[Federal Register Volume 81, Number 147 (Monday, August 1, 2016)]
[Notices]
[Pages 50563-50564]
[FR Doc No: 2016-18090]

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2009-0041]

Formaldehyde Standard; Extension of the Office of Management and
Budget's (OMB) Approval of Collections of Information

AGENCY: Occupational Safety and Health Administration (OSHA), Labor.

ACTION: Request for public comments.

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SUMMARY: OSHA solicits public comments concerning its proposal to
extend the Office of Management and Budget's (OMB) approval of the
collections of information contained in the Formaldehyde Standard (29
CFR 1910.1048).

DATES: Comments must be submitted (postmarked, sent, or received) by
September 30, 2016.

ADDRESSES:
    Electronically: You may submit comments and attachments
electronically at http://www.regulations.gov, which is the Federal
eRulemaking Portal. Follow the instructions online for submitting
comments.
    Facsimile: If your comments, including attachments, are not longer
than 10 pages you may fax them to the OSHA Docket Office at (202) 693-
1648.
    Mail, hand delivery, express mail, messenger, or courier service:
When using this method, you must submit your comments and attachments
to the OSHA Docket Office, Docket No. OSHA-2009-0041, Occupational
Safety and Health Administration, U.S. Department of Labor, Room N-
2625, 200 Constitution Avenue NW., Washington, DC 20210. Deliveries
(hand, express mail, messenger, and courier service) are accepted
during the Department of Labor's and Docket Office's normal business
hours, 8:15 a.m. to 4:45 p.m., e.t.
    Instructions: All submissions must include the Agency name and the
OSHA docket number (OSHA-2009-0041) for the Information Collection
Request (ICR). All comments, including any personal information you
provide, are placed in the public docket without change, and may be
made available online at http://www.regulations.gov. For further
information on submitting comments see the ``Public Participation''
heading in the section of this notice titled SUPPLEMENTARY INFORMATION.
    Docket: To read or download comments or other material in the
docket, go to http://www.regulations.gov or the OSHA Docket Office at
the address above. All documents in the docket (including this Federal
Register notice) are listed in the http://www.regulations.gov index;
however, some information (e.g., copyrighted material) is not publicly
available to read or download from the Web site. All submissions,
including copyrighted material, are available for inspection and
copying at the OSHA Docket Office. You may also contact Theda Kenney at
the address below to obtain a copy of the ICR.

FOR FURTHER INFORMATION CONTACT: Theda Kenney or Todd Owen, Directorate
of Standards and Guidance, OSHA, U.S. Department of Labor, Room N-3609,
200 Constitution Avenue NW., Washington, DC 20210; telephone (202) 693-
2222.

SUPPLEMENTARY INFORMATION:

I. Background

    The Department of Labor, as part of its continuing effort to reduce
paperwork and respondent (i.e., employer) burden, conducts a
preclearance consultation program to provide the public with an
opportunity to comment on proposed and continuing collections of
information in accord with the Paperwork Reduction Act of 1995 (PRA-95)
(44 U.S.C. 3506(c)(2)(A)). This program ensures that information is in
the desired format, reporting burden (time and costs) is minimal,
collection instruments are clearly understood, and OSHA's estimate of
the information collection burden is accurate. The Occupational Safety
and Health Act of 1970 (the OSH Act) (29 U.S.C. 651 et seq.) authorizes
information collection by employers as necessary or appropriate for
enforcement of the OSH Act or for developing information regarding the
causes and prevention of occupational injuries, illnesses, and
accidents (29 U.S.C. 657). The OSH Act also requires that OSHA obtain
such information with minimum burden upon employers, especially those
operating small businesses, and to reduce to the maximum extent
feasible unnecessary duplication of efforts in obtaining information
(29 U.S.C. 657). The standard protects workers from the adverse health
effects from occupational exposure to formaldehyde, including an itchy,
runny, and stuffy nose; a dry or sore throat; eye irritation;
headaches; and cancer of the lung, buccal cavity (mouth), and pharynyx
(throat). Formaldehyde solutions can damage the skin and burn the eyes.
    The standard specifies a number of collections of information. The
following is a brief description of the collections of information
contained in the Formaldehyde Standard. The standard requires employers
to conduct worker exposure monitoring to determine workers' exposure to
formaldehyde, notify workers of their formaldehyde exposures, provide
medical surveillance to workers, provide examining physicians with
specific information, ensure that workers receive a copy of their
medical examination results, maintain workers' exposure monitoring and
medical records for specific periods, and provide access to these
records by the affected workers, and their authorized representatives.

II. Special Issues for Comment

    OSHA has a particular interest in comments on the following issues:
     Whether the proposed collection of information
requirements are necessary for the proper performance of the Agency's
functions, including whether the information is useful;
     The accuracy of OSHA's estimate of the burden (time and
costs) of the collection of information requirements, including the
validity of the methodology and assumptions used;
     The quality, utility, and clarity of the information
collected; and
     Ways to minimize the burden on employers who must comply;
for example, by using automated or other technological information
collection and transmission techniques.

III. Proposed Actions

    The Agency is requesting an adjustment increase of 581 burden hours
(from 237,854 to 238,435 burden hours). The increase in burden hours is
due to an estimated increase in the number of covered establishments
and workers. There is also an estimated increase in operation and
maintenance costs of $1,835,764, from $ 41,724,296 to $43,560,060. The
increase in operation and maintenance costs is due to the estimated
increase in the number of covered workers undergoing exposure
monitoring and medical exams.
    OSHA is providing the following summary information about the
Formaldehyde Standard information collection:
    Type of Review: Extension of a currently approved collection.
    Title: Formaldehyde Standard (29 CFR 1910.1048).
    OMB Control Number: 1218-0145.
    Affected Public: Businesses or other for-profits.
    Number of Respondents: 86,320.
    Frequency of Responses: Various.
    Total Responses: 906,101.

    Average Time per Response: Various.
    Estimated Total Burden Hours: 238,435.
    Estimated Cost (Operation and Maintenance): $43,560,060.

