[Federal Register: January 14, 2008 (Volume 73, Number 9)]
[Proposed Rules]
[Page 2209-2210]
[DOCID:fr14ja08-25]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R03-OAR-2007-1010; FRL-8515-7]

Approval and Promulgation of Air Quality Implementation Plans;
West Virginia; Revised Motor Vehicle Emission Budgets for the
Charleston 8-Hour Ozone Maintenance Area

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA proposes to approve the State Implementation Plan (SIP)
revision submitted by the State of West Virginia for the purpose of
amending the 8-hour ozone maintenance plan for the Charleston area.
This revision amends the maintenance plans' 2009 and 2018 motor vehicle
emissions budgets (MVEBs) by reallocating a portion of the plans'
safety margins which results in an increase in the MVEBs. In the Final
Rules section of this Federal Register, EPA is approving the State's
SIP submittal as a direct final rule without prior proposal because the
Agency views this as a noncontroversial submittal and anticipates no
adverse comments. A detailed rationale for the approval is set forth in
the direct final rule. If no adverse comments are received in response
to this action, no further activity is contemplated. If EPA receives
adverse comments, the direct final rule will be withdrawn and all
public comments received will be addressed in a subsequent final rule
based on this proposed rule. EPA will not institute a second comment
period. Any parties interested in commenting on this action should do
so at this time.

DATES: Comments must be received in writing by February 13, 2008.

ADDRESSES: Submit your comments, identified by Docket ID Number EPA-
R03-OAR-2007-1010 by one of the following methods:
    A. http://www.regulations.gov. Follow the on-line instructions for

submitting comments.
    B. E-mail<EMAIL_ADDRESS>    C. Mail: EPA-R03-OAR-2007-1010, Carol Febbo, Chief, Energy,
Radiation and Indoor Environment Branch, Mailcode 3AP23, U.S.
Environmental

Protection Agency, Region III, 1650 Arch Street, Philadelphia,
Pennsylvania 19103.
    D. Hand Delivery: At the previously-listed EPA Region III address.
Such deliveries are only accepted during the Docket's normal hours of
operation, and special arrangements should be made for deliveries of
boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-R03-OAR-
2007-1010. EPA's policy is that all comments received will be included
in the public docket without change, and may be made available online
at http://www.regulations.gov, including any personal information provided,

unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through http://www.regulations.gov or e-mail.

The http://www.regulations.gov Web site 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 e-
mail comment directly to EPA without going through http://www.regulations.gov,

your e-mail 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.
    Docket: All documents in the electronic docket are listed in the
http://www.regulations.gov index. Although listed in the index, some

information is not publicly available, i.e., 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 in http://www.regulations.gov or

in hard copy during normal business hours at the Air Protection
Division, U.S. Environmental Protection Agency, Region III, 1650 Arch
Street, Philadelphia, Pennsylvania 19103. Copies of the State submittal
are available at the West Virginia Department of Environmental
Protection, Division of Air Quality, 601 57th Street, SE., Charleston,
WV 25304.

FOR FURTHER INFORMATION CONTACT: Martin Kotsch,<PHONE_NUMBER>, or by
e-mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: For further information, please see the
information provided in the direct final action, with the same title,
that is located in the ``Rules and Regulations'' section of this
Federal Register publication.

    Dated: December 27, 2007.
William T. Wisniewski,
Acting Regional Administrator, Region III.
[FR Doc. E8-287 Filed 1-11-08; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 83, Number 138 (Wednesday, July 18, 2018)]
[Notices]
[Pages 33939-33940]
[FR Doc No: 2018-15297]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-1324]

Advisory Committee; Science Board to the Food and Drug
Administration; Renewal

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; renewal of advisory committee.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the renewal of the Science Board to the Food and Drug Administration
(Committee) by the Commissioner of Food and Drugs (Commissioner). The
Commissioner has determined that it is in the public interest to renew
the Science Board to the Food and Drug Administration for an additional
2 years beyond the charter expiration date. The new charter will be in
effect until June 26, 2020.

DATES: Authority for the Science Board to the Food and Drug
Administration will expire on June 26, 2020, unless the Commissioner
formally determines that renewal is in the public interest.

FOR FURTHER INFORMATION CONTACT: Rakesh Raghuwanshi, Office of the
Chief Scientist, Office of the Commissioner, Food and Drug
Administration, White Oak Building 1, Rm. 3309, 10903 New Hampshire
Ave., Silver Spring, MD 20993,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: Pursuant to 41 CFR 102-3.65 and approval by
the Department of Health and Human Services pursuant to 45 CFR part 11
and by the General Services Administration, FDA is announcing the
renewal of the Science Board to the Food and Drug Administration. The
Committee is a discretionary Federal advisory committee established to
provide advice to the Commissioner. The Science Board advises the
Commissioner or designee in discharging responsibilities as they relate
to helping to ensure safe and effective drugs for human use and, as
required, any other product for which FDA has regulatory
responsibility. The Science Board shall provide advice to the
Commissioner and other appropriate officials on specific complex
scientific and technical issues important to FDA and its mission,
including emerging issues within the scientific community.
Additionally, the Science Board will provide advice that supports the
Agency in keeping pace with technical and scientific developments,
including in

