[Federal Register Volume 83, Number 19 (Monday, January 29, 2018)]
[Notices]
[Pages 4104-4108]
[FR Doc No: 2018-01542]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-82574; File No. SR-BX-2018-004]

Self-Regulatory Organizations; Nasdaq BX, Inc.; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change To Amend Chapter
IV, Section 3

January 23, 2018.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on January 16, 2018, Nasdaq BX, Inc. (``BX'' or ``Exchange'') filed
with the Securities and Exchange Commission (``SEC'' or ``Commission'')
the proposed rule change as described in Items I, II, and III, below,
which Items have been prepared by the Exchange. The Commission is
publishing this notice to solicit comments on the proposed rule change
from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend Chapter IV, Section 3 (Criteria for
Underlying Securities) to modify the criteria for listing an option on
an underlying covered security.
    The text of the proposed rule change is available on the Exchange's
website at http://nasdaqbx.cchwallstreet.com/, at the principal office
of the Exchange, and at the Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
sections A, B, and C below, of the most significant aspects of such
statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and the
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The purpose of the proposed rule change is to amend Chapter IV,
Section

3 to modify the criteria for listing options on an underlying security
as defined in Section 18(b)(1)(A) of the Securities Act of 1933
(hereinafter ``covered security'' or ``covered securities''). In
particular, the Exchange proposes to modify Section 3(b)v.1) to permit
the listing of an option on an underlying covered security that has a
market price of at least $3.00 per share for the previous three
consecutive business days preceding the date on which the Exchange
submits a certificate to the Options Clearing Corporation (``OCC'') for
listing and trading. The Exchange does not intend to amend any other
criteria for listing options on an underlying security in Chapter IV,
Section 3.
    This proposed rule change is identical to a recently-approved rule
change by the Exchange's affiliate, Nasdaq PHLX LLC (``Phlx''), to its
initial listing standards,\3\ and serves to align the rules of Phlx and
the Exchange.
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    \3\ See Securities Exchange Act Release No. 82474 (January 9,
2018) (SR-Phlx-2017-75) (Order Granting Approval of a Proposed Rule
Change) (``Phlx Filing''). The Exchange, together with its
affiliates, The Nasdaq Stock Market LLC (``Nasdaq'') and Nasdaq ISE,
LLC (``ISE''), all of which are wholly owned subsidiaries of Nasdaq,
Inc. (``Nasdaq HoldCo''), have filed identical rule change proposals
based on the Phlx Filing.
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    Currently the underlying covered security must have a closing
market price of $3.00 per share for the previous five consecutive
business days preceding the date on which the Exchange submits a
listing certificate to OCC. In the proposed amendment, the market price
will still be measured by the closing price reported in the primary
market in which the underlying covered security is traded, but the
measurement will be the price over the prior three consecutive business
day period preceding the submission of the listing certificate to OCC,
instead of the prior five business day period.
    The Exchange acknowledges that the Options Listing Procedures Plan
\4\ requires that the listing certificate be provided to OCC no earlier
than 12:01 a.m. and no later than 11:00 a.m. (Chicago time) on the
trading day prior to the day on which trading is to begin.\5\ The
proposed amendment will still comport with that requirement. For
example, if an initial public offering (``IPO'') occurs at 11 a.m. on
Monday, the earliest date the Exchange could submit its listing
certificate to OCC would be on Thursday by 12:01 a.m. (Chicago time),
with the market price determined by the closing price over the three-
day period from Monday through Wednesday. The option on the IPO would
then be eligible for trading on the Exchange on Friday. The proposed
amendment would essentially enable options trading within four business
days of an IPO becoming available instead of six business days (five
consecutive days plus the day the listing certificate is submitted to
OCC).
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    \4\ The Plan for the Purpose of Developing and Implementing
Procedures Designed to Facilitate the Listing and Trading of
Standardized Options Submitted Pursuant to Section 11a(2)(3)(B) of
the Securities Exchange Act of 1934 (a/k/a the Options Listing
Procedures Plan (``OLPP'')) is a national market system plan that,
among other things, sets forth procedures governing the listing of
new options series. See Securities Exchange Act Release No. 44521
(July 6, 2001), 66 FR 36809 (July 13, 2001) (Order approving OLPP).
The sponsors of OLPP include BX; OCC; BATS Exchange, Inc.; BOX
Options Exchange LLC; C2 Options Exchange, Incorporated Chicago
Board Options Exchange, Incorporated; EDGX Exchange Inc.; Miami
International Securities Exchange, LLC; MIAX PEARL, LLC; Nasdaq PHLX
LLC; The Nasdaq Stock Market LLC; Nasdaq GEMX, LLC; Nasdaq ISE, LLC;
Nasdaq MRX, LLC; NYSE American, LLC; and NYSE Arca, Inc.
    \5\ See OLPP at page 3.
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    The Exchange's initial listing standards for equity options in
Chapter IV, Section 3 (including the current price/time standard of
$3.00 per share for five consecutive business days) are substantially
similar to the initial listing standards adopted by other options
exchanges.\6\ At the time the options industry adopted the ``look
back'' period of five consecutive business days, it was determined that
the five-day period was sufficient to protect against attempts to
manipulate the market price of the underlying security and would
provide a reliable test for stability.\7\ Surveillance technologies and
procedures concerning manipulation have evolved since then to provide
adequate prevention or detection of rule or securities law violations
within the proposed time frame, and the Exchange represents that its
existing trading surveillances are adequate to monitor the trading in
the underlying security and subsequent trading of options on the
Exchange.\8\
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    \6\ See, e.g., Phlx Rule 1009, Commentary .01.
    \7\ See Securities Exchange Act Release Nos. 47190 (January 15,
2003), 68 FR 3072 (January 22, 2003) (SR-CBOE-2002-62); 47352
(February 11, 2003), 68 FR 8319 (February 20, 2003) (SR-PCX-2003-
06); 47483 (March 11, 2003), 68 FR 13352 (March 19, 2003) (SR-ISE-
2003-04); 47613 (April 1, 2003), 68 FR 17120 (April 8, 2003) (SR-
Amex-2003-19); and 47794 (May 5, 2003), 68 FR 25076 (May 9, 2003)
(SR-Phlx-2003-27).
    \8\ Such surveillance procedures generally focus on detecting
securities trading subject to opening price manipulation, closing
price manipulation, layering, spoofing or other unlawful activity
impacting an underlying security, the option, or both. As it relates
to IPOs, the Exchange has price movement alerts, unusual market
activity and order book alerts active for all trading symbols. These
real-time patterns are active for the new security as soon as the
IPO begins trading. The Nasdaq MarketWatch group, which provides
such real-time surveillance on the Exchange and its affiliated
markets, monitors trading activity in IPOs to see whether the new
issue moves substantially above or below the public offering price
in the first day or several days of trading.
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    Furthermore, the Exchange notes that the scope of its surveillance
program also includes cross market surveillance for trading that is not
just limited to the Exchange. In particular, the Financial Industry
Regulatory Authority (``FINRA''), pursuant to a regulatory services
agreement, operates a range of cross-market equity surveillance
patterns on behalf of the Exchange to look for potential manipulative
behavior, including spoofing, algorithm gaming, marking the close and
open, and momentum ignition strategies, as well as more general,
abusive behavior related to front running, wash sales, quoting/routing,
and Reg SHO violations. These cross-market patterns incorporate
relevant data from various markets beyond the Exchange and its
affiliates, including data from the New York Stock Exchange (``NYSE'').
    Additionally for options, the Nasdaq Options Surveillance team
utilizes an array of patterns that monitor manipulation of options, or
manipulation of equity securities (regardless of venue) for the purpose
of impacting options prices on any of the six Nasdaq HoldCo-operated
options markets (i.e., mini-manipulation strategies). Surveillance
coverage is initiated once options begin trading on any of Nasdaq
HoldCo's six options markets, including the Exchange. Accordingly, the
Exchange believes that the cross market surveillance performed by FINRA
on behalf of the Exchange, coupled with Exchange staff's real-time
monitoring of similarly violative activity on BX and its affiliated
markets as described herein, reflects a comprehensive surveillance
program that is adequate to monitor for manipulation of the underlying
security and overlying option within the proposed three-day look back
period.
    Furthermore, the Exchange notes that the proposed listing criteria
would still require that the underlying security be listed on NYSE, the
American Stock Exchange (now known as NYSE American), or the National
Market System of The Nasdaq Stock Market (now known as the Nasdaq
Global Market) (collectively, the ``Named Markets''), as provided for
in the definition of ``covered security'' from Section 18(b)(1)(A) of
the 1933 Act.\9\ Accordingly, the Exchange believes that the proposed
rule change would still ensure that the underlying security meets the
high listing standards of a Named Market, and would also ensure

