necessary and essential materials while being mindful of potential environmental impacts.
EPA acknowledges the comments and concludes that they support the final action and do not require further response.

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C. Potentially Impacted Entities This final rule may potentially impact individuals or groups that manufacture, process, import, or distribute into commerce certain ODS and mixtures.
These impacted entities and their associated North American Industrial Classification System NAICS codes may include but are not limited to:
Basic chemical manufacturing NAICS code 3251;
Pharmaceutical preparations manufacturing businesses NAICS code 325412;
Other chemical and allied production merchant wholesalers NAICS code 424690;
Environmental consulting services NAICS code 541620;
Research and development in the physical, engineering, and life sciences NAICS code 54171; and Medical laboratories NAICS code 621511.
This list is not intended to be exhaustive; rather, it provides a guide for readers regarding entities likely to be affected by this final action. The NAICS
codes provided above may assist in determining whether this final rule might apply to certain entities. Other types of entities not listed could also be affected, and EPA recommends that you consult the person listed under FOR
FURTHER INFORMATION CONTACT if there are applicability questions.
D. Background of the Laboratory and Analytical Use Exemption The United States was one of the original signatories to the 1987 Montreal Protocol and ratified it on April 12, 1988. After ratification, Congress enacted, and President George H.W.
Bush signed into law, the CAA

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Amendments of 1990, which included Title VI on Stratospheric Ozone Protection, codified as 42 U.S.C.
Chapter 85, Subchapter VI, to ensure, among other things, that the United States could satisfy its obligations under the Montreal Protocol.
The Montreal Protocol is a multinational environmental agreement to protect Earths ozone layer by phasing out the consumption and production of most chemicals that deplete it. The Montreal Protocol provides a set of schedules to phase out ODS and also provides for mechanisms to establish certain specific and limited exemptions.
For most class I ODS, the Parties to the Montreal Protocol may agree to grant exemptions to the ban on production and consumption of ODS for uses that they determine to be essential. For example, with respect to chlorofluorocarbons CFCs, Article 2A4 of the Montreal Protocol 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 other ODS, such as halons Article 2B, carbon tetrachloride Article 2D, and methyl chloroform Article 2E. As defined by Decision IV/
25 of the Parties, use of a controlled substance should qualify as 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 VI/
9 of the Parties established a timelimited exemption under the Montreal Protocol for essential laboratory and analytical uses, consistent with the specifications in Annex II of the report of the Sixth Meeting of the Parties MOP, which describes conditions applied to the exemption for laboratory and analytical uses such as purity, quantity, and specification for cylinders and handling for these controlled substances.
Consistent with the flexibility allowed for by the Parties, in 2001, EPA codified a L&A exemption in its domestic regulations see 66 FR 14760, March 13, 2001. In the preamble to that rule, EPA
determined that the statutory language in section 604 of the CAA provided grounds for the creation of a de minimis exemption for essential laboratory and analytical uses of certain class I ODS
id. at 1476465. The 2001 rule explains how the controls in place for laboratory and analytical uses provide
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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 under 40 CFR part 82, subpart A, 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
milliliters or smaller, as per Appendix G. Since issuing the original exemption, EPA has not received information that would suggest that the current controls in place for laboratory and analytical use do not provide adequate assurance that very little, if any, environmental damage will result from the handling and disposal of class I ODS used in such applications. As discussed later in this notice, the quantities of class I ODS
used for this exemption have declined substantially since the exemption was initially created.
As summarized in the proposal for this final action, the Parties subsequently issued several decisions related to the global exemption, including periodic extensions, and EPA
has also revised the exemption in its domestic regulations several times see 85 FR 4794192, August 7, 2020. Under Decision XXVI/5 at the 26th MOP, the Parties extended the global L&A
exemption until December 31, 2021, which EPA implemented domestically through a rulemaking in 2015 see 80 FR
3885, January 26, 2015. More recently, in November 2019, at the 31st MOP, the Parties agreed in Decision XXXI/5 to extend the global laboratory and analytical-use exemption indefinitely beyond 2021, without prejudice to the parties deciding to review the exemption at a future meeting. The Decision also encourages parties to further reduce their production and consumption of ODS for laboratory and analytical uses and to facilitate the introduction of laboratory standards that do not require such substances.
II. What action is EPA taking?
EPA is finalizing its August 7, 2020, proposal to indefinitely extend the global L&A exemption for class I ODS in 40 CFR 82.8b. This action makes the regulatory exemption indefinite unless or until it is limited or eliminated through future rulemaking, i.e., EPA
still has the authority to review the scope of and need for the exemption at a future date. Upon the effective date of this final action, the regulations will no longer contain an expiration date for the exemption. The list of laboratory and analytical uses codified in Appendix G
to 40 CFR part 82, subpart A, may also be revised through new rulemakings as
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