regulatory science; and input into the Agency's research agenda; and on
upgrading its scientific and research facilities and training
opportunities. It will also provide, where requested, expert review of
Agency-sponsored intramural and extramural scientific research
programs.
    The Committee shall consist of a core of 21 voting members
including a Chair and Co-Chair. The members, Chair, and Co-Chair are
selected by the Commissioner or designee from among authorities
knowledgeable in the fields of food science, safety, and nutrition;
chemistry; pharmacology; translational and clinical medicine and
research; toxicology; biostatistics; medical devices; imaging;
robotics; cell and tissue based-products; regenerative medicine; public
health and epidemiology; international health and regulation; product
safety; product manufacturing sciences and quality; and other
scientific areas relevant to FDA regulated products such as systems
biology, informatics, nanotechnology, and combination products. Members
will be invited to serve for overlapping terms of up to 4 years. Almost
all non-Federal members of this committee serve as Special Government
Employees. The core of voting members may include one technically
qualified member, selected by the Commissioner or designee, who is
identified with consumer interests and is recommended by either a
consortium of consumer-oriented organizations or other interested
persons. The Committee may also include technically qualified Federal
members. The Commissioner or designee shall have the authority to
select members of other scientific and technical FDA advisory
committees (normally not to exceed 10 members) to serve temporarily as
voting members and to designate consultants to serve temporarily as
voting members when: (1) Expertise is required that is not available
among current voting standing members of the Committee (when additional
voting members are added to the Committee to provide needed expertise,
a quorum will be based on the combined total of regular and added
members), or (2) to comprise a quorum when, because of unforeseen
circumstances, a quorum is or will be lacking. Because of the size of
the Committee and the variety in the types of issues that it will
consider, FDA may, in connection with a particular committee meeting,
specify a quorum that is less than a majority of the current voting
members. The Agency's regulations (21 CFR 14.22(d)) authorize a
committee charter to specify quorum requirements. If functioning as a
medical device panel, a non-voting representative of consumer interests
and a non-voting representative of industry interests will be included
in addition to the voting members.
    Further information regarding the most recent charter and other
information can be found at https://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/ScienceBoardtotheFoodandDrugAdministration/ucm115356.htm or by contacting the Designated Federal Officer (see FOR
FURTHER INFORMATION CONTACT). In light of the fact that no change has
been made to the committee name or description of duties, no amendment
will be made to 21 CFR 14.100.
    This document is issued under the Federal Advisory Committee Act (5
U.S.C. app.). For general information related to FDA advisory
committees, please check https://www.fda.gov/AdvisoryCommittees/default.htm.

    Dated: July 12, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-15297 Filed 7-17-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: December 20, 2006 (Volume 71, Number 244)]
[Proposed Rules]
[Page 76553-76555]
[DOCID:fr20de06-38]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 63

[EPA-HQ-OAR-2002-0051; FRL-8256-3]
RIN 2060-AJ78

National Emission Standards for Hazardous Air Pollutants From the
Portland Cement Manufacturing Industry: Notice of Reconsideration

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of reconsideration.

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SUMMARY: EPA is announcing that it is reconsidering the new source
standards for mercury and for total hydrocarbons (THC) which are part
of the National Emission Standards for Hazardous Air Pollutants From
the Portland Cement Manufacturing Industry, published on December 20,
2006.

DATES: Comments are due no later than February 20, 2007.

ADDRESSES: EPA has established a docket for this action under Docket ID
No. EPA-HQ-OAR-2002-0051. All documents in the docket are listed on the
http://www.regulations.gov Web site. 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 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
http://www.regulations.gov or in hard copy at the EPA Docket, EPA/DC, EPA

West, Room 3334, 1301 Constitution Ave., NW., Washington, DC. 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 EPA
Docket Center is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Mr. Keith Barnett, EPA, Office of Air
Quality Planning and Standards, Sector Policies and Programs Division,
Metals and Minerals Group (D243-02), Research Triangle Park, NC 27711;
telephone number<PHONE_NUMBER>; facsimile number<PHONE_NUMBER>; e-
mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

    A. Does this action apply to me? Entities potentially affected by
this action are those that manufacture portland cement. Regulated
categories and entities include:

                                       Table 1.--Regulated Entities Table
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              Category                   NAICS \1\                  Examples of regulated entities
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Industry............................           32731  Owners or operators of portland cement manufacturing
                                                       plants.
State...............................  ..............  None.
Tribal associations.................  ..............  None.
Federal agencies....................            None  None.
----------------------------------------------------------------------------------------------------------------
\1\ North American Industry Classification System.

    This table is not intended to be exhaustive, but rather provides a
guide for readers regarding entities likely to be regulated by this
action. This table lists the types of entities that may potentially be
regulated by this action. To determine whether your facility is
regulated by this action, you should carefully examine the
applicability criteria in 40 CFR 63.1340 of the rule. If you have
questions regarding the applicability of this action to a particular
entity, consult the person listed in the preceding FOR FURTHER
INFORMATION CONTACT section.
    Worldwide Web (WWW). In addition to being available in the docket,
an electronic copy of today's notice will also be available through the
http://WWW. Following the Administrator's signature, a copy of this action

will be posted on EPA's Technology Transfer Network (TTN) policy and
guidance page for newly proposed or promulgated rules at http://www.epa.gov/ttn/oarpg/.
 The TTN at EPA's Web site provides information

and technology exchange in various areas of air pollution control.

Reconsideration of the New Source Mercury Standard

    On December 2, 2005, EPA proposed amendments to the National
Emission Standards for Hazardous Air Pollutants from the Portland
Cement Manufacturing Industry (70 FR 72330). Among other things, we
proposed to amend the emission standards for mercury, hydrogen
chloride, and total hydrocarbons. We are publishing the final
amendments in another part of today's Federal Register. The final
amendments contain a mercury new source standard of 41 [mu]g/dscm for
cement kilns and kilns/in-line raw mills, or an alternative standard
requiring application of a limestone wet scrubber with a liquid-to-gas
ratio of 30 gallons per thousand actual cubic feet per minute of
exhaust gas with a site-specific numeric limit to be established based
on that scrubber's performance.
    In this notice, we are ourselves granting reconsideration of this
new source standard for mercury. We are doing so because we believe
that reconsideration is compelled by section 307(d)(7)(B) of the Act,
since the information on which the standard is based arose after the
period for public comment and (obviously) is of central relevance to
the rulemaking. In addition, as explained in the following paragraphs,
we believe that there remain important technical issues which we hope
to better resolve during the reconsideration process.
    In developing the final amendments, we noted that there are at
least five cement kilns that have limestone (wet) scrubbers for control
of SO2. As explained more fully in the preamble to the final
amendments, based on our experience with utility boilers, as well as on
general engineering principles, we expect that the scrubbers on cement
kilns remove mercury, although the amount of removal is uncertain.
Thus, assuming reductions occur, which we believe to be the case based
on the limited information in the record, a portland cement kiln
equipped with a scrubber would have the best performance for mercury
over time, since variability in mercury emissions attributable to raw
material and fuel inputs would be controlled in part.
    We have mercury test data from two portland cement kilns equipped
with wet scrubbers, measured exclusively at the scrubber outlet. These
data range from 0.42 to 30 [mu]g/dscm, which fall within the range of
test data from all

