[Federal Register Volume 85, Number 118 (Thursday, June 18, 2020)]
[Notices]
[Pages 36851-36855]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-13145]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OAR-2014-0471; FRL-10010-36-OAR]
RIN 2060-AS26
Granting Petitions To Add 1-bromopropane (Also Known as 1-BP) to
the List of Hazardous Air Pollutants
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: The U.S. Environmental Protection Agency (EPA) is granting
petitions to add n-propyl bromide (nPB) (Chemical Abstract Service
(CAS) No. 106-94-5) to the list of hazardous air pollutants (HAP)
contained in the Clean Air Act (CAA). The EPA is taking final action to
grant these petitions based on the petitioners having met the
requirements contained in CAA section 112(b)(3), which allows any
person to petition the Administrator to add a substance to the list of
HAP. The term 1-bromopropane (1-BP), which is used throughout this
document, is the common name for nPB. This is the first occasion on
which the EPA is granting petitions to add a substance to the list of
HAP that Congress created in 1990. Following this action, the EPA will
take a separate regulatory action to add 1-BP to the list of HAP under
CAA section 112(b)(1).
DATES: The petitions are granted as of June 18, 2020.
ADDRESSES: The EPA has established a docket for this document under
Docket ID No. EPA-HQ-OAR-2014-0471. All documents in the docket are
listed on the https://www.regulations.gov/ website. Although listed,
some information is not 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. Publicly available docket materials are available electronically
through https://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. There is a temporary suspension of mail delivery to the EPA,
and no hand deliveries are currently accepted. For further information
and updates on EPA Docket Center services and the current status,
please visit us online at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: For questions about this final action,
contact Mr. John Schaefer, Sector Policies and Programs Division,
Policies and Strategies Group (D205-02), Office of Air Quality Planning
and Standards, Environmental Protection Agency, Research Triangle Park,
North Carolina 27711; telephone number: (919) 541-0296; fax number:
(919)-541-4991; and email address: [email protected].
SUPPLEMENTARY INFORMATION:
Acronyms and abbreviations. We use multiple acronyms and terms in
this document. While this list may not be exhaustive, to ease the
reading of this document and for reference purposes, the EPA defines
the following terms and acronyms here:
1-BP 1-bromopropane (also known as n-propyl bromide (nPB))
CAA Clean Air Act
CAS Chemical Abstract Service
EPA Environmental Protection Agency
HAP hazardous air pollutant(s)
HSIA Halogenated Solvents Industry Alliance
ICL Israel Chemicals Ltd.
MOA mode of action
NESHAP national emission standards for hazardous air pollutants
NTP National Toxicology Program
NYSDEC New York State Department of Environmental Conservation
OMB Office of Management and Budget
PERC perchloroethylene
TRI Toxics Release Inventory
Organization of this document. The information in this document is
organized as follows:
I. Background
A. How do I obtain a copy of this document and other related
information?
B. CAA Authority: Petitions to Modify the List of HAP
C. Petitions Submitted to the EPA
II. What comments were received on the draft document to grant the
petitions to add 1-BP to the CAA section 112(b)(1) HAP list?
A. Comments Regarding Estimated 1-BP Emissions
B. Comments on 1-BP Cancer Risk Factors
C. Comments Requesting the Addition of 1-BP to the CAA Section
112(b)(1) HAP List
III. The EPA's Decision to Grant the Petitions
IV. Reducing Emissions from Sources of 1-BP
V. Statutory and Executive Order Review
[[Page 36852]]
A. Executive Order 12866: Regulatory Planning and Review and
Executive Order 13563: Improving Regulation and Regulatory Review
I. Background
A. How do I obtain a copy of this document and other related
information?
The docket number for this final action is Docket ID No. EPA-HQ-
OAR-2014-0471. In addition to being available in the docket, an
electronic copy of this document will also be available on the
internet. The EPA will post a copy of this final action at https://www3.epa.gov/ttn/atw/pollutants/atwsmod.html following official Agency
signature. Following publication in the Federal Register, the EPA will
post the Federal Register version and key technical documents on this
same website.
