[Federal Register: July 28, 2010 (Volume 75, Number 144)]
[Notices]
[Page 44256-44259]
[DOCID:fr28jy10-68]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2005-0494; FRL-8831-7]

Rotenone; Notice of Receipt of Requests to Voluntarily Cancel
Pesticide Registrations

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: In accordance with section 6(f)(1) of the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA), as amended, EPA is issuing a
notice of receipt of requests by the registrants to voluntarily cancel
their rotenone registrations. The requests would not terminate the last
rotenone products registered for use in the United States. EPA intends
to grant these requests at the close of the comment period for this
announcement unless the Agency receives substantive comments within the
comment period that would merit its further review of the requests, or
unless the registrants withdraw their requests. If these requests are
granted, any sale, distribution, or use of products listed in this
notice will be permitted after the registration has been cancelled only
if such sale, distribution, or use is consistent with the terms as
described in the final order.

DATES: Comments must be received on or before August 27, 2010.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2005-0494, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is<PHONE_NUMBER>.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2005-0494. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line 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 regulations.gov or e-
mail. The regulations.gov website is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through regulations.gov,
your e-mail address will be automatically captured and included as part
of the comment that is placed in the 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 docket index
available at http://www.regulations.gov. Although listed in the index,
some information is not publicly available, e.g., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, is not placed on the Internet
and will be publicly available only in hard copy form. Publicly
available docket materials are available either in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of
operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal holidays. The Docket Facility telephone
number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Veronica Dutch, Pesticide Re-
evaluation Division (7508P), Office of Pesticide

Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; e-mail
address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    This action is directed to the public in general, and may be of
interest to a wide range of stakeholders including environmental, human
health, and agricultural advocates; the chemical industry; pesticide
users; and members of the public interested in the sale, distribution,
or use of pesticides. Since others also may be interested, the Agency
has not attempted to describe all the specific entities that may be
affected by this action. If you have any questions regarding the
applicability of this action to a particular entity, consult the person
listed under FOR FURTHER INFORMATION CONTACT.

B. 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 e-mail. 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 submitting comments,
remember to:
    i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period
deadline identified.

II. Background on the Receipt of Requests to Cancel

    This notice announces receipt by EPA of requests from registrants
to cancel rotenone product registrations. Rotenone is an insecticide/
miticide/piscicide used to control flying and crawling insects and
invasive fish. In letters received by the Agency, the registrants
requested EPA to cancel affected pesticide product registrations
identified in Table 1 of Unit III. Specifically, the registrants have
requested voluntary cancellation of products containing rotenone. The
registrants' requests will not terminate the last rotenone product
registered in the United States.

III. What Action is the Agency Taking?

    This notice announces receipt by EPA of requests from registrants
to cancel 16 rotenone product registrations. The affected products and
the registrants making the requests are identified in Tables 1 and 2 of
this unit, respectively.
    Unless a request is withdrawn by the registrant or if the Agency
determines that there are substantive comments that warrant further
review of this request, EPA intends to issue an order canceling the
affected registrations.

   Table 1.--Rotenone Product Registrations with Pending Requests for
                              Cancellation
------------------------------------------------------------------------
       Registration Number           Product Name      Chemical Name(s)
------------------------------------------------------------------------
000004-00017                      Rotenone 1.0% Dust  Cube Resins other
                                                       than rotenone
                                                      Rotenone
------------------------------------------------------------------------
000004-00224                      Rotenone 5% Insect  Cube Resins other
                                   Control             than rotenone
                                                      Rotenone
------------------------------------------------------------------------
000004-00315                      Bonide Liquid       Cube Resins other
                                  Rotenone/            than rotenone
                                   Pyrethrins Spray.  Rotenone
------------------------------------------------------------------------
000004-00404                      Bonide Garden       Cube Resins other
                                   Rotenone Dust       than rotenone
                                                      Rotenone
------------------------------------------------------------------------
000004-00423                      Bonide Rotenone     Cube Resins other
                                   Garden Dust or      than rotenone
                                   Spray              Rotenone
------------------------------------------------------------------------
000270-00275                      Equi-Dust           Cube Resins other
                                                       than rotenone
                                                      Pyrethrins
                                                      Rotenone
------------------------------------------------------------------------
000769-00414                      Powdered Cube       Piperonyl butoxide
                                                      Pyrethrins
                                                      Rotenone
------------------------------------------------------------------------
000769-00857                      Science Red Arrow   Piperonyl butoxide
                                   Insect Spray       Cube Resins other
                                                       than rotenone
                                                      Pyrethrins
                                                      Rotenone
------------------------------------------------------------------------

