[Federal Register Volume 81, Number 90 (Tuesday, May 10, 2016)]
[Notices]
[Pages 28866-28867]
[FR Doc No: 2016-10992]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2015-0022; FRL-9945-50]

Pesticide Product Registrations; Receipt of Applications for New
Uses

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: EPA has received applications to register new uses for
pesticide products containing currently registered active ingredients.
Pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA), EPA is hereby providing notice of receipt and opportunity to
comment on these applications.

DATES: Comments must be received on or before June 9, 2016.

ADDRESSES: Submit your comments, identified by the Docket
Identification (ID) Number and the File Symbol or EPA Registration
Number of interest as shown in the body of this document, by one of the
following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html. Additional
instructions on commenting or visiting the docket, along with more
information about dockets generally, is available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Steve Knizer, Antimicrobials Division
(AD) (7510P), main telephone number:<PHONE_NUMBER>, email address:
<EMAIL_ADDRESS>Robert McNally, Biopesticides and Pollution
Prevention Division (BPPD) (7511P), main telephone number: (703) 305-
7090, email address<EMAIL_ADDRESS>or Susan Lewis,
Registration Division (RD) (7505P), main telephone number: (703) 305-
7090, email address<EMAIL_ADDRESS>The mailing address for each
contact person is: Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-
0001. As part of the mailing address, include the contact person's
name, division, and mail code. The division to contact is listed at the
end of each application summary.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    If you have any questions regarding the applicability of this
action to a particular entity, consult the person listed under FOR
FURTHER INFORMATION CONTACT for the division listed at the end of the
application summary of interest.

B. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or email. Clearly mark the part or all of the
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.
    2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.
    3. Environmental justice. EPA seeks to achieve environmental
justice, the fair treatment and meaningful involvement of any group,
including minority and/or low-income populations, in the development,
implementation, and enforcement of environmental laws, regulations, and
policies. To help address potential environmental justice issues, EPA
seeks information on any groups or segments of the population who, as a
result of their location, cultural practices, or other factors, may
have atypical or disproportionately high and adverse human health
impacts or environmental effects from exposure to the pesticides
discussed in this document, compared to the general population.

II. Registration Applications

    EPA has received applications to register new uses for pesticide
products containing currently registered active ingredients. Pursuant
to the provisions of FIFRA section 3(c)(4) (7 U.S.C. 136a(c)(4)), EPA
is hereby providing notice of receipt and opportunity to comment on
these applications. Notice of receipt of these applications does not
imply a decision by EPA on these applications. For actions being
evaluated under EPA's public participation process for registration
actions, there will be an additional opportunity for public comment on
the proposed decisions. Please see EPA's public participation Web site
for additional information on this process https://www.epa.gov/pesticide-registration/public-participation-process-registration-actions. EPA received the following applications to register new uses
for pesticide products containing currently registered active
ingredients:
    1. EPA Registration Numbers and File Symbol: 100-762, 100-763, and
81880-ET. Docket ID Number: EPA-HQ-OPP-2016-0218. Applicants: Syngenta
Crop Protection, LLC, 410 Swing Rd., P.O. Box 18300, Greensboro, NC
27419-8300; and Canyon Group, LLC, 370 S. Main St., Yuma, AZ 85364.
Active Ingredient: Prosulfuron. Product Type: Herbicide. Proposed Uses:
Technical and end-use products intended for use in or on cereal grains
group (crop group 15); forage, fodder, and straw of cereal grains group
(crop group 16); and rice. Contact: RD.
    2. EPA Registration Number: 100-1571. Docket ID Number: EPA-HQ-OPP-
2016-0049. Applicant: Syngenta Crop Protection, LLC, 410 Swing Rd.,
P.O. Box 18300, Greensboro, NC 27419-8300. Active Ingredient:
Oxathiapiprolin. Product Type: Fungicide. Proposed Uses: New food uses
on citrus fruit crop group 10-10. Contact: RD.
    3. EPA Registration Number: 352-890. Docket ID Number: EPA-HQ-OPP-
2016-0049. Applicant: E.I. du Pont de Nemours and Company, Inc., DuPont
Crop Protection, Stine-Haskell Research

Center, P.O. Box 30, Newark, DE 19714-0300. Active Ingredient:
Oxathiapiprolin. Product Type: Fungicide. Proposed Uses: New food uses
on citrus fruit crop group 10-10 and for soybean and sunflower seed
treatment. Contact: RD.
    4. EPA Registration Number: 499-540. Docket ID Number: EPA-HQ-OPP-
2016-0184. Applicant: BASF Corp., 26 Davis Dr., Research Triangle Park,
NC 27709-3528. Active Ingredients: Dinotefuran, prallethrin, and
pyriproxyfen. Product Type: Insecticide. Proposed Use: Mattress.
Contact: RD.
    5. EPA Registration Number: 73049-500. Docket ID Number: EPA-HQ-
OPP-2016-0065. Applicant: Valent BioSciences Corp., 870 Technology Way,
Libertyville, IL 60048. Active Ingredient: Methyl salicylate. Product
Type: Plant regulator (induced resistance promoter). Proposed Uses: All
vegetables and tobacco. Contact: BPPD.
    6. EPA Registration Number: 83019-1. Docket ID Number: EPA-HQ-OPP-
2016-0219. Applicant: BioSafe, Inc., 2425 Sidney St., Pittsburgh, PA
15203. Active Ingredient: 1-Octadecanaminium, N,N-dimethyl-N-(3-
(trimethoxysilyl)propyl)-, chloride. Product Type: Antimicrobial.
Proposed Use: Indirect food use contact. Contact: AD.
    7. EPA Registration Numbers: 87485-1 and 87485-2. Docket ID Number:
EPA-HQ-OPP-2016-0162. Applicant: DSM Food Specialties B.V., P.O. Box 1,
2600 MA Delft, The Netherlands (c/o Keller and Heckman, LLP, 1001 G St.
NW., Washington, DC 20001). Active Ingredient: Natamycin. Product Type:
Fungistat. Proposed Uses: Citrus, pome, and stone fruit crop groups;
avocado; kiwi; mango; and pomegranate. Contact: BPPD.

    Authority: 7 U.S.C. 136 et seq.

    Dated: May 3, 2016.
Mark A. Hartman,
Acting, Director, Biopesticides and Pollution Prevention Division,
Office of Pesticide Programs.
[FR Doc. 2016-10992 Filed 5-9-16; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 83, Number 196 (Wednesday, October 10, 2018)]
[Rules and Regulations]
[Pages 50821-50822]
[FR Doc No: 2018-21507]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2018-0281; Product Identifier 2018-NE-06-AD; Amendment
39-19437; AD 2018-20-03]
RIN 2120-AA64

Airworthiness Directives; Hoffmann GmbH & Co. KG Propellers

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: We are adopting a new airworthiness directive (AD) for certain
Hoffmann GmbH & Co. KG model HO-V 62 propellers. This AD was prompted
by the failure of the propeller blade lag screws. This AD requires
removal of the affected propeller blades and installation of modified
propeller blades marked with change letter ``A'' or ``B.'' We are
issuing this AD to address the unsafe condition on these products.