IV. Public Participation--Submission of Comments on this Notice and
Internet Access to Comments and Submissions

    You may submit comments in response to this document as follows:
(1) Electronically at http://www.regulations.gov, which is the Federal
eRulemaking Portal; (2) by facsimile; or (3) by hard copy. All
comments, attachments, and other material must identify the Agency name
and the OSHA docket number (Docket No. OSHA-2009-0041) for this ICR.
You may supplement electronic submissions by uploading document files
electronically. If you wish to mail additional materials in reference
to an electronic or facsimile submission, you must submit them to the
OSHA Docket Office (see the section of this notice titled ADDRESSES).
The additional materials must clearly identify your electronic comments
by your name, date, and the docket number so the Agency can attach them
to your comments.
    Because of security procedures, the use of regular mail may cause a
significant delay in the receipt of comments. For information about
security procedures concerning the delivery of materials by hand,
express delivery, messenger, or courier service, please contact the
OSHA Docket Office at<PHONE_NUMBER>, (TTY<PHONE_NUMBER>).
    Comments and submissions are posted without change at http://www.regulations.gov. Therefore, OSHA cautions commenters about
submitting personal information such as their social security number
and date of birth. Although all submissions are listed in the http://www.regulations.gov index, some information (e.g., copyrighted
material) is not publicly available to read or download from this Web
site. All submissions, including copyrighted material, are available
for inspection and copying at the OSHA Docket Office. Information on
using the http://www.regulations.gov Web site to submit comments and
access the docket is available at the Web site's ``User Tips'' link.
Contact the OSHA Docket Office for information about materials not
available from the Web site, and for assistance in using the Internet
to locate docket submissions.

V. Authority and Signature

    David Michaels, Ph.D., MPH, Assistant Secretary of Labor for
Occupational Safety and Health, directed the preparation of this
notice. The authority for this notice is the Paperwork Reduction Act of
1995 (44 U.S.C. 3506 et seq.) and Secretary of Labor's Order No. 1-2012
(77 FR 3912).

    Signed at Washington, DC, on July 27, 2016.
David Michaels,
Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. 2016-18090 Filed 7-29-16; 8:45 am]
 BILLING CODE 4510-26-P


[Federal Register Volume 84, Number 26 (Thursday, February 7, 2019)]
[Notices]
[Pages 2639-2643]
[FR Doc No: 2019-01381]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-85024; File No. SR-GEMX-2018-45]

Self-Regulatory Organizations; Nasdaq GEMX, LLC; Notice of Filing
and Immediate Effectiveness of a Proposed Rule Change To Amend the
Exchange's Provisions for Excluding a Day From Its Volume Calculations

February 1, 2019.
    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 December 21, 2018, Nasdaq GEMX, LLC (``GEMX'' or ``Exchange'') filed
with the Securities and Exchange Commission (``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 the Exchange's provisions for
excluding a day from its volume calculations for purposes of
determining pricing tiers.
    The text of the proposed rule change is available on the Exchange's
website at http://nasdaqgemx.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
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The purpose of the proposed rule change is to amend the Exchange's
provisions for excluding a day from its volume calculations for
purposes of determining pricing tiers. The Exchange is standardizing
its practice for removing a day from volume calculations in its Pricing
Schedule with its affiliated options market, Nasdaq PHLX LLC
(``Phlx'').\3\ Each change is discussed below.
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    \3\ See Phlx Pricing Schedule, Options 7, Section 1(b). The
Exchange's other affiliated options markets, Nasdaq ISE, Nasdaq MRX,
Nasdaq BX, and The Nasdaq Options Market will also file similar rule
change proposals to conform to Phlx's rule.
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Background

    To avoid penalizing members when aberrant low volume days result
from systems or other issues at the Exchange, or where the Exchange
closes early for holiday observance, the Exchange currently has
language in its Pricing Schedule allowing it to exclude certain days
from its average daily volume (``ADV'') calculations. Currently,
language in the Exchange's Pricing Schedule provides that, for purposes
of determining ADV for certain incentive programs,\4\ any day that the
market is not open for the entire trading day or the Exchange instructs
members in writing to route their orders to other markets may be
excluded from such calculation; provided that the Exchange will only
remove the day for members that would have a lower ADV with the day
included. The proviso language (hereinafter, the ``better of rule'')
ensures that members would only have the day removed when doing so is
beneficial for the member. As such, the Exchange only applies the
better of rule to ADV calculations, and not for other volume-based
pricing where members would not benefit from having the day excluded
(e.g., straight volume accumulations).
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    \4\ The current language in the Pricing Schedule applies to the
calculations of Total Affiliated Member ADV and Priority Customer
Maker ADV used to determine tiered maker rebates and taker fees for
members. See Options 7, Section 3, Table 1 (Qualifying Tier
Thresholds).
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Proposal
    In Options 7, Section 1, the Exchange proposes to adopt subsection
(a) with the title ``Removal of Days for Purposes of Pricing Tiers,''
and renumber the existing first paragraph (related to fee disputes) as
subsection (b). The Exchange also proposes to adopt new language in
subsection (a) that is substantially similar to language currently in
place on Phlx.\5\ Specifically, as proposed:
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    \5\ See note 3 above.
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    (1)(A) Any day that the Exchange announces in advance that it will
not be open for trading will be excluded from the options tier
calculations set forth in its Pricing Schedule; and (B) any day with a
scheduled early market close (``Scheduled Early Close'') may be
excluded from the options tier calculations only pursuant to paragraph
(3) below.
    (2) The Exchange may exclude the following days (``Unanticipated
Events'') from the options tier calculations only pursuant to paragraph
(3) below, specifically any day that:
    (A) The market is not open for the entire trading day, (B) the
Exchange instructs members in writing to route their orders to other
markets, (C) the Exchange is inaccessible to members during the 30-
minute period before the opening of trade due to an Exchange system
disruption, or (D) the Exchange's system experiences a disruption that
lasts for more than 60 minutes during regular trading hours.
    (3) If a day is to be excluded as a result of paragraph (1)(B) or
(2) above, the Exchange will exclude the day from any member's monthly
options tier calculations as follows:
    (A) The Exchange may exclude from the ADV calculation any Scheduled
Early Close or Unanticipated Event; or
    (B) the Exchange may exclude from any other applicable options tier
calculation provided for in its Pricing Schedule (together with (3)(A),
``Tier Calculations'') any Scheduled Early Close or Unanticipated
Event.