000869-00186                      Green Light         Cube Resins other
                                   Rotenone            than rotenone
                                                      Rotenone
------------------------------------------------------------------------
002217-00145                      Garden Protector    Cube Resins other
                                                       than rotenone
                                                      Rotenone
------------------------------------------------------------------------
008660-00050                      1% Rotenone Garden  Cube Resins other
                                   Dust                than rotenone
                                                      Rotenone
------------------------------------------------------------------------
028293-00042                      Unicorn Ear Mite    Cube Resins other
                                   Control             than rotenone
                                                      Rotenone
------------------------------------------------------------------------
030573-00002                      Pyrellin E.C.       Cube Resins other
                                                       than rotenone
                                                      Pyrethrins
                                                      Rotenone
------------------------------------------------------------------------
033955-00270                      Acme 1% Rotenone    Cube Resins other
                                   Garden Guard        than rotenone
                                                      Rotenone
------------------------------------------------------------------------
034911-00021                      Hi-Yield Rotenone   Rotenone
                                   100 Insecticide
                                   Dust
------------------------------------------------------------------------
047000-00026                      Pet Dust            Cube Resins other
                                                       than rotenone
                                                      Rotenone
------------------------------------------------------------------------

    Table 2 of this unit includes the names and addresses of record for
the registrants of the products listed in Table 1 of this unit, in
sequence by EPA company number. This number corresponds to the first
part of the EPA registration numbers of the products listed in Table 1
of this unit.

         Table 2.--Registrants Requesting Voluntary Cancellation
------------------------------------------------------------------------
              Company Number                  Company Name and Address
------------------------------------------------------------------------
4                                           Bonide Products, Inc.
                                            P.O. Box 1019
                                            Salem, VA 24153-3805
------------------------------------------------------------------------
270                                         Farnam Companies, Inc.
                                            301 West Osborn Road
                                            Phoenix, AZ 85013
------------------------------------------------------------------------
769                                         Value Gardens Supply, LLC
                                            P.O. Box 585
                                            Saint Joseph, MO 64502
------------------------------------------------------------------------
869                                         Green Light Company
                                            1600 Riviera Avenue, Suite
                                             200
                                            Walnut Creek, CA 94596
------------------------------------------------------------------------
2217                                        PBI/Gordon Corp.
                                            1217 West 12th St.
                                            P.O. Box 014090
                                            Kansas City, MO 64101-0090
------------------------------------------------------------------------
8660                                        United Industries
                                             Corporation
                                            P.O. Box 142642
                                            St. Louis, MO 63114-0642
------------------------------------------------------------------------
28293                                       Phaeton Corporation
                                            P.O. Box 1019
                                            Salem, VA 24153
------------------------------------------------------------------------
30573                                       Wright Webb Corporation
                                            P.O. Box 1572
                                            Fort Myers, FL 33902
------------------------------------------------------------------------
33955                                       PBI/Gordon Corp
                                            1217 West 12th. St.
                                            P.O. Box 014090
                                            Kansas City, MO 64101-0090
------------------------------------------------------------------------
34911                                       Hi-Yield Chemical Company
                                            6860 N. Dallas Pkwy., Suite
                                             200
                                            Plano, TX 75024
------------------------------------------------------------------------
47000                                       Chem-Tech, LTD.
                                            4515 Fleur Dr. 303
                                            Des Moines, IA 50321
------------------------------------------------------------------------

IV. What is the Agency's Authority for Taking this Action?

    Section 6(f)(1) of FIFRA provides that a registrant of a pesticide
product may at any time request that any of its pesticide registrations
be canceled or amended to terminate one or more uses. FIFRA further
provides that, before acting on the request, EPA must publish a notice
of receipt of any such request in the Federal Register.
    Section 6(f)(1)(B) of FIFRA requires that before acting on a
request for voluntary cancellation, EPA must provide a 30-day public
comment period on the request for voluntary cancellation or use
termination. In addition, FIFRA section 6(f)(1)(C) requires that EPA
provide a 180-day comment period on a request for voluntary
cancellation or termination of any minor agricultural use before
granting the request, unless:
    1. The registrants request a waiver of the comment period, or
    2. The EPA Administrator determines that continued use of the
pesticide would pose an unreasonable adverse effect on the environment.
    The rotenone registrants have requested that EPA waive the 180-day
comment period. Accordingly, EPA will provide a 30-day comment period
on the proposed requests.

V. Procedures for Withdrawal of Requests

    Registrants who choose to withdraw a request for product
cancellation or use deletion should submit the withdrawal in writing to
the person listed under FOR FURTHER INFORMATION CONTACT. If the
products(s) have been subject to a previous cancellation action, the
effective date of cancellation and all other provisions of any earlier
cancellation action are controlling.