portland cement kilns (those with wet scrubbers and those without wet
scrubbers). They are among the lowest end-of-stack mercury data in our
data base (although not the lowest). This could indicate that some
removal mechanism is involved. Variability of mercury emissions at the
scrubber-equipped kilns for which we have multiple test data differs by
orders of magnitude. See Summary of Mercury Test data in Docket EPA-HQ-
OAR-2002-0051.
    As noted above, we have no test data for mercury measured at the
scrubber inlet. As a result, we cannot, on the basis of the current
data, determine with absolute certainty if the outlet mercury emissions
from the wet scrubber-equipped kilns are a result of mercury removal by
the scrubber, or simply reflect the amounts of mercury in the raw
materials. Nonetheless, for the reasons described in the preamble to
the final amendments, we believe, based on the limited information in
the record, that it is reasonable to find that wet scrubbers remove
some mercury from cement kiln emissions.
    In the final amendments being published concurrently with this
notice, we developed an emissions limit of 41 [mu]g/dscm (corrected to
7 percent oxygen) using the following rationale. First, we limited the
analysis to data from wet scrubber-equipped kilns regardless of their
actual outlet emissions levels. Second, we ranked all the wet scrubber
mercury emissions with the raw mill off--a recurring mode of operation
for cement kilns reflecting the maximum variability a properly designed
and operated scrubber-equipped kiln would experience. We then took the
mean raw mill off value for mercury emissions from the best performing
wet scrubber-equipped cement kiln in our (limited) data base, and
multiplied it by a variability factor which accounts for normal,
unavoidable variation in mercury emissions. This variability factor is
the standard deviation of the data multiplied by 2.326 to produce the
99th confidence interval. We looked to all of the data we have from
cement kilns equipped with wet scrubbers, rather than just to data from
the single lowest-emitting kiln, because there are too few data points
from the lowest emitting kiln to properly estimate its variability. The
result of this analysis is a new source floor of 41 [mu]g/dscm, which
we then adopted as the new source standard. This standard must be met
continuously (raw mill on and raw mill off).
    Because of the limited performance data characterizing performance
of the lowest-emitting scrubber-equipped kiln, we also developed an
alternative new source mercury floor. The best performing kiln is
equipped with a wet scrubber. Therefore, if a new source installs a
properly designed and operated wet scrubber, and is unable to achieve
the 41 [mu]g/dscm standard, then whatever emission level the source
achieves (over time, considering all normal sources of variability)
would become the floor for that source. Based on the design of the wet
scrubbers that were the basis of the new source floor, this would be a
packed bed or spray tower wet scrubber with a minimum liquid-to-gas
ratio of 30 gallons per thousand actual cubic feet of exhaust gas. We
also adopted this alternative floor as an alternative new source
emission standard for mercury.
    As noted above, we are ourselves granting reconsideration of the
new source mercury standard adopted in the final amendments, both due
to substantive issues relating to performance of wet scrubbers and
because information about their performance in this industry has not
been available for public comment. As part of the reconsideration
process, we are initiating a test program to simultaneously measure
mercury emissions at the inlet and the outlet of wet scrubbers
currently installed on cement kilns. By doing so, we expect to be able
to better resolve the ultimate issues we are reconsidering: the
appropriateness of the new source standard (and floor), and whether wet
scrubbers remove mercury from portland cement kiln emissions, and if
so, to what extent.
    We intend to complete the reconsideration process by December 20,
2007. When data from the testing process are in hand, we will issue
another Federal Register notice describing the data and the testing
process by which the data were obtained, and seek public comment on
those data and on the testing process. As part of that notice, we may
also propose to amend the new source standard.
    At the present time, we are also soliciting any data that could
potentially be relevant in this reconsideration process. Given the
expedited schedule for reconsideration of the new source mercury
standard, we are asking that the data be submitted to EPA as soon as
possible, and no later than February 20, 2007, so that we can properly
consider it prior to publishing another notice in the Federal Register.
The data should be submitted to the person and address in the FOR
FURTHER INFORMATION CONTACT section.

Reconsideration of Existing and New Source Standard Banning Cement Kiln
Use of Certain Mercury-Containing Fly Ash

    As part of the final rule, EPA adopted a standard for both new and
existing sources banning the use of utility boiler fly ash in cement
kilns where the fly ash mercury content has been increased through the
use of activated carbon or any other sorbent unless the facility can
demonstrate that the use of that fly ash will not result in an increase
in mercury emissions over baseline emissions (i.e. emissions not using
the mercury increased fly ash). See section IV.A.2 to the preamble to
the final rule. EPA took this action because of the potential for
significant increases in mercury emissions from cement kilns, and
because the positive energy and non-air health and environmental
impacts from current recycling of utility fly ash as feed material in
cement kilns would not be significantly impeded. Although EPA alluded
to the possibility of this type of standard at proposal (70 FR 72334),
we nonetheless believe it appropriate to reconsider the issue to
provide further opportunity for comment on both the standard and the
underlying rationale, because we do not feel we have the level of
analysis we would like to support a beyond-the-floor determination. We
request that all comments be submitted to EPA no later than February
20, 2007.

Reconsideration of New Source Standard for THC

    As part of the final amendments, EPA also issued a standard for new
cement kilns of 20 ppmv (corrected to 7 percent oxygen) or 98 percent
reduction in THC emissions from uncontrolled levels. This standard is
based upon the performance of a single cement kiln which has installed
a regenerative thermal oxidizer (RTO) in series with a wet scrubber
(which precedes the RTO and enables its performance by preventing
plugging, fouling, and corrosion of the device). We are ourselves
granting reconsideration of this standard in this notice. We are doing
so because we believe that reconsideration is compelled by section
307(d)(7)(B) of the Act, since the information on which the standard is
based arose after the period for public comment and is of central
relevance to the rulemaking.
    We are specifically requesting comment on the new source standard
itself, as well as on the information upon which the standard is based.
We also are soliciting data on THC emission levels from preheater/
precalciner cement kilns. We further solicit

comment as to whether the promulgated standard is appropriate for
reconstructed new sources, should any be contemplated (it is our
understanding that all new source cement kilns will be newly
constructed). We request that all comment be submitted within February
20, 2007. EPA will evaluate all data and comments received, and
determine whether in light of those data and comment it is appropriate
to propose to amend the promulgated standard. If EPA does propose to
amend the standard, EPA would take final action on the proposal within
the same one year period that we are allotting for completion of the
reconsideration process for the new source mercury standard.