that the underlying is covered by the regulatory protections (including
market surveillance, investigation and enforcement) offered by these
exchanges for trading in covered securities conducted on their
facilities.
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    \9\ See 15 U.S.C. 77r(b)(1)(A).
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    In addition, The Nasdaq Stock Market LLC, the Exchange's affiliated
listing market, had no cases within the past five years where an IPO-
related issue for which it had pricing information qualified for the
$3.00 price requirement during the first three days of trading and did
not qualify for the $3.00 price requirement during the first five
days.\10\ In other words, none of these qualifying issues fell below
the $3.00 threshold within the first three or five days of trading. As
such, the Exchange believes that its existing surveillance program,
coupled with its findings related to the IPO-related issues on Nasdaq
as described herein, adequately address potential concerns regarding
possible manipulation or price stability within the proposed timeframe.
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    \10\ There were over 750 IPO-related issues on Nasdaq within the
past five years. Out of all of the issues with pricing information,
there was only one issue that had a price below $3 during the first
five consecutive business days. The Exchange notes, however, that
Nasdaq allows for companies to list on the Nasdaq Capital Market at
$2.00 or $3.00 per share in some instances, which was the case for
this particular issue. See Nasdaq Rule 5500 Series for initial
listing standards on the Nasdaq Capital Market.
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    The Exchange also believes that the proposed look back period can
be implemented in connection with the other initial listing criteria
for underlying covered securities. In particular, the Exchange
recognizes that it may be difficult to verify the number of
shareholders in the days immediately following an IPO due to the fact
that stock trades generally clear within two business days (T+2) of
their trade date and therefore the shareholder count will generally not
be known until T+2.\11\ The Exchange notes that the current T+2
settlement cycle was recently reduced from T+3 on September 5, 2017 in
connection with the Commission's amendments to Exchange Rule 15c6-1(a)
to adopt the shortened settlement cycle,\12\ and the look back period
of three consecutive business days proposed herein reflects this
shortened T+2 settlement period. As proposed, stock trades would clear
within T+2 of their trade date (i.e., within three business days) and
therefore the number of shareholders could be verified within three
business days, thereby enabling options trading within four business
days of an IPO (three consecutive business days plus the day the
listing certificate is submitted to OCC).
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    \11\ The number of shareholders of record can be verified from
large clearing agencies such as The Depository Trust and Clearing
Corporation (``DTCC'') upon the settlement date (i.e., T+2).
    \12\ See Securities Exchange Act Release No. 78962 (September
28, 2016), 81 FR 69240 (October 5, 2016) (Amendment to Securities
Transaction Settlement Cycle) (File No. S7-22-16).
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    Furthermore, the Exchange notes that it can verify the shareholder
count with various brokerage firms that have a large retail customer
clientele. Such firms can confirm the number of individual customers
who have a position in the new issue. The earliest that these firms can
provide confirmation is usually the day after the first day of trading
(T+1) on an unsettled basis, while others can confirm on the third day
of trading (T+2). The Exchange has confirmed with some of these
brokerage firms who provide shareholder numbers to the Exchange that
they are able to provide these numbers within T+2 after an IPO. For the
foregoing reasons, the Exchange believes that basing the proposed three
business day look back period on the T+2 settlement cycle would allow
for sufficient verification of the number of shareholders.
    The proposed rule change will apply to all covered securities that
meet the relevant criteria in Chapter IV, Section 3. Pursuant to
Section 3(b), BX Regulation establishes guidelines to be considered in
evaluating potential underlying securities for BX Options transactions.
However, the fact that a particular security may meet the standards
established by BX Regulation does not necessarily mean that it will be
selected as an underlying security.\13\ As part of the established
criteria, the issuer must be in compliance with any applicable
requirements of the Act and the rules thereunder.\14\ Additionally, in
considering the underlying security, BX Regulation relies on
information made publicly available by the issuer and/or the markets in
which the security is traded.\15\ The Exchange believes that these
measures, together with its existing surveillance procedures, provide
adequate safeguards in the review of any covered security that may meet
the proposed criteria for consideration of the option within the
timeframe contained in this proposal.
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    \13\ See Chapter IV, Section 3(b).
    \14\ See Chapter IV, Section 3(b)iii.
    \15\ See Chapter IV, Section 3(d).
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2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\16\ in general, and furthers the objectives of Section
6(b)(5) of the Act,\17\ in particular, in that it is designed to
promote just and equitable principles of trade, to remove impediments
to and perfect the mechanism of a free and open market and a national
market system, and, in general to protect investors and the public
interest.
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    \16\ 15 U.S.C. 78f(b).
    \17\ 15 U.S.C. 78f(b)(5).
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    The Exchange believes that the proposed changes to its listing
standards for covered securities would allow the Exchange to more
quickly list options on a qualifying covered security that has met the
$3.00 eligibility price without sacrificing investor protection. As
discussed above, the Exchange believes that its existing trading
surveillances provide a sufficient measure of protection against
potential price manipulation within the proposed three consecutive
business day timeframe. The Exchange also believes that the proposed
three consecutive business day timeframe would continue to be a
reliable test for price stability in light of its findings that none of
the IPO-related issues on Nasdaq within the past five years that
qualified for the $3.00 per share price standard during the first three
trading days fell below the $3.00 threshold during the fourth or fifth
trading day. Furthermore, the established guidelines to be considered
by the Exchange in evaluating the potential underlying securities for
Exchange option transactions,\18\ together with existing trading
surveillances, provide adequate safeguards in the review of any covered
security that may meet the proposed criteria for consideration of the
option within the proposed timeframe.
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    \18\ See notes 13-15 above.
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    In addition, the Exchange believes that basing the proposed
timeframe on the T+2 settlement cycle adequately addresses the
potential difficulties in confirming the number of shareholders of the
underlying covered security. Having some of the largest brokerage firms
that provide these shareholder counts to the Exchange confirm that they
are able to provide these numbers within T+2 further demonstrates that
the 2,000 shareholder requirement can be sufficiently verified within
the proposed timeframe. For the foregoing reasons, the Exchange
believes that the proposed amendments will remove and perfect the
mechanism of a free and open market and a national market system by
providing an avenue for investors to swiftly hedge their investment in
the stock in a shorter amount of time than what is currently in
place.\19\
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    \19\ This proposed rule change does not alter any obligations of
issuers or other investors of an IPO that may be subject to a lock-
up or other restrictions on trading related securities.

