[Federal Register: May 27, 2009 (Volume 74, Number 100)]
[Proposed Rules]
[Page 25200-25205]
[DOCID:fr27my09-14]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 260 and 261

[EPA-HQ-RCRA-2009-0315; FRL-8905-6]
RIN 2050-AG31

Definition of Solid Waste Public Meeting

AGENCY: Environmental Protection Agency.

ACTION: Definition of Solid Waste Notice of Public Meeting and Request
for Comments.

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SUMMARY: The Environmental Protection Agency (EPA) is announcing a
public meeting regarding the Agency's recent regulation on the
definition of solid waste under Subtitle C of the Resource Conservation
and Recovery Act (RCRA). Specifically, EPA is currently reviewing a
petition filed with the Administrator under RCRA section 7004(a)
requesting that the Agency reconsider and repeal the recently
promulgated revisions to the definition of solid waste for hazardous
secondary materials being reclaimed, and is soliciting comments and
information to assist the agency in evaluating the petition. EPA does
not plan to repeal the rule, but is interested in receiving comments on
possible revisions to the rule. Persons may register to speak at the
public meeting or may submit written comments to the address below.

DATES: The public meeting will be held on June 30, 2009, from 9 a.m. to
4:30 p.m. The closing date for advance registration is June 23, 2009.
Persons may also submit written or electronic comments by July 14, 2009
(see ADDRESSES). The administrative record

of the meeting will remain open for submissions until July 14, 2009.

ADDRESSES: Public meeting. The public meeting will be held at One
Potomac Yard, 2777 S. Crystal Drive, Arlington, VA 22202. Advance
registration for the meeting is available at http://www.epa.gov/
epawaste/hazard/dsw/publicmeeting.htm. For further information on
registering for the meeting, see section IV below. Written comments.
Submit your written comments, identified by Docket ID No. EPA-HQ-RCRA-
2009-0315 by one of the following methods:
     http://www.regulations.gov: Follow the online instructions
for submitting comments.
     E-mail: Comments may be sent by electronic mail (e-mail)
to<EMAIL_ADDRESS>Attention Docket ID No. EPA-HQ-RCRA-2009-0315.
     Fax: Fax comments to:<PHONE_NUMBER>, Attention Docket ID
No. EPA-HQ-RCRA-2009-0315.
     Mail: Send comments to: OSWER Docket, EPA Docket Center,
Mail Code 2822T, Environmental Protection Agency, 1200 Pennsylvania
Avenue, NW., Washington, DC 20460, Attention Docket ID No. EPA-HQ-RCRA-
2009-0315.
    Instructions: 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 docket are listed in the http://
www.regulations.gov index. Although listed in the index, some
information is not publicly available, such as CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in http://www.regulations.gov or in hard copy at the OSWER 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
OSWER Docket is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: For more detailed information on the
definition of solid waste regulations, contact Tracy Atagi, Office of
Resource Conservation and Recovery, Materials Recovery and Waste
Management Division, MC 5304P, Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460, at<PHONE_NUMBER>
(atagi.tracy@epa.gov). For information on specific aspects of the
public meeting, contact Amanda Geldard, Office of Resource Conservation
and Recovery, Materials Recovery and Waste Management Division, MC
5304P, Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460, at<PHONE_NUMBER>, (geldard.amanda@epa.gov).

SUPPLEMENTARY INFORMATION: Submitting CBI. Do not submit this
information to EPA through http://www.regulations.gov or e-mail.
Clearly mark part of all information that you claim to be CBI. For CBI
information in a disk or CD ROM that you mail to EPA, mark the outside
of the disk or CD ROM as CBI and then identify electronically within
the disk or CD ROM the specific information that is claimed as CBI. In
addition to one complete version of the comment that includes
information claimed as CBI, a copy of the comment that does not contain
the information claimed as CBI must be submitted for inclusion in the
public docket. Information so marked will not be disclosed, except in
accordance with procedures set forth in 40 CFR Part 2.

Outline

I. Background
    A. Definition of Solid Waste Final Rule
    B. Section 7004 Petition Submitted by Sierra Club
    C. Industry Coalition Response to Petition
II. Purpose and Scope of the Public Meeting
III. Issues for Discussion
    A. Definition of ``Contained''
    B. Notification
    C. Definition of Legitimacy
    D. Transfer-Based Exclusion
IV. How To Participate in the Public Meeting
V. Implementation and State Adoption

I. Background

A. Definition of Solid Waste Final Rule

    On October 30, 2008, EPA promulgated a final rule under the
Resource Conservation and Recovery Act (RCRA), 42 U.S.C. 6901, et seq.,
regarding regulation of hazardous secondary materials when they are
recycled via reclamation (73 FR 64668). The rule excludes from the RCRA
definition of solid waste for materials that are:
     Generated and legitimately reclaimed under the control of
the generator (``generator-controlled exclusion'');
     Generated and transferred to another company for
legitimate reclamation under specific conditions (``transfer-based
exclusion''); or
     Determined by EPA or an authorized State to be non-wastes
on a case-by-case basis via a petition process.
    The rule also contains a provision to determine whether recycling
activities are legitimate under the new exclusions and non-waste
determinations. In order to be excluded under the revised definition of
solid waste, hazardous secondary materials must be legitimately
reclaimed and must meet the conditions of the exclusions.

B. Section 7004 Petition Submitted by Sierra Club

    On January 29, 2009, the Sierra Club submitted a petition under
RCRA section 7004(a), 42 U.S.C. 6974(a),\1\ to the Administrator of EPA
requesting that the Agency repeal the October 2008 revisions to the
definition of solid waste (DSW) rule and stay the implementation of the
rule. A copy of the petition is in the docket to this notice. The
petition argues that the revised regulations are unlawful and that they
increase threats to public health and the environment without producing
compensatory

benefits, and therefore, should be repealed. Among other things, the
petition singles out the lack of a regulatory definition of
``contained'' and ``significant release'' and disagrees with the
Agency's findings that the rule would have no adverse environmental
impacts, including no adverse impact to environmental justice
communities or to children's health.
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    \1\ See Petition for Reconsideration of ``Revisions to the
Definition of Solid Waste,'' 73 FR 64668 (Oct. 30, 2008) and Request
for Stay, from Lisa Gollin Evans and Deborah Goldberg, Earthjustice,
Attorneys for Sierra Club, to Lisa Jackson, Administrator, U.S.
Environmental Protection Agency, January 29, 2009.
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C. Industry Coalition Response to Petition

    On March 6, 2009, a coalition of industry associations (``industry
coalition'') \2\ submitted a letter to the Administrator of EPA in
response to the Sierra Club petition.\3\ This letter requests that EPA
deny Sierra Club's petition on the grounds that the DSW final rule
comports with court cases construing the scope of EPA's jurisdiction to
regulate solid waste under RCRA, and that the DSW final rule achieves
significant economic and conservation benefits, while imposing
significant controls on the hazardous secondary material recycling
industry that are fully protective of the environment. A copy of this
letter is in the docket to this notice. The letter also responds to
each of the specific points raised by the Sierra Club in its petition.
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    \2\ The industry coalition includes the Metals Industries
Recycling Coalition (which includes the American Iron & Steel
Institute, the Copper and Brass Fabricator's Council, the Copper
Development Association Inc., the International Metals Reclamation
Company, Inc., the Specialty Steel Industry of North America, and
the Steel Manufacturers Association), the American Chemistry
Council, the Alliance of Automobile Manufacturers, the American Coke
& Coal Chemicals Institute, the National Paint and Coatings
Association, the Treated Wood Council, the American Forest and Paper
Association, and the Synthetic Organic Chemical Manufacturers
Association.
    \3\ See Response to Sierra Club's petition for Reconsideration
of ``Revisions to the Definition of Solid Waste,'' 73 FR 64668 (Oct.
30, 2008,) and Request for Stay, from John L. Wittenborn, Counsel to
Industry-Respondents, to Lisa Jackson, Administrator, U.S.
Environmental Protection Agency, March 6, 2009.
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II. Purpose and Scope of the Public Meeting