How can I get copies of the final amendments and other related
information?

    EPA has established the official public docket for this rulemaking
under docket ID No. EPA-HQ-OAR-2002-0051. Information on how to access
the docket is presented above in the ADDRESSES section. In addition,
information may be obtained from the Web page for the rulemaking at:
http:// www.epa.gov/ttn/atw/pcem/pcempg.html.

    Dated: December 8, 2006.
Stephen L. Johnson,
Administrator.
[FR Doc. E6-21404 Filed 12-19-06; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register: May 13, 2009 (Volume 74, Number 91)]
[Rules and Regulations]
[Page 22456-22460]
[DOCID:fr13my09-9]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2008-0093; FRL-8412-5]

Calcium Lactate Pentahydrate; Exemption from the Requirement of a
Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of calcium lactate pentahydrate (CAS Reg.
No. 5743-47-5) when used as an inert ingredient in pesticide
formulations applied to growing crops or to raw agricultural
commodities after harvest. SynTech Global LLC, on behalf of BioNext
sprl submitted a petition to EPA under the Federal Food, Drug, and
Cosmetic Act (FFDCA), as amended by the Federal Quality Protection Act
of 1996 (FQPA), requesting an exemption from the requirement of a
tolerance. This regulation eliminates the need to establish a maximum
permissible level for residues of calcium lactate pentahydrate.

DATES: This regulation is effective May 13, 2009. Objections and
requests for hearings must be received on or before July 13, 2009, 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-2008-0093. 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: Karen Samek, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
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 Access Electronic Copies of this Document?

    In addition to accessing electronically available documents at
http://www.regulations.gov, you may access this Federal Register
document electronically through the EPA Internet under the ``Federal
Register'' listings at http://www.epa.gov/fedrgstr. You may also access
a frequently updated electronic version of 40 CFR part 180 through the
Government Printing Office's e-CFR cite at http://www.gpoaccess.gov/
ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 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. The EPA procedural regulations which
govern the submission of objections and requests for hearings appear in
40 CFR part 178. 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-2008-0093 in the subject line on the first page of
your submission. All requests must be in writing, and must be mailed or
delivered to the Hearing Clerk on or before July 13, 2009.
    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 that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit your copies, identified by docket ID
number EPA-HQ-OPP-2008-0093, 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 June 4, 2008 (73 FR 31862) (FRL-8365-3),
EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C. 346a,
as amended by FQPA (Public Law 104-170), announcing the filing of a
pesticide petition (PP 7F7311) by SynTech Global LLC on behalf of
BioNext sprl, Passage des deportes, 2, B-5030 Gembloux, Belgium. The
petition requested that 40 CFR 180.910 be amended by establishing an
exemption from the requirement of a tolerance for residues of calcium
lactate pentahydrate when used as an inert ingredient in pesticide
formulations with the active ingredient Candida oleophila strain O as a
post- harvest treatment on stored apples and pears to control Botrytis
cinerea (grey mold) and Penicillium expansum (blue mold). That notice
included a summary of the petition prepared by the petitioner. There
were no comments received in response to the notice of filing.
    Based upon review of the data supporting the petition, EPA has
modified the exemption requested to include an exemption from the
requirement of a tolerance for residues of calcium lactate pentahydrate
(CAS Reg. No. 5743-47-5) under 40 CFR 180.910 when used as an inert
ingredient in pesticide formulations applied to growing crops or to raw
agricultural commodities after harvest. The reason for these changes
are explained in Unit IV.
    Section 408(b)(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 tolerance is ``safe.'' Section 408(b)(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 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 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. . . .''
    EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. First, EPA determines the
toxicity of pesticides. Second, EPA examines exposure to the pesticide
through food, drinking water, and through other exposures that occur as
a result of pesticide use in residential settings.

III. Inert Ingredient Definition

    Inert ingredients are all ingredients that are not active
ingredients as defined in 40 CFR 153.125 and include, but are not
limited to, the following types of ingredients (except when they have a
pesticidal efficacy of their own): Solvents such as alcohols and
hydrocarbons; surfactants such as polyoxyethylene ploymers and fatty
acids; carriers such as clay and diatomaceous earth; thickeners such as
carrageenan and modified cellulose; wetting, spreading, and dispersing
agents; propellants in aerosol dispensers; microencapsulating agents;
and emulsifiers. The term ``inert'' is not intended to imply
nontoxicity; the ingredient may or may not be chemically active.
Generally, EPA has exempted inert ingredients from the requirement of a
tolerance based on the low toxicity of the individual inert
ingredients.

IV. Toxicological Profile

    Consistent with section 408(b)(2)(D) of FFDCA, 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. The nature of the toxic effects caused by calcium
lactate pentahydrate are discussed in this unit.
    The Agency has reviewed the data submitted by the petitioner. The
data submitted includes data on lactic acid, as well as data on calcium
lactate. Because it is likely that calcium lactate readily
disassociates to lactic acid and calcium in the body, the Agency has
concluded that the data on lactic acid can be used in conjunction with
the data on calcium lactate and that these data are adequate to
characterize the toxicity of calcium lactate pentahydrate.
    Acute oral and inhalation toxicity of lactic acid to rats and acute
dermal toxicity of lactic acid to rabbits are low. L(+)-Lactic acid is
severely irritating and corrosive to rabbit skin. It is expected to be
severely irritating to the eyes. Dilute solutions are irritating to the
eyes of rabbits. L(+)-Lactic acid is not a dermal sensitizer in guinea
pigs. Repeat oral exposure of rats to calcium lactate for 90 days
produced no toxicity at doses up to 5,000 milligrams/kilograms/day (mg/
kg/day). No neurotoxicity studies are available; however, no signs of
neurotoxicity were observed in any of the available studies. Based on
the results of the mutagenicity studies, calcium lactate pentahydrate
is not likely to be mutagenic. A 2-year bioassay of calcium lactate in
rats showed no evidence of carcinogenicity or any systemic toxicity at
doses up to 5,000 mg/kg/day.
    No developmental or reproductive toxicity studies are available for
calcium lactate pentahydrate, however, the Agency concluded that no
developmental or reproductive studies are needed because there is no
systemic toxicity identified at doses up to 5,000 mg/kg/day in a 2-year
chronic toxicity study. In addition, a developmental toxicity study for
lactic acid resulted in no maternal or developmental effects and none
of the reproductive parameters were affected in mice at 570 mg/kg/day
(only dose tested).