DATES: This AD is effective November 14, 2018.

ADDRESSES: For service information identified in this final rule,
contact Hoffmann Propeller GmbH & Co. KG, Sales and Service,
K[uuml]pferlingstrasse 9, 83022 Rosenheim, Germany; phone: +49 (0) 8031
1878 0; fax: +49 (0) 8031 1878 78; email: prop.com">[email protected]prop.com. You
may view this service information at the FAA, Engine & Propeller
Standards Branch, 1200 District Avenue, Burlington, MA 01803. For
information on the availability of this material at the FAA, call 781-
238-7759. It is also available on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-
0281.

Examining the AD Docket

    You may examine the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-
0281; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this final rule, the mandatory continuing airworthiness information
(MCAI), the regulatory evaluation, any comments received, and other
information. The address for Docket Operations (phone:<PHONE_NUMBER>) is
U.S. Department of Transportation, Docket Operations, M-30, West
Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE,
Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Maureen Maisttison, Aerospace
Engineer, Boston ACO Branch, FAA, 1200 District Ave, Burlington, MA
01803; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
[email protected].

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 by adding an AD that would apply to certain Hoffmann GmbH & Co.
KG model HO-V 62 propellers. The NPRM published in the Federal Register
on July 12, 2018 (83 FR 32219). The NPRM was prompted by the failure of
the propeller blade lag screws. The NPRM proposed to require removal of
the affected propeller blades and installation of modified propeller
blades marked with change letter ``A'' or ``B.'' We are issuing this AD
to address the unsafe condition on these products.
    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Community, has issued EASA
AD 2017-0220, dated November 10, 2017 (referred to after this as ``the
MCAI''), to address the unsafe condition on these products. The MCAI
states:

    In 1983, occurrences were reported of fatigue failure of
propeller blade lag screws, at rotation speeds between 2950 and 3250
revolutions per minute (RPM) in flight.
    This condition, if not detected and corrected, could lead to in-
flight propeller blade detachment, possibly resulting in damage to
the powered sailplane and/or injury to persons on the ground.
    To address this potential unsafe condition, Hoffmann issued
Service Bulletin (SB) 4, providing the necessary instructions.
Consequently, LBA Germany issued AD 83-150 (later revised), which
applied only to HO-V 62 propellers with R/L 160T blades, when in
combination with a Limbach L 2000 engine, to require a limitation of
continuous operation to 2 900 RPM, to prohibit aerobatic flights,
calibrate the tachometer, install a placard, and inspection of the
propeller blades. LBA AD 83-150/4 also required overhaul and
replacement of the affected propeller blades with modified blades,
either having 5 lag screws with 12 mm diameter, or 6 screws, and
required implementing a time between overhaul (TBO) of 600 flight
hours (FH).
    Since that [LBA] AD was issued, based on a stress analysis of
lag screws on blades with continuous operating speed above 2 900
RPM, it was determined that the 6-screws configuration or the 5
screws configuration with increased strength is necessary to ensure
safe propeller operation. In addition, since the LBA AD applied only
to a limited population (Limbach engine only), many propellers have
not been modified as described in Hoffmann SB 4C. Consequently,
Hoffmann issued SB E34 Revision B, to provide blade replacement
instructions

    You may obtain further information by examining the MCAI in the AD
docket on the internet at http://www.regulations.gov by searching for
and locating Docket No. FAA-2018-0281.

Comments

    We gave the public the opportunity to participate in developing
this final rule. We received no comments on the NPRM or on the
determination of the cost to the public.

Revised the Name of the Type Certificate Holder

    We determined that the name of the type certificate (TC) design
holder that we used in the NPRM does not match the name used in the
type certificate data sheet. We have revised references in this AD from
``Hoffmann Propeller GmbH & Co. KG'' to ``Hoffmann GmbH & Co. KG'' when
we are referring to the name of the TC design holder.

Conclusion

    We reviewed the relevant data and determined that air safety and
the public interest require adopting this final rule as proposed except
for minor editorial changes. We have determined that these minor
changes:
     Are consistent with the intent that was proposed in the
NPRM for addressing the unsafe condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM.

Related Service Information

    We reviewed Hoffmann Propeller GmbH & Co. KG Service Bulletin (SB)
E34 Rev. B, dated September 18, 2017. The SB describes the instructions
for the removal and installation of the propeller blades.

Costs of Compliance

    We estimate that this AD affects 50 propellers installed on
airplanes of U.S. registry.
    We estimate the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
                Action                         Labor cost           Parts cost        product        operators
----------------------------------------------------------------------------------------------------------------
Replace blades between overhaul.......  3 work-hours x $85 per            $3,150          $3,405         $85,125
                                         hour = $255.
Replace blades at overhaul............  0 work-hours x $85 per             3,150           3,150          78,750
                                         hour = $0.
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Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    We are issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.
    This AD is issued in accordance with authority delegated by the
Executive Director, Aircraft Certification Service, as authorized by
FAA Order 8000.51C. In accordance with that order, issuance of ADs is
normally a function of the Compliance and Airworthiness Division, but
during this transition period, the Executive Director has delegated the
authority to issue ADs applicable to engines, propellers, and
associated appliances to the Manager, Engine and Propeller Standards
Branch, Policy and Innovation Division.

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will not have 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.
    For the reasons discussed above, I certify this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

2018-20-03 Hoffmann GmbH & Co. KG: Amendment 39-19437; Docket No.
FAA-2018-0281; Product Identifier 2018-NE-06-AD.

(a) Effective Date

    This AD is effective November 14, 2018.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Hoffmann GmbH & Co. KG model HO-V 62
propellers without modified blades marked with change letter ``A''
or ``B'' suffix to the serial number (S/N).

(d) Subject

    Joint Aircraft System Component (JASC) Code 6110, Propeller
Assembly.

(e) Unsafe Condition

    This AD was prompted by the failure of the propeller blade lag
screws. We are issuing the AD to prevent failure of the propeller.
The unsafe condition, if not addressed, could result in the release
of the propeller blade, damage to the aircraft, and injury and/or
loss of life.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Required Actions

    Within 30 days of the effective date of this AD, remove the
applicable propeller blades and install modified propeller blades
marked with a change letter ``A'' or ``B'' suffix to the S/N marked
on the blade.

(h) Installation Prohibition

    After the effective date of this AD, do not install a propeller
blade if it is not marked with a change letter ``A'' or ``B'' suffix
to the S/N marked on the blade.