    After meeting with representatives from both the Sierra Club and
the industry coalition,\4\ EPA has decided that it would be advisable
to hear from a broader range of stakeholders before making a decision
on how to best respond to Sierra Club's petition. The Agency has
determined that a public meeting, with opportunities to provide
comments both verbally and in writing, is an efficient and transparent
method for obtaining public input. EPA also notes that a number of
other letters were submitted to EPA by various members of the public
after the Agency held the meetings with Sierra Club and the industry
coalition. These letters are also in the docket to this notice.
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    \4\ See Memorandum to File from Alan Carpien, Attorney, EPA,
Office of General Counsel, April 28, 2009.
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    The scope of possible changes to the definition of solid waste is
governed by the concept of ``discard.'' As discussed in the preamble to
the DSW final rule, EPA used the concept of discard as the central
organizing idea behind the October 2008 revisions to the definition of
solid waste. As stated in RCRA section 1004(27), ``solid waste'' is
defined as ``* * * any garbage, refuse, sludge from a waste treatment
plant, water supply treatment plant, or air pollution control facility
and other discarded material * * * resulting from industrial,
commercial, mining and agricultural activities.'' (emphasis added)
Therefore, in the context of the DSW final rule, a key issue relates to
the circumstances under which a hazardous secondary material that is
recycled by reclamation is or is not discarded (73 FR 64675). In
exercising its discretion in the DSW final rule to define what
constitutes ``discard'' for hazardous secondary materials reclamation,
EPA included an explanation of how each provision of the final rule
relates to discard (73 FR 64676-64679).
    For example, in the DSW final rule, EPA determined that if the
generator maintains control over the recycled hazardous secondary
material and if the material is legitimately recycled under the
standards established in the final rule and not speculatively
accumulated within the meaning of EPA's regulations, then the hazardous
secondary material is not discarded. This is because the hazardous
secondary material is being treated as a valuable commodity rather than
as a waste. By maintaining control over, and potential liability for,
the reclamation process, the generator ensures that the hazardous
secondary materials are not discarded. See 73 FR 64676.
    Because the final revisions to the definition of solid waste are
closely tied to EPA's interpretation of the concept of ``discard,'' EPA
does not plan to repeal the rule in whole or stay its implementation.
Such an action could result in hazardous secondary materials that are
not discarded being regulated as hazardous waste. In particular, EPA
does not expect to repeal either the exclusion for hazardous secondary
materials reclaimed under the control of the generator or the non-waste
determination petition process.
    However, EPA believes that there may be opportunities to revise or
clarify the definition of solid waste rule, particularly with respect
to the definition of legitimacy and the transfer-based exclusion, in
ways that could improve implementation and enforcement of the
provisions, thus increasing environmental protection, while still
appropriately defining when a hazardous secondary material being
reclaimed is a solid waste and subject to hazardous waste regulation.
    In section III of this notice, EPA lists several possible issues
for discussion. These issues represent areas in which EPA is
particularly interested in obtaining public feedback on possible
changes to the definition of solid waste revisions. In addition to
these issues, commenters may file comments on any other changes to the
rule that they deem appropriate.
    Section IV of this notice explains how to participate in the
upcoming public meeting, while section V explains State adoption and
how the final rule is currently implemented.

III. Issues for Discussion

A. Definition of ``Contained''

    For both the generator-controlled and the transfer-based
exclusions, EPA requires that the hazardous secondary material be
``contained.'' EPA stated in the final rule preamble that whether
hazardous secondary materials are contained would be decided on a case-
by-case basis, and that such materials are generally contained if they
are placed in a unit that controls the movement of the hazardous
secondary materials out of the unit. EPA also stated that hazardous
secondary materials released to the environment and not immediately
recovered are solid wastes; in addition, hazardous secondary materials
remaining in the unit may also be a solid waste if they are not managed
as a valuable raw material, intermediate, or product, and, as a result,
a ``significant'' release of hazardous secondary materials from the
unit to the environment were to take place and the materials were not
immediately recovered. A release may be ``significant'' even if it is
not a large volume, if such a release has the potential of causing
significant damage over time (73 FR 64681).
    EPA did not include a regulatory definition of ``contained,'' nor
did we include specific performance or storage standards. EPA did not
believe such an approach was necessary for determining whether
hazardous secondary materials were discarded when sent for reclamation
and believed that the approach in the DSW final rule, covered the
breadth of activities that might take

place under the exclusion (73 FR 64729).
    However, by using a general performance standard (``contained'') in
the regulations to determine whether a material is ``contained,'' the
DSW final rule does not include specific requirements. Some commenters
asked that more specific requirements be included in the rule. The
Agency is considering developing a definition of ``contained'' in the
regulations; such a definition would need to apply to a range of
hazardous secondary materials and reclamation processes and still
remain within the scope of determining whether a hazardous secondary
material is ``discarded.'' EPA could also address this issue by setting
specific performance or storage standards as a condition of the
transfer-based exclusion. Finally, EPA could address this concern by
developing more detailed guidance on what might constitute
``contained,'' for different types of units or management practices.

B. Notification

    The DSW final rule required persons claiming one of the exclusions
to notify the appropriate regulatory agency before operating under the
exclusion. EPA explained that the notification requirement under the
authority of RCRA section 3007 would not be a condition of the
exclusion, and failure to notify, while constituting a violation of the
notification regulations, would not affect the excluded status of the
hazardous secondary materials. In other words, generators or reclaimers
could fail to notify yet still be considered to be legitimately
recycling their hazardous secondary materials according to the
conditions of the exclusion (73 FR 64682).
    EPA took this approach because it believed that the fact of
notification was separable from the question of whether a material has
been in fact ``discarded.'' At the same time, however, for both the
generator-controlled and the transfer-based exclusions, the
notification requirement is a key indication of a facility's intent to
reclaim a hazardous secondary material and not discard it. Thus, for
example, if during an inspection of a large quantity generator of
hazardous waste, EPA were to discover a hazardous secondary material
that had been stored onsite for more than 90 days without a RCRA permit
(an act that would typically be a violation of the hazardous waste
regulations), a previously filed notification would be an indication
that the facility was planning to reclaim the hazardous secondary
material under the conditions of the exclusion. Absent such a
notification, it might be difficult for EPA to determine the facility's
true intentions for the hazardous secondary material without arranging
for follow-up inspections or gathering additional information. If EPA
were to restructure the DSW final rule exclusions so that the
notification was a condition of the exclusions rather than a 3007
requirement as suggested by commenters, the notification would serve as
the first step in the facility's demonstrating that the hazardous
secondary material is not being discarded. Such a system might provide
a stronger incentive for facilities to notify and make it difficult for
a facility to claim, after the fact, that it intended to reclaim a
material, when it had no real intention of doing so.

C. Definition of Legitimacy

1. Applicability of Codified Definition
    In the October 2008 DSW final rule, EPA codified the definition of
``legitimacy'' as a requirement for both the generator-controlled and
transfer-based exclusions in the final rule and for the non-waste
determinations, but not for other hazardous secondary material
recycling. The purpose of defining legitimacy was to distinguish
``legitimate'' recycling from ``sham'' recycling (i.e., waste treatment
and/or disposal conducted in the guise of recycling). To avoid
confusion among the regulated community and the States, as well as the
other implementing regulatory agencies about the status of recycling
exclusions that were in existence prior to the October 2008 DSW final
rule, EPA codified the legitimacy factors as specifically applicable to
the new exclusions and non-waste determination procedures in that final
rule. However, the final rule also explained how the four legitimacy
factors codified in the final rule are substantively the same as the
existing legitimacy policy (73 FR 64707-64708).
    While this approach was intended to make it clear that legitimacy
determinations made for the existing exclusions are not affected by the
codified language, ultimately there may be greater clarity if there is
a single legitimacy standard for all recycling. Applying the regulatory
legitimacy factors to all recycling also might ensure that the factors
are better known and understood by the regulated community and easier
for the States and EPA to monitor and enforce.
2. Legitimacy Factors ``To Be Considered''
    In the October 2008 codified definition of legitimacy, EPA included
four factors, all of which must be considered. Two of these factors
must always be met,\5\ while two factors may in some cases not need to
be met, depending on such considerations as the protectiveness of the
storage methods, exposure from toxics in the product, the
bioavailability of the toxics in the product, and other relevant
considerations. The Agency took this approach because there were some
situations in which a legitimate recycling process did not conform to
one or both of these two factors, yet the reclamation activity, in the
Agency's judgment, was still legitimate. The two factors to consider
are: (1) Whether the hazardous secondary material is managed as a
valuable commodity, and (2) whether the product of the recycling
process contains hazardous constituents that are significantly elevated
in comparison to analogous products (i.e., ``toxics along for the
ride'') (73 FR 64701-64705).
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    \5\ The two factors which must always be met are (1) whether the
hazardous secondary material provides a useful contribution to the
recycling process or product, and (2) whether the product or
intermediate of the recycling process has value.
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    EPA believes that most situations where one or both of these two
factors are not met would be sham recycling. However, EPA expressed in
the final rule that legitimate recycling may sometimes occur in these
situations, and provided examples of where this might occur.
Consequently, EPA built into the definition of legitimacy the provision
that, after considering the factors, the regulated entity making the
legitimacy determination can decide, based on considerations such as
the protectiveness of the storage methods, exposure from toxics in the
product, and the bioavailability of the toxics in the product, that the
recycling is still legitimate (73 FR 64743-64744).
    Some commenter's have asserted that not having all legitimacy
factors be mandatory could mean that materials going for reclamation
might be significantly mismanaged, or could lead to recycled products
that present significant risks, compared to comparable virgin material
products. This certainly was not EPA's intent in the final rule; in
such a case EPA expects that regulatory agency would determine that
such activity is not legitimate recycling. However, we are looking for
comments on a different implementation approach that might require that
all four legitimacy factors must be met, unless the implementing agency
makes a determination (for example, through a petition process) that
the recycling is still legitimate

despite the fact that one or more of the latter two factors is not met.