V. Aggregate Exposures

    In examining aggregate exposure, section 408 of FFDCA directs EPA
to consider available information concerning exposures from the
pesticide residue in food and all other non-occupational exposures,
including drinking water from ground water or surface water and
exposure through pesticide use in gardens, lawns, or buildings
(residential and other indoor uses).
    Calcium lactate is used as a food additive and is a normal
constituent of the human diet. It is used as a firming agent in canned
fruits and can be found in jellies and preserves. It can be found
naturally in aged cheese and is used medically to treat calcium
deficiencies. Food and Drug Administration allows the use of calcium
lactate as a direct human food ingredient and has granted calcium
lactate generally recognized as safe (GRAS) status for use as a firming
agent, flavor enhancer, leavening agent, nutrient supplement,
stabilizer, and thickener.
    The primary route of exposure to calcium lactate pentahydrate from
its

use as an inert ingredient in pesticide products would most likely be
through consumption of food to which pesticide products containing it
have been applied, and possibly through drinking water (from runoff).
Residential (dermal and inhalation) exposures from home garden uses are
possible.
    No hazard was identified for the acute and chronic dietary
assessment (food and drinking water), or for the short-, intermediate-,
and long-term residential assessments, and therefore no aggregate risk
assessments were performed.

VI. Cumulative Effects

    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.''
    Unlike other pesticide ingredients for which EPA has followed a
cumulative risk approach based on a common mechanism of toxicity, EPA
has not made a common mechanism of toxicity finding as to calcium
lactate pentahydrate and any other substances and calcium lactate
pentahydrate does not appear to produce a toxic metabolite produced by
other substances. For the purposes of this tolerance action, therefore,
EPA has not assumed that calcium lactate pentahydrate 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
the policy statements released by EPA's Office of Pesticide Programs
concerning common mechanism determinations and procedures for
cumulating effects from substances found to have a common mechanism on
EPA's website at http://www.epa.gov/pesticides/cumulative.

VII. Determination of Safety for Infants and Children

    Section 408(b)(2)(c) of FFDCA provides that EPA shall apply an
additional tenfold (10X) 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 database on toxicity and exposure
unless EPA determines based on reliable data that a different margin of
safety will be safe for infants and children. This additional margin of
safety is commonly referred to as the FQPA safety factor (SF). In
applying this provision, EPA either retains the default value of 10X,
or uses a different additional safety factor when reliable data
available to EPA support the choice of a different factor.
    The toxicity database for calcium lactate is adequate for FQPA
assessement and the potential exposure is adequately characterized
given the low toxicity of the chemical. No acute or subchronic
neurotoxicity studies are available, but there were no clinical signs
of neurotoxicity observed in the available database at doses up to
5,000 mg/kg/day. Therefore, the Agency concluded that these studies are
not required. No developmental or reproductive toxicity studies are
available for calcium lactate pentahydrate, however, the Agency
concluded that no developmental or reproductive studies are needed
because there is no systemic toxicity identified at doses up to 5,000
mg/kg/day in a two-year chronic toxicity study. In addition, a
developmental toxicity study for lactic acid resulted in no maternal or
developmental effects and none of the reproductive parameters were
affected in mice at 570 mg/kg/day (only dose tested).
    In 1973, World Health Organization (WHO) evaluated lactic acid as
well as its ammonium, calcium, potassium, and sodium slats and stated
that ``There is some evidence that babies in their first three months
of life have difficulties in utilizing small amounts of DL and D(-)
lactic acids.'' (INCHEM. (1974). Seventeenth Report of the Joint FAO/
WHO Expert Committee on Food Additives, Lactic acid and its ammonium,
calcium, potassium and sodium salts. WHO Technical Report Series, No.
539; FAO Nutrition Meetings Report Series, 1974, No. 53. http://
www.inchem.org/documents/jecfa/jecmono/v05je86.htm). EPA believes that
exposure of premature or very young infants to lactic acid is unlikely.
As stated in the Agency's reassessment document for lactic acid,
``First, premature or very young infants ingest only formula or breast
milk. (It is generally recommended that infants not consume solid food
until 4 to 6 months of age). Regulation of infant formulas is under the
purview of FDA. (www.fda.gov/fdac/features/596_baby.html).'' (Stehlin,
I; (1996). Infant Formula: Second Best but Good Enough. FDA Consumer
Magazine. 30 (5)). To carry out their regulation of infant foods and
infant formulas, FDA published in 21 CFR 184.1207(c)(2) a very specific
limitation that calcium lactate cannot be used in infant foods and
infant formulas. Therefore, infants consuming only infant formula or
breast milk are not exposed to calcium lactate. Once past this initial
time-period, there is no longer a concern for potential sensitivity to
infants and children. Older infants, like adults, process calcium
lactate through well understood metabolic pathways.
    Based on this information, there is no concern, at this time, for
increased sensitivity to infants and children to calcium lactate
pentahydrate when used as an inert ingredient in pesticide formulations
applied to growing crops or to raw agricultural commodities after
harvest and a safety factor analysis has not been used to assess risk.
For the same reason, EPA has determined that an additional safety
factor is not needed to protect the safety of infants and children.

VIII. Determination of Safety for U.S. Population

    EPA establishes exemptions from the requirement of a tolerance only
in those cases where it can be demonstrated 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.
    Residues of concern are not anticipated for dietary exposure (food
and drinking water) or for residential exposure from the use of calcium
lactate pentahydrate for the proposed use pattern as an inert
ingredient in pesticide products. As discussed in Unit VIII., EPA
expects aggregate exposure to calcium lactate to pose no appreciable
dietary risk given that the data on calcium lactate show a lack of any
systemic toxicity at doses of up 5,000 mg/kg/day and a lack of any
apparent developmental effects and that lactic acid is a normal
component of human intermediary metabolism Furthermore, according to
the FDA website http://www.cfsan.fda.gov/~dms/opascogd.html ``the
Select committee concluded that: There is no evidence in the available
information on L(+) calcium lactate that demonstrates or suggests
reasonable grounds to suspect a hazard to the public when they are

used at levels that are now current or that might reasonably be
expected in the future. There is no evidence in the available
information on either of the isomers of lactic acid, their calcium
slats, and their racemates that demonstrates or suggests reasonable
grounds to suspect a hazard to individuals beyond infancy when they are
used at levels that are now current or that might reasonable be
expected in the future.''
    Taking into consideration all available information on calcium
lactate pentahydrate, EPA concludes that there is a reasonable
certainty that no harm will result to the general population or to
infants and children from aggregate exposure to calcium lactate
pentahydrate. Therefore, the establishment of an exemption from
tolerance under 40 CFR 180.910 for residues of calcium lactate
pentahydrate when used as an inert ingredient in pesticide formulations
applied to growing crops or to raw agricultural commodities after
harvest can be considered safe under section 408 of FFDCA.

