[Federal Register Volume 85, Number 153 (Friday, August 7, 2020)]
[Proposed Rules]
[Pages 47940-47943]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-16255]



[[Page 47940]]

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 82

[EPA-HQ-OAR-2020-0084; FRL-10011-84-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 (EPA).

ACTION: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: The Environmental Protection Agency (EPA) is proposing to 
revise regulations governing the production and import of class I 
ozone-depleting substances in the United States to extend indefinitely 
the global essential laboratory and analytical use exemption. This 
exemption currently expires on December 31, 2021. This change would 
allow 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 EPA as nonessential. This action is proposed 
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.

DATES: Comments on this notice of proposed rulemaking must be received 
on or before October 6, 2020. Any party requesting a public hearing 
must notify the contact listed below under FOR FURTHER INFORMATION 
CONTACT by 5 p.m. Eastern Daylight Time on August 12, 2020. If a public 
hearing is requested, the EPA would hold a virtual hearing on August 
24, 2020. If a hearing is requested, the date, time, and other relevant 
information for a hearing will be available at https://www.epa.gov/ods-phaseout/phaseout-exemptions-laboratory-and-analytical-uses.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
OAR-2020-0084, to the Federal eRulemaking Portal: http://www.regulations.gov. Out of an abundance of caution for members of the 
public and our staff, the EPA Docket Center and Reading Room was closed 
to public visitors on March 31, 2020, to reduce the risk of 
transmitting COVID-19. Our Docket Center staff will continue to provide 
remote customer service via email, phone, and webform. We encourage the 
public to submit comments via https://www.regulations.gov or email, as 
there may be a delay in processing mail, and hand deliveries may not be 
accepted. For further information on EPA Docket Center services and the 
current status, please visit us online at https://www.epa.gov/dockets.
    Follow the online instructions for submitting comments. Once 
submitted, comments cannot be edited or withdrawn. The EPA may publish 
any comment received to its public docket. Do not submit electronically 
any information you consider to be Confidential Business Information 
(CBI) or other information whose disclosure is restricted by statute. 
Multimedia submissions (audio, video, etc.) must be accompanied by a 
written comment. The written comment is considered the official comment 
and should include discussion of all points you wish to make. The EPA 
will generally not consider comments or comment contents located 
outside of the primary submission (e.g., on the web, cloud, or other 
file sharing system). For additional submission methods, the full EPA 
public comment policy, information about CBI or multimedia submissions, 
and general guidance on making effective comments, please visit https://www.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Jeremy Arling, U.S. Environmental 
Protection Agency, Stratospheric Protection Division, telephone number: 
202-343-9055; or email address: [email protected]. You may also 
visit the EPA's website at https://www.epa.gov/ods-phaseout/phaseout-exemptions-laboratory-and-analytical-uses for further information.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this proposed action apply to me?

    You may be potentially affected by this proposal if you 
manufacture, process, import, or distribute into commerce certain 
ozone-depleting substances (ODS) and mixtures. Potentially affected 
entities 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)
 Medical laboratories (NAICS code 621511)

    This list is not intended to be exhaustive, but rather provide a 
guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this section could also 
be affected. The North American Industrial Classification System 
(NAICS) codes have been provided to assist in determining whether this 
action might apply to certain entities. If you have any questions 
regarding the applicability of this action to a particular entity, 
consult the person listed under FOR FURTHER INFORMATION CONTACT.

B. What action is the Agency proposing?

    The EPA is proposing to revise regulations governing the production 
and import of class I \1\ ozone-depleting substances (ODS) in the 
United States to extend indefinitely the global essential laboratory 
and analytical use exemption (referred to hereafter as the ``L&A 
exemption''). Laboratory distributors currently supply around 1,000 
laboratories, and consumption \2\ for laboratory use was approximately 
4.4 ODP-weighted metric tons in 2018 under the L&A exemption.\3\ The 
EPA is proposing this action under the Clean Air Act (CAA) following a 
recent decision by the Parties to the Montreal Protocol on Substances 
that Deplete the Ozone Layer (Montreal Protocol) to extend the global 
L&A exemption indefinitely.\4\ The global exemption is implemented 
domestically through the EPA's regulations at 40 CFR part 82 subpart A 
and is currently in effect in the United States through December 31, 
2021. The change proposed in this notice would allow 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 the EPA as nonessential.
---------------------------------------------------------------------------

