[Federal Register Volume 86, Number 160 (Monday, August 23, 2021)]
[Rules and Regulations]
[Pages 46992-46995]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-17745]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 82

[EPA-HQ-OAR-2020-0084; FRL-7810-02-OAR]
RIN 2060-AU80


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

AGENCY: Environmental Protection Agency.

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency is taking final action to 
revise regulations governing the production and import of class I 
ozone-depleting substances in the United States to indefinitely extend 
the global essential laboratory and analytical use exemption. This 
exemption currently expires on December 31, 2021, and this final 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 the Environmental Protection Agency as nonessential. 
This final action is taken under the Clean Air Act, and is consistent 
with a decision by the Parties to the Montreal Protocol on Substances 
that Deplete the Ozone Layer to extend the global laboratory and 
analytical use exemption indefinitely beyond 2021. The proposed rule 
associated with this final action was published on August 7, 2020, and 
we received no adverse comments.

DATES: This final rule is effective on September 22, 2021.

ADDRESSES: The Environmental Protection Agency (EPA) has established a 
docket for this action under Docket ID No. EPA-HQ-OAR-2020-0084. All 
documents in the docket are listed on the https://www.regulations.gov 
website. Although listed in the index, some information may not be 
publicly available, e.g., Confidential Business Information 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. All other 
publicly available docket materials are available electronically in 
https://www.regulations.gov. Due to public health concerns related to 
COVID-19, the EPA Docket Center and Reading Room are closed to the 
public with limited exceptions. Our Docket Center staff will continue 
to provide remote customer service via email, phone, and webform. For 
further information on EPA Docket Center services and the current 
status, please visit us online at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Andy Chang, U.S. Environmental 
Protection Agency, Stratospheric Protection Division, telephone number: 
202-564-6658; or email address: [email protected]. You may also visit 
our website at https://www.epa.gov/ods-phaseout/phaseout-exemptions-laboratory-and-analytical-uses for further information.

SUPPLEMENTARY INFORMATION: Throughout this document, whenever ``we,'' 
``us,'' or ``our'' is used, we mean EPA. This supplementary information 
section is arranged as follows:

I. What is the background for this action?
    A. What is the Agency's authority for this final action?
    B. Summary of EPA's Proposed Rulemaking and Public Comments
    C. Potentially Impacted Entities
    D. Background of the Laboratory and Analytical Use Exemption
II. What action is EPA taking?
III. Statutory and Executive Order Reviews

I. What is the background for this action?

A. What is the Agency's authority for this final action?

    The Clean Air Act (CAA) provides EPA the authority to implement the 
Montreal Protocol on Substances that Deplete the Ozone Layer's 
(Montreal Protocol's) phaseout schedules for ozone-depleting substances 
(ODS) in the United States. Relevant to this rulemaking, CAA section 
604 requires EPA to issue regulations phasing out production and 
consumption of class I \1\ ODS according to a prescribed schedule; our 
phaseout regulations for class I ODS are codified at 40 CFR part 82, 
subpart A.
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    \1\ Under the CAA, certain ODS are classified as ``class I'' 
substances. Class I substances are listed in Appendix A to 40 CFR 
part 82, subpart A.
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B. Summary of EPA's Proposed Rulemaking and Public Comments

    EPA's August 7, 2020, proposed rulemaking (see 85 FR 47940) sought 
to align a provision in EPA's regulations governing the production and 
import of class I ODS regarding the essential laboratory and analytical 
use exemption (referred to hereafter as the ``L&A exemption'') with a 
recent decision taken by the Parties to the Montreal Protocol to extend 
the global L&A exemption indefinitely.\2\ In the United States, 
laboratory distributors currently supply around 1,000 laboratories, and 
consumption \3\ for laboratory use was approximately 4.4 ODP-weighted 
metric tons in 2018 under the L&A exemption \4\ and 4.2 ODP-weighted 
metric tons in 2019 under the L&A exemption.\5\ The global L&A 
exemption is implemented domestically through EPA's regulations at 40 
CFR part 82, subpart A and the current exemption is in effect in the 
United States through December 31, 2021. In the proposed rulemaking (85 
FR 47940), EPA proposed to remove the

[[Page 46993]]

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.
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    \2\ Decision XXXI/5: Laboratory and Analytical Uses, available 
online at: https://ozone.unep.org/treaties/montreal-protocol/meetings/thirty-first-meeting-parties/decisions/decision-xxxi5.
    \3\ Consumption is defined in Sec.  82.3 as ``production plus 
imports minus exports of a controlled substance (other than 
transhipments, or used controlled substances).''
    \4\ These 2018 data are available in the docket to this rule as 
well as on the Montreal Protocol's Ozone Secretariat's Data Centre 
web page: https://ozone.unep.org/countries/data-table.
    \5\ At the time of publication for the proposed rulemaking, the 
2019 data were not yet available, but can now be found on the 
Montreal Protocol's Ozone Secretariat's 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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    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 
cost- and 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.

