Granting Petitions To Add 1-bromopropane (Also Known as 1-BP) to the List of Hazardous Air Pollutants, 36851-36855 [2020-13145]
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ENVIRONMENTAL PROTECTION
AGENCY
ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–OAR–2014–0471; FRL–10010–36–
OAR]
RIN 2060–AS26
[EPA–HQ–ORD–2015–0635; FRL 10011–01–
ORD]
Board of Scientific Counselors (BOSC)
Chemical Safety for Sustainability and
Health and Environmental Risk
Assessment Subcommittee Meeting—
June 2020; Correction
Granting Petitions To Add 1bromopropane (Also Known as 1–BP)
to the List of Hazardous Air Pollutants
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
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
SUMMARY:
Environmental Protection
Agency (EPA).
AGENCY:
Notice of public meeting;
correction.
ACTION:
The Environmental Protection
Agency (EPA), Office of Research and
Development (ORD), published a
document in the Federal Register of
June 2, 2020, giving notice of a meeting
of the Board of Scientific Counselors
(BOSC) Chemical Safety for
Sustainability and Health and
Environmental Risk Assessment (CSS–
HERA) Subcommittee. The meeting has
been postponed until June 24, 2020. Due
to unforeseen administrative
circumstances, EPA is announcing this
meeting with less than 15 calendar days’
notice.
SUMMARY:
The
Designated Federal Officer (DFO) via
phone/voice mail at: (202) 564–6518 or
via email at: tracy.tom@epa.gov.
FOR FURTHER INFORMATION CONTACT:
SUPPLEMENTARY INFORMATION:
Correction
In the Federal Register of June 2,
2020, in FR Doc. 2020–11816, on page
33,665, column 1 correct the ‘‘DATES’’
caption to read:
The videoconference meeting
will be held on Wednesday, June 24,
2020, from 3:00 p.m. to 6:00 p.m. (EDT).
Meeting times are subject to change.
This meeting is open to the public.
Those who wish to attend must register
by June 23, 2020. Comments must be
received by June 22, 2020 to be
considered by the subcommittee.
Requests for the draft agenda or making
a presentation at the meeting will be
accepted until June 22, 2020.
DATES:
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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: schaefer.john@epa.gov.
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 npropyl 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
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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
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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-listhazardous-air-pollutantsmodifications#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,
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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.
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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
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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® 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.
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®) 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
1 https://www.regulations.gov/, Docket ID Item
No. EPA–HQ–OAR–2014–0471–0067.
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36853
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 2year 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.
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.
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
2 https://ntp.niehs.nih.gov/testing/status/agents/
ts-m000017.html.
3 https://ntp.niehs.nih.gov/ntp/roc/content/
profiles/bromopropane.pdf.
4 https://www.epa.gov/sites/production/files/
2013-09/documents/cancer_guidelines_final_3-2505.pdf.
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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
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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
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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
E:\FR\FM\18JNN1.SGM
18JNN1
Federal Register / Vol. 85, No. 118 / Thursday, June 18, 2020 / Notices
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/lawsand-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]
BILLING CODE 6560–50–P
FARM CREDIT SYSTEM INSURANCE
CORPORATION
Regular Meeting; Farm Credit System
Insurance Corporation Board
Farm Credit System Insurance
Corporation.
ACTION: Notice, regular meeting.
AGENCY:
Notice is hereby given, in
accordance with the provisions of
Article VI of the Bylaws of the Farm
Credit System Insurance Corporation
(FCSIC), that a regular meeting of the
Board of Directors of FCSIC will be held
June 25, 2020, at 10 a.m. EDT, until
such time as the Board may conclude its
business. Note: Because of the COVID–
19 pandemic, we will conduct the board
meeting virtually. If you would like to
observe the open portion of the virtual
meeting, see instructions below for
board meeting visitors.
Attendance: To observe the open
portion of the virtual meeting, go to
FCSIC.gov, select ‘‘News & Events,’’
then ‘‘Board Meetings.’’ There you will
find a description of the meeting and
‘‘Instructions for board meeting
visitors.’’ See SUPPLEMENTARY
SUMMARY:
INFORMATION for further information
about attendance requests.
FOR FURTHER INFORMATION CONTACT: Dale
Aultman, Secretary to the Board of the
Farm Credit System Insurance
Corporation (703) 883–4009. TTY is
(703) 883–4056.
SUPPLEMENTARY INFORMATION: Parts of
this meeting of the Board will be open
to the public, and parts will be closed.