B. CAA Authority: Petitions To Modify the List of HAP
The CAA section 112(b)(3)(A) specifies that any person may petition
the Administrator to modify the list of HAP contained in CAA section
112(b)(1) by adding or deleting a substance. CAA section 112(b)(3)(B)
sets out the substantive criteria for granting a petition. It calls for
the Administrator to add a substance to the CAA section 112(b)(1) list,
otherwise known as the HAP list, ``upon a showing by the petitioner or
on the Administrator's own determination that the substance is an air
pollutant and that emissions, ambient concentrations, bioaccumulation
or deposition of the substance are known to cause or may reasonably be
anticipated to cause adverse effects to human health or adverse
environmental effects.'' The Administrator is required under the CAA
section 112(b)(3)(A) to either grant or deny a petition within 18
months of the receipt of a complete petition by publishing a written
explanation of the reasons for the Administrator's decision. The
Administrator may not deny a petition based solely on inadequate
resources or time for review.
Finally, under the CAA section 112(e)(4), the Administrator's
decision to add a pollutant to the CAA section 112(b)(1) HAP list is
not a final Agency action subject to judicial review, except that any
such action may be reviewed when the Administrator promulgates emission
standards for the pollutant. Accordingly, this decision to grant
petitions to add 1-BP to the HAP list is not subject to judicial review
until the Administrator promulgates applicable the CAA section 112(d)
standards addressing emissions of 1-BP. Under the CAA section 112(d)
the EPA has a ``clear statutory obligation to set emissions standards
for each listed HAP.'' National Lime Association v. EPA, 233 F. 3d 625,
634 (D.C. Cir. 2000). Additionally, under CAA section 112(c)(5), the
EPA is required to promulgate emission standards under the CAA sections
112(d)(2) and (3) within two years of adding a new source category to
the CAA section 112(c)(1) source category list.
This is the first occasion on which the EPA is granting a petition
to add a substance to the list of HAP that Congress created in 1990.
Since 1990, the EPA has amended the CAA section 112(b)(1) HAP list by
removing four listed HAPs. They are caprolactam (61 FR 30816 (June 18,
1996)); ethylene glycol monobutyl ether (69 FR 69320 (August 2, 2000));
surfactant alcohol ethoxylates and their derivatives (these are
compounds that were considered to be included in glycol ethers, which
is a listed HAP; (65 FR 47342 (August 2, 2000)); and methyl ethyl
ketone (MEK) (70 FR 75047 (December 19, 2005)). For more information,
see https://www.epa.gov/haps/initial-list-hazardous-air-pollutants-modifications#mods. The EPA has also denied a petition to remove
methanol from the CAA section 112(b)(1) HAP list. 66 FR 21929 (May 2,
2001).
C. Petitions Submitted to the EPA
Halogenated Solvents Industry Alliance (HSIA) and New York State
Department of Environmental Conservation (NYSDEC) submitted petitions
to add 1-BP to the CAA section 112(b)(1) HAP list on October 28, 2010,
and November 24, 2011, respectively. Both HSIA and NYSDEC petitions
referred to the chemical as nPB and 1-BP. In an action published on
November 23, 2015, the EPA added the chemical by the name 1-BP to the
Community Right-to-Know Toxic Chemical Release Reporting requirements.
In addition, the chemical is listed in the EPA's Substance Registry
Services, the EPA's authoritative resource for basic information about
chemicals, as 1-BP. Finally, the chemical is currently undergoing an
EPA Toxic Substances Control Act risk evaluation, under Docket ID No.
EPA-HQ-OPPT-2015-0084 as 1-BP. Therefore, for this action and for
future regulations under the CAA, the EPA will refer to the chemical
identified by CAS No. 106-94-5 as 1-bromopropane or 1-BP.