D. Transfer-Based Exclusion

    As EPA explained in the October 2008 DSW final rule, businesses
often ship hazardous secondary materials to be reclaimed by a third
party or commercial facility or another manufacturer. In such
situations, EPA determined that the generator has relinquished control
of the hazardous secondary materials and the entity receiving such
materials may not have the same incentives to manage them as a useful
product. This conclusion is supported by the results of both the damage
case study and the market forces study that were performed in support
of the final rulemaking (73 FR 64677-64678).
    As a result of this conclusion, EPA developed specific conditions
for the transfer-based exclusion in order for the Agency to determine
which hazardous secondary materials transferred to another entity are
not discarded. In the preamble to the final rule, EPA explained how
each of these conditions specifically related to the concept of
discard, as evidenced by the rulemaking record (73 FR 64678-64679).
    EPA has identified a number of alternative approaches to the
transfer-based exclusion that may be used to identify when hazardous
secondary materials sent to another entity for reclamation are not
discarded, and to appropriately regulate materials subject to RCRA
regulation. These alternative approaches could include the following:
     EPA could repeal the transfer-based exclusion, and thus
return to regulating most hazardous secondary materials transferred to
third parties as discarded materials under traditional RCRA program
requirements, while keeping the generator-controlled exclusion and the
non-waste determination petition process as the basis for excluding
materials which are not discarded;
     EPA could revisit the approach taken in the 2003 DSW
proposal and limit the transfer-based exclusion to materials reclaimed
in a ``continuous industrial process within the generating industry.''
The 2003 DSW proposal used NAICS codes to define ``within the
generating industry.'' However, this approach was criticized by many
commenters following its proposal. Thus, commenters supporting this
option should address the practical problems involved in using this
approach or suggest another approach;
     EPA could limit the transfer-based exclusion to activities
where the generator is paid for the hazardous secondary material.
However, EPA in the past has rejected this approach on the grounds that
costs are subject to market uncertainty and manipulation, making this
option difficult to establish and enforce. See 50 FR 614, 617 (January
4, 1985), 48 FR 14481, 14478-14481 (April 4, 1983). Thus, commenters
supporting this option should address whether it could be practicably
implemented and enforced.

In addition, any of the above three options could be combined with
developing new more tailored exclusions focusing specifically on
reclamation of certain hazardous secondary materials or reclamation
performed in specific industries.
    Alternatively, EPA could consider focused changes to the transfer-
based exclusion. For example, EPA could revisit whether to allow
intermediate facilities storing hazardous secondary materials to be
eligible for the transfer-based exclusion. The purpose of including
such facilities was to provide an opportunity for generators of smaller
quantities of hazardous secondary materials to send these materials for
reclamation, but it also added another possible step or steps through
which the regulatory agencies must monitor materials to ensure that
they are being legitimately reclaimed and not discarded. EPA could also
explore requiring the equivalent of a ``closure plan'' for reclamation
and intermediate facilities (if the Agency decides to continue to allow
intermediate facilities to be eligible for the transfer-based
exclusion) operating under the exclusion. Such a plan would allow the
implementing agency additional upfront oversight to determine that the
facility has made provisions to ensure that its hazardous secondary
materials will not be abandoned (and therefore discarded). The plan
would also provide a further basis for the reclaimers to estimate how
much closure would cost, and therefore how much financial assurance is
needed. In addition, allowing a public notice and comment step could
help address concerns regarding the lack of participation by the
potentially affected community in making these determinations,
particularly if there are environmental justice concerns.
    EPA is interested in comments and information on these issues or
other areas that the public believes will assist the agency in
evaluating the petition. The public may register to speak at the public
meeting or may submit written comments as explained below.

IV. How To Participate in the Public Meeting

    Persons who wish to participate in the public meeting (either by
making a presentation or as a member of the audience) must register for
the meeting (see ADDRESSES section). Persons requiring special
accommodations due to a disability should inform the contact person of
their request (see FOR FURTHER INFORMATION CONTACT). Persons may also
submit written comments for the record. (see ADDRESSES section).
    Persons who register in advance of the meeting should check in at
the onsite registration desk between 8 a.m. and 9 a.m. We will also
accept registrations onsite on a first-come, first-served basis;
however, space will be limited and registration will be closed when the
maximum seating capacity is reached. Persons who wish to register
onsite on the day of the meeting may do so at the registration desk
between 8 a.m. and 9 a.m.
    We encourage all participants to attend the entire meeting. Because
the meeting will be held in a Federal building, meeting participants
must present photo identification and plan adequate time to pass
through the security system.
    Depending on the number of requests received, we may be obliged to
limit the time allotted for each presentation (e.g., 5 minutes each).
If time permits, we may allow interested persons who attend the
meeting, but did not register in advance to make an oral presentation
at the conclusion of the meeting. The schedule of speakers will be
available at the meeting. After the meeting, the schedule and a list of
participants will be placed on file in the docket (see ADDRESSES
section) under the docket number listed in brackets in the heading of
this document. We will post all submissions and received comments
without change, unless the submissions or comments contain CBI or other
information whose disclosure is restricted by statute to http://
www.regulations.gov, including any personal information provided.
    EPA will carefully consider all information, both verbal and
written, provided by stakeholders regarding the definition of solid
waste as the Agency decides how to respond to the Sierra Club petition.
Following review of all comments, EPA will decide how to respond to the
petition, which may include proposing to make changes to the DSW rule
through a notice of proposed rulemaking.

V. Implementation and State Adoption

    The DSW final rule promulgated on October 30, 2008, became
effective on December 29, 2008 (73 FR 64668) and remains in effect
unless EPA goes through another rulemaking process (proposed and final)
to repeal or amend

it. However, because the October 30, 2008 DSW revisions are less
stringent than the hazardous waste regulations that applied to the
affected hazardous secondary materials before the DSW rule went into
effect, States that have been authorized to administer the RCRA
Subtitle C hazardous waste program are not required to adopt these
revisions. For States who do not adopt these revisions, the State
hazardous waste regulations, as authorized by EPA, will remain the
standards that apply to hazardous wastes sent to reclamation in that
State.
    Because the DSW final rule is in effect, States may decide to adopt
these provisions (or to adopt a subset of these provisions, such as the
generator-controlled exclusion) at any time. States may also decide not
to adopt the DSW rule until such time as EPA completes the current
process of reviewing the Sierra Club petition. If EPA subsequently
decides to revise the rule, such that the revisions are more stringent
than the October 30, 2008, rule, then those States who adopted the
current version of the DSW rule would need to modify their program to
adopt the more stringent provisions (because State RCRA regulations can
be no less stringent than the Federal regulations).

    Dated: May 11, 2009.
Matt Hale,
Director, Office of Resource Conservation and Recovery.
[FR Doc. E9-12283 Filed 5-26-09; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 87, Number 170 (Friday, September 2, 2022)]
[Notices]
[Page 54232]
[FR Doc No: 2022-19033]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4663-DR; Docket ID FEMA-2022-0001]

Kentucky; Amendment No. 7 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the Commonwealth of Kentucky (FEMA-4663-DR), dated July 29, 2022,
and related determinations.

DATES: This amendment was issued August 12, 2022.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the Commonwealth of Kentucky is hereby amended to include Public
Assistance for the following areas among those areas determined to have
been adversely affected by the event declared a major disaster by the
President in his declaration of July 29, 2022.

    Breathitt, Leslie, Letcher, and Magoffin Counties for debris
removal [Category A] and permanent work [Categories C-G] (already
designated for Individual Assistance and emergency protective
measures [Category B], including direct federal assistance, under
the Public Assistance program).
    Johnson and Wolfe Counties for debris removal [Category A] and
permanent work [Categories C-G] (already designated emergency
protective measures [Category B], including direct federal
assistance, under the Public Assistance program).
    Whitley County for Public Assistance (already designated for
Individual Assistance).
    Cumberland County for Public Assistance.

    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households In Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050 Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

Deanne Criswell,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2022-19033 Filed 9-1-22; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 80, Number 41 (Tuesday, March 3, 2015)]
[Notices]
[Pages 11455-11456]
[FR Doc No: 2015-04376]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0001]

Pediatric Neurocognitive Workshop; Advancing the Development of
Pediatric Therapeutics Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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SUMMARY: The Food and Drug Administration's (FDA) Division of
Gastroenterology and Inborn Errors Products Division and Division of
Pediatric and Maternal Health in the Center for Drug Evaluation and
Research, and the Office of Pediatric Therapeutics in the Office of the
Commissioner are announcing a 2-day public workshop. Day 1 of the
workshop is entitled ``Assessment of Neurocognitive Outcomes in the
Inborn Errors of Metabolism''. Day 2 of the workshop is entitled,
``Advancing the Development of Pediatric Therapeutics: Assessment of
Pediatric Neurocognitive Outcomes''. The purpose of this 2-day workshop
is to provide a forum to consider issues related to advancing pediatric
regulatory science in the evaluation of neurocognitive outcomes in
pediatric patients.