    \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. This includes Groups I, II, III, IV, and V under 
the Montreal Protocol.
    \2\ Consumption is defined in Sec.  82.3 as production plus 
imports minus exports of a controlled substance (other than 
transshipments or used controlled substances).
    \3\ These 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.
    \4\ Decision XXXI/5: Laboratory and Analytical Use
---------------------------------------------------------------------------

C. What is the Agency's authority for this proposed action?

    The CAA grants the EPA the authority to implement the Montreal 
Protocol's phaseout schedules in the United States. CAA section 604 
requires the EPA to

[[Page 47941]]

issue regulations phasing out production and consumption of class I ODS 
according to a prescribed schedule. The EPA's phaseout regulations for 
class I ODS are codified at 40 CFR part 82, subpart A.

II. 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 the 
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 may agree to grant exemptions to the ban 
on production and import 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: it is necessary for 
the health, safety or is critical for the functioning of society 
(encompassing cultural and intellectual aspects); and there are no 
available technically and economically feasible alternatives or 
substitutes that are acceptable from the standpoint of environment and 
health.'' In addition, Annex II of the report of the Sixth Meeting of 
the Parties (MOP) from Decision VI/9 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.
    Decision X/19 under the Montreal Protocol extended the global 
exemption for essential laboratory and analytical uses through December 
31, 2005. Consistent with the flexibility allowed for by the Parties, 
in 2001, the EPA codified a L&A exemption at 40 CFR 82.4 (see 66 FR 
14760, March 13, 2001). In the preamble to that rule, the 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. 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, 
the EPA has not received information that would suggest otherwise. 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.
    Decision X/19 under the Montreal Protocol also requested the 
Montreal Protocol's Technology and Economic Assessment Panel (TEAP) 
report annually to the Parties to the Montreal Protocol on laboratory 
and analytical procedures that could be performed without the use of 
ODS. It further stated that at future MOPs, the Parties would decide 
whether such procedures should no longer be eligible for exemptions. 
Informed by the TEAP's report, the Parties to the Montreal Protocol 
decided in 1999, under Decision XI/15, that the general exemption no 
longer applied to the following uses: Testing of oil, grease, and total 
petroleum hydrocarbons in water; testing of tar in road-paving 
materials; and forensic finger-printing. The EPA incorporated these 
exclusions at Appendix G to subpart A of 40 CFR part 82 (see 67 FR 
6352, February 11, 2002).
    At the 18th MOP, the Parties acknowledged the need to use methyl 
bromide for laboratory and analytical procedures and added methyl 
bromide to the ODS covered by the L&A exemption in Appendix G. Decision 
XVIII/15 outlined specific uses and exclusions for methyl bromide under 
the exemption (see 72 FR 73264, December 27, 2007).
    In November 2009, at the 21st MOP, the Parties in Decision XXI/6 
extended the global L&A exemption through December 31, 2014. Based on 
this Decision, the EPA amended the regulation at 40 CFR 82.8(b) to 
extend the L&A exemption domestically through December 31, 2014 (see 76 
FR 77909, December 15, 2011). Decision XXI/6 lists laboratory and 
analytical uses of ODS 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.
    Under Decision XXVI/5 at the 26th MOP, the Parties extended the L&A 
exemption until December 31, 2021, which the EPA implemented 
domestically through a rulemaking in 2015 (see 80 FR 3885, January 26, 
2015). This Decision also requested the TEAP provide a report on the 
development and availability of laboratory and analytical uses that can 
be performed without using ODS, and Parties were encouraged to continue 
to investigate replacements to ODS for laboratory and analytical uses.
    In 2018, the TEAP and its Medical and Chemicals Technical Options 
Committee (MCTOC) provided a report on alternatives to ODS for 
laboratory and analytical uses, available in the docket. The report 
noted that annual data reported to the Ozone Secretariat under Article 
7 of the Montreal Protocol show a downward trend with global production 
of ODS for these uses of only 151 metric tons in 2016.
    Most 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.