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    Finally, it should be noted that a price/time standard for the
underlying security was first adopted when the listed options market
was in its infancy, and was intended to prevent the proliferation of
options being listed on low-priced securities that presented special
manipulation concerns and/or lacked liquidity needed to maintain fair
and orderly markets.\20\ When options trading commenced in 1973, the
Commission determined that it was necessary for securities underlying
options to meet certain minimum standards regarding both the quality of
the issuer and the quality of the market for a particular security.\21\
These standards, including a price/time standard, were imposed to
ensure that those issuers upon whose securities options were to be
traded were widely-held, financially sound companies whose shares had
trading volume and float substantial enough so as not to be readily
susceptible to manipulation.\22\ At that time, the Commission
determined that the imposition of these standards was reasonable in
view of the pilot nature of options trading and the limited experience
of investors with options trading.\23\
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    \20\ See Securities Exchange Act Release No. 29628 (August 29,
1991), 56 FR 43949-01 (September 5, 1991) (SR-AMEX-86-19; SR-CBOE-
86-15; SR-NYSE-86-20; SR-PSE-86-15; and SR-PHLX-86-21) (``1991
Approval Order'') at 43949 (discussing the Commission's concerns
when options trading initially commenced in 1973).
    \21\ See 1991 Approval Order at 43949.
    \22\ Id.
    \23\ Id.
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    Now more than 40 years later, the listed options market has evolved
into a mature market with sophisticated investors. In view of this
evolution, the Commission has approved various exchange proposals to
relax some of these initial listing standards throughout the years,\24\
including reducing the price/time standard in 2003 from $7.50 per share
for the majority of business days over a three month period to the
current $3.00 per share/five business day standard (``2003
Proposal'').\25\ It has been almost fifteen years since the Commission
approved the 2003 Proposal, and both the listed options market and
exchange technologies have continued to evolve since then. In this
instance, Nasdaq is only proposing a modest reduction of the current
five business day standard to three business days to correspond to the
securities industry's move to a T+2 standard settlement cycle.\26\ The
$3.00 per share standard and all other initial options listing criteria
in Chapter IV, Section 3 will remain unchanged by this proposal. For
the reasons discussed herein, the Exchange therefore believes that the
proposed three business day period will be beneficial to the
marketplace without sacrificing investor protections.
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    \24\ See e.g., 1991 Approval Order (modifying a number of
initial listing criteria, including the reduction of the price/time
standard from $10 per share each day during the preceding three
calendar months to $7.50 per share for the majority of days during
the same period).
    \25\ See note 7 above.
    \26\ See note 12 above.
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B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act. The proposed rule change
reduces the number of days to list options on an underlying security,
and is intended to bring new options listings to the marketplace
quicker.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    No written comments were either solicited or received.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Because the proposed rule change does not (i) significantly affect
the protection of investors or the public interest; (ii) impose any
significant burden on competition; and (iii) become operative for 30
days from the date on which it was filed, or such shorter time as the
Commission may designate if consistent with the protection of investors
and the public interest, the proposed rule change has become effective
pursuant to Section 19(b)(3)(A) of the Act \27\ and Rule 19b-4(f)(6)
thereunder.\28\
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    \27\ 15 U.S.C. 78s(b)(3)(A).
    \28\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii)
requires the Exchange to give the Commission written notice of the
Exchange's intent to file the proposed rule change, along with a
brief description and text of the proposed rule change, at least
five business days prior to the date of filing of the proposed rule
change, or such shorter time as designated by the Commission. The
Exchange has satisfied this requirement.
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    A proposed rule change filed under Rule 19b-4(f)(6) \29\ normally
does not become operative for 30 days after the date of filing.
However, pursuant to Rule 19b-4(f)(6)(iii),\30\ the Commission may
designate a shorter time if such action is consistent with the
protection of investors and the public interest. The Exchange has asked
the Commission to waive the 30-day operative delay so that the proposal
may become operative upon filing. The Commission believes that waiving
the 30-day operative delay is consistent with the protection of
investors and the public interest as it will allow the Exchange to
align its initial options listing standards with that of its
affiliates, and the Exchange's proposal does not raise new issues.
Accordingly, the Commission hereby waives the 30-day operative delay
requirement and designates the proposed rule change as operative upon
filing.\31\
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    \29\ 17 CFR 240.19b-4(f)(6).
    \30\ 17 CFR 240.19b-4(f)(6)(iii).
    \31\ For purposes only of waiving the 30-day operative delay,
the Commission has also considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
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    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings to
determine whether the proposed rule should be approved or disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
File Number SR-BX-2018-004 on the subject line.

Paper Comments

     Send paper comments in triplicate to Secretary, Securities
and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.

All submissions should refer to File Number SR-BX-2018-004. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements

with respect to the proposed rule change that are filed with the
Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549, on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-BX-2018-004, and should be submitted on
or before February 20, 2018.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\32\
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    \32\ 17 CFR 200.30-3(a)(12).
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Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2018-01542 Filed 1-26-18; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 83, Number 21 (Wednesday, January 31, 2018)]
[Notices]
[Pages 4480-4481]
[FR Doc No: 2018-01914]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-ORD-2017-0497; FRL-9973-15-ORD]

Availability of the Systematic Review Protocol for the Chloroform
Integrated Risk Information System (IRIS) Assessment.

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of public comment period.

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SUMMARY: The Environmental Protection Agency (EPA) is announcing a 30-
day public comment period associated with the Systematic Review
Protocol for the IRIS Chloroform Assessment. The protocol describes the
systematic review procedures and other methodology planned for use in
developing the chloroform assessment. EPA is making this Protocol
available to the public via the docket and the IRIS website. These
documents were prepared by the National Center for Environmental
Assessment (NCEA) within EPA's Office of Research and Development
(ORD).

DATES: The 30-day public comment period begins January 31, 2018, and
ends March 2, 2018. Comments must be received on or before March 2,
2018. The Systematic Review Protocol for chloroform can also be found
on the chemical landing page on the IRIS website (https://cfpub.epa.gov/ncea/iris2/chemicalLanding.cfm?substance_nmbr=25).

ADDRESSES: The Systematic Review Protocol for the chloroform IRIS
assessment, will be available via the internet on IRIS website at
https://cfpub.epa.gov/ncea/iris2/chemicalLanding.cfm?substance_nmbr=25
and in the public docket at http://www.regulations.gov, Docket ID: EPA-
HQ-ORD-2017-0497.

FOR FURTHER INFORMATION CONTACT: For information on the docket, contact
the ORD Docket at the EPA Headquarters Docket Center; telephone: 202-
566-1752; facsimile:<PHONE_NUMBER>; or email: [email protected].
    For technical information on the protocol, contact Dr. James Avery,
NCEA; telephone:<PHONE_NUMBER>; or email: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background Information on the IRIS Program and Systematic Review
Protocols

    EPA's IRIS Program is a human health assessment program that
evaluates quantitative and qualitative risk information on effects that
may result from exposure to chemicals found in the environment. Through
the IRIS Program, EPA provides the highest quality science-based human
health assessments to support the Agency's regulatory activities and
decisions to protect public health. As part of developing a draft IRIS
assessment, EPA presents a methods document, referred to as the
protocol, for conducting a chemical-specific systematic review of the
available scientific literature. Protocols include strategies for
literature searches, criteria for study inclusion or exclusion,
considerations for evaluating study methods, information management for
extracting data, approaches for synthesis within and across lines of
evidence, and methods for derivation of toxicity values.
    The protocol serves to inform the subsequent development of the
draft assessment and is made available to the public. EPA may update
the protocol based on the evaluation of the literature and any updates
will be posted to the docket and on the IRIS website.

II. How To Submit Technical Comments to the Docket at http://www.regulations.gov

    Submit your comments, identified by Docket ID No. EPA-HQ-ORD-2017-
0497 for chloroform, by one of the following methods:
     http://www.regulations.gov: Follow the on-line
instructions for submitting comments.
     Email: [email protected].
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Environmental Protection Agency, EPA Docket
Center (ORD Docket), Mail Code: 28221T, 1200 Pennsylvania Avenue NW,
Washington, DC 20460. The phone number is<PHONE_NUMBER>.
     Hand Delivery: The ORD Docket is located in the EPA
Headquarters Docket Center, EPA West Building, Room 3334, 1301
Constitution Avenue NW, Washington, DC 20229.
    The EPA Docket Center Public Reading Room is open from 8:30 a.m. to
4:30 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Public Reading Room is<PHONE_NUMBER>.
Deliveries are only accepted during the docket's normal hours of
operation, and special arrangements should be made for deliveries of
boxed information. If you provide comments by mail or hand delivery,
please submit three copies of the comments. For attachments, provide an
index, number pages consecutively with the comments, and submit an
unbound original and three copies.
    Instructions: Direct your comments to EPA-HQ-ORD-2017-0497 for
chloroform. Please ensure that your comments are submitted within the
specified comment period. Comments received after the closing date will
be marked ``late,'' and may only be considered if time permits. It is
EPA's policy to include all comments it receives in the public docket
without change and to make the comments available online at https://www.regulations.gov, including any personal information provided,
unless a comment includes information claimed to be Confidential
Business Information (CBI) or other information for which disclosure is
restricted by statute. Do not submit information through https://www.regulations.gov or email that you consider to be CBI or otherwise
protected. The https://www.regulations.gov website is an ``anonymous
access'' system, which means EPA will not know your identity or contact
information unless you

provide it in the body of your comment. If you send an email comment
directly to EPA without going through https://www.regulations.gov, your
email address will be automatically captured and included as part of
the comment that is placed in the public docket and made available on
the internet. If you submit an electronic comment, EPA recommends that
you include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses. For additional
information about EPA's public docket visit the EPA Docket Center
homepage at https://www.epa.gov/dockets.
    Docket: Documents in the docket are listed in the https://www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other materials,
such as copyrighted material, are publicly available only in hard copy.
Publicly available docket materials are available either electronically
in https://www.regulations.gov or hard copy at the ORD Docket in the
EPA Headquarters Docket Center.