VI. Provisions for Disposition of Existing Stocks

    Existing stocks are those stocks of registered pesticide products
that are currently in the United States and that were packaged,
labeled, and released for shipment prior to the effective date of the
action. If the requests for voluntary

cancellation are granted, the Agency intends to publish the
cancellation order in the Federal Register.
    In any order issued in response to these requests for cancellation
of product registrations, EPA proposes to include the following
provisions for the treatment of any existing stocks of the products
listed in Table 1 of Unit III.
    Because the Agency has potential risk concerns associated with
these pesticide products, upon cancellation of the products identified
in Table 1 of Unit III., EPA anticipates allowing registrants to sell
and distribute existing stocks of these products until May 2011.
Thereafter, registrants will be prohibited from selling or distributing
the pesticides identified in Table 1 of Unit III., except for export
consistent with FIFRA section 17 or for proper disposal. Persons other
than registrants will generally be allowed to sell, distribute, or use
existing stocks until May 2011.

List of Subjects

    Environmental protection, Pesticides and pests.

    Dated: June 10, 2010.
Richard P. Keigwin,
Director, Pesticide Re-evaluation Division, Office of Pesticide
Programs.

[FR Doc. 2010-18377 Filed 7-27-10; 8:45 am]
BILLING CODE 6560-50-S


[Federal Register Volume 81, Number 218 (Thursday, November 10, 2016)]
[Rules and Regulations]
[Pages 78932-78937]
[FR Doc No: 2016-27204]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2015-0745; FRL-9954-04]

Trifloxystrobin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
trifloxystrobin in or on Cottonseed subgroup 20C; Cotton, gin
byproducts; and amends the existing tolerance on Corn, field, forage.
Bayer CropScience LP requested these tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective November 10, 2016. Objections and
requests for hearings must be received on or before January 9, 2017,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2015-0745, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW., Washington, DC 20460-0001. 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 OPP
Docket is<PHONE_NUMBER>. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Michael Goodis, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone
number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
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).

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

    You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2015-0745 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
January 9, 2017. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified

by docket ID number EPA-HQ-OPP-2015-0745, 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 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.

II. Summary of Petitioned-for Tolerance

    In the Federal Register of June 22, 2016 (81 FR 40594) (FRL-9947-
32), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
5F8380) by Bayer CropScience, 2 TW Alexander Drive, P.O. Box 12014,
Research Triangle Park, NC 27709. The petition requested that 40 CFR
180.555 be amended by establishing tolerances for residues of the
fungicide trifloxystrobin in or on cotton, undelinted seed, (Crop
subgroup 20C) at 0.5 parts per million (ppm); cotton, gin byproducts at
3 ppm; and revising the existing tolerance for corn, field, forage from
6 ppm to 8 ppm. That document referenced a summary of the petition
prepared by Bayer CropScience LP, the registrant, which is available in
the docket, http://www.regulations.gov. A comment was received on the
notice of filing. EPA's response to this comment is discussed in Unit
IV.C.
    Based upon review of the data supporting the petition, EPA has
corrected the commodity definitions for the requested cotton
commodities. The reason for these changes is explained in Unit IV.D.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
    Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for trifloxystrobin including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with trifloxystrobin
follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. Trifloxystrobin exhibits very low toxicity following single
oral, dermal and inhalation exposures. It is a strong dermal sensitizer
and a mild dermal and eye irritant. In repeated dose studies in rats,
mice, and dogs, liver effects and reduced body weights along with
reduction in food consumption are the common findings for
trifloxystrobin. Liver effects included an increase in liver weights
and an increased incidence of hepatocellular hypertrophy and/or
hepatocellular necrosis. In the rabbit developmental toxicity study, an
increase in the incidence of fused sternabrae was seen at a dose 10
times higher than the maternal lowest observed adverse effect level
(LOAEL), while no developmental effects was seen in the rat
developmental study at a limit dose. In the rat reproduction study,
both parents and offspring showed decreases in body weight during
lactation. The rat and rabbit developmental and the rat reproduction
toxicity data do not demonstrate an increase in susceptibility in the
fetus or other offspring. Trifloxystrobin is classified as: ``Not
likely to be Carcinogenic to Humans'' based on both the negative
results in the battery of mutagenicity tests (except at a cytotoxic
dose in one in vitro test), and from the long-term carcinogenicity
studies in rats and mice. There is no concern for neurotoxicity or
immunotoxicity in the database.
    Specific information on the studies received and the nature of the
adverse effects caused by trifloxystrobin as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies are discussed in the document
``Trifloxystrobin. Human Health Risk Assessment for the Proposed New
Use on Cottonseed Subgroup 20C and a Tolerance Amendment on Corn Field
Forage.,'' dated September 13, 2016.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for trifloxystrobin used
for human risk assessment is discussed in Unit Unit III B of the final
rule published in the Federal Register of June 11, 2010 (75 FR 33192)
(FRL-8829-2). However, subsequent to that Federal Register publication,
EPA reassessed the liver effects seen in the 28-day dermal toxicity
study according