III. Proposed Rule

    The EPA is proposing to indefinitely extend the L&A exemption for 
class I ODS in 40 CFR 82.8(b). This proposal would make the regulatory 
exemption indefinite unless or until it is limited or eliminated 
through future rulemaking. If the Agency finalizes this action as 
proposed, the Agency would still have authority to review the scope of 
and need for the exemption at a future date;

[[Page 47942]]

however, the regulations would no longer contain an expiration date for 
the exemption. The EPA could also change the list of uses in Appendix 
G, as alternatives are identified through new standards.
    This proposed action is consistent with the Montreal Protocol's 
Decision XXXI/5. 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 and ISO 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.
    The Agency is also proposing to add clarifying text to explain that 
the 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. The text in 40 CFR 82.8(b) 
establishes the exemption for essential laboratory and analytical uses 
but does 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 the 2001 rule (see 66 FR 
14760, March 13, 2001).
    Making the L&A exemption indefinite will have little effect on the 
stratospheric ozone layer. Exempted production and consumption of ODS 
for laboratory and analytical uses in the United States is on a general 
decline. Consumption 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.\5\ This indicates that many users, primarily laboratories, have 
been able to transition from ODS even with this exemption available to 
them. However, certain laboratory and analytical procedures continue to 
require the use of class I ODS 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.
---------------------------------------------------------------------------

    \5\ 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.
---------------------------------------------------------------------------

    The EPA requests comment on the proposal to indefinitely extend the 
L&A exemption. The EPA is also seeking comment from standards 
organizations that either continue to use ODS in their standards or who 
have developed new standards. For instance, the EPA is seeking comment 
on which standards still exist that use ODS, if there are any plans or 
actions underway to replace those existing standards, and whether there 
are alternatives to using ODS. Likewise, the EPA seeks comment from 
laboratories that continue to use ODS or that have transitioned to 
ozone-safe alternatives. The EPA is seeking comments from laboratories 
on whether they use ODS or have transitioned to alternatives and, if 
they have not transitioned, which methods are still being employed that 
require the use of ODS. The EPA encourages laboratories to continue 
ongoing efforts to transition to methods that do not require the use of 
ODS, and information provided by commenters could be aggregated and 
shared to assist others.

IV. 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. Executive Order 13771: Reducing Regulations and Controlling 
Regulatory Costs

    This action is expected to be an Executive Order 13771 deregulatory 
action. This proposed rule is expected to provide meaningful burden 
reduction because it allows for the continued use of ODS for laboratory 
and analytical use.

C. 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 would allow 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 EPA as nonessential, and therefore there are no PRA 
implications. This action proposes to indefinitely remove the 
expiration date for the existing exemption from the prohibitions in 
production and import of class I ODS.

D. 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.

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

F. 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.

G. 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. The 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.

[[Page 47943]]

H. 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 the 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,'' 1st ed. London, England: Blackwell Science, 1997: 
63-6; (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, DK. ``How sun exposure 
causes skin cancer: an epidemiological perspective,'' Prevention of 
Skin Cancer. 2004. 89-116. However, because maintaining the laboratory 
and analytical exemption would have negligible environmental impacts 
(as discussed in sections II and III of the preamble), the EPA does not 
expect any additional risks to children.

I. 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.

J. National Technology Transfer and Advancement Act (NTTAA)

    This rulemaking does not involve technical standards.

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

    The EPA believes that it is not feasible to quantify any 
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).

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.

Andrew Wheeler,
Administrator.
    For the reasons set out in the preamble, 40 CFR part 82 is proposed 
to be 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. 2020-16255 Filed 8-6-20; 8:45 am]
BILLING CODE 6560-50-P