    Dated: January 8, 2018.
Tina Bahadori,
Director, National Center for Environmental Assessment.
[FR Doc. 2018-01914 Filed 1-30-18; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 82, Number 181 (Wednesday, September 20, 2017)]
[Proposed Rules]
[Pages 43925-43926]
[FR Doc No: 2017-19936]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R07-OAR-2017-0208; FRL-9967-92-Region 7]

Approval of Implementation Plans; State of Iowa; Elements of the
Infrastructure SIP Requirements for the 2010 Nitrogen Dioxide National
Ambient Air Quality Standard (NAAQS)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve elements of a State Implementation Plan (SIP) submission, and
an amended SIP submission from the State of Iowa for the 2010 Nitrogen
Dioxide (NO2) National Ambient Air Quality Standard (NAAQS).
Infrastructure SIPs address the applicable requirements of Clean Air
Act (CAA) section 110, which requires that each state adopt and submit
a SIP for the implementation, maintenance, and enforcement of each new
or revised NAAQS promulgated by the EPA. These SIPs are commonly
referred to as ``infrastructure'' SIPs. The infrastructure requirements
are designed to ensure that the structural components of each state's
air quality management program are adequate to meet the state's
responsibilities under the CAA.
    In the ``Rules and Regulations'' section of this Federal Register,
we are approving the state's SIP revisions as a direct final rule
without a prior proposed rule. If we receive no adverse comment, we
will not take further action on this proposed rule.

DATES: Comments must be received on or before October 20, 2017.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R07-
OAR-2017-0208, to https://www.regulations.gov. Follow the online
instructions for submitting comments. Once submitted, comments cannot
be edited or removed from Regulations.gov. 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 (i.e. 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://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Heather Hamilton, Air Planning and
Development Branch, U.S. Environmental Protection Agency, Region 7,
11201 Renner Boulevard, Lenexa, KS 66219 at<PHONE_NUMBER>, or by email
at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: This document proposes to take direct final
action on Iowa's infrastructure SIP submissions for the 2010
NO2 NAAQS. We have published a direct final rule approving
the State's SIP revision(s) in the ``Rules and Regulations'' section of
this Federal Register, because we view this as a noncontroversial
action and anticipate no relevant adverse comment. We have explained
our reasons for this action in the preamble to the direct final rule. A
detailed Technical Support Document (TSD) is included in this
rulemaking docket to address the following: A description of Clean Air
Act section 110(a)(1) and (2)

infrastructure SIPs; the applicable elements under sections 110(a)(1)
and (2); EPA's approach to the review of infrastructure SIP
submissions, and EPA's evaluation of how Iowa addressed the relevant
elements of sections 110(a)(1) and (2). If we receive no adverse
comment, we will not take further action on this proposed rule. If we
receive adverse comment, we will withdraw the direct final rule and it
will not take effect. We would address all public comments in any
subsequent final rule based on this proposed rule. We do not intend to
institute a second comment period on this action. Any parties
interested in commenting must do so at this time. For further
information, please see the information provided in the ADDRESSES
section of this document.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Nitrogen dioxide, Reporting and
recordkeeping requirements.

    Dated: September 8, 2017.
Cathy Stepp,
Acting Regional Administrator, Region 7.
[FR Doc. 2017-19936 Filed 9-19-17; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register: June 11, 2008 (Volume 73, Number 113)]
[Rules and Regulations]
[Page 33007-33013]
[DOCID:fr11jn08-12]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 82

[EPA-HQ-OAR-2007-0297; FRL-8577-9]
RIN 2060-AO44

Protection of Stratospheric Ozone: Allocation of Essential Use
Allowances for Calendar Year 2008

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: With this action, EPA is allocating essential use allowances
for import and production of Class I stratospheric ozone-depleting
substances (ODSs) for calendar year 2008. Essential use allowances
enable a person to obtain controlled Class I ODSs as part of an
exemption to the regulatory ban on the production and import of these
chemicals, which became effective as of January 1, 1996. EPA allocates
essential use allowances for exempted production or import of a
specific quantity of Class I ODSs solely for the designated essential
purpose. The allocation in this action is 27.0 metric tons (MT) of
chlorofluorocarbons (CFCs) for use in metered dose inhalers (MDIs) for
2008.

DATES: This final rule is effective June 11, 2008.

ADDRESSES: EPA has established a docket for this action under Docket ID
No. EPA-HQ-OAR-2007-0297. All documents in the docket are listed on the
www.regulations.gov Web site. Although listed in the index, some
information is not publicly available, e.g., confidential business
information (CBI) 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 either
electronically through www.regulations.gov or in hard copy at the Air
Docket, EPA/DC, EPA West, Room 3334, 1301 Constitution Ave., NW.,
Washington, DC 20460. This Docket Facility is open from 8:30 a.m.

to 4:30 p.m., Monday through Friday, excluding legal holidays. The
Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the Air
Docket is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Kirsten Cappel, by regular mail: U.S.
Environmental Protection Agency, Stratospheric Protection Division
(6205J), 1200 Pennsylvania Ave., NW., Washington, DC 20460; by courier
service or overnight express: 1310 L Street, NW., Room 1047C,
Washington, DC 20005; by telephone:<PHONE_NUMBER>; by fax: (202) 343-
2338; or by e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION

Table of Contents

I. Basis for Allocating Essential Use Allowances
    A. What are essential use allowances?
    B. Under what authority does EPA allocate essential use
allowances?
    C. What is the process for allocating essential use allowances?
II. Response to Comments
III. Allocation of Essential Use Allowances for Calendar Year 2008
IV. Statutory and Executive Order Reviews
    A. Executive Order 12866: Regulatory Planning and Review
    B. Paperwork Reduction Act
    C. Regulatory Flexibility
    D. Unfunded Mandates Reform Act
    E. Executive Order 13132: Federalism
    F. Executive Order 13175: Consultation and Coordination With
Indian Tribal Governments
    G. Executive Order 13045: Protection of Children From
Environmental Health Risks and Safety Risks
    H. Executive Order 13211: Actions That Significantly Affect
Energy Supply, Distribution, or Use
    I. National Technology Transfer and Advancement Act
    J. Executive Order 12898: Federal Actions To Address
Environmental Justice in Minority Populations and Low-Income
Populations
    K. Congressional Review Act
V. Judicial Review
VI. Effective Date of This Final Rule

I. Basis for Allocating Essential Use Allowances

A. What are essential use allowances?

    Essential use allowances are allowances to produce or import
certain ODSs in the United States for purposes that have been deemed
``essential'' by the U.S. Government and by the Parties to the Montreal
Protocol on Substances that Deplete the Ozone Layer (Montreal
Protocol).
    The Montreal Protocol is an international agreement aimed at
reducing and eliminating the production and consumption \1\ of ODSs.
The elimination of production and consumption of Class I ODSs has been
accomplished through adherence to phase-out schedules for specific
Class I ODSs,\2\ which include CFCs, halons, carbon tetrachloride, and
methyl chloroform. As of January 1, 1996, production and import of most
Class I ODSs were phased out in developed countries, including the
United States.
---------------------------------------------------------------------------