to current policy, and determined that these effects should not be
considered adverse. The NOAEL for the 28-day dermal study was set at
1,000 mg/kg/day, and a LOAEL was not established. Because the Agency no
longer considers there to be a toxic endpoint for dermal exposure, the
endpoints assessed as part of this action exclude the endpoint for
dermal exposure identified in the table published in the above-
referenced Federal Register on June 11, 2010.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to trifloxystrobin, EPA considered exposure under the
petitioned-for tolerances as well as all existing trifloxystrobin
tolerances in 40 CFR 180.555. EPA assessed dietary exposures from
trifloxystrobin in food as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure.
    Such effects were identified for trifloxystrobin. In estimating
acute dietary exposure, EPA used food consumption information from the
United States Department of Agriculture (USDA) 2003-2008 Nationwide
Continuing Surveys of Food Intake by Individuals (CSFII). As to residue
levels in food, EPA conducted the acute dietary assessment assuming
tolerance level residues and 100 percent crop treated (PCT) for all
commodities.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 2003-2008
CSFII. As to residue levels in food, EPA assumed 100% crop treated,
tolerance level residues, average residues for some crops, and default
processing factors.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that trifloxystrobin does not pose a cancer risk to humans.
Therefore, a dietary exposure assessment for the purpose of assessing
cancer risk is unnecessary.
    iv. Anticipated residue information. Section 408(b)(2)(E) of FFDCA
authorizes EPA to use available data and information on the anticipated
residue levels of pesticide residues in food and the actual levels of
pesticide residues that have been measured in food. If EPA relies on
such information, EPA must require pursuant to FFDCA section 408(f)(1)
that data be provided 5 years after the tolerance is established,
modified, or left in effect, demonstrating that the levels in food are
not above the levels anticipated. For the present action, EPA will
issue such data call-ins as are required by FFDCA section 408(b)(2)(E)
and authorized under FFDCA section 408(f)(1). Data will be required to
be submitted no later than 5 years from the date of issuance of these
tolerances.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for trifloxystrobin in drinking water. These simulation
models take into account data on the physical, chemical, and fate/
transport characteristics of trifloxystrobin. Further information
regarding EPA drinking water models used in pesticide exposure
assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the PRZM/EXAMS (Pesticide Root Zone Model)/(Exposure
Analysis Modeling System) and Pesticide Root Zone Model Ground Water
(PRZM GW), the estimated drinking water concentrations (EDWCs) of
trifloxystrobin for acute exposures are estimated to be 29 parts per
billion (ppb) for surface water and 427 ppb for ground water,
respectively. For chronic non-cancer exposure assessments, EDWCs are
estimated to be 23 ppb for surface water and 365 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For acute dietary risk
assessment, the water concentration value of 427 ppb was used to assess
the contribution to drinking water. For chronic dietary risk
assessment, the water concentration of value 365 ppb was used to assess
the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
    Trifloxystrobin is currently registered for the following uses that
could result in residential exposures: ornamental plants and turfgrass.
EPA assessed residential exposure from relevant registered
trifloxystrobin products using the Agency's 2012 Residential Standard
Operating Procedures (SOPs) along with updates in policy regarding body
weight in addition to the following assumptions:
    i. Residential handler exposures. Residential handler exposure is
expected to be short-term only. Intermediate-term exposures are not
likely because of the intermittent nature of applications by
homeowners. Dermal handler exposures were not assessed since no adverse
systemic dermal hazard was identified for trifloxystrobin.
    ii. Residential post-application exposures. Because dermal hazard
has not been identified for trifloxystrobin, a quantitative post-
application assessment for dermal exposure is not necessary and the
only exposure scenarios quantitatively assessed are for children 1 to
<2 years old who may experience short-term incidental oral exposure to
trifloxystrobin from treated turf. Incidental oral granule ingestion is
not applicable because there is no endpoint identified for the acute
dietary duration for infants and children. Intermediate-term incidental
oral post-application exposures are not expected because
trifloxystrobin is not persistent in soil or water; furthermore, the
short-term incidental oral risk estimates would be protective of the
possible intermediate-term incidental oral exposures because the POD
for both durations is the same. Post-application inhalation exposure is
expected to be negligible for the proposed residential uses. Further
information regarding EPA standard assumptions and generic inputs for
residential exposures may be found at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
    EPA has not found trifloxystrobin to share a common mechanism of
toxicity with any other substances, and trifloxystrobin does not appear
to produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
trifloxystrobin does not have a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for