IX. Other Considerations

A. Endocrine Disruptors

    EPA is required under FFDCA, as amended by FQPA, to develop a
screening program to determine whether certain substances (including
all pesticide active and other ingredients) ``may have an effect in
humans that is similar to an effect produced by a naturally occurring
estrogen, or other such endocrine effects as the Administrator may
designate.'' Following recommendations of its Endocrine Disruptor and
Testing Advisory Committee (EDSTAC), EPA determined that there was a
scientific basis for including, as part of the program, the androgen
and thyroid hormone systems, in addition to the estrogen hormone
system. EPA also adopted EDSTAC's recommendation that the program
include evaluations of potential effects in wildlife. For pesticide
chemicals, EPA will use the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA), as amended, and to the extent that effects in
wildlife may help determine whether a substance may have an effect in
humans, FFDCA authority to require the wildlife evaluations. As the
science develops and resources allow, screening of additional hormone
systems may be added to the Endocrine Disruptor Screening Program
(EDSP).
    When additional appropriate screening and/or testing protocols
being considered under the Agency's EDSP have been developed, calcium
lactate pentahydrate may be subjected to further screening and/or
testing to better characterize effects related to endocrine disruption.

B. Analytical Method

    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.

C. International Tolerances

    The Agency is not aware of any country requiring a tolerance for
calcium lactate pentahydrate nor have any CODEX Maximum Residue Levels
been established for any food crops at this time.

D. Revisions to Petitioned-For Exemption

    Based upon review of the data supporting the petition, EPA has
modified the exemption requested to include an exemption from the
requirement of a tolerance for residues of calcium lactate pentahydrate
(CAS Reg. No. 5743-47-5) under 40 CFR 180.910 when used as an inert
ingredient in pesticide formulations applied to growing crops or to raw
agricultural commodities after harvest because no hazard was identified
and therefore, no limitations are necessary.

X. Conclusions

    Based on the information in this preamble, EPA concludes that there
is a reasonable certainty of no harm from aggregate exposure to
residues of calcium lactate pentahydrate. Accordingly, EPA finds that
exempting calcium lactate pentahydrate from the requirement of a
tolerance when used as an inert ingredient in pesticide formulations
applied to growing crops or to raw agricultural commodities after
harvest will be safe.

XI. Statutory and Executive Order Reviews

    This final rule establishes a tolerance 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 types of actions 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 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).
    Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the tolerance 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. 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) (Public Law 104-4).
    This action does not 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).

XII. 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 final rule in
the Federal Register. This final 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: April 29, 2009.
Meredith F. Laws,
Acting Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
Therefore, 40 CFR chapter I is amended as follows:

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. 180.910, the table is amended by adding alphabetically the
following inert ingredient to read as follows:

Sec.  180.910  Inert ingredients used pre- and post-harvest; exemptions
from the requirement of a tolerance.

* * * * *

------------------------------------------------------------------------
        Inert ingredients               Limits               Uses
------------------------------------------------------------------------
                                * * * * *
Calcium lactate pentahydrate      ..................  Nutrient,
 (CAS Reg. No. 5743-47-5).                             stabilizer
                                * * * * *
------------------------------------------------------------------------

[FR Doc. E9-10769 Filed 5-12-09; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register Volume 82, Number 42 (Monday, March 6, 2017)]
[Notices]
[Pages 12577-12578]
[FR Doc No: 2017-04217]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP17-61-000]

Steppe Petroleum USA Inc., Bakken Hunter, LLC; Notice of
Application

    Take notice that on February 14, 2017, Steppe Petroleum USA Inc.
and Bakken Hunter, LLC, filed a joint application in Docket No. CP17-
61-000 under section

3 of the Natural Gas Act (NGA), and part 153 of the Commission's
regulations requesting authorization to transfer the NGA section 3
Authorization and Presidential Permit issued to Bakken Hunter, LLC on
April 24, 2014 in Docket No. CP14[hyphen]24[hyphen]000 to Steppe
Petroleum USA Inc. This authorization would transfer to Steppe
Petroleum USA Inc. the authorization to operate and maintain natural
gas pipeline facilities at a point on the International Boundary
between the United States of America and Canada in the vicinity of
Divide County, North Dakota, and to transfer to Steppe Petroleum USA
Inc. the permit to construct, operate and maintain the border crossing
facilities, all as more fully set forth in the application which is on
file with the Commission and open to public inspection. This filing is
available for review at the Commission in the Public Reference Room or
may 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, please contact FERC Online Support at
<EMAIL_ADDRESS>or toll free at<PHONE_NUMBER>, or for TTY,
contact<PHONE_NUMBER>.
    Any questions regarding this application should be directed to
Shaun Robinson, P. Eng, Senior Project Engineer, Polaris Engineering,
Ltd. 200, 1120--29th Avenue NE., Calgary, AB, Canada, T2E 7P1 or by
calling<PHONE_NUMBER> (telephone) or<PHONE_NUMBER> (fax)
<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 5 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 commentors 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 commentors will not be required to serve copies of filed
documents on all other parties. However, the non-party commentors 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.
    The Commission strongly encourages electronic filings of comments,
protests and interventions in lieu of paper using the ``eFiling'' link
at http://www.ferc.gov. Persons unable to file electronically should
submit an original and 5 copies of the protest or intervention to the
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive email
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: March 17, 2017.