    \1\ ``Consumption'' is defined as the amount of a substance
produced in the United States, plus the amount imported into the
United States, minus the amount exported to Parties to the Montreal
Protocol (see Section 601(6) of the Clean Air Act).
    \2\ Class I ozone depleting substances are listed at 40 CFR Part
82 subpart A, appendix A.
---------------------------------------------------------------------------

    However, the Montreal Protocol and the Clean Air Act (the Act)
provide exemptions that allow for the continued import and/or
production of Class I ODSs for specific uses. Under the Montreal
Protocol, exemptions may be granted for uses that are determined by the
Parties to be ``essential.'' Decision IV/25, taken by the Parties to
the Protocol in 1992, established criteria for determining whether a
specific use should be approved as essential, and set forth the
international process for making determinations of essentiality. The
criteria for an essential use, as set forth in paragraph 1 of Decision
IV/25, are the following:

    ``(a) That a use of a controlled substance should qualify as
`essential' only if:
    (i) It is necessary for the health, safety or is critical for
the functioning of society (encompassing cultural and intellectual
aspects); and
    (ii) There are no available technically and economically
feasible alternatives or substitutes that are acceptable from the
standpoint of environment and health;
    (b) That production and consumption, if any, of a controlled
substance for essential uses should be permitted only if:
    (i) All economically feasible steps have been taken to minimize
the essential use and any associated emission of the controlled
substance; and
    (ii) The controlled substance is not available in sufficient
quantity and quality from existing stocks of banked or recycled
controlled substances, also bearing in mind the developing
countries' need for controlled substances.''

B. Under what authority does EPA allocate essential use allowances?

    Title VI of the Act implements the Montreal Protocol for the United
States. Section 604(d) of the Act authorizes EPA to allow the
production of limited quantities of Class I ODSs after the phaseout
date for the following essential uses:
    (1) Methyl chloroform, ``solely for use in essential applications
(such as nondestructive testing for metal fatigue and corrosion of
existing airplane engines and airplane parts susceptible to metal
fatigue) for which no safe and effective substitute is available.''
Under the Act, this exemption was available only until January 1, 2005.
Prior to that date, EPA issued essential use allowances for methyl
chloroform to the U.S. Space Shuttle and Titan Rocket programs.
    (2) Medical devices (as defined in section 601(8) of the Act), ``if
such authorization is determined by the Commissioner [of the Food and
Drug Administration], in consultation with the Administrator [of EPA]
to be necessary for use in medical devices.'' EPA issues essential use
allowances to manufacturers of metered dose inhalers (MDIs) that use
CFCs as propellant for the treatment of asthma and chronic obstructive
pulmonary disease (COPD).
    (3) Aviation safety, for which limited quantities of halon-1211,
halon-1301, and halon-2402 may be produced ``if the Administrator of
the Federal Aviation Administration, in consultation with the
Administrator [of EPA] determines that no safe and effective substitute
has been developed and that such authorization is necessary for
aviation safety purposes.'' Neither EPA nor the Parties have ever
granted a request for essential use allowances for halon because in
most cases alternatives are available and existing quantities of this
substance are large enough to provide for any needs for which
alternatives have not yet been developed.
    An additional essential use exemption under the Montreal Protocol,
as agreed in Decision X/19, is the general exemption for laboratory and
analytical uses. This exemption is reflected in EPA's regulations at 40
CFR Part 82, Subpart A. While the Act does not specifically provide for
this exemption, EPA has determined that an exemption for essential
laboratory and analytical uses is allowable under the Act as a de
minimis exemption. The de minimis exemption is addressed in EPA's final
rule of March 13, 2001 (66 FR 14760-14770). The Parties to the Protocol
subsequently agreed (Decision XI/15) that the general exemption does
not apply to the following uses: Testing of oil and grease, and total
petroleum hydrocarbons in water; testing of tar in road-paving
materials; and forensic finger-printing. EPA incorporated this
exemption at Appendix G to Subpart A of 40 CFR Part 82 on February 11,
2002 (67 FR 6352). In a December 29, 2005, final rule, EPA extended the
general exemption for laboratory and analytical uses through December
31, 2007 (70 FR 77048), in accordance with Decision

XV/8 of the Parties to the Protocol. In a notice of proposed rulemaking
published in the Federal Register on September 13, 2007 (72 FR 52332),
EPA proposed to extend the global laboratory and analytical use
exemption beyond December 31, 2007 contingent upon and consistent with
future anticipated action by the Parties to the Montreal Protocol. At
the 19th Meeting of the Parties in September 2007, the Parties agreed
to extend the global laboratory and analytical use exemption through
December 31, 2011 in Decision XIX/18. In a December 27, 2007 final
rulemaking EPA took action to (1) extend the laboratory and analytical
use exemption to December 31, 2011 for specific laboratory uses, (2)
apply the laboratory and analytical use exemption to the production and
import of methyl bromide, and (3) eliminate the testing of organic
matter in coal from the laboratory and analytical use exemption (72 FR
73264).

C. What is the process for allocating essential use allowances?

    Before EPA will allocate an essential use allowance, the Parties to
the Montreal Protocol must first authorize the United States' request
to produce or import essential Class I ODSs. The procedure set out by
Decision IV/25 calls for individual Parties to nominate essential uses
and the total amount of ODSs needed for those essential uses on an
annual basis. The Montreal Protocol's Technology and Economic
Assessment Panel (TEAP) evaluates the nominated essential uses and
makes recommendations to the Parties. The Parties make the final
decisions at their annual meeting on whether to authorize a Party's
essential use nomination. This nomination-and-authorization cycle
begins approximately two years before the year in which the allowances
would be in effect. The allowances allocated through this action were
nominated by the United States in January 2006.
    Once the Parties authorize the U.S. nomination, EPA allocates
essential use allowances to specific entities through notice-and-
comment rulemaking in a manner consistent with the Act. For MDIs, EPA
requests information from manufacturers about the number and type of
MDIs they plan to produce, as well as the amount of CFCs necessary for
production. EPA then forwards the information to the Food and Drug
Administration (FDA), which determines the amount of CFCs for MDIs in
the coming calendar year that are necessary to protect public health.
Based on FDA's determination, EPA proposes allocations for each
eligible entity. Under the Act and the Montreal Protocol, EPA allocates
essential use allowances in quantities that together are below or equal
to the total amount authorized by the Parties. EPA will not allocate
essential use allowances in amounts higher than the total authorized by
the Parties. For 2008, the Parties authorized the United States to
allocate up to 385 MT of CFCs for essential uses. In the nomination for
2008 essential use allowances, the United States did not request CFCs
for use in MDIs where the sole active ingredient is albuterol. In a
notice of proposed rulemaking published in the Federal Register on June
12, 2007 (72 FR 32269), EPA proposed to allocate 27.0 MT of CFC-114 for
the production of epinephrine MDIs for the calendar year 2008. In this
final rule, EPA is allocating 27.0 MT of CFC-114 for the production of
epinephrine MDIs for 2008.