(i) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Boston ACO Branch, FAA, has the authority to
approve AMOCs for this AD, if requested using the procedures found
in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request
to your principal inspector or local Flight Standards District
Office, as appropriate. If sending information directly to the
manager of the Boston ACO Branch, send it to the attention of the
person identified in paragraph (j)(1) of this AD.
    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.

(j) Related Information

    (1) For more information about this AD, contact Maureen
Maisttison, Aerospace Engineer, Boston ACO Branch, FAA, 1200
District Ave, Burlington, MA, 01803; phone:<PHONE_NUMBER>; fax: 781-
238-7151; email: [email protected].
    (2) Refer to European Aviation Safety Agency AD 2017-0220, dated
November 10, 2017, for more information. You may examine the EASA AD
in the AD docket on the internet at http://www.regulations.gov by
searching for and locating Docket No. FAA-2018-0281.

    Issued in Burlington, Massachusetts, on September 27, 2018.
Robert J. Ganley,
Manager, Engine and Propeller Standards Branch, Aircraft Certification
Service.
[FR Doc. 2018-21507 Filed 10-9-18; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 83, Number 212 (Thursday, November 1, 2018)]
[Rules and Regulations]
[Pages 54869-54872]
[FR Doc No: 2018-23863]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 73

[Docket No. FDA-2017-C-6238]

Listing of Color Additives Exempt From Certification; Synthetic
Iron Oxide

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA or we) is amending the
color additive regulations to provide for the expanded safe use of
synthetic iron oxides as color additives to include use in dietary
supplement tablets and capsules. This action is in response to a color
additive petition (CAP) filed by Colorcon, Inc.

DATES: This rule is effective December 4, 2018. See section X for
further information on the filing of objections. Submit either
electronic or written objections and requests for a hearing on the
final rule by December 3, 2018.

ADDRESSES: You may submit objections and requests for a hearing as
follows. Please note that late, untimely filed objections will not be
considered. Electronic objections must be submitted on or before
December 3, 2018. The https://www.regulations.gov electronic filing
system will accept comments until 11:59 p.m. Eastern Time at the end of
December 3, 2018. Objections received by mail/hand delivery/courier
(for written/paper submissions) will be considered timely if they are
postmarked or the delivery service acceptance receipt is on or before
that date.

Electronic Submissions

    Submit electronic objections in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Objections submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your

objection will be made public, you are solely responsible for ensuring
that your objection does not include any confidential information that
you or a third party may not wish to be posted, such as medical
information, your or anyone else's Social Security number, or
confidential business information, such as a manufacturing process.
Please note that if you include your name, contact information, or
other information that identifies you in the body of your objection,
that information will be posted on https://www.regulations.gov.
     If you want to submit an objection with confidential
information that you do not wish to be made available to the public,
submit the objection as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper objections submitted to the Dockets
Management Staff, FDA will post your objection, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2017-C-6238 for ``Listing of Color Additives Exempt from
Certification; Synthetic Iron Oxide.'' Received objections, those filed
in a timely manner (see ADDRESSES), will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at https://www.regulations.gov or with the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit an objection with
confidential information that you do not wish to be made publicly
available, submit your objections only as a written/paper submission.
You should submit two copies total. One copy will include the
information you claim to be confidential with a heading or cover note
that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The
Agency will review this copy, including the claimed confidential
information, in our consideration of comments. The second copy, which
will have the claimed confidential information redacted/blacked out,
will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management
Staff. If you do not wish your name and contact information to be made
publicly available, you can provide this information on the cover sheet
and not in the body of your comments and you must identify this
information as ``confidential.'' Any information marked as
``confidential'' will not be disclosed except in accordance with 21 CFR
10.20 and other applicable disclosure law. For more information about
FDA's posting of comments to public dockets, see 80 FR 56469, September
18, 2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Molly A. Harry, Center for Food Safety
and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr.,
College Park, MD 20740-3835,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Introduction

    In a document published in the Federal Register on November 9, 2017
(82 FR 52037), we announced that we filed a color additive petition
(CAP 7C0308) submitted by Colorcon, Inc., 275 Ruth Rd., Harleysville,
PA 19438. The petition proposed to amend the color additive regulations
in Sec.  73.200 Synthetic iron oxide (21 CFR 73.200) by expanding the
permitted uses of synthetic iron oxides as a color additive to include
use in dietary supplement tablets and capsules, including coatings and
printing inks. The petitioner requested that the proposed uses be
permitted at a maximum use level of 5 milligrams (mg), calculated as
elemental iron, per day for labeled dosages.

II. Background

    Synthetic iron oxides and their hydrated forms are currently
approved as color additives for use in human foods and drugs: (1) In
sausage casings intended for human consumption in an amount not to
exceed 0.10 percent by weight of the finished food (Sec.  73.200); (2)
in soft and hard candy, mints, and chewing gum at levels consistent
with good manufacturing practice (GMP), except that they may not be
used to color foods for which standards of identity have been issued
under section 401 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 431) (FD&C Act), unless the use of the added color is authorized
by such standards (Sec.  73.200); and (3) in ingested or topically
applied drugs with a limit for ingested drugs of 5 mg, calculated as
elemental iron, per day for labeled or prescribed dosages (21 CFR
73.1200). Synthetic iron oxides also are approved for use as color
additives in cosmetics generally, including cosmetics applied to the
area of the eye, in amounts consistent with GMP (21 CFR 73.2250).
    Synthetic iron oxides and their hydrated forms include red iron
oxide (synthetic hematite), yellow iron oxide (synthetic geoethite),
black iron oxide (synthetic magnetite), and brown iron oxide, which is
a blend of various iron oxides. For the subject petition, synthetic
iron oxides are intended for coloring dietary supplement tablets and
capsules, including coatings for tablets and capsules and printing inks
applied to dietary supplement tablets and capsules, such that the total
amount of elemental iron in the dietary supplements does not exceed 5
mg per day for labeled dosages.

III. Safety Evaluation

    Under section 721(b)(4) of the FD&C Act (21 U.S.C. 379e(b)(4)), a
color additive cannot be listed for a particular use unless the data
and information available to FDA establish that the color additive is
safe for that use. FDA's color additive regulations in 21 CFR 70.3(i)
define ``safe'' to mean that there is convincing evidence that
establishes with reasonable certainty that no harm will result from the
intended use of the color additive.
    To establish with reasonable certainty that a color additive
intended for use in foods is not harmful under its intended conditions
of use, we consider the projected human dietary exposure to the color
additive, the additive's toxicological data, and other relevant
information (such as published literature) available to us. We compare
an individual's estimated exposure, or estimated daily intake (EDI), of
the color additive from all sources to an acceptable daily intake level
established by toxicological data. The EDI is determined by projections
based on the amount of the color additive proposed for use in
particular foods and on data regarding the amount consumed from all
sources of the color additive. We commonly use the EDI for the 90th
percentile consumer of a color additive as a measure of high chronic
exposure.