DATES: The public workshop will be held on April 16 and 17, 2015, from
8 a.m. to 5 p.m.

ADDRESSES: The public workshop will be held in the FDA White Oak
Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great
Room (Rm. 1503A), Silver Spring, MD 20993-0002. Entrance for the public
workshop participants (non-FDA employees) is through Building 1 where
routine security check procedures will be performed. For parking and
security information, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.

FOR FURTHER INFORMATION CONTACT: For questions regarding Day 1 of the
workshop, contact Richard (Wes) Ishihara, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
<EMAIL_ADDRESS>    For questions regarding Day 2 of the workshop, contact Denise Pica-
Branco, Center for Drug Evaluation and Research, Food and Drug

Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-
0002,Telephone:<PHONE_NUMBER>, FAX:<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The first day of the workshop will focus on
approaches for assessing the efficacy of therapeutic products on
neurocognitive outcomes in patients diagnosed with inborn errors of
metabolism disorders. The session will address the role of natural
history studies and methodological approaches for selecting appropriate
assessment scales and standardizing neurocognitive assessments. The
second day of the workshop will discuss identification of signals in
animal studies and clinical trials that warrant further clinical
investigation and testing that may be predictive of neurocognitive
outcome in children. Additionally, strategies and methods to address
the challenges of assessing long-term neurocognitive outcomes for
products used to treat pediatric patients will be discussed.

Participation in the Public Workshop

    Registration: There is no fee to attend the public workshop, but
attendees should register in advance. Space is limited, and
registration will be on a first-come, first-served basis. Persons
interested in attending this workshop must register online at
<EMAIL_ADDRESS>before March 31, 2015. For those
without Internet access, please contact Denise Pica-Branco (see FOR
FURTHER INFORMATION CONTACT) to register. Onsite registration will not
be available.
    If you need special accommodations due to a disability, please
contact Denise Pica-Branco (see FOR FURTHER INFORMATION CONTACT) at
least 7 days in advance.
    Transcripts: Transcripts of the workshop will be available for
review at the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and
at http://www.regulations.gov approximately 30 days after the workshop.
A transcript will also be available in either hard copy or on CD-ROM,
after submission of a Freedom of Information request. Send written
requests to the Division of Freedom of Information (ELEM-1029), Food
and Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville,
MD 20857. Send faxed requests to<PHONE_NUMBER>.

    Dated: February 24, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-04376 Filed 3-2-15; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 82, Number 189 (Monday, October 2, 2017)]
[Notices]
[Pages 45899-45900]
[FR Doc No: 2017-20982]

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2013-0030]

International Association of Plumbing and Mechanical Officials
EGS: Grant of Expansion of Recognition

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

ACTION: Notice.

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SUMMARY: In this notice, OSHA announces its final decision to expand
the scope of recognition for International Association of Plumbing and
Mechanical Officials EGS as a Nationally Recognized Testing Laboratory
(NRTL).

DATES: The expansion of the scope of recognition takes place on October
2, 2017.

FOR FURTHER INFORMATION CONTACT: Information regarding this notice is
available from the following sources:
    Press inquiries: Contact Mr. Frank Meilinger, Director, OSHA Office
of Communications, U.S. Department of Labor, telephone:<PHONE_NUMBER>;
email<EMAIL_ADDRESS>    General and technical information: Contact Mr. Kevin Robinson,
Director, Office of Technical Programs and Coordination Activities,
Directorate of Technical Support and Emergency Management, Occupational
Safety and Health Administration, U.S. Department of Labor, telephone:
(202) 693-2110; email<EMAIL_ADDRESS>OSHA's Web page includes
information about the NRTL Program (see http://www.osha.gov/dts/otpca/nrtl/index.html).

SUPPLEMENTARY INFORMATION:

I. Notice of Final Decision

    OSHA hereby gives notice of the expansion of the scope of
recognition of International Association of Plumbing and Mechanical
Officials EGS (IAPMO) as a NRTL. IAPMO's expansion covers the addition
of four test standards to its scope of recognition.
    OSHA recognition of a NRTL signifies that the organization meets
the requirements specified by 29 CFR 1910.7. Recognition is an
acknowledgment that the organization can perform independent safety
testing and certification of the specific products covered within its
scope of recognition, and is not a delegation or grant of government
authority. As a result of recognition, employers may use products
properly approved by the NRTL to meet OSHA standards that require
testing and certification of the products.
    The Agency processes applications by a NRTL for initial
recognition, or for expansion or renewal of this recognition, following
requirements in Appendix A to 29 CFR 1910.7. This appendix requires
that the Agency publish two notices in the Federal Register in
processing an application. In the first notice, OSHA announces the
application and provides its preliminary finding and, in the second
notice, the Agency provides its final decision on the application.
These notices set forth the NRTL's scope of recognition or
modifications of that scope. OSHA maintains an informational Web page
for each NRTL that details its scope of recognition. These pages are
available from the Agency's Web site at: http://www.osha.gov/dts/otpca/nrtl/index.html.
    IAPMO submitted an application, dated January 12, 2016, (OSHA-2013-
0030-0006) to expand its recognition to include eight additional test
standards. OSHA staff performed a comparability analysis and reviewed
other pertinent information. OSHA staff performed an on-site review of
IAPMO's testing facility on March 1-2, 2016, in relation to this
application, in which assessors found some nonconformances with the
requirements of 29 CFR 1910.7. IAPMO addressed these issues
sufficiently, and

OSHA staff determined that OSHA should grant the application to expand
IAPMO's NRTL recognition to include four of the eight requested
standards.
    OSHA published the preliminary notice announcing IAPMO's expansion
application in the Federal Register on March 15, 2017 (82 FR 13868).
The Agency requested comments by March 30, 2017, and received three
comments in response to this notice. One comment supported IAPMO's
expansion application (OSHA-2013-0030-0010), while the other two (OSHA-
2013-0030-0008 and OSHA-2013-0030-0009) were not specifically related
to it, but rather questioned the funding and oversight of the NRTL
Program more generally. Because the comments were anonymous, the Agency
could not respond directly to the commenters. However, the Agency
reiterates that its NRTL procedures are governed by 29 CFR 1910.7 and
notes that these procedures serve simply to protect workers under the
OSH Act by allowing NRTLs to certify that a particular product complies
with the requirements of one or more appropriate product safety test
standards. OSHA now is proceeding with this final notice to grant
expansion of IAPMO's scope of recognition.
    To obtain or review copies of all public documents pertaining to
IAPMO's application, go to: http://www.regulations.gov or contact the
Docket Office, Occupational Safety and Health Administration, U.S.
Department of Labor, 200 Constitution Avenue NW., Room N-3653,
Washington, DC 20210. Docket No. OSHA-2013-0030 contains all materials
in the record concerning IAPMO's recognition.

II. Final Decision and Order

    OSHA staff examined IAPMO's expansion application, its capability
to meet the requirements of the test standards, and other pertinent
information. Based on its review of this evidence, OSHA finds that
IAPMO meets the requirements of 29 CFR 1910.7 for expansion of its
recognition, subject to the limitation and conditions listed below.
OSHA, therefore, is proceeding with this final notice to grant IAPMO's
scope of recognition. OSHA limits the expansion of IAPMO's recognition
to testing and certification of products for demonstration of
conformance to the test standards listed in Table 1 below.

  Table 1--List of Appropriate Test Standards for Inclusion in IAPMO's
                        NRTL Scope of Recognition
------------------------------------------------------------------------
            Test standard                     Test standard title
------------------------------------------------------------------------
UL 875...............................  Standard for Electric Dry-Bath
                                        Heaters.
UL 979...............................  Standard for Water Treatment
                                        Appliances.
UL 1241..............................  Standard for Junction Boxes for
                                        Swimming Pool Luminaires.
UL 1261..............................  Standard for Electric Water
                                        Heaters for Pools and Tubs.
------------------------------------------------------------------------

    OSHA's recognition of any NRTL for a particular test standard is
limited to equipment or materials for which OSHA standards require
third-party testing and certification before using them in the
workplace. Consequently, if a test standard also covers any products
for which OSHA does not require such testing and certification, a
NRTL's scope of recognition does not include these products.
    The American National Standards Institute (ANSI) may approve the
test standards listed above as American National Standards. However,
for convenience, OSHA may use the designation of the standards-
developing organization for the standard as opposed to the ANSI
designation. Under the NRTL Program's policy (see OSHA Instruction CPL
1-0.3, Appendix C, paragraph XIV), any NRTL recognized for a particular
test standard may use either the proprietary version of the test
standard or the ANSI version of that standard. Contact ANSI to
determine whether a test standard is currently ANSI-approved.