II. Response to Comments

    EPA received comments from four entities on the proposed rule.
    One commenter opposed EPA's proposed allocation and opposed
allowing MDI manufacturers to produce any MDIs that damage the ozone
layer. The commenter further stated that MDI manufacturers should
research and adopt alternatives that are healthful for all.
    The Parties grant essential use exemptions contingent on a finding
that the use for which an exemption is being requested is essential for
health, safety, or the functioning of society, and that there are no
available technically and economically feasible alternatives or
substitutes that are acceptable from the standpoint of health or the
environment. FDA regulations at 21 CFR 2.125 provide criteria for
removing ODS-containing medical devices from the list of essential uses
(see also FDA's July 24, 2002 final rule at 67 FR 48370). EPA notes
that the transition to ozone-safe alternatives is well underway and
that, for example, the allocation of essential use allowances for CFC-
based MDIs decreased from 3,136.3 MT in 2000 to 167.0 MT in 2007. FDA,
in consultation with EPA, has determined that 27.0 MT of CFC-114 is
necessary in 2008 for the production of epinephrine MDIs. As
therapeutic alternatives become available, FDA will, consistent with
its regulations, continue to initiate rulemakings for removal of
essential use designations for certain MDIs in a manner that is
protective of public health.
    With respect to the comment that MDI manufacturers should research
alternatives to replace CFC MDIs, EPA agrees that companies applying
for essential use allocations to manufacture essential use MDIs should
demonstrate ongoing research and development of alternatives to CFC
MDIs. EPA honors commitments under the Montreal Protocol to demonstrate
progress in the transition to alternatives by considering this
information in the application and nomination phase of the essential
use process. Decision VIII/10, taken in 1997, provides for applicants
to submit information on the status of research and development into
alternatives, and Decision XIX/13, taken in September 2007, provides
for applicants to submit related information describing their progress
in transitioning to CFC-free formulations. EPA will continue to
consider companies' progress in the transition to CFC-free inhalers as
a factor in the essential use nomination process.
    A second commenter observed that for the 2008 proposed allocation
EPA used a ``new criterion'' under which allowances would be made
available only to companies that held less than one year's stockpile of
essential use CFCs. The commenter observed that if its allocation for
2009--as well as its allocation for 2008--were zero, it would most
likely not have sufficient CFC supplies to meet anticipated patient
demand for other moieties during 2009. (The commenter noted that FDA
has proposed, and not yet finalized, a rule to remove the essential use
designation for those moieties as of December 31, 2009, but that it
would need an allocation for 2009 regardless.)
    The commenter also noted that it is a contract manufacturer that
makes products for clients. As a result, according to the commenter,
although it could purchase CFCs from the pre-1996 stockpile to
supplement its CFC supply, such action is not reasonable. The commenter
explained that the price of pre-1996 CFCs is not regulated and that as
a result, the material is available, if at all, only at higher prices
than CFCs manufactured with essential use allowances. The commenter
stated that it cannot absorb the higher cost of the pre-1996 material
because the prices of its finished products are fixed.
    With respect to the comment that EPA used a new approach for the
2008 proposal, EPA responds that EPA and FDA used the same procedure
for 2008 as for prior years to determine the essential use allocation
for each requesting MDI company. That is, to assess the amount of new
CFC production required to satisfy 2008 essential uses, EPA and FDA
applied the terms of Decision XVII/5, including the provision that
Parties should allocate such that manufacturers of

MDIs maintain no more than one-year operational supply of CFCs for
essential uses. FDA articulated to EPA that in making its determination
for 2008, FDA calculated the quantity of CFCs that a manufacturer
needed to produce essential use MDIs for the year and subtracted from
that quantity any CFC stocks owned by the MDI manufacturer exceeding a
one-year operational supply. The remainder, if more than zero, was the
quantity of newly produced or imported CFCs needed by that
manufacturer. In addition, FDA informed EPA that consistent with the
language of Decision XVII/5, FDA evaluated each company on an
individual basis, rather than the aggregate CFC supplies owned by all
entities. The use of this approach has been previously described in
EPA's 2006 and 2007 final rulemakings for allocating essential use
allowances, 71 FR 58504 and 72 FR 32212, respectively.
    With respect to the comment about not being able to meet patient
demand in 2009 if its allocation in 2009 is zero, EPA and FDA will
assess 2009 allocations beginning in 2008 once more current information
is available regarding the medical need for CFCs in MDIs. However, EPA
expects that it and FDA will follow an approach for 2009 that is
similar to that used for 2008 and previous control periods.
    Under this approach, FDA, in close collaboration with EPA, will
undertake a thorough and comprehensive analysis of a number of factors
to determine the amount of CFCs necessary for the manufacture of
essential use MDIs for the 2009 control period. First, FDA would
evaluate the medical necessity by assessing the number of CFC MDIs
necessary to protect public health in the U.S. (including the
consideration of current data on the prevalence of asthma and COPD) and
the quantity of CFCs necessary to ensure the manufacture and continuous
availability of those MDIs. Second, FDA would analyze the most current
data available regarding the existing inventory of CFCs held by each
MDI manufacturer. Third, FDA would account for the implementation of
the terms of Decision XVII/5, including the provision that FDA allocate
such that manufacturers maintain no more than a one-year operational
supply. Finally, FDA would consider how manufacturers' existing CFC
supplies would be drawn down as they manufacture essential use MDIs
throughout the year.
    In response to the comment regarding potential outcomes of the FDA
rulemaking that is now in the proposal stage, EPA asserts that concerns
about the potential need for additional allowances would be best
addressed in its essential use rulemaking for the 2009 control period.
    With respect to the commenter's assertion that it cannot afford the
cost of pre-January 1, 1996 CFCs, EPA and FDA do not regulate the price
of CFCs, whether in the pre-January 1, 1996 stockpile or produced or
imported post-January 1, 1996 with essential use allowances. Rather,
market mechanisms determine the price of CFCs. As discussed above, if
FDA determines that there is a medical need for new production of CFCs
for the manufacture of essential use MDIs, then FDA will recommend
allocation of the necessary amount to the requesting MDI manufacturer
to make those MDIs. That MDI manufacturer is permitted to purchase
newly produced and/or imported CFCs up to the amount that it has been
allocated. EPA and FDA would not expect a MDI manufacturer to need pre-
January 1, 1996 CFCs when FDA has determined that that manufacturer
should be allocated essential use allowances.
    To supplement its CFC allocation for a particular year, an MDI
manufacturer may purchase any pre-January 1, 1996 CFCs that are
available in the marketplace, or it may acquire essential use CFCs
through a transfer with another manufacturer (subject to EPA
regulations for such transfers). However, EPA notes that in making
determinations for annual essential use allocations for MDI
manufacturers, FDA takes into account the entirety of each MDI
manufacturer's stocks of CFCs, including pre- and post-January 1, 1996
stocks and CFCs acquired through transfers.
    A third commenter supported EPA's proposed allocation and stated
that it is sufficient to protect human health and provide a smooth
transition to non-CFC alternatives, consistent with the principles and
obligations of the Montreal Protocol, and that it conforms with the
Clean Air Act and other U.S. law. The commenter stated that according
to publicly available information, the quantity of pharmaceutical-grade
CFCs in the United States is sufficient to meet patient needs and that
EPA's proposed amount will provide a smooth transition to CFC-free
alternatives. In particular, the commenter stated that the zero
allocation for CFC-albuterol, which started with the 2007 allocation,
will allow for the gradual phase-down of CFC albuterol on the market,
and is optimal for patient care. The commenter also noted that the
proposal will foster a smooth transition by not allocating CFCs to
other CFC MDI products where there are CFC-free therapeutic
alternatives available.
    A fourth commenter, who submitted comments claimed as CBI, opposed
EPA's proposed allocation as too low and requested additional essential
use allowances for calendar year 2008. A redacted version of these
comments has been placed in the docket. In the public version of the
comments, the commenter stated that based on an internal assessment of
its current stockpile, it would not be able to meet production needs of
Primatene Mist[supreg] if EPA did not grant it essential use allowances
for calendar year 2008. To further evaluate the needs of the commenter,
on August 8, 2007, EPA sent a letter to the commenter requesting
additional information about its current and projected stockpile of
CFCs, as well as current and projected production of Primatene
Mist[supreg]. A copy of this letter is available in the docket. On
August 21, 2007, the commenter sent a letter to EPA withdrawing its
comments on the 2008 proposed rulemaking. In that letter the commenter
noted that its withdrawal of its 2008 comments on the proposed
rulemaking should not affect its request for essential use allowances
in future years. A copy of this letter is also available in the docket.

III. Allocation of Essential Use Allowances for Calendar Year 2008

    With this action, EPA is allocating essential use allowances for
calendar year 2008 to the entity listed in Table 1. These allowances
are for the production or import of the specified quantity of Class I
controlled substances solely for the specified essential use.