prenatal and postnatal toxicity and the completeness of the database on
toxicity and exposure unless EPA determines based on reliable data that
a different margin of safety will be safe for infants and children.
This additional margin of safety is commonly referred to as the FQPA
Safety Factor (SF). In applying this provision, EPA either retains the
default value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
    2. Prenatal and postnatal sensitivity. There is no indication of
increased quantitative or qualitative susceptibility to trifloxystrobin
in rats or rabbits. In the prenatal developmental study in rats, there
was no developmental toxicity up to or at the limit dose. In the
prenatal developmental study in rabbits, developmental toxicity was
seen at a dose that was higher than the dose causing maternal toxicity.
In the multigeneration study, offspring and parental LOAELs are at the
same dose level
    3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X. That decision is based on the following
findings:
    i. The toxicity database for trifloxystrobin is complete.
    ii. There is no indication that trifloxystrobin is a neurotoxic
chemical and there is no need for a developmental neurotoxicity study
or additional UFs to account for neurotoxicity.
    iii. There is no evidence that trifloxystrobin results in increased
susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study.
    iv. There are no residual uncertainties identified in the exposure
databases. The exposure databases are complete or are estimated based
on data that reasonably account for potential exposures. The exposure
assessments will not underestimate the potential dietary (food and
drinking water) or non-dietary exposures for infants and children from
the use of trifloxystrobin. The chronic dietary food exposure
assessment was conservatively based on 100%CT assumptions and
conservative ground water drinking water modeling estimates. The
dietary drinking water assessment utilizes water concentration values
generated by models and associated modeling parameters which are
designed to provide conservative, health protective, high-end estimates
of water concentrations, and are not likely to be exceeded. In
addition, the residential post-application assessment is based upon the
residential SOPs employing surrogate study data. The Residential SOPs
are based upon reasonable ``worst-case'' assumptions and are not
expected to underestimate risk. These data are reliable and are not
expected to underestimate risk to adults or children.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
    1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to trifloxystrobin will occupy 5% of the aPAD for 13-49 year old
females, the population group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
trifloxystrobin from food and water will utilize 71% of the cPAD for
infants (<1 year old), the population group receiving the greatest
exposure. Based on the explanation in Unit III.C.3., regarding
residential use patterns, chronic residential exposure to residues of
trifloxystrobin is not expected.
    3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
    Trifloxystrobin is currently registered for uses that could result
in short-term residential exposure, and the Agency has determined that
it is appropriate to aggregate chronic exposure through food and water
with short-term residential exposures to trifloxystrobin.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water,
and residential exposures result in aggregate MOEs of 290 for adults
and 130 for children 1-<2 years old. Because EPA's level of concern for
trifloxystrobin is a MOE of 100 or below, these MOEs are not of
concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level). An intermediate-term aggregate risk assessment (1 to 6 months
of exposure to trifloxystrobin residues from food, drinking water, and
residential pesticide uses) is not expected to occur based on the
intermittent nature of homeowner applications, and the short soil half-
life of trifloxystrobin (about 2 days). Therefore, an intermediate-term
aggregate risk assessment was not performed.
    5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, trifloxystrobin is not expected to pose a cancer risk to
humans.
    6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to trifloxystrobin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (gas chromatography with nitrogen
phosphorus detection (GC/NPD), Method AG-659A) is available to enforce
the tolerance expression for the combined residues of trifloxystrobin
and CGA-321113 in plant and livestock commodities. The lowest level of
method validation (LLMV) is equivalent to the limit of quantitation
(LOQ) which was 0.010 ppm for each analyte in/on all matrices.
    The method may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program,

and it is recognized as an international food safety standards-setting
organization in trade agreements to which the United States is a party.
EPA may establish a tolerance that is different from a Codex MRL;
however, FFDCA section 408(b)(4) requires that EPA explain the reasons
for departing from the Codex level.
    The Codex has not established a MRL for trifloxystrobin on cotton,
gin byproducts; cottonseed subgroup 20C; or corn, field, forage.

C. Response to Comments

    The Agency received one anonymous public comment suggesting that we
deny this tolerance because there are ``too many toxic chemicals
applied to food with no accurate long term tests that show any safety
at all.'' No supporting data was included to support this comment.
    The Agency considered a complete set of scientific data to assess
the risk of this chemical and these new uses. These data, along with
conservative models/assumptions, were used to assess the safety of
these tolerances. The Agency understands the commenter's concerns and
recognizes that some individuals believe that pesticides should be
banned on agricultural crops. However, the existing legal framework
provided by section 408 of the FFDCA states that tolerances may be set
when persons seeking such tolerances or exemptions have demonstrated
that the pesticide meets the safety standard imposed by that statute.
The citizen's comments appear to be directed at the underlying statute
and not EPA's implementation of it; the citizens have made no
contention that EPA has acted in violation of the statutory framework.