On November 28, 2012, in response to the EPA's requests for
additional data, HSIA supplemented its petition. Following the receipt
of the petitions, the EPA conducted a review to determine whether the
petitions were complete according to Agency criteria for the CAA
section 112(b) actions, which we explained in the February 6, 2015,
document (80 FR 6676). Specifically, after reviewing these petitions
and supplemental information, the EPA determined that the petitions
addressed all the necessary subject areas for the Agency to assess
whether emissions, ambient concentrations, bioaccumulation, or
deposition of 1-BP are known to cause or may reasonably be anticipated
to cause adverse human health effects or adverse environmental effects.
The EPA determined these petitions to add 1-BP to the HAP list to be
complete and published a notification of receipt of a complete petition
in the Federal Register on February 6, 2015 (80 FR 6676), and invited
the public to comment on the technical merits of these petitions and to
submit any information relevant to the technical review of the
petitions. On March 11, 2015 (80 FR 12794), the EPA agreed to extend
the comment period for the notification of receipt of complete
petitions to May 7, 2015.
On January 9, 2017, the EPA published a draft document in the
Federal Register containing the Agency's intended rationale for
granting the petitions to add 1-BP to the CAA section 112(b)(1) HAP
list (82 FR 2354). In the draft document, the EPA determined that these
petitions met criteria specified in the CAA section 112(b): i.e., 1-BP
is an air pollutant and its emissions and ambient concentrations ``may
reasonably be anticipated to cause adverse effects to human health.''
Subsequently, on June 6, 2017, the EPA published an action granting the
request by Albemarle Corporation, a U.S.-based manufacturer of 1-BP, to
extend the comment period until October 1, 2017, to provide an
opportunity for prospective commenters to review the 2017 Toxics
Release Inventory (TRI), which included newly required emission
reporting of 1-BP (82 FR 26091). This current action is the final step
in granting the petitioners' request to add 1-BP to the CAA section
112(b)(1) HAP list. Even following the granting of this petition to add
1-BP to the list, sources will remain under no regulatory or statutory
obligation to reduce emissions of 1-BP until a separate regulatory
action is taken. In section IV of this document, we explain the future
additional regulatory actions that the EPA intends to consider either
simultaneously with the addition of 1-BP to the CAA section 112(b)(1)
HAP list or soon thereafter.
[[Page 36853]]
II. What comments were received on the draft document to grant the
petitions to add 1-BP to the CAA section 112(b)(1) HAP list?
The EPA received 12 comments on the draft document to add 1-BP to
the CAA section 112(b)(1) list of HAP. Two commenters opposed adding 1-
BP to the CAA section 112(b)(1) HAP list, while 10 commenters supported
the action. All comments are in the docket for this action. A summary
of the major comments and our responses are presented in this section.
A. Comments Regarding Estimated
1-BP Emissions
Comment: Albemarle Corporation requested that the EPA extend the
comment period to October 1, 2017, to ensure that data from the TRI
database for 1-BP would inform the final document. Albemarle
Corporation stated the extension would provide the public with an
opportunity to review the TRI dataset for 1-BP usage, sources, and
emissions and also to use those data to prepare meaningful comments on
the draft document.
Response: The EPA also agreed that it would be useful to review
reported TRI emissions releases for 1-BP prior to finalizing the
document. Since January 2017, when the draft document was published,
two years of emissions data had been submitted to the EPA's TRI.
Specifically, one commenter provided TRI data for 1-BP for calendar
year 2016 during the extended comment period. Further, according to the
EPA's TRI, in 2016, 55 facilities (in 27 states) reported emissions
totaling 626,659 pounds (more than 313 tons) of 1-BP into the air, with
multiple sources reporting emissions in excess of 20,000 pounds (10
tons per year). Total 1-BP air emissions reported to TRI in 2017 were
746,562 pounds (more than 373 tons).
Finally, the emissions data provided supported the risk analysis
submitted by HSIA. The primary risk driver for the analysis was a
degreasing operation in Collegeville, Pennsylvania, where the maximum
individual lifetime risk was estimated at 38-in-1 million. The
emissions reported by the facility to the TRI database showed
approximately 70 tons per year of 1-BP emissions, which supports the
petitioner's emissions estimates and the assertion that 1-BP may
present a risk to human health.
