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Federal Register / Vol. 86, No. 160 / Monday, August 23, 2021 / Rules and Regulations
alternatives are identified through new standards.
Consistent with the proposal, this final action also contains clarifying text to explain that the global L&A
exemption allows for the production and import of class I ODS that have been phased out in the United States, subject to certain restrictions as described in Appendix G to 40 CFR part 82, subpart A, and subject to the recordkeeping and reporting requirements at 40 CFR 82.13u through x. The previous text in 40 CFR 82.8b established the exemption for essential laboratory and analytical uses but did not explicitly state that the exemption is from the prohibitions on production and import of class I ODS, although that is clear from context and the explanation in a previous rule see 66 FR 14760, March 13, 2001. Consistent with the proposal, this final rule states the exemption more explicitly.
As noted in the proposed rule, there are several reasons why the Agency is making these changes. This action is consistent with Decision XXXI/5 by the Parties to the Montreal Protocol, and it will provide certainty with regards to the exemption without the need for periodic rulemakings to extend the exemption. This is important since nonODS replacements for class I ODS may not be identified for all uses given the effort required to establish new analytical procedures for such small quantities of material. While some analytical procedures have transitioned, many ASTM International formerly known as the American Society for Testing and Materials and ISO
International Organization for Standardization standards still require small amounts of ODS, and it could take years for standards organizations to develop alternatives and for laboratories to adopt the new standards.
From an environmental impact perspective, removing the deadline from the L&A exemption will also have little effect on the stratospheric ozone layer due to a combination of factors including the general decline of production and consumption of ODS for laboratory and analytical uses in the United States and the existing controls in place for laboratory and analytical uses.
Exempted consumption for laboratory and analytical uses in the United States peaked in 2004 at 55 ODP-weighted metric tons, and was only 4.4 ODPweighted metric tons in 2018, which is a negligible amount.6 Data for 2019, 6 These data are available in the docket to this rule as well as on the Ozone Secretariats Data
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which became available after the publication date for EPAs proposed rulemaking, indicates that the exempted consumption for laboratory and analytical uses in the United States has decreased further to 4.2 ODP-weighted metric tons.7 This sharp decline since 2004 indicates that many users primarily laboratories have been able to transition from ODS even with this exemption being available to them; as these laboratories continue to use nonODS and/or continue to transition to non-ODS alternatives for laboratory and analytical uses, EPA anticipates that the decreasing trend for class I ODS for exempted consumption will generally continue. However, certain laboratory and analytical procedures continue to require the use of class I ODS in the United States. In the United States, there are currently ten laboratory distributors that supply around 1,000
laboratories with primarily carbon tetrachloride but also small quantities of chlorobromomethane, CFCs, methyl chloroform, and methyl bromide.
Maintaining this exemption would provide laboratories with essential class I ODS for which no alternatives are currently available, with negligible environmental impacts.
Additionally, this action does not make any change in the controls that are in place for laboratory and analytical uses, and as discussed above in the section titled, Background of the Laboratory and Analytical Use Exemption, EPAs March 13, 2001, rule explains how these controls provide adequate assurance that very little, if any, environmental damage will result from the handling and disposal of small amounts of class I ODS used in such applications. Further, EPA has the authority to review the scope of and need for the exemption at a future date, for example if alternative methods become available or consumption begins to increase. Lastly, as noted earlier in this notice, we received two supportive comments and no adverse comments on the proposed rule associated with this final action. Based on consideration of all this information and the two comments that both supported the proposed rule, EPA is finalizing the action as proposed.
Centre web page: https ozone.unep.org/countries/
data-table.
7 These data can now be found on the Montreal Protocols Ozone Secretariats Data Centre web page: https ozone.unep.org/countries/data-table.
Data specific to the United States amounts consumed for laboratory and analytical uses, including 2019 data, can be found on this web page:
https ozone.unep.org/countries/profile/usa. These data have been added to the docket for this rulemaking.

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EPA encourages laboratories to continue ongoing efforts to transition to methods that do not require the use of ODS, and to share such information when available, as it could assist others in similar situations.
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 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 20600170. The laboratory and analytical use exemption currently expires on December 31, 2021, and this action allows for continued production and import of class I substances in the United States solely for laboratory and analytical uses that have not been identified by EPA as nonessential, and therefore there are no PRA implications.
This action indefinitely removes the expiration date for the existing exemption from the prohibitions in production and import of class I ODS.
C. Regulatory Flexibility Act RFA
I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. This action does not modify the recordkeeping and reporting requirements that apply to laboratory distributors who utilize the exemption.
These requirements will continue to apply to distributors who use the exemption; however, the requirements are minimal and impose no significant burden. Further, nothing in this rule compels any entity to use the exemption. The Agency thus assumes that the burden reduction provided by the exemption from the phaseout on production and import of class I ODS
outweighs the limited cost associated with recordkeeping and reporting.
Otherwise, laboratory distributors could choose not to use the exemption, removing the need for relevant recordkeeping and reporting.
D. Unfunded Mandates Reform Act UMRA
This action does not contain any unfunded mandate as described in UMRA, 2 U.S.C. 15311538, and does
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