IV. Safety of Petitioned Use of Color Additive

A. Estimated Dietary Exposure

    To support the safety of the proposed use of synthetic iron oxides,
Colorcon proposed a maximum use level of the color additive in dietary
supplements such that the total amount of elemental iron consumed shall
not exceed 5 mg per day for labeled dosages. Using 2-day food
consumption data from the 2009-2010 National Health and Nutrition
Examination Survey (NHANES) food consumption database, Colorcon
estimated exposure to elemental iron from the proposed use in dietary
supplements. From the NHANES data, Colorcon determined that 2 dietary
supplements are consumed in a 24-hour period at the mean, and 4 at the
90th percentile. We note that these values could represent 2 or 4
different dietary supplements, respectively, with each supplement
containing up to 5 mg elemental iron. Considering this, FDA has
estimated exposure to elemental iron resulting from the petitioned use
of synthetic iron oxides in dietary supplements as described below.
    Using more recent NHANES data (2011-2014), FDA determined that the
U.S. population aged 2 years and older consumes 2 dietary supplements
per day at the mean and 5 supplements per day at the 90th percentile
(Ref. 1). In estimating exposure, we presumed that: (1) Each dietary
supplement could contain up to 5 mg elemental iron for labeled dosages
from the use of synthetic iron oxides, resulting in an exposure to
elemental iron of 10 milligrams per person per day (mg/p/d) at the mean
and 25 mg/p/d at the 90th percentile; (2) all dietary supplements would
contain added synthetic iron oxides; and (3) the added synthetic iron
oxides would contain a maximum amount (72 percent) of elemental iron;
therefore, the use level of 5 mg elemental iron per labeled dosage of
dietary supplement would result in a use level of 6.9 mg synthetic iron
oxides per labeled dosage of dietary supplement (Ref. 1).
    We estimated an upper-bound exposure to synthetic iron oxides from
its use as a color additive in dietary supplement tablets and capsules
and in coatings applied to dietary supplement tablets and capsules, but
excluding its use in printing inks applied on tablets and capsules, to
be 13.8 mg/p/d at the mean and 34.5 mg/p/d at the 90th percentile for
the U.S. population aged 2 years and older (Ref. 1). The exposure to
elemental iron from the petitioned use of synthetic iron oxides is
estimated to be 10 mg/p/d at the mean and 25 mg/p/d at the 90th
percentile. Regarding exposure to elemental iron resulting from the
proposed use of synthetic iron oxides in printing inks applied on
tablets and capsules, we estimated that the amount of elemental iron
from the use of synthetic iron oxides in inks for use on tablets and
capsules is no more than 5.4 micrograms ([micro]g) per tablet or
capsule, which corresponds to 10.8 [micro]g elemental iron/p/d at the
mean (2 tablets or capsules) and 27 [micro]g elemental iron/p/d at the
90th percentile level (5 tablets or capsules) (Ref. 1). This exposure
is negligible compared to that for use of elemental iron as a color
additive in tablets and capsules and in coatings applied to dietary
supplements.
    In the final rule approving the use of synthetic iron oxides for
use in candy, mints, and chewing gum (80 FR 14839, March 20, 2015), FDA
discussed that elemental iron from synthetic iron oxides is not readily
bioavailable and is poorly absorbed by the human gastrointestinal tract
(80 FR 14839 at 14840). Approximately 18 percent of iron from
conventional foods and dietary supplements is bioavailable and about 1
percent of iron from synthetic iron oxides is bioavailable (Ref. 1).
Taking into account the bioavailability of iron from synthetic iron
oxides, the exposure to elemental iron from the petitioned use of
synthetic iron oxides for the U.S. population aged 2 years and older is
estimated to be 0.10 mg/p/d at the mean and 0.25 mg/p/d at the 90th
percentile (Ref 1).
    We previously estimated the cumulative exposure to bioavailable
elemental iron for the U.S. population to be 3.48 mg/p/d at the mean
(Ref. 1). Therefore, considering the exposure of 0.10 mg/p/d for
elemental iron from the proposed use of synthetic iron oxides, the
updated cumulative exposure to bioavailable iron from the current and
proposed sources for the U.S. population aged 2 years and older is
estimated to be 3.6 mg/p/d at the mean and 7.2 mg/p/d at the pseudo-
90th percentile (Ref. 1).

B. Acceptable Intake Level for Iron

    In 2001, the Institute of Medicine (IOM) published a report on
dietary reference intakes for vitamins and minerals (Ref. 2). In the
report, IOM determined dietary reference intakes and upper limits (ULs)
for iron of 40 mg/d for children (2-13 years of age) and 45 mg/d for
adolescents and adults (14 years and older) (Ref. 2). The IOM considers
the UL as the highest daily intake level of a nutrient that poses no
risk of adverse effects with chronic consumption of the nutrient (Ref.
2). The UL is determined using a risk assessment model developed
specifically for nutrients and may consider intake from such sources as
food, water, nutrient supplements, and pharmacological agents (Ref. 2).
The dose-response assessment, which concludes with an estimate of the
UL, is built upon three toxicological concepts commonly used in
assessing the risk of exposures to chemical substances: No-observed-
adverse-effect level, lowest-observed-effect level, and an uncertainty
factor (Ref. 2).
    We considered the UL established by IOM for iron (45 mg/d) relative
to the cumulative exposure for bioavailable elemental iron of 7.2 mg/p/
d (at the 90th percentile for U.S. population 2 years and older) as the
primary basis for assessing the safety of exposure to elemental iron
from the proposed use of synthetic iron oxides (Ref. 3). Additionally,
we reviewed scientific articles and other relevant studies available to
FDA on the safety of iron (Ref. 3). Because the 90th percentile
exposure estimate to bioavailable elemental iron from all dietary
sources, including the proposed use of synthetic iron oxides to color
dietary supplement tablets and capsules, is significantly below the UL
determined by IOM, we conclude that there is a reasonable certainty of
no harm from the proposed use of synthetic iron oxide as a color
additive in dietary supplement tablets and capsules (Ref. 3).

V. Conclusion

    FDA reviewed the data and information in the petition and other
available relevant material and determined the petitioned use of
synthetic iron oxides in dietary supplement tablets and capsules is
safe. We further conclude that the color additive will achieve its
intended technical effect and is suitable for the petitioned use.
Consequently, we are amending the color additive regulations in 21 CFR
part 73 as set forth in this document. In addition, based upon the
factors listed in 21 CFR 71.20(b), we continue to conclude that
certification of synthetic iron oxides is not necessary for the
protection of public health.