D. Revisions to Petitioned-for Tolerances

    The Agency is revising the commodity definitions for the requested
tolerances to reflect the common commodity vocabulary currently used by
the Agency. Specifically, the requested ``Cotton, undelinted seed (Crop
subgroup 20C)'' was changed to ``Cottonseed subgroup 20C''; the
requested ``Cotton, Gin By-products'' was changed to ``Cotton, gin
byproducts''.

V. Conclusion

    Therefore, tolerances are established for residues of
trifloxystrobin, benzeneacetic acid, (E,E)-[alpha]-(methoxyimino)-2-
[[[[1-[3-(trifluoromethyl) phenyl]ethylidene] amino]oxy]methyl]-,
methyl ester, and the free form of its acid metabolite CGA-321113,
(E,E)-methoxyimino-[2-[1-(3-trifluoromethyl-phenyl)-
ethylideneaminooxymethyl]-phenyl]acetic acid, calculated as the
stoichiometric equivalent of trifloxystrobin, in or on cottonseed
subgroup 20C at 0.50 ppm; cotton, gin byproducts at 3.0 ppm. The
existing corn, field, forage tolerance of 6.0 parts per million (ppm)
is increased to 8.0 ppm.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) in
response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
    This action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

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

    Dated: October 21, 2016.
Michael Goodis,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

0
2. In Sec.  180.555, in the table in paragraph (a):
0
a. Revise the entry for ``Corn, field, forage'';
0
b. Add alphabetically entries for ``Cotton, gin byproducts'' and
``Cottonseed subgroup 20C''.
    The revisions and additions read as follows:

Sec.  180.555   Trifloxystrobin; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------

                                * * * * *
Corn, field, forage......................................           8.0

                                * * * * *
Cotton, gin byproducts...................................           3.0
Cottonseed subgroup 20C..................................           0.50

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

* * * * *

[FR Doc. 2016-27204 Filed 11-9-16; 8:45 am]
 BILLING CODE 6560-50-P


To:  The Record

From:  Elaine Eby

Re:  Placement of Email in the Rulemaking Record

On Monday, November 26, 2007 I spoke to Rosalie Herrera,, Environmental
Engineer, Waste/Water Permitting, BP Products, Whiting Refinery to
inform her that the email she sent me on February 7, 2007 would be
placed in the rulemaking record for the following final rule:
Regulation of Oil-Bearing Hazardous Secondary Materials From the
Petroleum Refining Industry Processed in a Gasification System to
Produce Synthesis Gas.


[Federal Register: May 3, 2010 (Volume 75, Number 84)]
[Notices]
[Page 23316-23318]
[DOCID:fr03my10-99]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-61979; File No. SR-FINRA-2010-003]

Self-Regulatory Organizations; Financial Industry Regulatory
Authority, Inc.; Order Approving Proposed Rule Change, as Modified by
Amendment Nos. 1 and 2, Relating to Trade Reporting of OTC Equity
Securities and Restricted Equity Securities

April 23, 2010.

I. Introduction

    On January 15, 2010, Financial Industry Regulatory Authority, Inc.
(``FINRA'') filed with the Securities and Exchange Commission
(``Commission'' or ``SEC''), 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 relating to trade reporting of
OTC Equity Securities and certain restricted equity securities. On
February 5, 2010, FINRA filed Amendment No. 1 to the proposed rule
change. The proposed rule change, as modified by Amendment No. 1, was
published for comment in the Federal Register on February 19, 2010.\3\
The Commission received no comment letters on the proposed rule change.
On March 25, 2010, FINRA filed Amendment No. 2 to the proposed rule
change.\4\ Because Amendment No. 2 is technical in nature, the
Commission is not publishing it for comment. This order approves the
proposed rule change, as modified by Amendment Nos. 1 and 2.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 61510 (February 5,
2010), 75 FR 7530 (``Notice'').
    \4\ Amendment No. 2 reflects changes to FINRA Rule 6635 that
were made in SR-FINRA-2010-002, which was filed with the Commission
for immediate effectiveness on January 14, 2010. See Securities
Exchange Act Release No. 61427 (January 27, 2010), 75 FR 5834
(February 4, 2010).
---------------------------------------------------------------------------