Comment: Albemarle Corporation also commented that the emission
estimates used by petitioners to estimate the fenceline ambient
concentration of 1-BP lacked accuracy and were ``wholly inadequate to
support the petition.'' They requested an extension of the comment
period to October 1, 2017, in order to resolve the significant
differences between the estimates provided by the petitioner, HSIA, and
the commenter's estimated emissions.
Response: The EPA agreed that resolving any differences between the
commenter's emission estimates and the petitioner's estimates was an
important issue that needed to be resolved prior to deciding on the
petitions. Therefore, the EPA extended the comment period until October
1, 2017 (82 FR 26091, June 6, 2017). The commenter, however, did not
provide additional information during the comment period extension. The
EPA evaluated HSIA's emission estimates and modeling assumptions and
found them to be reasonable and found their risk assessment methodology
consistent with the best practices for estimating carcinogenic risk for
an air pathway analysis. Given that no evidence was provided to change
the EPA's previous review of the petitioner's risk assessment, the
petitioner's original emission estimates used for the air pathway risk
modeling were found to be acceptable and to provide the basis for a
reasonable analysis of the risks associated with inhalation of 1-BP.
B. Comments on 1-BP Cancer Risk Factors
Comment: Israel Chemicals Ltd. (ICL) requested that the EPA
reconsider its initial decision to add 1-BP to the HAP list. ICL made
this request based on a September 2016 study titled In Vivo Mutation
Assay of n-Propyl Bromide at the cII Locus in Big Blue[supreg]
Transgenic B6C3F1 Mice Exposed via Whole-Body Inhalation.\1\ Based on
this study, ICL argued for removing cancer as a potential hazard from
1-BP exposure, which, in their view, would eliminate the basis for
listing 1-BP as a HAP.
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\1\ https://www.regulations.gov/, Docket ID Item No. EPA-HQ-OAR-
2014-0471-0067.
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Response: The EPA rejects the premise that the results of a single
assay for mutagenicity in a single gene locus in a transgenic (Big
Blue[supreg]) mouse strain can be used to make general statements on
potential mutagenicity or carcinogenicity. The EPA finds adequate
support from submitted evidence and comments that 1-BP presents a
potential cancer hazard and, therefore, is granting these petitions to
list 1-BP as a HAP for purposes of regulatory actions based on the
following considerations:
First, not all carcinogens operate via a mutagenic mode of action
(MOA). In fact, many of the National Toxicology Program (NTP)
substances categorized as ``Known to be a human carcinogen'' are
carcinogenic via non-mutagenic mechanisms. There is mixed evidence of
mutations in bacterial and mammalian cells and limited data on DNA
damage in 1-BP-exposed workers. However, there is clear evidence for
the carcinogenicity of 1-BP in multiple tissues in two rodent species
from a 2-year cancer bioassay \2\ by the NTP. The NTP's Report on
Carcinogens, 14th Edition \3\ finds 1-BP is ``reasonably anticipated to
be a human carcinogen'' based on sufficient evidence of carcinogenicity
from studies in experimental animals.
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\2\ https://ntp.niehs.nih.gov/testing/status/agents/ts-m000017.html.
\3\ https://ntp.niehs.nih.gov/ntp/roc/content/profiles/bromopropane.pdf.
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Second, regarding the ICL claim that if 1-BP is not a mutagen, any
cancer potential will be a threshold effect. The 2005 EPA Cancer
Guidelines \4\ provide the latitude to apply a non-linear model when
data positively establish the MOA to be non-linear. However, it is not
automatically assumed that a non-linear MOA is operational if a
chemical is not a mutagen.
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\4\ https://www.epa.gov/sites/production/files/2013-09/documents/cancer_guidelines_final_3-25-05.pdf.
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Third, as explained in greater detail in the draft document, there
is significant evidence that 1-BP poses a negative health impact for
noncancer effects including reproductive toxicity and neurotoxicity in
both controlled and uncontrolled environments; the evidence for these
noncancer effects provides sufficient justification to list 1-BP as a
HAP, regardless of the potential for a cancer effect (82 FR 2354, 2360-
61, January 9, 2017).