provided, in each case, that the Exchange will only remove the day for
members that would have a lower Tier Calculation with the day included.
    The proposed language: (i) Applies the rule for excluding days to
all volume based calculations rather than specified incentive
programs,\6\ (ii) expands upon the existing scenarios where the
Exchange may remove a day to adopt two additional situations related to
Exchange systems disruptions, (iii)

categorizes the potential excluded days into days that are known in
advance (i.e., days in proposed paragraph (1), including Scheduled
Early Closes) and days that are not (i.e., Unanticipated Events in
proposed paragraph (2)), (iv) clarifies how the potential excluded days
proposed above would be removed from the ADV and other applicable
volume based tier calculations in the Pricing Schedule, and (v)
generally adds more detail to clarify the application of the better of
rule. As it relates to Unanticipated Events, the Exchange will inform
all members if any such day will be excluded from its Tier Calculations
through a system status message disseminated to all members. The
Exchange notes that it is not proposing to amend the thresholds a
member must achieve to become eligible for, or the dollar amount
associated with, the tiered rebates or fees.
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    \6\ See note 4 above. Since the proposed language will now apply
to all current and future programs administered by the Exchange that
are based on ADV and other applicable volume calculations, the
current rule in Options 7, Section 3 will be replaced by the
proposed language in Section 1(a) with the modifications described
above, including language providing that the rule will apply to all
Tier Calculations in its Pricing Schedule.
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Rule Application
    Currently, the Exchange's rule for removing a day from its ADV
calculations applies to specific ADV calculations of Total Affiliated
Member ADV \7\ and Priority Customer Maker ADV.\8\ As applied, the
Exchange can remove a day from tier calculations for the maker rebates
\9\ and taker fees \10\ assessed to members.\11\ The Exchange now
believes it is appropriate to expand this provision to cover all volume
based calculations including ADV rather than limit it to specific
enumerated programs. Applying this rule to all volume based
calculations will benefit members by permitting the Exchange to exclude
atypical low volume days from its volume calculations regardless of the
specific pricing program impacted. As is the case today, the Exchange
would only remove the day for members that would have a lower volume
calculation with the day included. This change will standardize the
Exchange's practice with Phlx, which currently applies its rule to
cover all ADV and other volume calculations set forth in its pricing
schedule rather than specified programs.\12\
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    \7\ The Total Affiliated Member ADV category includes all volume
in all symbols and order types, including both maker and taker
volume and volume executed in the PIM, Facilitation, Solicitation,
and QCC mechanisms. For purposes of determining a member's
eligibility for the volume-based tiers in the Total Affiliated
Member ADV category, the Exchange uses either numeric thresholds
that measure a member's absolute volume or, as an alternative, a
percentage-based calculation that considers a member's volume
relative to total customer industry volume (i.e., the ``Customer
Total Consolidated Volume''). For purposes of measuring Total
Affiliated Member ADV, Customer Total Consolidated Volume means the
total volume cleared at The Options Clearing Corporation in the
Customer range in equity and ETF options in that month.
    \8\ The Priority Customer Maker ADV category includes all
Priority Customer volume that adds liquidity in all symbols.
    \9\ The Exchange provides tiered maker rebates to Market Maker
and Priority Customer orders in Penny Symbols and SPY, as well as in
Non-Penny Symbols (excluding index options), all of which are based
on Total Affiliated Member ADV and Priority Customer Maker ADV. See
Option 7, Section 3.
    \10\ Members are charged tiered taker fees in Penny Symbols and
SPY, as well as in Non-Penny Symbols (excluding index options), all
of which are based on Total Affiliated Member ADV and Priority
Customer Maker ADV. See Option 7, Section 3.
    \11\ All eligible volume from affiliated Members will be
aggregated in determining applicable tiers, provided there is at
least 75% common ownership between the Members as reflected on each
Member's Form BD, Schedule A. The highest tier threshold attained
applies retroactively in a given month to all eligible traded
contracts and applies to all eligible market participants.
    \12\ See note 3 above.
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Exchange Systems Disruptions
    The Exchange proposes to adopt two additional scenarios as
``Unanticipated Events'' that the Exchange may determine to exclude
from its Tier Calculations. First, the Exchange proposes to exclude
days where the Exchange is inaccessible to members during the 30-minute
period before the opening of trade (i.e., between 9:00 a.m. to 9:30
a.m. Eastern Time) due to an Exchange system disruption, even if the
Exchange does not instruct members to route away to other markets. As
discussed above, the Exchange's current ability to remove days is
limited to days where the market is not open for the entire trading
day, and where the Exchange instructs members to route away to other
markets. This allows the Exchange to exclude days, for example, where
the Exchange honors a market-wide trading halt declared by another
market, closes early for holiday observance, or instructs members to
route away to other markets because of a systems issue in the morning,
which ultimately does not carry over into the trading day. The Exchange
notes, however, that it may not always instruct members to route away.
For instance, the Exchange may be inaccessible to members in the
morning due to a systems disruption but the Exchange resolves the issue
shortly before 9:30 a.m. and as a result, the Exchange does not
instruct members to route away. In such cases, the Exchange is not
permitted to exclude the day from its ADV calculations. The Exchange
generally experiences a high volume of member participation within the
30-minute window leading up to the opening of trade from members who
submit eligible interest be included in the Exchange's opening process.
As a result, days where members are precluded from submitting eligible
interest during this 30-minute time period due to an Exchange systems
disruption, even if the issue is ultimately resolved by the Exchange
before the market opens (and members therefore are not instructed to
route away), are likely to have lower trading volume. Including such
days in calculations of ADV will therefore make it more difficult for
members to achieve particular pricing tiers for that month.
Accordingly, excluding such days will diminish the likelihood of a cost
increase occurring because a member is not able to reach a pricing tier
on that date that it would reach on other trading days during the
month. Phlx currently has identical language allowing it to remove such
days from its volume based tiers.\13\
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    \13\ See id. at paragraph 2(C).
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    Second, the Exchange proposes to exclude days where there is an
Exchange system disruption that lasts for more than 60 minutes during
regular trading hours (i.e., 9:30 a.m. to 4:00 p.m. Eastern Time), even
if such disruption would not be categorized as a complete outage of the
Exchange's system. Such a disruption may occur where a certain options
series traded on the Exchange is unavailable for trading due to an
Exchange systems issue, or where the Exchange may be able to perform
certain functions with respect to accepting and processing orders, but
may have a failure to another significant process, such as routing to
other market centers, that would lead members who rely on such
processes to avoid using the Exchange until the Exchange's entire
system was operational. The Exchange believes that certain system
disruptions that are not complete system outages could preclude some
members from submitting orders to the Exchange. The Exchange notes that
this proposal is consistent with the rules of Phlx and other options
exchanges.\14\
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    \14\ See id. at paragraph 2(D). See also BATS [sic] BZX Options
Exchange Fee Schedule (defining an ``Exchange System Disruption'' as
any day that the exchange's system experiences a disruption that
lasts for more than 60 minutes during regular trading hours); and
NYSE Arca Options Fee Schedule (defining an ``Exchange System
Disruption'' as a disruption affects an Exchange system that lasts
for more than 60 minutes during regular trading hours).
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    The Exchange believes that the two scenarios proposed above are
reasonable and equitable because the intent of the current rule has
always been to avoid penalizing members that might otherwise qualify
for certain tiered pricing but that because of aberrant low volume days
resulting, for instance, from Exchange systems disruptions, did not
participate on the Exchange to the