A. Conditions

    In addition to those conditions already required by 29 CFR 1910.7,
IAPMO must abide by the following conditions of the recognition:
    1. IAPMO must inform OSHA as soon as possible, in writing, of any
change of ownership, facilities, or key personnel, and of any major
change in its operations as a NRTL, and provide details of the
change(s);
    2. IAPMO must meet all the terms of its recognition and comply with
all OSHA policies pertaining to this recognition; and
    3. IAPMO must continue to meet the requirements for recognition,
including all previously published conditions on IAPMO's scope of
recognition, in all areas for which it has recognition.
    Pursuant to the authority in 29 CFR 1910.7, OSHA hereby expands the
scope of recognition of IAPMO, subject to the limitation and conditions
specified above.

III. Authority and Signature

    Loren Sweatt, Deputy Assistant Secretary of Labor for Occupational
Safety and Health, authorized the preparation of this notice.
Accordingly, the Agency is issuing this notice pursuant to 29 U.S.C.
657(g)(2), Secretary of Labor's Order No. 1-2012 (77 FR 3912, Jan. 25,
2012), and 29 CFR 1910.7.

    Signed at Washington, DC, on September 25, 2017.
Loren Sweatt,
Deputy Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. 2017-20982 Filed 9-29-17; 8:45 am]
 BILLING CODE 4510-26-P


[Federal Register Volume 83, Number 247 (Thursday, December 27, 2018)]
[Rules and Regulations]
[Pages 66625-66627]
[FR Doc No: 2018-28131]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2018-0168]
RIN 1625-AA00

Safety Zone; Ohio River, Louisville, KY

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing an emergency temporary safety
zone for all navigable waters of the Ohio River extending from mile
marker (MM) 530.6 to MM 533.0. This emergency safety zone is needed to
protect life, vessels, and the marine environment due to the increase
in river level, extreme currents and excessive drift causing vessels to
allide with Markland Lock and Dam. Entry of vessels or persons into
this zone is prohibited unless specifically authorized by the Captain
of the Port Sector Ohio Valley (COTP) or a designated representative.

DATES: This rule is effective without actual notice from December 27,
2018 through January 20, 2019. For the purposes of enforcement, actual
notice will be used from December 20, 2018 until December 27, 2018.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to http://www.regulations.gov, type USCG-
2018-0168 in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rule.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Petty Officer Riley Jackson, Sector Ohio Valley, U.S.
Coast Guard; telephone<PHONE_NUMBER>, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
COTP Captain of the Port Sector Ohio Valley
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of Proposed Rulemaking
Sec.  Section
U.S.C. United States Code

II. Background Information and Regulatory History

    The Coast Guard is issuing this temporary rule without prior notice
and opportunity to comment pursuant to authority under section 4(a) of
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a Notice of Proposed Rulemaking (NPRM)
with respect to this rule because it is impracticable and contrary to
the public interest. In the past 36 hours, increase in the river level,
extreme currents and excessive drift were noted as causal factors for
two allisions with the long wall to the Markland Lock approach. The
safety zone must be established immediately to protect people and
vessels transiting the Ohio River, and we lack sufficient time to
provide a reasonable comment period and then consider those comments
before issuing the rule.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. Delaying the effective date of
this rule would be contrary to public interest because immediate action
is needed to protect personnel, vessels, and the marine environment
from potential hazards due to the increase in the river level, and
extreme currents and drift conditions.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 33 U.S.C.
1231. The Captain of the Port Sector Ohio Valley (COTP) has determined
that potential hazards associated with the river current at Markland
Lock and Dam will be a safety concern for anyone on within the 3.6-mile
span of the Ohio River. This rule is necessary to protect persons,
vessels, and the marine environment in the navigable waters within the
safety zone.

IV. Discussion of the Rule

    The Coast Guard is establishing a temporary emergency safety zone
for all navigable waters on the Ohio River from Mile Marker (MM) 530.6
and MM 533.0, extending the entire width of the Ohio River. Transit
into and through this area is prohibited for all traffic beginning
December 20, 2018 and will continue through January 20, 2019 or until
the hazard has been decreased, whichever occurs first. The COTP or a
designated representative will terminate the enforcement of this safety
zone before January 20, 2019 if the river conditions decrease. Entry
into this safety zone is prohibited unless specifically authorized by
the COTP or his designated representative. A designated representative
is a commissioned, warrant, or petty officer of the U.S. Coast Guard
assigned to units under the operational control of USCG Sector Ohio
Valley.
    Requests for entry will be considered and reviewed on a case-by-
case basis. The COTP may be contacted by telephone at<PHONE_NUMBER> or
can be reached by VHF-FM channel 16. Persons and vessels permitted to
enter this safety zone must transit at their slowest safe speed and
comply with all lawful directions issued by the COTP or the designated
representative.

V. Regulatory Analyses

    We developed this rule after considering numerous statutes and
Executive orders related to rulemaking. Below we summarize our analyses
based on a number of these statutes and Executive orders, and we
discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. Executive Order 13771 directs agencies to control
regulatory costs through a budgeting process. This rule has not been
designated a ``significant regulatory action,'' under Executive Order
12866. Accordingly, this rule has not been reviewed by the Office of
Management and Budget (OMB), and pursuant to OMB guidance it is exempt
from the requirements of Executive Order 13771.
    This regulatory action determination is based on the size,
location, duration, and time-of-year of the safety zone. This safety
zone will restrict vessel traffic from entering or transiting within a
3.6 mile area of navigable waterways on the Ohio River between MMs
530.6 and 533.0. Moreover, the Coast Guard will issue Broadcast Notice
to Mariners via VHF-FM marine channel 16 about the safety zone, and the
rule allows vessels to seek permission to enter the safety zone.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule
will not have a significant economic impact on a substantial number of
small entities.
    While some owners or operators of vessels intending to transit the
temporary safety zone may be small entities, for the reasons stated in
section V.A above, this rule will not have a significant economic
impact on any vessel owner or operator.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
contact the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

C. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this rule under that Order and have
determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this rule does not have tribal implications under Executive
Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it does not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes. If
you believe this rule has implications for federalism or Indian tribes,
please contact the person listed in the FOR FURTHER INFORMATION CONTACT
section above.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

F. Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01, which guides the Coast Guard in complying
with the National Environmental Policy Act of 1969 (NEPA)(42 U.S.C.
4321-4370f), and have determined that this action is one of a category
of actions that do not individually or cumulatively have a significant
effect on the human environment. This rule is categorically excluded
from further review under paragraph L60(d) of Appendix A, Table 1 of
DHS Instruction Manual 023-01-001-01, Rev. 01. Because this safety zone
is established in response to an emergency situation a Record of
Environmental Consideration (REC) is not required, but if necessary,
will be

made available as indicated under ADDRESSES.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places or vessels.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority: 33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1,
6.04-6, and 160.5; Department of Homeland Security Delegation No.
0170.1.

0
2. Add Sec.  165.T08-0168 to read as follows:

Sec.  165.T08-0168  Safety Zone; Ohio River, Louisville, KY.

    (a) Location. The following area is a safety zone: All navigable
waters of the Ohio River from Mile Marker (MM) 530.6 to MM 533.0,
extending the entire width of the river.
    (b) Enforcement period. This section is effective without actual
notice from December 27, 2018 through January 20, 2019, or until the
hazard has decreased, whichever occurs first. For the purposes of
enforcement, actual notice will be used from December 20, 2018 until
December 27, 2018.
    (c) Regulations. (1) In accordance with the general regulations in
Sec.  165.23, entry of vessels or persons into this zone is prohibited
unless specifically authorized by the Captain of the Port Sector Ohio
Valley (COTP) or designated representative. A designated representative
is a commissioned, warrant, or petty officer of the U.S. Coast Guard
assigned to units under the operational control of USCG Sector Ohio
Valley.
    (2) Vessels requiring entry into this safety zone must request
permission from the COTP or a designated representative. To seek entry
into the safety zone, contact the COTP or the COTP's representative by
telephone at<PHONE_NUMBER> or on VHF-FM channel16.
    (3) Persons and vessels permitted to enter this safety zone must
transit at their slowest safe speed and comply with all lawful
directions issued by the COTP or the designated representative.
    (d) Information broadcasts. The COTP or a designated representative
will inform the public through Broadcast Notices to Mariners of any
changes in the planned schedule.