        Table 1.--Essential Use Allowances for Calendar Year 2008
------------------------------------------------------------------------
                                                          2008 Quantity
             Company                     Chemical         (metric tons)
------------------------------------------------------------------------
 (i) Metered Dose Inhalers (for oral inhalation) for Treatment of Asthma
                and Chronic Obstructive Pulmonary Disease
------------------------------------------------------------------------
Armstrong Pharmaceuticals........  CFC-114 (production              27.0
                                    of epinephrine
                                    MDIs only).
------------------------------------------------------------------------

IV. Statutory and Executive Order Reviews

A. Executive Order 12866: Regulatory Planning and Review

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), this
action is a ``significant regulatory action'' because it raises novel
legal or policy issues. Accordingly, EPA submitted this action to the
Office of Management and Budget (OMB) for review under EO 12866 and any
changes made in response to OMB recommendations have been documented in
the docket for this action.

B. Paperwork Reduction Act

    This action does not impose any new information collection burden.
The recordkeeping and reporting requirements included in this action
are already included in an existing information collection burden and
this action does not make any changes that would affect the burden. The
Office of Management and Budget (OMB) has previously approved the
information collection requirements contained in the existing
regulations at 40 CFR Part 82, Subpart A under the provisions of the
Paperwork Reduction Act, 44 U.S.C. 3501 et seq. and has assigned OMB
control number 2060-0170. The OMB control numbers for EPA's regulations
are listed in 40 CFR part 9.

C. Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA) generally requires an agency
to prepare a regulatory flexibility analysis of any rule subject to
notice-and-comment rulemaking requirements under the Administrative
Procedure Act or any other statute unless the agency certifies that the
rule will not have a significant economic impact on a substantial
number of small entities. Small entities include small businesses,
small organizations, and small governmental jurisdictions.
    For purposes of assessing the impact of this rule on small
entities, small entities are defined as: (1) A small business that is
primarily engaged in pharmaceutical preparations manufacturing (NAICS
code 325412) and that has fewer than 750 employees (based on Small
Business Administration size standards); (2) a small governmental
jurisdiction that is a government of a city, county, town, school
district or special district with a population of less than 50,000; and
(3) a small organization that is any not-for-profit enterprise that is
independently owned and operated and is not dominant in its field.
    After considering the economic impacts of this final rule on small
entities, I certify that this action will not have a significant
economic impact on a substantial number of small entities. In
determining whether a rule has a significant economic impact on a
substantial number of small entities, the impact of concern is any
significant adverse economic impact on small entities, since the
primary purpose of the regulatory flexibility analyses is to identify
and address regulatory alternatives ``which minimize any significant
economic impact of the proposed rule on small entities.'' 5 U.S.C. 603
and 604. Thus, an agency may conclude that a rule will not have a
significant economic impact on a substantial number of small entities
if the rule relieves regulatory burden, or otherwise has a positive
economic effect on all of the small entities subject to the rule. This
rule provides an otherwise unavailable benefit to those companies that
are receiving essential use allowances. We have therefore concluded
that this final rule will relieve regulatory burden for all small
entities.

D. Unfunded Mandates Reform Act

    Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public
Law 104-4, establishes requirements for Federal agencies to assess the
effects of their regulatory actions on State, local, and tribal
governments and the private sector. Under section 202 of the UMRA, EPA
generally must prepare a written statement, including a cost-benefit
analysis, for proposed and final rules with ``Federal mandates'' that
may result in expenditures to State, local, and tribal governments, in
the aggregate, or to the private sector, of $100 million or more in any
one year.
    Before promulgating an EPA rule for which a written statement is
needed, section 205 of the UMRA generally requires EPA to identify and
consider a reasonable number of regulatory alternatives and adopt the
least costly, most cost-effective, or least burdensome alternative that
achieves the objectives of the rule. The provisions of section 205 do
not apply when they are inconsistent with applicable law. Moreover,
section 205 allows EPA to adopt an alternative other than the least
costly, most cost-effective, or least burdensome alternative, if the
Administrator publishes with the final rule an explanation why that
alternative was not adopted.
    Before EPA establishes any regulatory requirements that may
significantly or uniquely affect small governments, including tribal
governments, it must have developed a small government agency plan
under section 203 of the UMRA. The plan must provide for notifying
potentially affected small governments, enabling officials of affected
small governments to have meaningful and timely input in the
development of EPA regulatory proposals with significant Federal
intergovernmental mandates, and informing, educating, and advising
small governments on compliance with the regulatory requirements.
    This rule contains no Federal mandates (under the regulatory
provisions of Title II of the UMRA) for State, local, or tribal
governments or the private sector, since it merely provides exemptions
from the 1996 phase-out of Class I ODSs. Similarly, EPA has determined
that this rule contains no regulatory requirements that might
significantly or uniquely affect small governments, because this rule
merely allocates essential use exemptions to entities as an exemption
to the ban on production and import of Class I ODSs.

E. Executive Order 13132: Federalism

    Executive Order 13132, entitled ``Federalism'' (64 FR 43255, August
10, 1999), requires EPA to develop an accountable process to ensure
``meaningful and timely input by State and local officials in the
development of regulatory policies that have federalism implications.''
``Policies that have federalism implications'' is defined in the
Executive Order to include regulations that 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.''
    This final rule 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,
as specified in Executive Order 13132. Thus, Executive Order 13132 does
not apply to this rule.

F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

    Executive Order 13175, entitled ``Consultation and Coordination
with Indian Tribal Governments'' (65 FR 67249, November 9, 2000),
requires EPA to develop an accountable process to ensure ``meaningful
and timely input by tribal officials in the development of regulatory
policies that have tribal implications.'' This final rule does not have
tribal implications, as specified in Executive Order 13175. This rule
affects only the companies that requested essential use allowances.
Thus, Executive Order 13175 does not apply to this rule.

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

    Executive Order 13045, ``Protection of Children from Environmental
Health risks and Safety Risks'' (62 FR 19885, April 23, 1997), applies
to any rule that (1) is determined to be ``economically significant''
as defined under Executive Order 12866, and (2) concerns an
environmental health and safety risk that EPA has reason to believe may
have a disproportionate effect on children. If the regulatory action
meets both criteria, the Agency must evaluate the environmental health
or safety effects of the planned rule on children, and explain why the
planned regulation is preferable to other potentially effective and
reasonably feasible alternatives considered by the Agency.
    EPA interprets Executive Order 13045 as applying only to those
regulatory actions that are based on health or safety risks, such that
the analysis required under section 5-501 of the Order has the
potential to influence the regulation. This final rule is not subject
to Executive Order 13045 because it implements the phaseout schedule
and exemptions established by Congress in Title VI of the Clean Air
Act.

H. Executive Order 13211: Actions That Significantly Affect Energy
Supply, Distribution, or Use

    This rule is not a ``significant energy action'' as defined in
Executive Order 13211, ``Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use'' (66 FR 28355
(May 22, 2001)) because it is not likely to have a significant adverse
effect on the supply, distribution, or use of energy. The rule affects
only the pharmaceutical companies that requested essential use
allowances of CFCs.

I. National Technology Transfer and Advancement Act

    Section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (``NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note) directs EPA to use voluntary consensus standards in regulatory
activities unless to do so would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., materials specifications, test methods, sampling
procedures, and business practices) that are developed or adopted by
voluntary consensus standards bodies. The NTTAA directs EPA to provide
Congress, through OMB, explanations when the Agency decides not to use
available and applicable voluntary consensus standards. This final rule
does not involve technical standards. Therefore, EPA did not consider
the use of any voluntary consensus standards.

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

    Executive Order 12898 (59 FR 7629 (February 16, 1994)) establishes
federal executive policy on environmental justice. Its main provision
directs federal agencies, to the greatest extent practicable and
permitted by law, to make environmental justice part of their mission
by identifying and addressing, as appropriate, disproportionately high
and adverse human health or environmental effects of their programs,
policies, and activities on minority populations and low-income
populations in the United States.
    EPA has determined that this final rule will not have
disproportionately high and adverse human health or environmental
effects on minority or low-income populations, because it affects the
level of environmental protection equally for all affected populations
without having any disproportionately high and adverse human health or
environmental effects on any population, including any minority or low-
income population. Any stratospheric ozone depletion that results from
this final rule will impact all affected populations equally because
ozone depletion is a global environmental problem with environmental
and human effects that are, in general, equally distributed across
geographical regions in the U.S.

K. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. Therefore, EPA will submit a report containing this rule
and other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. This rule is not a
``major rule'' as defined by 5 U.S.C. 804(2). This rule will be
effective June 11, 2008.

V. Judicial Review

    Under section 307(b)(1) of the Act, EPA finds that these
regulations are of national applicability. Accordingly, judicial review
of the action is available only by the filing of a petition for review
in the United States Court of Appeals for the District of Columbia
Circuit within sixty days of publication of the action in the Federal
Register. Under section 307(b)(2), the requirements of this rule may
not be challenged later in judicial proceedings brought to enforce
those requirements.

VI. Effective Date of This Final Rule

    Section 553(d) of the Administrative Procedures Act (APA) generally
provides that rules may not take effect earlier than 30 days after they
are published in the Federal Register. This final rule is issued under
section 307(d) of the CAA, which states, ``The provisions of section
553 through 557 of Title 5 shall not, except as expressly provided in
this subsection, apply to actions to which this subsection applies.''
Thus, section 553(d) of the APA does not apply to this rule. EPA
nevertheless is acting consistently with the policies underlying APA
section 553(d) in making this rule effective June 11, 2008. APA section
553(d) provides an exception for any action that grants or recognizes
an exemption or relieves a restriction. Because this action grants an
exemption to the phaseout of

production and consumption of CFCs, EPA is making this action effective
immediately to ensure continued availability of CFCs for medical
devices.

List of Subjects in 40 CFR Part 82

    Environmental protection, Administrative practice and procedure,
Air pollution control, Chemicals, Exports, Imports, Ozone, Reporting
and recordkeeping requirements.

    Dated: June 5, 2008.
Stephen L. Johnson,
Administrator.

0
40 CFR part 82 is amended as follows:

PART 82--PROTECTION OF STRATOSPHERIC OZONE

0
1. The authority citation for part 82 continues to read as follows:

    Authority: 42 U.S.C. 7414, 7601, 7671-7671q.

Subpart A--Production and Consumption Controls

0
2. Section 82.8 is amended by revising the table in paragraph (a) to
read as follows:

Sec.  82.8  Grants of essential use allowances and critical use
allowances.

    (a) * * *

        Table I.--Essential Use Allowances for Calendar Year 2008
------------------------------------------------------------------------
                                                          2008 Quantity
             Company                     Chemical         (metric tons)
------------------------------------------------------------------------
 (i) Metered Dose Inhalers (for oral inhalation) for Treatment of Asthma
                and Chronic Obstructive Pulmonary Disease
------------------------------------------------------------------------
Armstrong Pharmaceuticals........  CFC-114 (production              27.0
                                    of epinephrine
                                    MDIs only).
------------------------------------------------------------------------

* * * * *
 [FR Doc. E8-13088 Filed 6-10-08; 8:45 am]

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[Federal Register Volume 78, Number 127 (Tuesday, July 2, 2013)]
[Notices]
[Pages 39717-39718]
[FR Doc No: 2013-15860]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[ Docket No. CP13-502-000]

Iroquois Gas Transmission System, LP; Notice of Application

    Take notice that on June 13, 2013, Iroquois Gas Transmission
System, LP, (Iroquois), filed in Docket No. CP13-502-000, an
application pursuant to Section 7(c) of the Natural Gas Act (NGA) and
Part 157 of the Commission's regulations, requesting authorization to
construct, install, own, operate, and maintain certain new compression
facilities to be located in Wright, New York, and to modify certain
existing facilities at that same location, and to lease the incremental
capacity associated with these new and modified facilities to
Constitution Pipeline Company, LLC (Constitution), a proposed new
interstate gas pipeline company for which Commission authorization is
being sought concurrently with this application (Docket No. CP13-499-
000). Iroquois' proposed project will allow Iroquois to establish a new
receipt interconnection with Constitution and create an incremental
650,000 dekatherms per day (Dth/d) of primary firm transmission
capacity from that new point of interconnection with Constitution to
interconnections with Iroquois' mainline system as well as Tennessee
Gas Pipeline Company, LLC. The new capacity will be leased to
Constitution under a long-term capacity lease, to be operated as part
of Constitution's FERC-jurisdictional natural gas pipeline system and
subject to the service terms of Constitution's FERC gas tariff.
Iroquois also requests the Commission's approval of its proposed
Capacity Lease Agreement with Constitution, all as more fully set forth
in the application which is on file with the Commission and open to
public inspection. This filing may also be viewed on the Commission's
Web site at http://www.ferc.gov using the ``eLibrary'' link. Enter the
docket number, excluding the last three digits, in the docket number
field to access the document. For assistance, call<PHONE_NUMBER> or
TTY,<PHONE_NUMBER>.
    Any questions regarding this application should be directed to
Helen M. Gallagher, Director of Legal Services and Secretary, Iroquois
Pipeline Operating Company, One Corporate Drive, Suite 600, Shelton,
Connecticut, 06484, or by calling<PHONE_NUMBER> (telephone<EMAIL_ADDRESS>

    Pursuant to Section 157.9 of the Commission's rules, 18 CFR 157.9,
within 90 days of this Notice the Commission staff will either:
complete its environmental assessment (EA) and place it into the
Commission's public record (eLibrary) for this proceeding, or issue a
Notice of Schedule for Environmental Review. If a Notice of Schedule
for Environmental Review is issued, it will indicate, among other
milestones, the anticipated date for the Commission staff's issuance of
the final environmental impact statement (FEIS) or EA for this
proposal. The filing of the EA in the Commission's public record for
this proceeding or the issuance of a Notice of Schedule for
Environmental Review will serve to notify federal and state agencies of
the timing for the completion of all necessary reviews, and the
subsequent need to complete all federal authorizations within 90 days
of the date of issuance of the Commission staff's FEIS or EA.
    There are two ways to become involved in the Commission's review of
this project. First, any person wishing to obtain legal status by
becoming a party to the proceedings for this project should, on or
before the comment date stated below, file with the Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426, a
motion to intervene in accordance with the requirements of the
Commission's Rules of Practice and Procedure (18 CFR 385.214 or
385.211) and the Regulations under the NGA (18 CFR 157.10). A person
obtaining party status will be placed on the service list maintained by
the Secretary of the Commission and will receive copies of all
documents filed by the applicant and by all other parties. A party must
submit 14 copies of filings made with the Commission and must mail a
copy to the applicant and to every other party in the proceeding. Only
parties to the proceeding can ask for court review of Commission orders
in the proceeding.
    However, a person does not have to intervene in order to have
comments considered. The second way to participate is by filing with
the Secretary of the Commission, as soon as possible, an original and
two copies of comments in support of or in opposition to this project.
The Commission will consider these comments in determining the
appropriate action to be taken, but the filing of a comment alone will
not serve to make the filer a party to the proceeding. The Commission's
rules require that persons filing comments in opposition to the project
provide copies of their protests only to the party or parties directly
involved in the protest.
    Persons who wish to comment only on the environmental review of
this project should submit an original and two copies of their comments
to the Secretary of the Commission. Environmental commenters will be
placed on the Commission's environmental mailing list, will receive
copies of the environmental documents, and will be notified of meetings
associated with the Commission's environmental review process.
Environmental commenters will not be required to serve copies of filed
documents on all other parties. However, the non-party commenters will
not receive copies of all documents filed by other parties or issued by
the Commission (except for the mailing of environmental documents
issued by the Commission) and will not have the right to seek court
review of the Commission's final order.
    Motions to intervene, protests and comments may be filed
electronically via the internet in lieu of paper; see, 18 CFR
385.2001(a) (1) (iii) and the instructions on the Commission's Web site
under the ``e-Filing'' link. The Commission strongly encourages
electronic filings.
    Comment Date: July 17, 2013.

    Dated: June 26, 2013.
Kimberly D. Bose,
Secretary.
[FR Doc. 2013-15860 Filed 7-1-13; 8:45 am]
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