extent they might have otherwise participated.
    In addition, to avoid penalizing members that step up and trade on
a day with artificially low volume, the Exchange currently only removes
days for members that would have a lower ADV calculation with the day
included (i.e., the better of rule). The Exchange believes that
applying the better of rule to the proposed system disruption-related
scenarios would be similarly helpful as it would ensure that members
that continue to execute a large volume of contracts on such days are
not inadvertently disadvantaged when the Exchange removes a systems
disruption-related day from its calculations of ADV. This is consistent
with the treatment of such days on Phlx.\15\
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    \15\ See note 3 above at paragraph 3.
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Categories of Excluded Days
    Similar to Phlx, the Exchange seeks to restructure the existing
rule by separating out the different scenarios between days that are
known in paragraph (1) and days that are not in paragraph (2), and
define the latter as Unanticipated Events.
    For planned days, the Exchange proposes to further distinguish
between days that the Exchange announces in advance that it will not be
open for trading in paragraph (1)(A) (e.g., Thanksgiving), and
Scheduled Early Closes in paragraph (1)(B) (e.g., the trading day after
Thanksgiving). The Exchange notes that it currently considers Scheduled
Early Closes as a subset of days that the market is not open for the
entire trading day. The Exchange believes it would be more clear to
distinguish Scheduled Early Closes in paragraph (1) as a day that is
planned for in advance, and separately consider days that are not open
for the entire trading day as Unanticipated Events in paragraph (2)(A).
As proposed, (2)(A) would continue to cover unplanned days where the
Exchange declares a trading halt in all securities or honors a market-
wide trading halt declared by another market. The other scenarios that
will be categorized as Unanticipated Events in paragraph (2) are the
two systems-related disruptions proposed above, and days that the
Exchange instructs members in writing to route their orders to other
markets, which is an existing scenario covered under the current rule
as described above.
Exclusion of Days by Tier Calculation
    The Exchange proposes to further amend the existing rule to align
with the Phlx rule by specifying how the days in paragraphs (1) and (2)
will be excluded from its Tier Calculations. As it relates to days
where the Exchange announces in advance that it will not be open for
trading, the Exchange notes that it will exclude those days from all
options tier calculations set forth in its Pricing Schedule.\16\ This
is also the case today since no trading activity occurs on those days,
and the Exchange is only clarifying its current practice within the
proposed rule text in paragraph (1)(A).
---------------------------------------------------------------------------

    \16\ See id. at paragraph (1)(A) for similar language on Phlx.
---------------------------------------------------------------------------

    As discussed above, the Exchange currently removes Scheduled Early
Closes as provided in paragraph (1)(B), and the Unanticipated Events in
paragraphs (2)(A) and (2)(B), from its calculations of ADV only for
members that would have a lower ADV with the day included. The Exchange
is not changing how it currently excludes these days from the ADV
calculations. And as further discussed above, the Exchange is proposing
to adopt the same principle-based approach for excluding the two
Unanticipated Events related to Exchange system disruptions as provided
in paragraphs (2)(C) and (2)(D). Accordingly, the proposed language in
paragraph (3)(A) will clarify for the ADV calculation that the Exchange
may exclude any Scheduled Early Close or Unanticipated Event, subject
to the better of rule.\17\
---------------------------------------------------------------------------

    \17\ See id. at paragraph (3)(A) for similar language on Phlx.
---------------------------------------------------------------------------

    Similar to Phlx, the proposal also adds a ``catch-all'' provision
in paragraph (3)(B) that would apply to other applicable volume based
tier calculations that are set forth in its Pricing Schedule, but are
not specified within paragraph (3)(A) (i.e., not an ADV
calculation).\18\ This catch-all provision will provide the Exchange
with flexibility to apply the better of rule going forward to all
pricing programs administered by the Exchange that are based on volume
calculations. The Exchange believes that adopting a similar principle-
based approach for its options volume calculations would ensure that
days are removed from such calculations only if doing so would be
beneficial for the member. Accordingly, the proposed language will not
apply to straight volume accumulations, as is the case today, and the
Exchange will continue to not exclude days from such calculations as
members do not benefit when volume executed on an excluded day is
removed from straight volume accumulations.
---------------------------------------------------------------------------

    \18\ See id. at paragraph (3)(C) for similar language on Phlx.
---------------------------------------------------------------------------

Clarifying Changes
    The Exchange proposes to add further details similar to Phlx's rule
to bring greater transparency as to how the Exchange will apply the
better of rule when removing days from its Tier Calculations. In
particular, the Exchange proposes to make clear that it will only
remove days pursuant to the better of rule by specifying in paragraphs
(1)(B) and (2) that such days may be excluded from the Tier
Calculations only pursuant to paragraph (3).\19\ Paragraph (3) will
then provide that if a day is to be excluded as a result of paragraph
(1)(B) or (2), the Exchange will be required to exclude the day from
any member's monthly options volume tier calculations as detailed
within paragraph (3).\20\ With the proposed changes, the Exchange seeks
to clarify that it will exclude days from any member's Tier
Calculations in a uniform manner to ensure that days are removed only
in situations where the member benefits. The Exchange will look at each
potential excluded day in a month and determine for every member their
ADV or other applicable volume calculation based on their trading
volume on that day. If any member would have a lower Tier Calculation
with the particular day included, the Exchange will exclude that day
for that member. This is how the Exchange applies the better of rule
today for ADV calculations. As such, the proposed changes are intended
to make clear that the Exchange will apply the better of rule in a
uniform manner for all members, and that there is no arbitrary
selection of ``winners'' or ``losers'' when the Exchange excludes days.
In addition, the Exchange proposes to make two technical changes within
the better of rule; first, to clarify that the rule applies in each
case of the tier calculations specified in paragraph (3), and second,
to use the defined term Tier Calculations instead of ADV to reflect the
changes proposed herein.
---------------------------------------------------------------------------

    \19\ See id. at paragraphs (1)(B) and (2) for similar language
on Phlx.
    \20\ See id. at paragraph (3) for similar language on Phlx.
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\21\ in general, and furthers the objectives of
Sections 6(b)(4) and 6(b)(5) of the Act,\22\ in particular, in that it
provides for the equitable allocation of reasonable dues, fees and
other charges among members and issuers and other persons using any
facility, and is not designed to permit unfair

discrimination between customers, issuers, brokers, or dealers.
---------------------------------------------------------------------------

    \21\ 15 U.S.C. 78f(b).
    \22\ 15 U.S.C. 78f(b)(4) and (5).
---------------------------------------------------------------------------