    Dated: December 20, 2018.
M.B. Zamperini,
Captain, U.S. Coast Guard, Captain of the Port Sector Ohio Valley.
[FR Doc. 2018-28131 Filed 12-26-18; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 86, Number 57 (Friday, March 26, 2021)]
[Notices]
[Pages 16226-16227]
[FR Doc No: 2021-06258]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1682]

Ursula Wing: Final Debarment Order

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is issuing an order
under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring
Ursula Wing for a period of 5 years from importing or offering for
import any drug into the United States. FDA bases this order on a
finding that Ms. Wing was convicted of one felony count under Federal
law for conspiracy to defraud the United States. Ms. Wing was given
notice of the proposed debarment and an opportunity to request a
hearing to show why she should not be debarred within the timeframe
prescribed by regulation. Ms. Wing failed to request a hearing. Ms.
Wing's failure to respond and request a hearing constitutes a waiver of
her right to a hearing concerning this matter.

DATES: This order is applicable March 26, 2021.

ADDRESSES: Submit applications for termination of debarment to the
Dockets Management Staff (HFA-305), Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>, or at
https://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Jaime Espinosa, Division of
Enforcement (ELEM-4029), Office of Strategic Planning and Operational
Policy, Office of Regulatory Affairs, Food and Drug Administration,
12420 Parklawn Dr., Rockville, MD 20857,<PHONE_NUMBER>, or at
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    Section 306(b)(1)(D) of the FD&C Act (21 U.S.C. 335a(b)(1)(D))
permits debarment of an individual from importing or offering for
import any drug into the United States if FDA finds, as required by
section 306(b)(3)(C) of the FD&C Act, that the individual has been
convicted of a felony for conduct relating to the importation into the
United States of any drug or controlled substance. On July 10, 2020,
Ms. Wing was convicted, as defined in section 306(l)(1) of the FD&C
Act, in the U.S. District Court for the Western District of Wisconsin,
when the court accepted her plea of guilty and entered judgment against
her for the felony offense of conspiracy to defraud the United States
in violation of 18 U.S.C. 371.
    FDA's finding that debarment is appropriate is based on this felony
conviction referenced herein. The factual basis for this conviction is
as follows: As contained in count 1 of the indictment in Ms. Wing's
case, filed on June 26, 2019, to which she pleaded guilty, from in or
about June 2016 and continuing to on or about June 21, 2018, she
operated a blog under the name ``the Macrobiotic Stoner'' and a fake
jewelry business under the name ``Morocco International Inc.'' Ms. Wing
used both entities to sell unapproved and misbranded prescription drugs
to consumers in the United States and around the world and to process
payments for those drugs. Throughout the course of this conspiracy Ms.
Wing did not possess a valid wholesale drug distribution license,
pharmacy license, or a license to prescribe prescription drugs. She was
also not registered under section 510 of the FD&C Act (21 U.S.C. 360)
as a person who owns or operates an establishment engaged in the
manufacture, preparation, propagation, compounding, or processing of a
drug.
    As part of this conspiracy, Ms. Wing imported foreign-sourced
prescription drugs in wholesale quantities from India into the United
States. The imported drugs contained U.S. Customs Declaration Forms
falsely stating that the contents were ``personal supply medication''
and did not contain any dangerous articles or articles prohibited by
postal or customs regulations. The drugs Ms. Wing imported were foreign
versions of mifepristone and misoprostol. There are two 200 mg
mifepristone tablets that are FDA-

approved for use in a regimen with misoprostol for the medical
termination of early pregnancy. There are no approved drug applications
pursuant to section 505 of the FD&C Act (21 U.S.C. 355) in effect for
the mifepristone and misoprostol Ms. Wing imported and sold via her
website. In addition to being unapproved, the drugs sold via Ms. Wing's
website were also misbranded because they failed to bear adequate
directions for their intended use (see 21 U.S.C. 352(f)(1) and 21 CFR
201.5) and are prescription medications that were dispensed without a
prescription from a practitioner licensed by law to administer such
drugs (21 U.S.C. 353(b)(1) and 331(k)).
    Ms. Wing broke down the bulk shipments of unapproved and misbranded
drugs she received from India and repackaged them into retail
quantities which she then shipped to customers in the United States and
around the world via U.S. mail. To disguise her sales, Ms. Wing created
a fake company called ``Fatima's Bread Basket,'' which she listed as
the shipper on the envelope going to the customer. Ms. Wing then
inserted a piece of jewelry in the shipping envelope to serve as the
cover piece of merchandise being mailed to the customer. She packaged
the unapproved and misbranded prescription drugs in a smaller packet
that was in a hidden panel and taped to the inside of the shipping
envelope. Ms. Wing disguised the nature of the item being purchased by
listing on the invoice alternate jewelry product names, each of which
had a code to indicate the actual item (unapproved and misbranded
drug(s)) being ordered.
    As a result of this conviction, FDA sent Ms. Wing, by certified
mail on October 15, 2020, a notice proposing to debar her for a 5-year
period from importing or offering for import any drug into the United
States. The proposal was based on a finding under section 306(b)(3)(C)
of the FD&C Act that Ms. Wing's conviction for one felony count under
Federal law, for conspiracy to defraud the United States, was for
conduct relating to the importation into the United States of any drug
or controlled substance because she illegally smuggled unapproved and
misbranded prescription drugs from India into the United States and
then distributed those misbranded and unapproved drugs to consumers
both in the United States and abroad.
    In proposing a debarment period, FDA weighed the considerations set
forth in section 306(c)(3) of the FD&C Act that it considered
applicable to Ms. Wing's offense, and concluded that this felony
offense warranted the imposition of a 5-year period of debarment. The
proposal informed Ms. Wing of the proposed debarment and offered her an
opportunity to request a hearing, providing her 30 days from the date
of receipt of the letter in which to file the request, and advised her
that failure to request a hearing constituted a waiver of the
opportunity for a hearing and of any contentions concerning this
action. Ms. Wing received the proposal and notice of opportunity for a
hearing on October 19, 2020. Ms. Wing failed to request a hearing
within the timeframe prescribed by regulation and has, therefore,
waived her opportunity for a hearing and waived any contentions
concerning her debarment (21 CFR part 12).

II. Findings and Order

    Therefore, the Assistant Commissioner, Office of Human and Animal
Food Operations, under section 306(b)(3)(C) of the FD&C Act, under
authority delegated to the Assistant Commissioner, finds that Ms.
Ursula Wing has been convicted of a felony under Federal law for
conduct relating to the importation into the United States of any drug
or controlled substance. FDA finds that the offense should be accorded
a debarment period of 5 years as provided by section 306(c)(2)(A)(iii)
of the FD&C Act.
    As a result of the foregoing finding, Ms. Wing is debarred for a
period of 5 years from importing or offering for import any drug into
the United States, effective (see DATES). Pursuant to section 301(cc)
of the FD&C Act (21 U.S.C. 331(cc)), the importing or offering for
import into the United States of any drug or controlled substance by,
with the assistance of, or at the direction of Ms. Wing is a prohibited
act.
    Any application by Ms. Wing for termination of debarment under
section 306(d)(1) of the FD&C Act should be identified with Docket No.
FDA-2020-N-1682 and sent to the Dockets Management Staff (see
ADDRESSES). The public availability of information in these submissions
is governed by 21 CFR 10.20(j).
    Publicly available submissions will be placed in the docket and
will be viewable at https://www.regulations.gov or at the Dockets
Management Staff (see ADDRESSES) between 9 a.m. and 4 p.m., Monday
through Friday,<PHONE_NUMBER>.

    Dated: March 19, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-06258 Filed 3-25-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: January 18, 2008 (Volume 73, Number 13)]
[Notices]
[Page 3457-3458]
[DOCID:fr18ja08-44]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project Nos. 2436-235; 2447-226; 2448-229; 2449-194; 2450-190; 2451-
189; 2452-199; 2453-223; 2468-204; 2580-255; 2599-222]

Consumers Energy Company; Notice of Filing of Projects Retirement
Study Report and Soliciting Comments, Motions To Intervene, and
Protests