VI. Public Disclosure

    In accordance with Sec.  71.15 (21 CFR 71.15), the petition and the
documents that we considered and relied upon in reaching our decision
to approve the petition will be made available for public disclosure
(see FOR FURTHER INFORMATION CONTACT). As provided in Sec.  71.15, we
will delete from the documents any materials that are not available for
public disclosure.

VII. Analysis of Environmental Impact

    We previously considered the environmental effects of this rule, as
stated in the November 9, 2017, Federal Register notification of
petition for CAP 7C0308 (82 FR 52037). We stated that we had
determined, under 21 CFR 25.32(k), that this action is of a type that
does not individually or cumulatively have a significant effect on the
human environment such that neither an environmental assessment nor an
environmental impact statement is required. We have not received any
new information or comments that would affect our previous
determination.

VIII. Paperwork Reduction Act of 1995

    This final rule contains no collection of information. Therefore,
clearance by the Office of Management and Budget under the Paperwork
Reduction Act of 1995 is not required.

IX. Section 301(ll) of the Federal Food, Drug, and Cosmetic Act

    Our review of this petition was limited to section 721 of the FD&C
Act. This final rule is not a statement regarding compliance with other
sections of the FD&C Act. For example, section 301(ll) of the FD&C Act
prohibits the introduction or delivery for introduction into interstate
commerce of any food that contains a drug approved under section 505 of
the FD&C Act (21 U.S.C. 355), a biological product licensed under
section 351 of the Public Health Service Act (42 U.S.C. 262), or a drug
or biological product for which substantial clinical investigations
have been instituted and their existence has been made public, unless
one of the exemptions in section 301(ll)(1) to (4) of the FD&C Act
applies. In our review of this petition, we did not consider whether
section 301(ll) of the FD&C Act or any of its exemptions apply to food
containing this color additive. Accordingly, this final rule should not
be construed to be a statement that a food containing this color
additive, if introduced or delivered for introduction into interstate
commerce, would not violate section 301(ll) of the FD&C Act.
Furthermore, this language is included in all color additive final
rules that pertain to food and therefore should not be construed to be
a statement of the likelihood that section 301(ll) of the FD&C Act
applies.

X. Objections

    This rule is effective as shown in the DATES section, except as to
any provisions that may be stayed by the filing of proper objections.
If you will be adversely affected by one or more provisions of this
regulation, you may file with the Dockets Management Staff (see
ADDRESSES) either electronic or written objections. You must separately
number each objection, and within each numbered objection you must
specify with particularity the provision(s) to which you object, and
the grounds for your objection. Within each numbered objection, you
must specifically state whether you are requesting a hearing on the
particular provision that you specify in that numbered objection. If
you do not request a hearing for any particular objection, you waive
the right to a hearing on that objection. If you request a hearing,
your objection must include a detailed description and analysis of the
specific factual information you intend to present in support of the
objection in the event that a hearing is held. If you do not include
such a description and analysis for any particular objection, you waive
the right to a hearing on the objection.
    Any objections received in response to the regulation may be seen
in the Dockets Management Staff between 9 a.m. and 4 p.m., Monday
through Friday, and will be posted to the docket at https://www.regulations.gov. We will publish notice of the objections that we
have received or lack thereof in the Federal Register.

XI. References

    The following references marked with an asterisk (*) are on display
in the Dockets Management Staff (see ADDRESSES) and are available for
viewing by interested persons between 9 a.m. and 4 p.m., Monday through
Friday; they are also available electronically at https://www.regulations.gov. The reference without an asterisk is not on public
display at https://www.regulations.gov because it has copyright
restriction but is available at the website address. The reference
without an asterisk is available for viewing only at the Dockets
Management Staff. FDA has verified the website address, as of the date
this document publishes in the Federal Register, but websites are
subject to change over time.

*1. Memorandum from D. Doell, Chemistry Review Team, Division of
Petition Review, Office of Food Additive Safety (OFAS), Center for
Food Safety and Applied Nutrition (CFSAN), FDA to M. Harry, Division
of Petition Review, OFAS, CFSAN, FDA, September 17, 2018.
2. Institute of Medicine, ``Dietary Reference Intakes for Vitamin A,
Vitamin K, Arsenic, Boron, Chromium, Copper, Iodine, Iron,
Manganese, Molybdenum, Nickel, Silicon, Vanadium, and Zinc.''
Washington, DC: National Academies Press (U.S.); 2001. https://www.ncbi.nlm.nih.gov/books/NBK222310/pdf/Bookshelf_NBK222310.pdf.
*3. Memorandum from T. Thurmond, Toxicology Team, Division of
Petition Review, OFAS, CFSAN, FDA to M. Harry, Division of Petition
Review, OFAS, CFSAN, FDA, September 17, 2018.

List of Subjects in 21 CFR Part 73

    Color additives, Cosmetics, Drugs, Foods, Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
73 is amended as follows:

PART 73--LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION

0
1. The authority citation for part 73 continues to read as follows:

    Authority:  21 U.S.C. 321, 341, 342, 343, 348, 351, 352, 355,
361, 362, 371, 379e.

0
2. Section 73.200 is amended by revising paragraph (c)(1) to read as
follows:

Sec.  73.200   Synthetic iron oxide.

* * * * *
    (c) * * *
    (1) Synthetic iron oxide may be safely used for human food use
subject to the following restrictions:
    (i) In sausage casings intended for human consumption in an amount
not exceeding 0.10 percent by weight of the finished food.
    (ii) In soft and hard candy, mints, and chewing gum at levels
consistent with good manufacturing practice, except that it may not be
used to color foods for which standards of identity have been issued
under section 401 of the Federal Food, Drug, and Cosmetic Act, unless
the use of the added color is authorized by such standards.
    (iii) In dietary supplement tablets and capsules, including
coatings and printing inks, such that the total amount of elemental
iron per day for labeled dosages does not exceed 5 milligrams.
* * * * *

    Dated: October 26, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-23863 Filed 10-31-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: July 7, 2008 (Volume 73, Number 130)]
[Notices]
[Page 38484-38487]
[DOCID:fr07jy08-134]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-58058; File No. SR-NYSEArca-2008-65]

Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing
and Order Granting Accelerated Approval of Proposed Rule Change to
Trade Shares of the MacroShares Oil Trusts Pursuant to Unlisted Trading
Privileges

June 30, 2008.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on June 19, 2008, NYSE Arca, Inc. (``NYSE Arca'' or the ``Exchange''),
through its wholly owned subsidiary NYSE Arca Equities, Inc. (``NYSE
Arca Equities'' or the ``Corporation''), filed with the Securities and
Exchange Commission (``Commission'') the proposed rule change as
described in Items I and II below, which Items have been substantially
prepared by the Exchange. This order provides notice of the proposed
rule change and approves the proposal on an accelerated basis.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to trade pursuant to unlisted trading
privileges (``UTP'') under NYSE Arca Equities Rule 8.400 (``Paired
Trust Shares'') shares of the MacroShares $100 Oil Up Trust (``Up
Trust'') and the MacroShares $100 Oil Down Trust (``Down Trust'')
(collectively, the ``Trusts''). The text of the proposed rule change is
available at the Exchange's principal office, the Commission's Public
Reference Room, and http://www.nyse.com.