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 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 Earth's 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 2A(4) 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 time-limited 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 14764-65). The 2001 rule 
explains 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 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 47941-92, 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 82.8(b). 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

[[Page 46994]]

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 82.13(u) through (x). The previous 
text in 40 CFR 82.8(b) 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 non-ODS 
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 ODP-weighted metric tons in 2018, which is a negligible 
amount.\6\ Data for 2019, which became available after the publication 
date for EPA's 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 non-ODS 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.
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    \6\ These data are available in the docket to this rule as well 
as on the Ozone Secretariat's Data Centre web page: https://ozone.unep.org/countries/data-table.
    \7\ These data can now be found on the Montreal Protocol's Ozone 
Secretariat's 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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    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,'' EPA's 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.
    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 2060-0170. 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. 1531-1538, and does

[[Page 46995]]

not significantly or uniquely affect small governments. The action 
imposes no enforceable duty on any state, local, or tribal governments 
or the private sector.

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

    This action does not have tribal implications as specified in 
Executive Order 13175. It will not have substantial direct effects on 
tribal governments, on the relationship between the federal government 
and Indian tribes, or on the distribution of power and responsibilities 
between the federal government and Indian tribes, as specified in 
Executive Order 13175. Thus, Executive Order 13175 does not apply to 
this action. EPA periodically updates tribal officials on air 
regulations through the monthly meetings of the National Tribal Air 
Association and will share information on this rulemaking through this 
and other fora.

G. Executive Order 13045: Protection of Children From Environmental 
Health Risks and Safety Risks

    This action is not subject to Executive Order 13045 because it is 
not economically significant as defined in Executive Order 12866, and 
because EPA does not believe the environmental health or safety risks 
addressed by this action present a disproportionate risk to children. 
Depletion of stratospheric ozone results in greater transmission of the 
sun's ultraviolet (UV) radiation to the earth's surface. The following 
studies describe the effects of excessive exposure to UV radiation on 
children: (1) Westerdahl J, Olsson H, Ingvar C. ``At what age do 
sunburn episodes play a crucial role for the development of malignant 
melanoma,'' Eur J Cancer 1994; 30A:1647-54; (2) Elwood JM, Japson J. 
``Melanoma and sun exposure: An overview of published studies,'' Int J 
Cancer 1997; 73:198-203; (3) Armstrong BK. ``Melanoma: Childhood or 
lifelong sun exposure,'' In: Grobb JJ, Stern RS, Mackie RM, Weinstock 
WA, eds. Epidemiology, causes and prevention of skin diseases (pp 63-
66), London: Blackwell Science, 1997; (4) Whiteman D, Green A. 
``Melanoma and Sunburn,'' Cancer Causes Control, 1994; 5:564-72; (5) 
Heenan, PJ. ``Does intermittent sun exposure cause basal cell 
carcinoma? A case control study in Western Australia,'' Int J Cancer 
1995; 60:489-94; (6) Gallagher RP, Hill GB, Bajdik CD, et al. 
``Sunlight exposure, pigmentary factors, and risk of nonmelanocytic 
skin cancer I, Basal cell carcinoma,'' Arch Dermatol 1995; 131:157-63; 
(7) Armstrong, BK. ``How sun exposure causes skin cancer: An 
epidemiological perspective,'' In: Hill D, Elwood JM, English DR (eds.) 
Prevention of Skin Cancer. Cancer Prevention--Cancer Causes, vol. 3 (pp 
89-116). Dordrecht: Springer, 2004. However, as described in the 
section above titled ``What Action is EPA Taking?'', the environmental 
impacts are expected to be negligible.

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 (NTTAA)

    This rulemaking does not involve technical standards.

J. Executive Order 12898: Federal Actions To Address Environmental 
Justice in Minority Populations and Low-Income Populations

    The environmental impacts of this regulation are expected to be 
negligible given the low level of ODS produced and imported for the L&A 
exemption. As such, there are no disproportionately high and adverse 
human health or environmental effects from this action on minority 
populations, low-income populations, and/or indigenous peoples, as 
specified in Executive Order 12898 (59 FR 7629, February 16, 1994).

K. Congressional Review Act

    This action is subject to the Congressional Review Act, and EPA 
will submit a rule report to each House of the Congress and to the 
Comptroller General of the United States. This action is not a ``major 
rule'' as defined by 5 U.S.C. 804(2).

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.

Michael S. Regan,
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) There is a global exemption for the production and import of 
class I controlled substances for essential laboratory and analytical 
uses, 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. 2021-17745 Filed 8-20-21; 8:45 am]
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