January 11, 2008.
    Take notice that the following report has been filed with the
Commission and is available for public inspection:
    a. Filing Type: Projects Retirement Study Report.
    b. Project Nos: 2436-235, 2447-226, 2448-229, 2449-194, 2450-190,
2451-189, 2452-199, 2453-223, 2468-204, 2580-255, and 2599-222.
    c. Date Filed: June 4, 2007.
    d. Applicant: Consumers Energy Company.
    e. Name of Projects: Foote, Alcona, Mio, Loud, Cooke, Rogers,
Hardy, Five Channels, Croton, Tippy, and Hodenpyl.
    f. Location: on the Au Sable, Manistee, and Muskegon Rivers in
Iosco, Alcona, Oscoda, Manistee, Wexford, Newaygo and Mecosta Counties,
Michigan.
    g. Filed Pursuant to: Articles 204 and 205 of the licenses.
    h. Applicant Contact: William A. Schoenlein, Director of Hydro
Generation, Consumers Energy Company, 330 Chestnut Street, Cadillac, MI
49601-1821,<PHONE_NUMBER>.
    i. FERC Contact: Jake Tung, Telephone<PHONE_NUMBER>, and e-mail:
<EMAIL_ADDRESS>

    j. Deadline for filing comments, motions to intervene, and protest:
February 11, 2008. All documents (original and eight copies) should be
filed with: Secretary, Federal Energy Regulatory Commission, 888 First
Street, NE., Washington, DC 20426.
    The Commission's Rules of Practice and Procedure require all
intervenors filing documents with the Commission to serve a copy of
that document on each person whose name appears on the official service
list for the project. Further, if an intervenor files comments or
documents with the Commission relating to the merits of an issue that
may affect the responsibilities of a particular resource agency, they
must also serve a copy of the document on that resource agency. A copy
of any motion to intervene must also be served upon each representative
of the Applicant specified in the particular application.
    k. Description of the Report: Consumers Energy Company filed the
Retirement Study Report, pursuant to Articles 204 and 205 of the
licenses. Consumers prepared the report in accordance with the
Retirement Study Plans, which was approved by the Commission on April
7, 2005 (111 FERC ] 62,029).
    l. Locations of the Report: A copy of the report is available for
inspection and reproduction at the Commission's Public Reference Room,
located at 888 First Street, NE., Room 2A, Washington, DC 20426, or by
calling<PHONE_NUMBER>. This filing may also be viewed on the
Commission's Web site at http://www.ferc.gov using the ``eLibrary''

link. Enter the docket number excluding the last three digits in the
docket number field to access the document. You may also register
online at http://www.ferc.gov/docs-filing/esubscription.asp to be

notified via e-mail of new filings and issuances related to this or
other pending projects. For assistance, call 1-866-208-3676 or e-mail
<EMAIL_ADDRESS>for TTY, call<PHONE_NUMBER>. A copy is

also available for inspection and reproduction at the address in item
(h) above.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Comments, Protests, or Motions To Intervene: Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214. In determining the appropriate action to take, the Commission
will consider all protests or other comments filed, but only those who
file a motion to intervene in accordance with the Commission's Rules
may become a party to the proceeding. Any comments, protests, or
motions to intervene must be received on or before the specified
comment date for the report.
    o. Any filings must bear in all capital letters the title
``COMMENTS'', ``PROTEST'', or ``MOTION TO INTERVENE'', as applicable,
and the Project Number of the particular application to which the
filing refers.
    p. Agency Comments: Federal, state, and local agencies are invited
to file comments on the described report. A copy of the report may be
obtained by agencies directly from the Applicant. If an agency does not
file comments within the time specified for filing comments, it will be
presumed to have no comments. One copy of an agency's comments must
also be sent to the Applicant's representatives.
    q. Comments, protests and interventions may be filed electronically
via the Internet in lieu of paper. See, 18 CFR 385.2001(a)(1)(iii) and
the instructions on the Commission's Web site at http://www.ferc.gov

under the ``e-Filing'' link.

Kimberly D. Bose,
Secretary.
[FR Doc. E8-863 Filed 1-17-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 85, Number 239 (Friday, December 11, 2020)]
[Notices]
[Pages 80206-80207]
[FR Doc No: 2020-27199]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-90575; File No. SR-NYSEArca-2020-46]

Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of
Designation of a Longer Period for Commission Action on Proceedings To
Determine Whether To Approve or Disapprove a Proposed Rule Change To
Amend NYSE Arca Rule 5.2-E(j)(6) Relating to Options-Linked Securities

December 7, 2020.
    On June 10, 2020, NYSE Arca, Inc. (``Exchange'' or ``NYSE Arca'')
filed with the Securities and Exchange Commission (``Commission''),
pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ a proposed rule change to
amend NYSE Arca Rule 5.2-E(j)(6) to accommodate Exchange listing and
trading of Options-Linked Securities. The proposed rule change was
published for comment in the Federal Register on June 22, 2020.\3\ On
July 28, 2020, pursuant to Section 19(b)(2) of the Act,\4\ the
Commission designated a longer period within which to approve the
proposed rule change, disapprove the proposed rule change, or institute
proceedings to determine whether to disapprove the proposed rule
change.\5\ On September 16, 2020, the Commission instituted proceedings
under Section 19(b)(2)(B) of the Act \6\ to determine whether to
approve or disapprove the proposed rule change.\7\ The Commission has
received no

comment letters on the proposed rule change.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 89073 (June 16,
2020), 85 FR 37488 (``Notice'').
    \4\ 15 U.S.C. 78s(b)(2).
    \5\ See Securities Exchange Act Release No. 89412, 85 FR 46744
(August 3, 2020).
    \6\ 15 U.S.C. 78s(b)(2)(B).
    \7\ See Securities Exchange Act Release No. 89898, 85 FR 59572
(September 22, 2020). Specifically, the Commission instituted
proceedings to allow for additional analysis of the proposed rule
change's consistency with Section 6(b)(5) of the Act, which
requires, among other things, that the rules of a national
securities exchange be ``designed to prevent fraudulent and
manipulative acts and practices, to promote just and equitable
principles of trade,'' and ``to protect investors and the public
interest.'' See id. at 59573 (citing 15 U.S.C. 78f(b)(5)).
---------------------------------------------------------------------------

    Section 19(b)(2) of the Act \8\ provides that, after initiating
disapproval proceedings, the Commission shall issue an order approving
or disapproving the proposed rule change not later than 180 days after
the date of publication of notice of filing of the proposed rule
change. The Commission may extend the period for issuing an order
approving or disapproving the proposed rule change, however, by not
more than 60 days if the Commission determines that a longer period is
appropriate and publishes the reasons for such determination. The date
of publication of notice of filing of the proposed rule change was June
22, 2020. December 19, 2020, is 180 days from that date, and February
17, 2021, is 240 days from that date.
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78s(b)(2).
---------------------------------------------------------------------------

    The Commission finds it appropriate to designate a longer period
within which to issue an order approving or disapproving the proposed
rule change so that it has sufficient time to consider this proposed
rule change. Accordingly, the Commission, pursuant to Section 19(b)(2)
of the Act,\9\ designates February 17, 2021, as the date by which the
Commission shall either approve or disapprove the proposed rule change
(File No. SR-NYSEArca-2020-46).
---------------------------------------------------------------------------

    \9\ Id.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\10\
---------------------------------------------------------------------------

    \10\ 17 CFR 200.30-3(a)(57).
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J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2020-27199 Filed 12-10-20; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 80, Number 51 (Tuesday, March 17, 2015)]
[Notices]
[Pages 13934-13936]
[FR Doc No: 2015-06013]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-74483; File No. SR-CFE-2015-002]

Self-Regulatory Organizations; CBOE Futures Exchange, LLC; Notice
of Filing and Immediate Effectiveness of a Proposed Rule Change
Regarding Exchange of Contract for Related Position Transactions and
Block Trades

March 11, 2015.
    Pursuant to Section 19(b)(7) of the Securities Exchange Act of 1934
(``Act''),\1\ notice is hereby given that on February 25, 2015 CBOE
Futures Exchange, LLC (``CFE'' or ``Exchange'') filed with the
Securities and Exchange Commission (``SEC'' or ``Commission'') the
proposed rule change described in Items I, II, and III below, which
Items have been prepared by CFE. The Commission is publishing this
notice to solicit comments on the proposed rule change from interested
persons. CFE also has filed this proposed rule change with the
Commodity Futures Trading Commission (``CFTC''). CFE filed a written
certification with the CFTC under Section 5c(c) of the Commodity
Exchange Act (``CEA'')\2\ on February 25, 2015.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(7).
    \2\ 7 U.S.C. 7a-2(c).
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Description of the Proposed Rule
Change

    The Exchange proposes to amend its rules related to Exchange of
Contract for Related Position (``ECRP'') transactions and block trades.
The scope of this filing is limited solely to the application of the
rule amendments to security futures traded on CFE. The only security
futures currently traded on CFE are traded under Chapter 16 of CFE's
Rulebook which is applicable to Individual Stock Based and Exchange-
Traded Fund Based Volatility Index security futures. The text of the
proposed rule change is attached as Exhibit 4 to the filing but is not
attached to the publication of this notice.

