Rule2021-17745
Protection of Stratospheric Ozone: Extension of the Laboratory and Analytical Use Exemption for Essential Class I Ozone-Depleting Substances
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
August 23, 2021
Effective
September 22, 2021
Issuing agencies
Environmental Protection Agency
Abstract
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.
Full Text
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<title>Federal Register, Volume 86 Issue 160 (Monday, August 23, 2021)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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
<a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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 <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
FOR FURTHER INFORMATION CONTACT: Andy Chang, U.S. Environmental
Protection Agency, Stratospheric Protection Division, telephone number:
202-564-6658; or email address: <a href="/cdn-cgi/l/email-protection#492a2128272e6728272d30092c3928672e263f"><span class="__cf_email__" data-cfemail="e08388818e87ce818e8499a0859081ce878f96">[email protected]</span></a>. You may also visit
our website at <a href="https://www.epa.gov/ods-phaseout/phaseout-exemptions-laboratory-and-analytical-uses">https://www.epa.gov/ods-phaseout/phaseout-exemptions-laboratory-and-analytical-uses</a> 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: <a href="https://ozone.unep.org/treaties/montreal-protocol/meetings/thirty-first-meeting-parties/decisions/decision-xxxi5">https://ozone.unep.org/treaties/montreal-protocol/meetings/thirty-first-meeting-parties/decisions/decision-xxxi5</a>.
\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: <a href="https://ozone.unep.org/countries/data-table">https://ozone.unep.org/countries/data-table</a>.
\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:
<a href="https://ozone.unep.org/countries/data-table">https://ozone.unep.org/countries/data-table</a>. Data specific to the
United States' amounts consumed for laboratory and analytical uses,
including 2019 data, can be found on this web page: <a href="https://ozone.unep.org/countries/profile/usa">https://ozone.unep.org/countries/profile/usa</a>. 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:
<bullet> Basic chemical manufacturing (NAICS code 3251);
<bullet> Pharmaceutical preparations manufacturing businesses
(NAICS code 325412);
<bullet> Other chemical and allied production merchant wholesalers
(NAICS code 424690);
<bullet> Environmental consulting services (NAICS code 541620);
<bullet> Research and development in the physical, engineering, and
life sciences (NAICS code 54171); and
<bullet> 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: <a href="https://ozone.unep.org/countries/data-table">https://ozone.unep.org/countries/data-table</a>.
\7\ These data can now be found on the Montreal Protocol's Ozone
Secretariat's Data Centre web page: <a href="https://ozone.unep.org/countries/data-table">https://ozone.unep.org/countries/data-table</a>. Data specific to the United States' amounts
consumed for laboratory and analytical uses, including 2019 data,
can be found on this web page: <a href="https://ozone.unep.org/countries/profile/usa">https://ozone.unep.org/countries/profile/usa</a>. 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]
BILLING CODE 6560-50-P
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