    Dated: February 24, 2017.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2017-04217 Filed 3-3-17; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 87, Number 176 (Tuesday, September 13, 2022)]
[Notices]
[Pages 56107-56109]
[FR Doc No: 2022-19686]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-95697; File No. SR-NYSECHX-2022-20]

Self-Regulatory Organizations; NYSE Chicago, Inc.; Notice of
Filing and Immediate Effectiveness of Proposed Rule Change To Transfer
the Services and Fees Related to Colocation

September 7, 2022.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby given
that on August 24, 2022, NYSE Chicago, Inc. (``NYSE Chicago'' or the
``Exchange'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I and II
below, which Items have been prepared by the self-regulatory
organization. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to (1) transfer the services and fees related
to colocation from its Fee Schedule to the schedule of Wireless
Connectivity Fees and Charges, and (2) change the name of the schedule
of Wireless Connectivity Fees and Charges to the ``Connectivity Fee
Schedule.'' The proposed rule change is available on the Exchange's
website at www.nyse.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 self-regulatory organization
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 those 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 parts 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 Exchange proposes to (1) transfer the services and fees related
to colocation from the Fee Schedule to the schedule of Wireless
Connectivity Fees and Charges (``Connectivity Fee Schedule''), and (2)
change the name of the schedule of Wireless Connectivity Fees and
Charges to the ``Connectivity Fee Schedule.'' There would be no changes
to the existing colocation services and fees as a result of these
administrative changes.
Background
    The colocation services and related fees offered by the Exchange
are currently listed in the Exchange's Fee Schedule. Each of the
Exchange's Affiliate SROs \4\ similarly includes the colocation
services and related fees in its own separate price list or fee
schedule.\5\ The colocation portions of each of these price lists and
fee schedules are substantively identical.
---------------------------------------------------------------------------

    \4\ The ``Affiliate SROs'' are the Exchange's affiliates New
York Stock Exchange LLC, NYSE American LLC, NYSE Arca, Inc., and
NYSE National, Inc.
    \5\ See ``Co-Location Fees'' in ``New York Stock Exchange Price
List 2022'' at https://www.nyse.com/publicdocs/nyse/markets/nyse/NYSE_Price_List.pdf; ``NYSE American Equities Price List'' at
https://www.nyse.com/publicdocs/nyse/markets/nyse-american/NYSE_America_Equities_Price_List.pdf; ``NYSE American Options Fee
Schedule'' at https://www.nyse.com/publicdocs/nyse/markets/american-options/NYSE_American_Options_Fee_Schedule.pdf; ``NYSE Arca Equities
Fees and Charges'' at https://www.nyse.com/publicdocs/nyse/markets/nyse-arca/NYSE_Arca_Marketplace_Fees.pdf; ``NYSE Arca Options Fees
and Charges'' at https://www.nyse.com/publicdocs/nyse/markets/arca-options/NYSE_Arca_Options_Fee_Schedule.pdf; ``Fee Schedule of NYSE
Chicago, Inc.'' at https://www.nyse.com/publicdocs/nyse/NYSE_Chicago_Fee_Schedule.pdf; and ``NYSE National, Inc. Schedule of
Fees and Rebates'' at https://www.nyse.com/publicdocs/nyse/regulation/nyse/NYSE_National_Schedule_of_Fees.pdf.
---------------------------------------------------------------------------

    In December 2020, the Exchange and the Affiliate SROs created the
Connectivity Fee Schedule to list their wireless connectivity services
and related fees. Instead of including the wireless connectivity
services and related fees in the seven price lists and fee schedules of
the Exchange and the Affiliate SROs, the Connectivity Fee Schedule
contains the wireless connectivity services and charges for the
Exchange and the Affiliate SROs in one single fee schedule.
    In an administrative change, the Exchange now proposes to remove
its colocation services and related fees from its Fee Schedule and to
move them into the Connectivity Fee Schedule, so that services and fees
related to connectivity within, into and from the Mahwah Data Center
would appear in the same Connectivity Fee Schedule. Each of the
Affiliate SROs is contemporaneously making a similar filing.\6\ To
reflect the fact that the schedule would include services and fees for
connectivity with the Mahwah Data Center that are not wireless, the
Exchange also proposes to change its name to the ``Connectivity Fee
Schedule.''
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    \6\ Each of the Affiliate SROs has submitted substantially
similar rule changes to move their colocation price lists to the
Connectivity Fee Schedule. See SR-NYSE-2022-40, SR-NYSEAMER-2022-37,
SR-NYSEARCA-2022-56, and SR-NYSENAT-2022-16.
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Proposed Amendments to the Fee Schedule
    As shown in the attached Exhibit 5A [sic], the Exchange proposes to
delete the entirety of the text in the Exchange's Fee Schedule under
the heading ``Co-Location Fees.''
Proposed Amendments to the Connectivity Fee Schedule
    As shown in the attached Exhibit 5B [sic], the Exchange proposes to
amend the title to the ``Connectivity Fee Schedule.''
    The Exchange proposes to insert the entirety of the text currently
located in the Exchange's Fee Schedule under the heading ``Co-Location
Fees'' into the Connectivity Fee Schedule under the heading ``A.
Colocation Fees.'' No changes would be made to any of this text, except
for the following clarifying and non-substantive changes:
    1. The subheading ``Definitions'' would be amended to ``Colocation
Definitions.''
    2. The subheading ``General Notes'' would be amended to
``Colocation Notes'' and current General Note 1 would be deleted, as it
would no longer be necessary since it would be duplicative of the
existing General Note in the Connectivity Fee Schedule. The remainder
of the current General Notes 2-8 would be renumbered as Colocation
Notes 1-7 and the cross references in current General Note 8 would be
updated accordingly.
    3. In a conforming change, in the table of services and fees, the
note to the Partial Cabinet Solution bundles would be amended to change
the cross