    The Exchange believes that the proposed rule change is reasonable
and equitable as it provides a new framework for removing days from the
Exchange's volume calculations that the Exchange believes is beneficial
to members and consistent with similar provisions already in place on
Phlx. The proposed rule change would permit the Exchange to remove a
day from its pricing tiers in more circumstances, and ensures that the
Exchange will only do so in circumstances where beneficial for the
member because the member would have a lower volume calculation with
the day included.
    By applying the rule to all volume based calculations rather than
specified incentive programs based on Total Affiliated Member ADV and
Priority Customer Maker ADV, the Exchange believes that members will be
further protected if the Exchange experiences a systems or other issue
that results in a day being excluded from the Exchange's volume
calculations. Without this change, members would only have the day
excluded for the specific ADV based pricing programs described above,
and would not get the benefit for other un-enumerated programs.
    The Exchange believes it is reasonable and equitable to exclude a
day from its volume based calculations when the Exchange's system
experiences a disruption during the 30-minute period prior to the
opening of trade that renders the Exchange inaccessible to members as
this preserves the Exchange's intent behind adopting volume-based
pricing. Without this change, members that are precluded from
submitting eligible interest during the 30-minute window before the
opening of trade may be negatively impacted, even if the Exchange
resolves the issue before the market opens and as a result, does not
instruct members to route away. The proposed change to exclude such
days will diminish the likelihood of a cost increase occurring because
a member is not able to reach a volume tier calculation on that date
that it would reach on other trading days during the month.
    Similarly, excluding a day where the Exchange's system experiences
a disruption that lasts for more than 60 minutes intra-day is
reasonable and equitable because the proposal seeks to avoid penalizing
members that might otherwise qualify for certain tiered pricing but
that, because of an Exchange systems disruption, did not participate on
the Exchange to the extent they might have otherwise participated. The
Exchange believes that certain systems disruptions could preclude some
members from sending order flow to the Exchange even if such issue is
not actually a complete systems outage.
    In addition, the Exchange believes that it is reasonable and
equitable to apply the better of rule to both systems disruption-
related scenarios. Without these changes, members that step up and
trade significant volume on excluded trading days may be negatively
impacted, resulting in an effective cost increase for those members.
The proposal would align the Exchange's approach to how it applies this
rule today for days where the market is not open for the entire trading
day or where the Exchange instructs members to route away.
    Furthermore, the Exchange believes that categorizing the potential
excluded days is reasonable and equitable because it will bring greater
transparency to the application of its rule. Specifically, the Exchange
is distinguishing between planned and unplanned days in paragraphs (1)
and (2), defining the latter as Unanticipated Events, and stipulating
how the Exchange will exclude such days pursuant to this rule.
Categorizing days in this manner will clarify the application of its
rule in light of the Exchange's proposal to expand the rule to adopt
additional days that may be excluded from its tier calculations.
Providing in paragraph (1)(A) that the Exchange will always exclude
from its tier calculations days that it announces in advance it will
not be open for trading will clarify current practice. Furthermore, the
Exchange believes that the proposed changes to specify how days in
paragraphs (1) and (2) may be excluded from its tier calculations will
bring greater transparency by delineating the various circumstances in
which the better of rule will apply. Providing in paragraph (3) that
the Exchange may exclude any Scheduled Early Close or Unanticipated
Event from the ADV and other Tier Calculations, subject to the better
of rule, will make clear that the Exchange will take a consistent
approach when excluding days for purposes of its volume based pricing
tiers. In addition, having a catch-all in paragraph (3)(B) so that the
better of rule applies to other options volume calculations than ADV to
allow the Exchange to apply the rule going forward to all pricing
programs based on volume calculations will further protect members. The
Exchange notes that aberrant low volume days resulting from, for
instance, an Unanticipated Event, impacts all volume-based
calculations, and allowing the Exchange to exclude such days from any
Tier Calculation if the member would have a lower Tier Calculation with
the day included will further protect members from being inadvertently
penalized.
    Furthermore, the proposed changes specifying that the days in
paragraphs (1)(B) and (2) may be excluded only pursuant to paragraph
(3), and requiring the Exchange to exclude such days pursuant to the
specifications in paragraph (3) will likewise make clear that the
Exchange will take a consistent approach with respect to excluding days
from its volume calculations. As discussed above, these modifications
will clarify that the Exchange will apply the better of rule in a
uniform manner to all members, and that there is no arbitrary selection
of ``winners'' or ``losers.'' The Exchange also believes that the two
technical changes proposed in the better of rule to reflect the changes
proposed herein will likewise bring greater clarity to its rule.
    Finally, the Exchange further believes that the proposed rule
change is not unfairly discriminatory because it will apply equally to
all members. While the Exchange currently has rules in place for
removing a day from its pricing, the Exchange believes that the
proposed changes will benefit all members by providing more
circumstances to remove a day, and ensuring that such days are removed
only in situations where the member benefits.

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 is
designed to protect members from the possibility of a cost increase by
excluding days when overall member participation might be significantly
lower than a typical trading day. The Exchange believes that the
proposed modifications to its tier calculations are pro-competitive and
will result in lower total costs to end users, a positive outcome of
competitive markets. Furthermore, other options exchanges have adopted
rules that are substantially similar to the Exchange's proposal.\23\
---------------------------------------------------------------------------

    \23\ See notes 3 and 14 above.
---------------------------------------------------------------------------

    The Exchange operates in a highly competitive market in which
market participants can readily direct their order flow to competing
venues. In such an environment, the Exchange must continually review,
and consider adjusting, its fees and rebates to remain competitive with
other exchanges. For the reasons described above, the

Exchange believes that the proposed fee changes reflect this
competitive environment.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(ii) of the Act.\24\ 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: (i) Necessary or appropriate in the public
interest; (ii) for the protection of investors; or (iii) 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.
---------------------------------------------------------------------------

    \24\ 15 U.S.C. 78s(b)(3)(A)(ii).
---------------------------------------------------------------------------

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_ADDRESS>Please include
File Number SR-GEMX-2018-45 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-GEMX-2018-45. 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-GEMX-2018-45 and should be submitted on
or before February 22, 2019.
---------------------------------------------------------------------------

    \25\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\25\
Eduardo A. Aleman,
Deputy Secretary.
[FR Doc. 2019-01381 Filed 2-6-19; 8:45 am]
 BILLING CODE 8011-01-P


			  UNITED STATES OF AMERICA

		        DEPARTMENT OF TRANSPORTATION

			  OFFICE OF THE SECRETARY

			          WASHINGTON, D.C.

Issued by the Department of Transportation on July 22, 2003

NOTICE OF ACTION TAKEN -- DOCKET OST-2003-15552

________________________________________________________________________
__________________________________________

This serves as notice to the public of the action described below, taken
by the Department official indicated (no additional confirming order
will be issued in this matter).

Applicant:  Sky Unlimited Ltd.				Date Filed:  July 1, 2003, as amended
July 7, 2003

Relief requested: Exemption authority from 49 U.S.C. § 41301 to engage
in charter foreign air transportation of persons, property and mail
between any point or points in the Bahamas and any point or points in
Florida, with small aircraft.