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

    In its filing with the Commission, CFE 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. CFE 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 CFE rule amendments included as part of
this rule change is to: (i) Amend CFE Rule 414 (Exchange of Contract
for Related Position) to extend the time to report ECRP transactions to
the Exchange from ten minutes to thirty minutes; and (ii) amend CFE
Rules 414 and 415 (Block Trading) to clarify that the CFE Help Desk can
provide written transaction summaries for ECRP transactions and block
trades on the business day for which the transaction is submitted for
clearing or the calendar day of the transaction. The rule amendments
included as part of this rule change are to apply to all products
traded on CFE, including both non-security futures and security
futures.
Reporting Timeframe for ECRP Transactions
    CFE is proposing to amend CFE Rule 414 (Exchange of Contract for
Related Position) to extend the timeframe for reporting ECRP
transactions. CFE Rule 414 currently provides that each party to an
ECRP transaction is obligated to have an Authorized Reporter (which is
defined in CFE Rule 414(h) and 415(f)) \3\ notify the CFE Help Desk of
the terms of the ECRP transaction no later than ten minutes after the
transaction is agreed upon. The amendments extend this current
reporting window for ECRP transactions to thirty minutes.
---------------------------------------------------------------------------

    \3\ CFE Rule 414(h) and CFE Rule 415(f) require that each CFE
Trading Privilege Holder (``TPH'') executing an Exchange of Contract
for Related Position transaction or a side of a block trade must
have designated at least one Authorized Reporter that is pre-
authorized by a CFE clearing member to report the ECRP transaction
or block trade on behalf of the TPH.
---------------------------------------------------------------------------

    CFE believes this extension is justified for the following reasons.
First, it will allow CFE to stay competitive with other futures
exchanges that currently provide market participants with additional
time to report these transactions. Specifically, CME Group provides
that such transactions ``must be submitted within one hour after the
relevant terms have been determined,'' \4\ and ICE Futures U.S.
provides no definitive timeframe and rather that such transactions
``should be submitted to the Exchange as soon as possible following
agreement to the terms by the relevant parties.'' \5\ Second, the
extension takes into account the specific, logistical aspects
associated with these off-exchange transactions, which entail related
transactions in two different instruments. Specifically, ECRP
transactions in CFE products frequently involve contra-parties that
operate on a trading floor instead of an office setting. In addition,
the required recordkeeping presents logistical issues as each contra-
party to an ECRP must coordinate with an Authorized Reporter to report
to the CFE Help Desk the relevant ECRP transaction as well as collect
or create records evidencing compliance with the criteria set forth in
CFE Rule 414 as required by CFE Rule 414 (g).\6\ CFE believes a limited
additional window for compliance is justified given these logistical
aspects. Accordingly, CFE believes that extending the timeframe from
ten to thirty minutes represents a sound balance that takes into
account the above competitive and logistical considerations while
remaining sufficiently limited in duration so as not to be detrimental
to CFE's market.
---------------------------------------------------------------------------

    \4\ CME Group, Market Regulation Advisory Notice (Aug. 4, 2014),
Q&A22, available at http://www.cmegroup.com/rulebook/files/ra1311-5r.pdf.
    \5\ ICE Futures U.S., EFRP FAQs (Sept. 5, 2014), Q&A 17,
available at https://www.theice.com/publicdocs/futures_us/EFRP_FAQ.pdf.
    \6\ CFE Rule 414 (g) requires that each TPH involved in any ECRP
transaction shall either maintain records evidencing compliance with
the criteria set forth in Rule 414 or be able to obtain such records
from its Customer involved in the ECRPs. Information required to be
maintained but which is not systematically provided in conjunction
with the processing of these trades may include the options delta
utilized at the time of the trade in order to demonstrate that the
Contract transaction would serve as an appropriate hedge for the
Related Position.
---------------------------------------------------------------------------

Clarification Regarding Written Summaries for ECRP Transactions and
Block Trades
    CFE is proposing to amend CFE Rule 414 (Exchange of Contract for
Related Position) and CFE Rule 415 (Block Trading) to clarify that the
CFE Help Desk can provide written transaction summaries for ECRP
transactions and block trades on the business day for which the
transaction is submitted for clearing or the calendar day of the
transaction. CFE Rules 414 and 415 currently contain language that
imply that the CFE Help Desk always provides a written transaction
summary of an ECRP transaction or a block trade on the business day for
which the transaction is submitted for clearing. The amendments clarify
that the CFE Help Desk can provide a written transaction summary of an
ECRP transaction or block trade to each Authorized Reporter on either
the business day for which the transaction is submitted for clearing or
on the calendar day of the transaction.
    For ECRP transactions and block trades that occur during most of
the trading day, the CFE Help Desk would provide a transaction summary
on the business day for which the transaction is submitted for
clearing. However, there are circumstances in which the CFE Help Desk
would provide a transaction summary on the calendar day of the
transaction and not on the business day for which the transaction is
submitted for clearing. For example, this could occur if an ECRP
transaction or block trade in CBOE Volatility Index (``VIX'') futures
was reported to the CFE Help Desk between 3:30 p.m. and 4:00 p.m. on a
Monday through Thursday and was designated by the parties for clearance
on the calendar day of the transaction. In that case, the next business
day would have already started when the transaction is reported to the
CFE Help Desk pursuant to the extended trading hours schedule in VIX
futures, as the prior business day would have ended at 3:15 p.m. and
the new business day would have started at 3:30 p.m. Accordingly, the
CFE Help Desk would be providing a written transaction summary to the
Authorized Reporters on the calendar day of the transaction and not on
the business day for which the transaction would be submitted for
clearing (since in this case the transaction would be submitted for
clearing for the prior business day).
    CFE is also making a technical, non-substantive change to CFE Rule
415(c) to correct a typographical error. Rule 415(c) incorrectly
references Rule 415(i) for the reporting deadline instead of to Rule
415(g) where the relevant reporting deadline is contained and this rule
change corrects this cross-reference.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) of the Act,\7\ in general, and furthers the
objectives of Sections 6(b)(5) \8\ and 6(b)(7) \9\ in particular in
that it is designed:
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78f(b).
    \8\ 15 U.S.C. 78f(b)(5).
    \9\ 15 U.S.C. 78f(b)(7).
---------------------------------------------------------------------------

     To foster cooperation and coordination with persons
engaged in facilitating transactions in securities, and
     to remove impediments to and perfect the mechanism of a
free and open market and a national market system, and in general, to
protect investors and the public interest.

    The Exchange believes that the proposed rule change would benefit
market participants because it would provide them with a limited amount
of additional time to report ECRP transactions. First, the change will
allow CFE to stay competitive with other futures exchanges that
currently provide market participants with additional time to report
these transactions.\10\ Second, the extension takes into account the
logistical aspects associated with these transactions, which entail
related transactions in two different instruments. Specifically, ECRP
transactions involve contra-parties operating on a trading floor
instead of an office setting. In addition, the required recordkeeping
presents logistical issues as each contra-party to an ECRP must
coordinate with an Authorized Reporter to report to the CFE Help Desk
its ECRP transaction as well as conduct the required recordkeeping
manually. CFE believes extending the timeframe from ten to thirty
minutes represents a sound balance that takes into account the above
competitive and logistical considerations while remaining sufficiently
limited in duration so as not to be detrimental to CFE's market.
---------------------------------------------------------------------------

    \10\ See CME Group, Market Regulation Advisory Notice (Aug. 4,
2014), Q&A22, available athttp://www.cmegroup.com/rulebook/files/ra1311-5r.pdf; ICE Futures U.S., EFRP FAQs (Sept. 5, 2014), Q&A 17,
available athttp://www.theice.com/publicdocs/futures_us/
EFRP_FAQ.pdf.
---------------------------------------------------------------------------

    In addition, the proposed rule change benefits market participants
by clarifying to them that their Authorized Reporters will receive
written transactions summaries: (i) Regarding ECRP transactions on
either the business day for which the contract leg of the ECRP
transaction is submitted for clearing or the calendar day of the
transaction; and (ii) regarding block trades, on either the business
day for which the block trade is submitted for clearing or on the
calendar day of the transaction.

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

    CFE 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. Specifically, the Exchange believes that the
proposed rule change will not burden competition because the new ECRP
reporting timeframe and timeframe for receiving written summaries of
ECRP transactions and block trades will apply to all persons and the
revised rule provisions do not discriminate between market
participants.

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 will become effective on March 11, 2015.
    At any time within 60 days of the date of effectiveness of the
proposed rule change, the Commission, after consultation with the CFTC,
may summarily abrogate the proposed rule change and require that the
proposed rule change be refiled in accordance with the provisions of
Section 19(b)(1) of the Act.\11\
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78s(b)(1).
---------------------------------------------------------------------------

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-CFE-2015-002 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-CFE-2015-002. 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 Web site (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 Web site 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 such filing also will be available
for inspection and copying at the principal offices of the Exchange.
All comments received will be posted without change; the Commission
does not edit personal identifying information from submissions. You
should submit only information that you wish to make available
publicly. All submissions should refer to File Number SR-CFE-2015-002,
and should be submitted on or before April 7, 2015.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\12\
---------------------------------------------------------------------------

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

Brent J. Fields,
Secretary.
[FR Doc. 2015-06013 Filed 3-16-15; 8:45 am]
 BILLING CODE 8011-01-P