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

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

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

1. Purpose
    The Exchange proposes to trade pursuant to UTP shares of the Up
Trust (``Up MacroShares'') and the Down Trust (``Down MacroShares'')
(collectively, the ``Shares'') under NYSE Arca Equities Rule 8.400.\3\
The Up MacroShares and the Down MacroShares will be offered by the Up
Trust and the Down Trust, respectively, established by MACRO Securities
Depositor LLC, as depositor, under the laws of the State of New York.
The Trusts are not registered with the Commission as investment
companies.\4\ Recently, the Commission approved a proposal by Amex to
list and trade the Shares.\5\
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    \3\ The Commission approved trading a similar product on the
Exchange pursuant to unlisted trading privileges (``UTP'') when it
approved NYSE Arca Equities Rule 8.400. See Securities Exchange Act
Release No. 55033 (December 29, 2006), 72 FR 1253 (January 10, 2007)
(SR-NYSEArca-2006-75) (approving UTP trading of Claymore MACROshares
Oil Up Tradeable Shares and Claymore MACROshares Oil Down Tradeable
Shares). The Commission also approved those products for listing and
trading on the American Stock Exchange LLC (``Amex''). See
Securities Exchange Act Release No. 54839 (November 29, 2006), 71 FR
70804 (December 6, 2006) (SR-Amex-2006-82).
    \4\ The Shares are being offered by the Trusts under the
Securities Act of 1933. On April 17, 2008, the depositor filed with
the Commission a Registration Statement on Form S-1 for both the Up
MacroShares (File No. 333-150282-01) (``Up Trust Registration
Statement'') and the Down MacroShares (File No. 333-150282-02)
(``Down Trust Registration Statement'' and together with the Up
Trust Registration Statement, the ``Registration Statements'').
    \5\ See Securities Exchange Act Release No. 58057 (June 30,
2008). See also Securities Exchange Act Release No. 57925 (June 5,
2008), 73 FR 33121 (SR-Amex-2008-36) (``Amex Notice'').
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(a) Description of the Fund and the Trust
    The Up Trust and the Down Trust intend to issue Up MacroShares and
Down MacroShares, respectively, on a continuous basis at the direction
of authorized participants, as described in the Amex Notice. The Up
MacroShares and the Down MacroShares represent undivided beneficial
interests in the Up Trust and the Down Trust, respectively. The assets
of each Trust will include an income distribution agreement and
settlement contracts entered into with the other Trust. Under the
income distribution agreement, as of any distribution date, each Trust
will either (a) be required to pay all or a portion of its available
income to the other Trust or (b) be entitled to receive all or a
portion of the other Trust's available income, based, in each case, on
the level of the Applicable Reference Price of Crude Oil (as defined
below) for each day during the preceding calculation period. Under each
settlement contract, in connection with the final scheduled termination
date, an early termination date or any redemption date, each Trust will
either (a) be required to make a final payment out of its assets to the
other Trust or (b) be entitled to receive a final payment from the
other Trust out of the assets of the other Trust, based, in each case,
on the change in the level of the Applicable Reference Price of Crude
Oil from its starting level on the closing date to its ending level on
the relevant price determination day preceding the final scheduled
termination date, early termination date, or redemption date, as the
case may be.
    Each Trust will also hold U.S. Treasuries and repurchase agreements
on U.S. Treasuries to secure its obligations under the income
distribution agreement and the settlement contracts. Each Trust will
make quarterly distributions of income on the treasuries and a final
distribution of all assets it holds on deposit on the final scheduled
termination date, an early termination date, or a redemption date.\4\
Each quarterly and final distribution will be based on the value of the
Applicable Reference Price of Crude Oil, which is defined as the
settlement price of the NYMEX division light sweet crude oil futures
contract of the designated maturity, as established and reported by
NYMEX on a per-barrel basis in U.S. dollars at the end of each price
determination day. For this purpose, a price determination day refers
to each day on which trading of the light sweet crude oil futures
contract of the designated maturity occurs by open outcry on the
trading floor of NYMEX.\6\ The Applicable Reference Price of Crude Oil
is the reference value on the basis of which quarterly and final
distributions on the Up MacroShares and Down MacroShares are
calculated.
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    \6\ If trading of the NYMEX division's light sweet crude oil
futures contract ceases to occur by open outcry and is transferred
by NYMEX to an electronic platform, a price determination day will
be based upon trading on such electronic platform.
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    With respect to the Up Trust, if the level of the Applicable
Reference Price of Crude Oil on any price determination day exceeds its
starting level on the closing date (the date on which the Trusts
entered into the income distribution agreement), the underlying value
of the Up Trust will increase to include all of its assets plus a
portion of the assets of the paired Down Trust. Conversely, if the
level of the Applicable Reference Price of Crude Oil

on any price determination day falls below its starting level, the Up
Trust's underlying value will decrease because a portion of its assets
will be included in the underlying value of the paired Down Trust. The
underlying value of the Up Trust on each price determination day
represents the aggregate amount of the assets in the paired Trusts to
which the Up Trust would be entitled if the settlement contracts were
settled on that day.
    With respect to the Down Trust, if the level of the Applicable
Reference Price of Crude Oil on any price determination day exceeds its
starting level on the closing date, the underlying value of the Down
Trust will decrease because a portion of its assets will be included in
the underlying value of the paired Up Trust. Conversely, if the level
of the Applicable Reference Price of Crude Oil on any price
determination day falls below its starting level, the Down Trust's
underlying value will increase to include all of its assets plus a
portion of the assets of the paired Up Trust. The underlying value of
the Down Trust on each price determination day represents the aggregate
amount of the assets in the paired Trusts to which the Down Trust would
be entitled if the settlement contracts were settled on that day.
    The Registration Statements for the Trusts will provide a detailed
description of the Shares, the Trusts, the Applicable Reference Price
of Crude Oil, quarterly distributions, final distributions, underlying
values, risks, fees and expenses, termination triggers, and creation
and redemption procedures.
(b) Availability of Information
    Intraday Indicative Values. According to the Amex Notice,
throughout each price determination day, Amex, acting as the
calculation agent for each Trust, will calculate and disseminate, at
least every 15 seconds during regular Amex trading hours, through the
facilities of the Consolidated Tape Association (``CTA''), an estimated
value (referred to as an ``Intraday Indicative Value'' or ``IIV'') for
the underlying value per Share of both the Up MacroShares and the Down
MacroShares. To enable this calculation, Amex will receive real-time
price data from the NYMEX through two major market data vendors for the
light sweet crude oil futures contract of the designated maturity that
trades on the NYMEX.
    Because the NYMEX market for the light sweet crude oil futures
contract will be closed for portions of the Amex trading day, the IIV
calculated values will become fixed and will not be updated at such
times that the NYMEX contract is not trading.\7\ Conversely, at times
when the light sweet crude oil futures contract of the designated
maturity is trading on NYMEX, those trades will be used to update the
IIV values.
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    \7\ The IIV calculated during the period following the daily
opening of trading of the Shares on Amex but prior to any trades
taking place on the NYMEX in the relevant light sweet crude oil
futures contract will be based on the final price of the futures
contract on the prior trading day.
---------------------------------------------------------------------------