If renewal, date and citation of last action:  New authority

Applicant representative:  Pierre Murphy<PHONE_NUMBER>

DOT Analyst:  Gordon H. Bingham<PHONE_NUMBER>

Responsive pleadings:  None filed

	DISPOSITION

Action:  Approved							Action date:  July 22, 2003

Effective dates of authority granted:  July 22, 2003-July 22, 2004

Basis for approval (bilateral agreement/reciprocity):  Comity and
reciprocity with the Bahamas

Except to the extent exempted/waived, this authority is subject to the
terms, conditions, and limitations indicated:

X  Standard exemption conditions (Attached)

Special conditions/Partial grant/Denial basis/Remarks:  Based on the
record in this case, we found that Sky Unlimited is financially and
operationally qualified to perform the services authorized above.  In
addition, we found that Sky Unlimited is substantially owned and
effectively controlled by Bahamian citizens.  The carrier is properly
licensed by the Government of the Bahamas to perform the proposed
services.  By memorandum dated July 9, 2003, the FAA advised us that it
knew of no reason why we should act unfavorably on Sky Unlimited’s
application.

The charter authority granted to Sky Unlimited above is limited to
operations involving aircraft designed to have a maximum passenger
capacity of not more than 60 seats or a maximum payload capacity of not
more than 18,000 pounds.

Action taken by:  Paul L. Gretch, Director

		     Office of International Aviation

________________________________________________________________________
__________________________________________

Under authority assigned by the Department in its regulations, 14 CFR
Part 385, we found that (1) the applicant was qualified to perform the
proposed operations; (2) our action was consistent with Department
policy; (3) grant of the authority was consistent with the public
interest; and (4) grant of the authority would not constitute a major
regulatory action under the Energy Policy and Conservation Act of 1975.
To the extent not granted/deferred/dismissed, we denied all requests in
the referenced Docket.  We may amend, modify, or revoke the authority
granted in this Notice at any time without hearing at our discretion.

2

Persons entitled to petition the Department for review of the action set
forth in this Notice under the Department’s regulations, 14 CFR §
385.30, may file their petitions within seven (7) days after the date of
issuance of this Notice.  This action was effective when taken, and the
filing of a petition for review will not alter such effectiveness.

An electronic version of this document is available on the World Wide
Web at:

  HYPERLINK "http://dms.dot.gov//reports/reports_aviation.asp"
http://dms.dot.gov//reports/reports_aviation.asp

					Attachment

Foreign Carrier Exemption Conditions

In the conduct of the operations authorized, the foreign carrier
applicant(s) shall:

(1)  Not conduct any operations unless it holds a currently effective
authorization from its homeland for such operations, and it has filed a
copy of such authorization with the Department;

(2)  Comply with all applicable requirements of the Federal Aviation
Administration, including, but not limited to, 14 CFR Parts 129, 91, and
36, and with all applicable U.S. Government requirements concerning
security;1

(3)  Comply with the requirements for minimum insurance coverage
contained in 14 CFR Part 205, and, prior to the commencement of any
operations under this authority, file evidence of such coverage, in the
form of a completed OST Form 6411, with the Federal Aviation
Administration’s Program Management Branch (AFS-260), Flight Standards
Service (any changes to, or termination of, insurance also shall be
filed with that office);

(4)  Not operate aircraft under this authority unless it complies with
operational safety requirements at least equivalent to Annex 6 of the
Chicago Convention;

(5)  Conform to the airworthiness and airman competency requirements of
its Government for international air services;

(6)  Except as specifically exempted or otherwise provided for in a
Department Order, comply with the requirements of 14 CFR Part 203,
concerning waiver of Warsaw Convention liability limits and defenses;

(7)  Agree that operations under this authority constitute a waiver of
sovereign immunity, for the purposes of 28 U.S.C. 1605(a), but only with
respect to those actions or proceedings instituted against it in any
court or other tribunal in the United States that are: (a)  based on its
operations in international air transportation that, according to the
contract of carriage, include a point in the United States as a point of
origin, point of destination, or agreed stopping place, or for which the
contract of carriage was purchased in the United States; or (b) based on
a claim under any international agreement or treaty cognizable in any
court or other tribunal of the United States.  In this condition, the
term "international air transportation" means "international
transportation" as defined by the Warsaw Convention, except that all
States shall be considered to be High Contracting Parties for the
purpose of this definition;

(8)  Except as specifically authorized by the Department, originate or
terminate all flights to/from the United States in its homeland;

(9)  Comply with the requirements of 14 CFR Part 217, concerning the
reporting of scheduled, nonscheduled, and charter data;

(10) If charter operations are authorized, except as otherwise provided
in the applicable aviation agreement, comply with the Department's rules
governing charters (including 14 CFR Parts 212 and 380); and

(11) Comply with such other reasonable terms, conditions, and
limitations required by the public interest as may be prescribed by the
Department, with all applicable orders or regulations of other U.S.
agencies and courts, and with all applicable laws of the United States.

This authority shall not be effective during any period when the holder
is not in compliance with the conditions imposed above.  Moreover, this
authority cannot be sold or otherwise transferred without explicit
Department approval under Title 49 of the U.S. Code.

____________________________

1 To assure compliance with all applicable U.S. Government requirements
concerning security, the holder should, before commencing any new
service (including charter flights) from a foreign airport that would be
the holder’s last point of departure for the United States, contact
its Principal Security Inspector (PSI) to advise the PSI of its plans
and to find out whether the Transportation Security Administration has
determined that security is adequate to allow such airport(s) to be
served.

  Sky Unlimited is owned by three Bahamian citizens (Heuter B. Rolle,
Godfrey Culmer and Nathaniel Gibbs)

06/2003


[Federal Register Volume 83, Number 165 (Friday, August 24, 2018)]
[Rules and Regulations]
[Pages 42780-42783]
[FR Doc No: 2018-18407]

=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2017-0520; FRL-9979-94]

Lignosulfonic Acid, Calcium, Comp. With 1,6 Hexanediamine Polymer
With Guanidine Hydrochloride (1:1); Tolerance Exemption

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of lignosulfonic acid, calcium, comp. with
1,6 hexanediamine polymer with guanidine hydrochloride (1:1) number
average molecular weight 4,500 to 7,000 when used as an inert
ingredient in a pesticide chemical formulation. Acadia Regulatory
Consulting on behalf of Lidan, Inc. submitted a petition to EPA under
the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an
exemption from the requirement of a tolerance. This regulation
eliminates the need to establish a maximum permissible level for
residues of lignosulfonic acid, calcium, comp. with 1,6 hexanediamine
polymer with guanidine hydrochloride (1:1) on food or feed commodities.