Finally, as also explained in the draft document, the EPA
``interpret[s] the CAA section 112(b)(3)(B) as invoking the
Administrator's expertise in considering information/data that
addresses the potential or likelihood of harm rather than concrete
proof of actual harm,'' and that the Administrator is authorized to
``act in the face of uncertainty as to the proven health effects of a
substance'' and to ``draw inferences from the data'' before him. (82 FR
2357, January 9, 2017); see generally Id. at 2356-58, 2361-62.
C. Comments Requesting the Addition of 1-BP to the CAA Section
112(b)(1) HAP List
Comment: Ten commenters supported the EPA's initial decision to
grant petitions to add 1-BP to the CAA section 112(b)(1) HAP list and
encouraged the EPA to issue a final action granting the petitions. They
also
[[Page 36854]]
stated that petitioners had provided substantial evidence to support
the conclusion that 1-BP either is known to cause or can reasonably be
anticipated to cause cancer and noncancer health effects in humans.
Their comments generally discussed this evidence.
One commenter stated that the decision to list 1-BP as a HAP under
the CAA depends only on showing potential adverse effects from a
chemical, not whether exposure is at levels that cause those effects.
The commenter also noted that exposures of concern for 1-BP are already
occurring. The commenter likewise disagreed with the negative
mutagenesis assay findings submitted by ICL, stating that results of a
single assay for mutagenicity cannot be used to apply across-the-board
statements on potential mutagenicity.
Response: The EPA acknowledges commenters' statements. The EPA also
agrees with the comments on the availability of substantial evidence to
support the addition of 1-BP to the CAA section 112(b)(1) HAP list.
III. The EPA's Decision To Grant the Petitions
Consistent with the draft document, petitioners have provided
sufficient information demonstrating the adverse health effects of 1-BP
that supports the EPA's determination that 1-BP is an air pollutant as
defined under the CAA section 302(g) and that ``emissions, ambient
concentrations, bioaccumulation or deposition of the substance are
known to cause or may reasonably be anticipated to cause adverse
effects to human health or adverse environmental effects'' as specified
under CAA section 112(b)(3)(B). The documented known or anticipated
adverse health effects of 1-BP, which are based on established sound
scientific principles, include carcinogenicity, reproductive toxicity,
and neurotoxicity. The EPA also concludes that petitioners' assessments
regarding estimates of potential ambient concentrations of 1-BP that
are likely to result at a facility's fenceline, process emissions
related information, and chemical usage information that are
representative of normal operating conditions are reasonable. The EPA
is, therefore, granting petitions to add 1-BP to the CAA section
112(b)(1) list of HAP. This action concludes the petition process under
the CAA section 112(b)(3). As previously explained, the EPA's granting
of the petitions by itself, as accomplished by this document, does not
impose any regulatory or statutory obligations on sources of 1-BP
emissions. Following this action, the EPA will take a separate
regulatory action to add 1-BP to the list of HAP under the CAA section
112(b)(1). At that time, the EPA will publish a Federal Register
document that formally proposes the addition of 1-BP to the CAA section
112(b)(1) HAP list and assess the impacts of adding 1-BP to the HAP
list on potentially affected sources.
IV. Reducing Emissions From Sources of 1-BP
The first step in this process is to grant the petitions requesting
that 1-BP be listed as a HAP, which we are completing with this action.
As a general matter, granting a petition to add an air pollutant to the
CAA section 112(b)(1) HAP list initiates the process of bringing the
air pollutant into consideration in the national emission standards for
hazardous air pollutants (NESHAP) program, under the CAA section
112(d). (The CAA section 112(d) imposes a ``clear statutory obligation
to set emissions standards for each listed HAP.'' National Lime
Association v. EPA, 233 F. 3d 625, 634 (D.C. Cir. 2000)). As previously
explained, by itself, granting the petitions will not create new
regulatory or statutory obligations for sources that emit 1-BP, until
further actions are taken by the Agency. During the period from when
this document is published and until the next step of adding 1-BP to
the CAA section 112(b)(1) HAP list is taken, sources emitting 1-BP will
have no regulatory obligations related to approval of the petitions.