    Availability of Other Information and Data. According to the Amex
Notice, at the end of each price determination day, Amex will also
calculate the premium or discount of the midpoint of the bid/offer for
the Up MacroShares at the Amex close relative to the underlying value
of one of those Shares for that price determination day, after the
latter is calculated and provided to Amex by the trustee. Amex will
also perform the same calculation with respect to the Down MacroShares.
Amex will then post these premiums/discounts, together with the end-of-
day price information for the Shares, on its Web site at http://
www.amex.com/amextrader. Further, Amex will post on its Web site any
corrections made by NYMEX to the Applicable Reference Price of Crude
Oil that was reported by NYMEX for any price determination day. Amex
also intends to disseminate a variety of data with respect to the
Shares on a daily basis by means of CTA and CQ High Speed Lines,
including quotation and last-sale data information.
    On each price determination day, State Street Bank and Trust
Company, the trustee for the Up Trust and the Down Trust, will
calculate the underlying value of the Up Trust and the Down Trust and
the per-Share underlying value of the Up MacroShares and the Down
MacroShares, based on the Applicable Reference Price of Crude Oil
established and reported by NYMEX. The trustee will then provide such
values to the administrative agent, which will post them on its Web
site at http://www.macromarkets.com. All investors and market
participants will have access to the administrative agent's Web site at
no charge. Information regarding secondary market prices and volume of
the Shares will be broadly available on a real-time basis throughout
the trading day on brokers' computer screens and other electronic
services. The previous day's closing price and trading volume
information will be published daily in the financial section of
newspapers.
(c) Trading Halts
    The Exchange represents that it will cease trading the Shares if
the listing market stops trading the Shares because of a regulatory
halt similar to a halt based on NYSE Arca Equities Rule 7.12. Trading
in the Shares will also be governed by the trading halt provisions of
NYSE Arca Equities Rule 7.34, relating to temporary interruptions in
the calculation or wide dissemination of the IIV or the value of the
underlying index, as applicable.
    With respect to trading halts, the Exchange may consider all
relevant factors in exercising its discretion to halt or suspend
trading in the Shares. Trading may be halted because of market
conditions or for reasons that, in the view of the Exchange, make
trading in the Shares inadvisable. These may include: (1) The extent to
which trading is not occurring in the underlying securities; or (2)
whether other unusual conditions or circumstances detrimental to the
maintenance of a fair and orderly market are present. NYSE Arca
Equities Rule 8.400(d)(2) sets forth circumstances under which Shares
may be halted.
    If the Exchange becomes aware that the underlying value per share
of the Up MacroShares or the Down MacroShares is not disseminated to
all market participants at the same time, it will halt trading in the
relevant Shares until such time as the underlying value per share is
available to all market participants.
(d) Trading Rules
    The Exchange deems the Shares to be equity securities, thus
rendering trading in the Shares subject to the Exchange's existing
rules governing the trading of equity securities. Shares will trade on
the NYSE Arca Marketplace from 4 a.m. to 8 p.m. Eastern Time in
accordance with NYSE Arca Equities Rule 7.34 (Opening, Core, and Late
Trading Sessions). The Exchange has appropriate rules to facilitate
transactions in the Shares during all trading sessions.
(e) Surveillance
    The Exchange intends to utilize its existing surveillance
procedures applicable to derivative securities products, including
Paired Trust Shares, to monitor trading in the Shares. The Exchange
represents that these procedures are adequate to properly monitor
Exchange trading of the Shares in all trading sessions and to deter and
detect violations of Exchange rules or applicable federal securities
laws.
    The Exchange's current trading surveillance focuses on detecting
securities trading outside their normal patterns. When such situations
are detected, surveillance analysis follows and investigations are
opened, where

appropriate, to review the behavior of all relevant parties for all
relevant trading violations.
    The Exchange may obtain information via the Intermarket
Surveillance Group (``ISG'') from other exchanges who are members of
the ISG.\8\
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    \8\ For a list of the current members of ISG, see http://
www.isgportal.org.
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    In addition, the Exchange also has a general policy prohibiting the
distribution of material, non-public information by its employees.
(f) Information Bulletin
    Prior to the commencement of trading, the Exchange will inform its
ETP Holders in an Information Bulletin (``Bulletin'') of the special
characteristics and risks associated with trading the Shares, including
risks inherent with trading the Shares during the Opening and Late
Trading Sessions when the updated IIV is not calculated and
disseminated. Specifically, the Bulletin will discuss the following:
(1) What the Shares are; (2) the procedures for purchases and
redemptions of Shares in MacroShares Units (and that Shares are not
individually redeemable); (3) NYSE Arca Equities Rule 9.2(a), which
provides that an ETP Holder, before recommending a transaction, must
have reasonable grounds to believe that the recommendation is suitable
for the customer based on any facts disclosed by the customer as to his
other security holdings and as to his financial situation and needs;
\9\ (4) the requirement that ETP Holders deliver a prospectus to
investors purchasing newly issued Shares prior to or concurrently with
the confirmation of a transaction; (5) how information regarding the
IIV is disseminated; and (6) trading information.
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    \9\ Further, the rule provides, with a limited exception, that
prior to the execution of a transaction recommended to a non-
institutional customer, the ETP Holder shall make reasonable efforts
to obtain information concerning the customer's financial status,
tax status, investment objectives, and any other information that
the ETP Holder believes would be useful to make a recommendation.
See Securities Exchange Act Release No. 54026 (June 21, 2006), 71 FR
36850 (June 28, 2006) (SR-PCX-2005-115).
---------------------------------------------------------------------------

    In addition, the Bulletin will reference that the Shares are
subject to various fees and expenses described in the Registration
Statements. The Bulletin will discuss any exemptive, no-action, and
interpretive relief granted by the Commission from any rules under the
Act.
2. Statutory Basis
    The proposed rule change is consistent with Section 6(b)(5) of the
Act \10\ which requires that the rules of the exchange are designed to
prevent fraudulent and manipulative acts and practices, to promote just
and equitable principles of trade, to remove impediments to, and
perfect the mechanism of a free and open market and, in general, to
protect investors and the public interest. The Exchange believes that
the proposed rule change will facilitate unlisted trading of an
additional type of exchange-traded product that will enhance
competition among market participants, to the benefit of investors and
the marketplace. In addition, the listing and trading criteria set
forth in the Rule 8.400 are intended to protect investors and the
public interest.
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    \10\ 15 U.S.C. 78f(b)(5).
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    In addition, the proposed rule change is consistent with Rule 12f-5
under the Act \11\ because it deems the Shares to be equity securities,
thus rendering the Shares subject to the Exchange's rules governing the
trading of equity securities.
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    \11\ 17 CFR 240.12f-5.
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B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act.