DATES: This regulation is effective August 24, 2018. Objections and
requests for hearings must be received on or before October 23, 2018,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2017-0520. All documents in the
docket are listed in the docket index available at http://www.regulations.gov. 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 in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S Crystal Dr., Arlington, VA. The Docket
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket Facility telephone number is (703)
305-5805.

FOR FURTHER INFORMATION CONTACT: Michael Goodis, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number:
(703) 305-7090; email address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to

certain entities. If you have any questions regarding the applicability
of this action to a particular entity, consult the person listed under
FOR FURTHER INFORMATION CONTACT.

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR
part 180 through the Government Publishing Office's e-CFR site at
http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. Can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2017-0520 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
October 23, 2018. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket. Information not marked confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA without prior notice. Submit a copy of
your non-CBI objection or hearing request, identified by docket ID
number EPA-HQ-OPP-2017-0520, by one of the following methods.
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave.
NW, Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S Crystal Dr., Arlington, VA. Deliveries are only accepted
during the Docket Facility's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket Facility telephone number is<PHONE_NUMBER>.

II. Background and Statutory Findings

    In the Federal Register of March 21, 2018 (83 FR 12311) (FRL-9974-
76), EPA issued a notification pursuant to section 408 of FFDCA, 21
U.S.C. 346a, announcing the receipt of a pesticide petition (PP IN-
11005) filed by Acadia Regulatory Consulting, LLC (331 W King Road,
Ithaca, NY 14850) on behalf of Lidan, Inc. (30 Wall Street, 8th Floor,
New York, NY 10005). The petition requested that 40 CFR 180.960 be
amended by establishing an exemption from the requirement of a
tolerance for residues of lignosulfonic acid, calcium, comp. with 1,6
hexanediamine polymer with guanidine hydrochloride (1:1); CAS Reg. No.
1905409-74-6 as a stabilizer and safener in pesticide formulations.
That notification included a summary of the petition prepared by the
petitioner and solicited comments on the petitioner's request. The
Agency did not receive any comments.
    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the exemption is ``safe.'' Section 408(c)(2)(A)(ii) of FFDCA defines
``safe'' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.'' This includes exposure through
drinking water and use in residential settings, but does not include
occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure of infants and children to the
pesticide chemical residue in establishing an exemption from the
requirement of a tolerance and to ``ensure that there is a reasonable
certainty that no harm will result to infants and children from
aggregate exposure to the pesticide chemical residue . . .'' and
specifies factors EPA is to consider in establishing an exemption.

III. Risk Assessment and Statutory Findings

    EPA establishes exemptions from the requirement of a tolerance only
in those cases where it can be shown that the risks from aggregate
exposure to pesticide chemical residues under reasonably foreseeable
circumstances will pose no appreciable risks to human health. In order
to determine the risks from aggregate exposure to pesticide inert
ingredients, the Agency considers the toxicity of the inert in
conjunction with possible exposure to residues of the inert ingredient
through food, drinking water, and through other exposures that occur as
a result of pesticide use in residential settings. If EPA is able to
determine that a finite tolerance is not necessary to ensure that there
is a reasonable certainty that no harm will result from aggregate
exposure to the inert ingredient, an exemption from the requirement of
a tolerance may be established.
    Consistent with FFDCA section 408(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
this action and considered its validity, completeness and reliability
and the relationship of this information to human risk. EPA has also
considered available information concerning the variability of the
sensitivities of major identifiable subgroups of consumers, including
infants and children. In the case of certain chemical substances that
are defined as polymers, the Agency has established a set of criteria
to identify categories of polymers expected to present minimal or no
risk. The definition of a polymer is given in 40 CFR 723.250(b) and the
exclusion criteria for identifying these low-risk polymers are
described in 40 CFR 723.250(d). Lignosulfonic acid, calcium, comp. with
1,6 hexanediamine polymer with guanidine hydrochloride (1:1) conforms
to the definition of a polymer given in 40 CFR 723.250(b) and meets the
following criteria that are used to identify low-risk polymers.
    1. The polymer is a cationic polymer or it is reasonably
anticipated to become a cationic polymer in natural aquatic
environments; however, the polymer is a solid material that is not
soluble or dispersible in water and will be used only in the solid
phase and is not excluded from exemption by other factors.
    2. The polymer does contain as an integral part of its composition
at least two of the atomic elements carbon, hydrogen, nitrogen, oxygen,
silicon, and sulfur.
    3. The polymer does not contain as an integral part of its
composition, except as impurities, any element other than those listed
in 40 CFR 723.250(d)(2)(ii).
    4. The polymer is neither designed nor can it be reasonably
anticipated to substantially degrade, decompose, or depolymerize.
    5. The polymer is manufactured or imported from monomers and/or
reactants that are already included on the TSCA Chemical Substance
Inventory or manufactured under an applicable TSCA section 5 exemption.

    6. The polymer is not a water absorbing polymer with a number
average molecular weight (MW) greater than or equal to 10,000 daltons.
    Additionally, the polymer also meets as required the following
exemption criteria specified in 40 CFR 723.250(e).
    7. The polymer does not contain certain perfluoroalkyl moieties
consisting of a CF3- or longer chain length as listed in 40 CFR
723.250(d)(6).
    Additionally, the polymer also meets as required the following
exemption criteria: Specified in 40 CFR 723.250(e):
    The polymer's number average MW of is greater than 1,000 and less
than 10,000 daltons. The polymer contains less than 10% oligomeric
material below MW 500 and less than 25% oligomeric material below MW
1,000, and the polymer and does not contain any reactive functional
groups.
    Thus, lignosulfonic acid, calcium, comp. with 1,6 hexanediamine
polymer with guanidine hydrochloride (1:1) meets the criteria for a
polymer to be considered low risk under 40 CFR 723.250. Based on its
conformance to the criteria in this unit, no mammalian toxicity is
anticipated from dietary, inhalation, or dermal exposure to
lignosulfonic acid, calcium, comp. with 1,6 hexanediamine polymer with
guanidine hydrochloride (1:1).

IV. Aggregate Exposures

    For the purposes of assessing potential exposure under this
exemption, EPA considered that lignosulfonic acid, calcium, comp. with
1,6 hexanediamine polymer with guanidine hydrochloride (1:1) could be
present in all raw and processed agricultural commodities and drinking
water, and that non-occupational non-dietary exposure was possible. The
number average MW of lignosulfonic acid, calcium, comp. with 1,6
hexanediamine polymer with guanidine hydrochloride (1:1) is 4,500 to
7,000 daltons. Generally, a polymer of this size would be poorly
absorbed through the intact gastrointestinal tract or through intact
human skin. Since lignosulfonic acid, calcium, comp. with 1,6
hexanediamine polymer with guanidine hydrochloride (1:1) conform to the
criteria that identify a low-risk polymer, there are no concerns for
risks associated with any potential exposure scenarios that are
reasonably foreseeable. The Agency has determined that a tolerance is
not necessary to protect the public health.