The second step is to publish a Federal Register document that
formally announces the addition of 1-BP to the CAA section 112(b)(1)
HAP list. In granting the petitions to list 1-BP as a HAP, the EPA has
learned that most source categories emitting 1-BP will not become
subject to emission standards until the EPA amends or promulgates new
maximum achievable control technology standards for specific source
categories. The single largest user of 1-BP is the Halogenated Solvent
Cleaning source category. However, the current Halogenated Solvent
Cleaning NESHAP (40 CFR part 63, subpart T) does not regulate 1-BP
emissions because only emissions of methylene chloride,
perchloroethylene (PERC), and trichloroethylene (TCE) are subject to
the rule. Therefore, the use of 1-BP as a solvent degreaser will not be
subject to regulation until such time as the EPA revises 40 CFR part
63, subpart T, issues new standards, or takes other actions to reduce
1-BP emissions from the Halogenated Solvent Cleaning source category.
Further, the EPA may need to take additional regulatory action to
address 1-BP emissions from certain dry cleaning operations. The PERC
Dry Cleaning source category, which sets out requirements for these
operations, covers only PERC emissions. PERC is a solvent used in dry
cleaning and has been identified as a probable human carcinogen. 40 CFR
63.322(o)(5)(i) requires that the existing co-residential dry cleaning
subcategory phase out the use of PERC by December 21, 2020. The EPA has
learned that 1-BP is currently used as a replacement solvent in this
subcategory. Considering the public health effects discussed earlier in
this document and the information before us, the EPA is concerned about
the use of 1-BP as a substitute for PERC in the co-residential dry
cleaning subcategory. Further, these public health effects may call for
the need for adequate controls for 1-BP emissions from other dry
cleaning subcategories other than the dry cleaning co-residential
subcategory. The EPA is, therefore, planning in a future action to
modify the CAA section 112(c)(1) source category list to add a new
source category that would cover 1-BP emissions from all dry cleaning
operations. Under the CAA section 112(c)(5), the EPA may add additional
source categories to the CAA section 112(c)(1) source category list.
Beyond the Halogenated Solvent Cleaning source category and 1-BP
dry cleaning operations, the EPA does not believe that other source
categories need to be added to the source category list or otherwise
modified to reduce emissions of 1-BP. After adding a new source
category to regulate 1-BP emissions from dry cleaning operations, the
EPA would be required under CAA section 112(c)(5), to promulgate
emission standards under the CAA section 112(d) within two years.
Additionally, some sources could become immediately subject to
existing standards once 1-BP is placed on the CAA section 112(b)(1)
list given that these sources may become major sources of HAP emissions
(greater than 10 tons per year of a single HAP or 25 tons per year of
total HAP). For these sources, 40 CFR 63.6(c)(5) allows three years to
comply after 1-BP is added to the HAP list unless the underlying rule
specifies another schedule.
These future actions that the EPA intends to consider for purposes
of addressing 1-BP emissions reduction, such as the listing of new
source categories under the CAA section 112(c)(1), can occur either
simultaneously with listing 1-BP on the HAP list or shortly thereafter.
In sum, as a result of granting these petitions, the EPA intends to
consider taking additional regulatory actions as a result
[[Page 36855]]
of adding 1-BP to the CAA section 112(b)(1) HAP list.
V. Statutory and Executive Order Review
Additional information about this Executive Order can be found at
https://www.epa.gov/laws-regulations/laws-and-executive-orders.
A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulation and Regulatory Review
This action is a significant regulatory action that was submitted
to the Office of Management and Budget (OMB) for review because it
raises novel legal or policy issues. Any changes made in response to
OMB recommendations have been documented in the docket.
Andrew Wheeler,
Administrator.
[FR Doc. 2020-13145 Filed 6-17-20; 8:45 am]
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