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

    The Exchange has neither solicited nor received written comments on
the proposed rule change.

III. 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 e-mail to<EMAIL_ADDRESS>Please include
File Number NYSEArca-2008-65 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 NYSEArca-2008-65. This file
number should be included on the subject line if e-mail 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 inspection and
copying in the Commission's Public Reference Room, 100 F Street, NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at the principal office 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 No. NYSEArca-2008-65 and should be
submitted on or before July 28, 2008.

IV. Commission's Findings and Order Granting Accelerated Approval of
Proposed Rule Change

    The Commission finds that the proposed rule change is consistent
with the requirements of the Act and the rules and regulations
thereunder applicable to a national securities exchange.\12\ In
particular, the Commission finds that the proposed rule change is
consistent with Section 6(b)(5) of the Act,\13\ in that it is designed
to prevent fraudulent and manipulative acts and practices, to promote
just and equitable principles of trade, to foster cooperation and
coordination with persons engaged in facilitating transactions in
securities, 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 Commission believes that
this proposal should benefit investors by increasing

competition among markets that trade the Shares.
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    \12\ In approving this rule change, the Commission notes that it
has considered the proposed rule's impact on efficiency,
competition, and capital formation. See 15 U.S.C. 78c(f).
    \13\ 15 U.S.C. 78f(b)(5).
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    In addition, the Commission finds that proposal is consistent with
Section 12(f) of the Act,\14\ which permits an exchange to trade,
pursuant to UTP, a security that is listed and registered on another
exchange.\15\ The Commission notes that it approved the original
listing and trading of the Shares on Amex.\16\ The Commission also
finds that the proposal is consistent with Rule 12f-5 under the
Act,\17\ which provides that an exchange shall not extend UTP to a
security unless the exchange has in effect a rule or rules providing
for transactions in the class or type of security to which the exchange
extends UTP. The Exchange has represented that it meets this
requirement because it deems the Shares to be equity securities, thus
rendering trading in the Shares subject to the Exchange's existing
rules governing the trading of equity securities.
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    \14\ 15 U.S.C. 78l(f).
    \15\ Section 12(a) of the Act, 15 U.S.C. 78l(a), generally
prohibits a broker-dealer from trading a security on a national
securities exchange unless the security is registered on that
exchange pursuant to Section 12 of the Act. Section 12(f) of the Act
excludes from this restriction trading in any security to which an
exchange ``extends UTP.'' When an exchange extends UTP to a
security, it allows its members to trade the security as if it were
listed and registered on the exchange even though it is not so
listed and registered.
    \16\ See supra note 5.
    \17\ 17 CFR 240.12f-5.
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    The Commission further believes that the proposal is consistent
with Section 11A(a)(1)(C)(iii) of the Act,\18\ which sets forth
Congress's finding that it is in the public interest and appropriate
for the protection of investors and the maintenance of fair and orderly
markets to assure the availability to brokers, dealers, and investors
of information with respect to quotations for and transactions in
securities. Quotations for and last-sale information regarding the
Shares will be disseminated through the facilities of the CTA and
Consolidated Quote High Speed Lines. Amex will disseminate through the
facilities of the CTA an IIV on a per-share basis at least every 15
seconds during regular trading hours. Amex will post the premium or
discount of the midpoint of the bid/offer, together with the end-of-day
price information, for the Shares on its Web site. In addition, the
per-Share underlying value for the Shares on each price determination
day will be publicly disseminated.
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    \18\ 15 U.S.C. 78k-1(a)(1)(C)(iii).
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    The Commission also believes that the proposal is reasonably
designed to prevent trading in the Shares when transparency is
impaired. The Exchange represents that it will halt trading in the
Shares if the listing market institutes a regulatory halt in trading in
the Shares. The Exchange also has represented that it would follow the
procedures with respect to trading halts set forth in NYSE Arca
Equities Rule 7.34, which provides, inter alia, for trading halts in
certain circumstances when the IIV is not being disseminated as
anticipated. In addition, if the Exchange becomes aware that the
underlying value per-Share of the Up MacroShares or the Down
MacroShares is not disseminated to all market participants at the same
time, it would halt trading in the relevant Shares until such time as
the underlying value per-Share is available to all market participants.
    The Commission notes that, if the Shares should be delisted by the
listing exchange, NYSE Arca would no longer have authority to trade the
Shares pursuant to this order.
    In support of the proposed rule change, the Exchange has made the
following representations:
    1. The Exchange intends to utilize its existing surveillance
procedures applicable to derivative securities products, including
Paired Trust Shares, to monitor trading in the Shares. The Exchange
represents that these procedures are adequate to properly monitor
Exchange trading of the Shares in all trading sessions and to deter and
detect violations of Exchange rules or applicable federal securities
laws.
    2. The Exchange will inform its ETP Holders in a Bulletin of the
special characteristics and risks associated with trading the Shares,
including risks inherent with trading the Shares during the Opening and
Late Trading Sessions when the updated IIV is not calculated and
disseminated.
    3. The Bulletin will reference the requirement that ETP Holders
deliver a prospectus to investors purchasing newly issued Shares prior
to or concurrently with the confirmation of a transaction.
    This approval order is based on these representations.
    The Commission finds good cause for approving this proposed rule
change prior to the thirtieth day after the publication of notice
thereof in the Federal Register. As noted above, the Commission
previously found that the listing and trading of these Shares on Amex
is consistent with the Act.\19\ The Commission presently is not aware
of any issue that would cause it to revisit that finding or preclude
the trading of the Shares on the Exchange pursuant to UTP. Therefore,
accelerating approval of this proposed rule change should benefit
investors by creating, without undue delay, additional competition in
the market for the Shares.
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    \19\ See supra note 5.
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V. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the Act,
that the proposed rule change (SR-NYSEArca-2008-65), is hereby approved
on an accelerated basis.\20\
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    \20\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\21\
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    \21\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Acting Secretary.
 [FR Doc. E8-15238 Filed 7-3-08; 8:45 am]

BILLING CODE 8010-01-P