If you wish to observe the open portion,
follow the instructions above in the
‘‘Attendance’’ section at least 24 hours
before the meeting. Please note that this
meeting begins at 10:00 a.m. EDT with
a session that is closed to the public.
You may join this meeting at 11:15 a.m.
EDT. We will begin the open session
promptly at 11:30 a.m. EDT.
Assistance: If you need assistance for
accessibility reasons or if you have any
questions, contact Dale Aultman,
Secretary to the Farm Credit
Administration Board, at (703) 883–
4009. The matters to be considered at
the meeting are as follows:
A. Closed Session—Risk Management
Reports
• FCSIC Report on Insurance Risk/
Premium Risk Factors
B. Open Session
Approval of Minutes
• March 12, 2020
C. Quarterly Business Reports
• FCSIC Financial Report
• Report on Insured Obligations
• Report on Annual Performance Plan
D. New Business
• Mid-Year Review of Insurance
Premium Rates
Dated: June 15, 2020.
Dale Aultman,
Secretary, Farm Credit System Insurance
Corporation.
[FR Doc. 2020–13178 Filed 6–17–20; 8:45 am]
BILLING CODE 6705–01–P
FEDERAL ELECTION COMMISSION
Sunshine Act Meeting
Tuesday, June 23, 2020
at 10:00 a.m. and its continuation on
June 25, 2020 at 10:00 a.m.
TIME AND DATE:
1050 First Street NE,
Washington, DC (This meeting will be a
virtual meeting).
STATUS: This meeting will be closed to
the public.
MATTERS TO BE CONSIDERED: Compliance
matters pursuant to 52 U.S.C. 30109.
Matters concerning participation in civil
actions or proceedings or arbitration.
*
*
*
*
*
CONTACT PERSON FOR MORE INFORMATION:
Judith Ingram, Press Officer; Telephone:
(202) 694–1220.
PLACE:
Vicktoria J. Allen,
Acting Deputy Secretary of the Commission.
[FR Doc. 2020–13303 Filed 6–16–20; 4:15 pm]
BILLING CODE 6715–01–P
FEDERAL TRADE COMMISSION
Granting of Requests for Early
Termination of the Waiting Period
Under the Premerger Notification
Rules
Section 7A of the Clayton Act, 15
U.S.C. 18a, as added by Title II of the
Hart-Scott-Rodino Antitrust
Improvements Act of 1976, requires
persons contemplating certain mergers
or acquisitions to give the Federal Trade
Commission and the Assistant Attorney
General advance notice and to wait
designated periods before
consummation of such plans. Section
7A(b)(2) of the Act permits the agencies,
in individual cases, to terminate this
waiting period prior to its expiration
and requires that notice of this action be
published in the Federal Register.
The following transactions were
granted early termination—on the dates
indicated—of the waiting period
provided by law and the premerger
notification rules. The listing for each
transaction includes the transaction
number and the parties to the
transaction. The grants were made by
the Federal Trade Commission and the
Assistant Attorney General for the
Antitrust Division of the Department of
Justice. Neither agency intends to take
any action with respect to these
proposed acquisitions during the
applicable waiting period.
EARLY TERMINATIONS GRANTED MAY 1, 2020 THRU MAY 31, 2020
05/01/2020
20201000 ......
G
The Carle Foundation; Advocate Aurora Health, Inc.; The Carle Foundation.
05/04/2020
20200999 ......
20201001 ......
VerDate Sep<11>2014
G
G
TPG Partners VIII, L.P.; LifeStance Health, LLC; TPG Partners VIII, L.P.
Quincy Health, LLC; Quorum Health Corp.; Quincy Health, LLC.
17:40 Jun 17, 2020
Jkt 250001
PO 00000
Frm 00028
Fmt 4703
Sfmt 4703
36855
E:\FR\FM\18JNN1.SGM
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Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\1\ https://www.regulations.gov/, Docket ID Item No. EPA-HQ-OAR-
2014-0471-0067.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\2\ https://ntp.niehs.nih.gov/testing/status/agents/ts-m000017.html.
\3\ https://ntp.niehs.nih.gov/ntp/roc/content/profiles/bromopropane.pdf.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\4\ https://www.epa.gov/sites/production/files/2013-09/documents/cancer_guidelines_final_3-25-05.pdf.
---------------------------------------------------------------------------
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]
BILLING CODE 6560-50-P