V. Cumulative Effects From Substances With a Common Mechanism of
Toxicity

    Section 408(b)(2)(D)(v) of FFDCA requires that, when considering
whether to establish, modify, or revoke a tolerance, the Agency
consider ``available information'' concerning the cumulative effects of
a particular pesticide's residues and ``other substances that have a
common mechanism of toxicity.''
    EPA has not found lignosulfonic acid, calcium, comp. with 1,6
hexanediamine polymer with guanidine hydrochloride (1:1) to share a
common mechanism of toxicity with any other substances, and
lignosulfonic acid, calcium, comp. with 1,6 hexanediamine polymer with
guanidine hydrochloride (1:1) does not appear to produce a toxic
metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has assumed that lignosulfonic acid,
calcium, comp. with 1,6 hexanediamine polymer with guanidine
hydrochloride (1:1) does not have a common mechanism of toxicity with
other substances. For information regarding EPA's efforts to determine
which chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's website at http://www.epa.gov/pesticides/cumulative.

VI. Additional Safety Factor for the Protection of Infants and Children

    Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an
additional tenfold margin of safety for infants and children in the
case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the data base unless EPA concludes
that a different margin of safety will be safe for infants and
children. Due to the expected low toxicity of lignosulfonic acid,
calcium, comp. with 1,6 hexanediamine polymer with guanidine
hydrochloride (1:1), EPA has not used a safety factor analysis to
assess the risk. For the same reasons the additional tenfold safety
factor is unnecessary.

VII. Determination of Safety

    Based on the conformance to the criteria used to identify a low-
risk polymer, EPA concludes that there is a reasonable certainty of no
harm to the U.S. population, including infants and children, from
aggregate exposure to residues of lignosulfonic acid, calcium, comp.
with 1,6 hexanediamine polymer with guanidine hydrochloride (1:1).

VIII. Other Considerations

A. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes since
the Agency is establishing an exemption from the requirement of a
tolerance without any numerical limitation.

IX. Conclusion

    Accordingly, EPA finds that exempting residues of lignosulfonic
acid, calcium, comp. with 1,6 hexanediamine polymer with guanidine
hydrochloride (1:1) from the requirement of a tolerance will be safe.

X. Statutory and Executive Order Reviews

    This final rule establishes a tolerance exemption under section
408(d) of FFDCA in response to a petition submitted to the Agency. The
Office of Management and Budget (OMB) has exempted these rules from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this final rule has been
exempted from review under Executive Order 12866, this final rule is
not subject to Executive Order 13211, entitled Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
Protection of Children from Environmental Health Risks and Safety Risks
(62 FR 19885, April 23, 1997). This final rule does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it involve any
technical standards that would require Agency consideration of
voluntary consensus standards pursuant to 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).
    Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the tolerance
exemption in this final rule, do not require the issuance of a proposed
rule, the requirements of the Regulatory Flexibility Act (RFA) (5
U.S.C. 601 et seq.) do not apply.
    This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between

the Federal Government and Indian tribes, or otherwise have any unique
impacts on local governments. Thus, the Agency has determined that
Executive Order 13132, entitled Federalism (64 FR 43255, August 10,
1999) and Executive Order 13175, entitled Consultation and Coordination
with Indian Tribal Governments (65 FR 67249, November 9, 2000) do not
apply to this final rule. In addition, this final rule does not impose
any enforceable duty or contain any unfunded mandate as described under
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L.
104-4).
    Although this action does not require any special considerations
under Executive Order 12898, entitled Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994), EPA seeks to achieve
environmental justice, the fair treatment and meaningful involvement of
any group, including minority and/or low-income populations, in the
development, implementation, and enforcement of environmental laws,
regulations, and policies. As such, to the extent that information is
publicly available or was submitted in comments to EPA, the Agency
considered whether groups or segments of the population, as a result of
their location, cultural practices, or other factors, may have atypical
or disproportionately high and adverse human health impacts or
environmental effects from exposure to the pesticide discussed in this
document, compared to the general population.

XI. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. 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 this rule in the Federal
Register. This rule is not a ``major rule'' as defined by 5 U.S.C.
804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: August 16, 2018.
Michael Goodis,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. In Sec.  180.960, the table is amended by adding alphabetically the
following polymers to read as follows:

Sec.  180.960  Polymers; exemptions from the requirement of a
tolerance.

* * * * *

------------------------------------------------------------------------
                         Polymer                              CAS No.
------------------------------------------------------------------------

                              * * * * * * *
Lignosulfonic acid, calcium, comp. with 1,6                 1905409-74-6
 hexanediamine polymer with guanidine hydrochloride
 (1:1), minimum number average molecular weight (in
 amu); 4,500 daltons....................................

                              * * * * * * *
------------------------------------------------------------------------

[FR Doc. 2018-18407 Filed 8-23-18; 8:45 am]
 BILLING CODE 6560-50-P


      [†]Limitations of use: EPA makes no claims regarding the accuracy or precision of data concerning Indian country locations or boundaries. EPA has simply attempted to collect certain readily available information relating to Indian country locations. Questions concerning data should be referred to the originating program or Agency which can be identified in the Envirofacts tribal query metadata files Lower48 Tribal Areas, Alaska Reservation, Alaska Native Villages, or Alaska Native Allotments . The Indian country locations shown here are suitable only for general spatial reference and do not necessarily reflect EPA's position on any Indian country locations or boundaries or the land status of any specific location. The inclusion of Indian country information on the EnviroFacts website does not represent any final EPA action addressing Indian country locations or boundaries. This information cannot be relied upon to create any rights, substantive or procedural, enforceable by any party in litigation with the United States or third parties. EPA reserves the right to change information on EnviroFacts at any time without public notice.
EPA uses the US Census Bureau 2010 tribal boundary layer data when developing environmental data query responses for tribes in the lower 48 United States and Bureau of Land Management Alaska State Office when developing environmental data query responses for tribes in Alaska. The tribal boundary locations identified are suitable only for general spatial reference and do not necessarily reflect EPA's position on any Indian country locations or boundaries, or the land status of any specific location. EPA seeks to use the best available national federal data and may refine the tribal boundary layer in the future as more accurate national federal data becomes available.
*Monitor coverage indicates the existence of monitoring sites within Tribal land that are reporting data (as of July 2012) to EPA's Air Quality System (AQS) and that collect the data using Federal Reference Method or equivalent.