reference from ``Note 2 under `General Notes' '' to ``Note 1 under
`Colocation Notes.' ''
    4. In a conforming change, in the table of services and fees, the
note to the Data Center Fiber Cross Connect would be amended to change
the cross reference from ``General Note 3'' to ``Colocation Note 2.''
    5. With the addition of the Colocation Fees at subheading ``A.'' of
the Connectivity Fee Schedule, each of the subsequent headings would be
renumbered accordingly. Specifically, ``A. Wireless Connectivity''
would become ``B. Wireless Connectivity,'' and ``B. Wireless
Connectivity to Market Data'' would become ``C. Wireless Connectivity
to Market Data.''
Application and Impact of the Proposed Changes
    As noted above, the proposed change is administrative in nature.
Any market participant that requests to receive colocation services
directly from the Exchange (a ``User'') \7\ is currently subject to the
described services and fees, none of which are new or novel. Current
Users would not incur any new fees and the Exchange does not expect to
attract any new Users as a result of the proposed change. Rather, the
change would simply move the description of the existing colocation
services and fees to the Connectivity Fee Schedule and change its title
accordingly.
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    \7\ See Securities Exchange Act Release No. 87408 (October 28,
2019), 84 FR 58778 at n.6 (November 1, 2019) (SR-NYSECHX-2019-12).
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    As a result of the proposed change, the services and fees related
to connectivity within, into, and from the Mahwah Data Center,
including colocation, would appear in the same Connectivity Fee
Schedule, and market participants would be able to see all such
connectivity services and fees in one place.
    The proposed change is not targeted at, or expected to be limited
in applicability to, a specific segment of market participant, as
colocation is available to any market participant that wishes to be a
User.
    The proposed changes are not otherwise intended to address any
other issues, and the Exchange is not aware of any problems that member
organizations would have in complying with the proposed change.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) of the Act,\8\ in general, and with Section 6(b)(1)
\9\ in particular, in that it enables the Exchange to be so organized
as to have the capacity to be able to carry out the purposes of the
Exchange Act and to comply, and to enforce compliance by its exchange
members and persons associated with its exchange members, with the
provisions of the Exchange Act, the rules and regulations thereunder,
and the rules of the Exchange. The Exchange also believes that the
proposed change furthers the objectives of Section 6(b)(5) of the Act
\10\ because it is designed to prevent fraudulent and manipulative acts
and practices, to promote just and equitable principles of trade, to
foster cooperation and coordination with persons engaged in regulating,
clearing, settling, processing information with respect to, and
facilitating transactions in securities, to remove impediments to, and
perfect the mechanisms of, a free and open market and a national market
system and, in general, to protect investors and the public interest
and because it is not designed to permit unfair discrimination between
customers, issuers, brokers, or dealers.
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    \8\ 15 U.S.C. 78f(b).
    \9\ 15 U.S.C. 78f(b)(1).
    \10\ 15 U.S.C. 78f(b)(5).
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    The proposed rule change is a non-substantive change and does not
impact the services available to Users or the fees charged for such
services. Currently, colocation services and the related fees for the
Exchange and its Affiliate SROs are substantively identical yet are
located in seven separate price lists and fee schedules and not in the
Connectivity Fee Schedule. The Exchange believes that the proposed rule
change would enable the Exchange to continue to be so organized as to
have the capacity to carry out the purposes of the Exchange Act and
comply and enforce compliance with the provisions of the Exchange Act
by its members and persons associated with its members, because moving
the description of the existing colocation services and fees to the
Connectivity Fee Schedule and changing the Connectivity Fee Schedule's
title would mean that the services and fees related to connectivity
within, into, and from the Mahwah Data Center, including colocation,
would appear in one Connectivity Fee Schedule. All market participants
would be able to enjoy the convenience of seeing such connectivity
services and fees in one place, alleviating any possible market
participant confusion that could currently arise from having to consult
more than one document. Making the change would therefore contribute to
the orderly operation of the Exchange by adding clarity and
transparency regarding what connectivity is offered within, into, and
from the Mahwah Data Center.
    The Exchange believes that the proposed change would remove
impediments to, and perfect the mechanisms of, a free and open market
and a national market system and, in general, protect investors and the
public interest because moving the colocation services and charges from
the Exchange's Fee Schedule to the Connectivity Fee Schedule would more
accurately reflect the fact that Users are not required to be members
of the Exchange or of any of the Affiliate SROs. A User, like any
market participant, could more easily navigate, understand, and comply
with the list of colocation services and fees, without having to access
the price list or fee schedule of an exchange of which it is not a
member. The Exchange believes that the proposed change would thereby
reduce potential investor or market participant confusion. Similarly,
the Exchange believes that the proposed change would reduce potential
investor or market participant confusion because market participants
would be able to see all connectivity services and fees in one place,
alleviating any possible market participant confusion that could
currently arise from having to consult more than one document.
    For the reasons above, the proposed changes do not unfairly
discriminate between or among market participants that are otherwise
capable of satisfying any applicable colocation fees, requirements,
terms, and conditions established from time to time by the Exchange.
    For these reasons, the Exchange believes that the proposal is
consistent with the Act.

B. Self-Regulatory Organization's Statement on Burden on Competition

    In accordance with Section 6(b)(8) of the Act,\11\ the Exchange
believes that the proposed rule change will not impose any burden on
competition that is not necessary or appropriate in furtherance of the
purposes of the Act because it is ministerial in nature and is not
designed to have any competitive impact. Rather, the change would
simply move the description of the existing colocation services and
fees to the Connectivity Fee Schedule and change its title. As a result
of the proposed rule change, the services and fees related to
connectivity within, into, and from the Mahwah Data Center would appear
in the same Connectivity Fee Schedule. All market participants would be
able to see the connectivity services and fees within,

into, and from the Mahwah Data Center in one place, alleviating any
possible market participant confusion.
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    \11\ 15 U.S.C. 78f(b)(8).
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    For the reasons described above, the Exchange believes that the
proposed rule change reflects 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 solicited or received with respect to the
proposed rule change.

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

    The proposed rule change has become effective pursuant to Section
19(b)(3)(A) of the Act \12\ and Rule 19b-4(f)(3) \13\ thereunder in
that the proposed rule change is concerned solely with the
administration of the Exchange.
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    \12\ 15 U.S.C. 78s(b)(3)(A).
    \13\ 17 CFR 240.19b-4(f)(3).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of such 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 under
Section 19(b)(2)(B) \14\ of the Act to determine whether the proposed
rule change should be approved or disapproved.
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    \14\ 15 U.S.C. 78s(b)(2)(B).
---------------------------------------------------------------------------

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-NYSECHX-2022-20 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-NYSECHX-2022-20. 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-NYSECHX-2022-20 and should be submitted
on or before October 4, 2022.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\15\
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    \15\ 17 CFR 200.30-3(a)(12).
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J. Matthew DeLesDernier,
Deputy Secretary.
[FR Doc. 2022-19686 Filed 9-12-22; 8:45 am]
BILLING CODE 8011-01-P