Background

    In 1990, the SEC adopted Rule 144A (``SEC Rule 144A'') under the
Securities Act of 1933 \5\ (``Securities Act'') to establish a safe
harbor for the private resale of ``restricted securities'' to
``qualified institutional buyers'' (``QIBs'').\6\ At the same time,
FINRA (formerly known as the National Association of Securities
Dealers, Inc. (``NASD'')) created the PORTAL Market to serve as a
system for quoting, trading, and reporting trades in certain designated
restricted securities that were eligible for resale under SEC Rule 144A
(``PORTAL securities'').\7\ In September 2008, the NASDAQ Stock Market
(``NASDAQ'') ceased the operation of the PORTAL Market.\8\ NASDAQ
explained in its rule filing that it is taking a minority stake in a
consortium that will control and operate a new electronic platform for
handling transactions in SEC Rule 144A-eligible securities.\9\ In
October 2009, NASDAQ filed a proposed rule change with the Commission
for immediate effectiveness terminating NASDAQ's PORTAL security
designation process and removing rules related to the PORTAL Market
from its rulebook.\10\ As a result, NASDAQ no longer accepts new
applications for debt or equity securities seeking PORTAL
designation.\11\
---------------------------------------------------------------------------

    \5\ 17 CFR 230.144A.
    \6\ See Securities Act Release No. 6862 (April 23, 1990), 55 FR
17933 (April 30, 1990). For the purpose of SEC Rule 144A, a QIB is
generally defined as any institution acting for its own account, or
for the accounts of other QIBs, that in the aggregate owns and
invests on a discretionary basis at least $100 million in securities
of issuers that are not affiliated with the institution.
    \7\ See Securities Exchange Act Release No. 27956 (April 27,
1990), 55 FR 18781 (May 4, 1990).
    \8\ See Securities Exchange Act Release No. 58638 (September 24,
2008), 73 FR 57188 (October 1, 2008). As part of the separation of
NASDAQ from FINRA, certain functionality relating to PORTAL,
including the qualification and designation of PORTAL securities,
became part of NASDAQ's rules and were eliminated from the NASD
rules. See Securities Exchange Act Release No. 53128 (January 13,
2006), 71 FR 3550 (January 23, 2006).
    \9\ In addition to NASDAQ ceasing operation of the PORTAL
Market, the Commission has also approved the deletion of the
Depository Trust Company (``DTC'') requirement that a SEC Rule 144A
security, other than investment grade securities, be included in an
``SRO Rule 144A System'' in order to be eligible for DTC's deposit,
book-entry delivery, and other depository services. See Securities
Exchange Act Release No. 59384 (February 11, 2009), 74 FR 7941
(February 20, 2009). The PORTAL Market was the only ``SRO Rule 144A
System.'' Id.
    \10\ Securities Exchange Act Release No. 60991 (November 12,
2009), 74 FR 60006 (November 19, 2009).
    \11\ See id. NASDAQ noted in the filing that nothing in the
proposal was ``intended to impact securities previously designated
as PORTAL securities or alter any existing regulatory obligation
applicable to such securities, including, but not limited to, any
trade reporting obligation imposed by any self-regulatory
organization.'' Id.
---------------------------------------------------------------------------

    In the instant rule proposal, FINRA has proposed to delete certain
PORTAL rules from its rulebook, amend certain other rules to address
gaps that elimination of such PORTAL rules would create, amend certain
definitions to create consistent use of terminology in FINRA rules, and
make certain other clarifying changes.

III. Description of the Proposal

    Current FINRA Rule 6610 requires that members report transactions
in ``OTC Equity Securities'' to the OTC

Reporting Facility (``ORF'').\12\ Under the current definitions in Rule
6420, ``restricted securities,'' as defined by SEC Rule 144(a)(3), and
securities designated in the PORTAL Market are carved out of the ORF
reporting requirement.\13\ Transaction reporting for certain of these
securities to the ORF--specifically, restricted equity securities that
are designated for inclusion in the PORTAL Market--is instead required
by FINRA Rule 6633(a).\14\
---------------------------------------------------------------------------

    \12\ See FINRA Rule 6610.
    \13\ See FINRA Rule 6420(c) and (d).
    \14\ See FINRA Rule 6633(a). See also, Notice, supra note 3.
---------------------------------------------------------------------------

    In light of the recent elimination of NASDAQ's PORTAL rules, FINRA
has proposed to eliminate certain of its PORTAL rules.\15\ However,
because FINRA has determined that elimination of the PORTAL rules that
govern transaction reporting would create a gap in the transaction
reporting requirements for SEC Rule 144A securities, FINRA proposed to
amend FINRA Rule 6622, to ensure that all equity securities that are
``restricted securities'' under Rule 144(a)(3); \16\ and that are
traded pursuant to SEC Rule 144A, will continue to be reported to the
ORF. Under the proposal, transactions in all restricted equity
securities effected pursuant to Commission Rule 144A would generally be
required to be reported to the ORF no later than 8 p.m. Eastern Time
without interruption.\17\ Transactions in restricted equity securities
effected pursuant to Commission Rule 144A and executed between 8 p.m.
and midnight would be required to be reported the following business
day (T+1) by 8 p.m.
---------------------------------------------------------------------------

    \15\ FINRA Rule 6633(a). The proposed rule change is limited in
scope to equity securities and would not affect the Trade Reporting
and Compliance Engine Service (``TRACE'') or the reporting
requirements with respect to transactions in debt securities. See
Notice supra note 3. In addition to the reporting rules, current
FINRA Rule 6635 specifies which FINRA rules are and are not
applicable to transactions and business activities relating to
PORTAL securities. Under the proposal FINRA will retain FINRA Rule
6635 as FINRA Rule 6630 to maintain the status quo with respect to
the application of FINRA rules to those securities designated as
PORTAL securities prior to October 26, 2009.
    \16\ See 17 CFR 230.144.
    \17\ See Notice supra note 3, explaining that the ORF reporting
session deadline is 8:00 p.m.
---------------------------------------------------------------------------

    In addition, FINRA proposed to amend the definition of ``OTC Equity
Security'' in Rule 6420 to delete the reference to securities that
``qualify for real-time trade reporting'' and, instead, to define the
term as any equity security that is not an ``NMS stock'' as defined by
the Commission in Regulation NMS.\18\ The proposed rule change also
would eliminate the defined term ``non-exchange-listed security'' from
Rule 6420.\19\ The effect of these changes is that any security or
class of securities for which transaction reports are collected,
processed, and made available pursuant to an effective transaction
reporting plan will be excluded from the definition of ``OTC Equity
Security'' in Rule 6420.
---------------------------------------------------------------------------

    \18\ Rule 600 of Regulation NMS defines ``NMS stock'' as any NMS
security other than an option. ``NMS security'' is defined as ``any
security or class of securities for which transaction reports are
collected, processed, and made available pursuant to an effective
transaction reporting plan, or an effective national market system
plan for reporting transactions in listed options.'' See 17 CFR
242.600(b)(46), 242.600(b)(47).
    \19\ FINRA Rule 6440 (Submission of SEA Rule 15c2-11 Information
on Non-Exchange-Listed Securities) and NASD Rule 2320(f), which is
often referred to as the Three Quote Rule, use the term ``non-
exchange-listed security.'' Because the proposed rule change deletes
the term ``non-exchange-listed security'' from Rule 6420, the
proposed rule change also amends FINRA Rule 6440 and NASD Rule
2320(f) to define the term for purposes of those rules. The proposed
definition in each rule is identical to the definition as it
appeared in FINRA Rule 6420. Consequently, there is no change in the
application of either rule as a result of the proposed rule change.
---------------------------------------------------------------------------

    Further, the proposal would amend the ORF rules to address
explicitly transactions in OTC Equity Securities that are executed on
an exchange. FINRA's trade reporting rules historically have been
limited to only trades executed ``otherwise than on an exchange.'' \20\
As explained in the Notice, the FINRA/NASDAQ TRF Rules, the FINRA/NYSE
TRF Rules, and the ADF Rules all include an exception from the
reporting obligations for transactions reported on or through an
exchange.\21\ These rules collectively provide for the submission of
trade reports to FINRA for transactions in NMS stocks only if the
transaction is executed over-the-counter. FINRA Rule 6622, which
governs the submission of transaction reports to the ORF for
transactions in OTC Equity Securities, does not include a similar
exception for transactions in otherwise eligible securities that are
reported on or through an exchange.\22\ Thus, FINRA proposed to amend
Rule 6622 to include an explicit exception for transactions in OTC
Equity Securities reported on or through an exchange, and to amend Rule
6420(k) and Rule 6610 to clarify further that transactions in OTC
Equity Securities must be reported to the ORF where such transactions
are executed otherwise than on or through an exchange.
---------------------------------------------------------------------------

    \20\ See, e.g., FINRA Rule 6100, 6200, and 6300 Series.
    \21\ See FINRA Rules 6282(i)(1)(C), 6380A(e)(1)(C),
6380B(e)(1)(C).
    \22\ The ORF Rules do include an exception for transactions in
foreign equity securities when the transaction is executed on and
reported to a foreign securities exchange or the transaction is
executed over-the-counter in a foreign country and is reported to
the regulator of securities markets for that country. See FINRA Rule
6622(g).
---------------------------------------------------------------------------

    FINRA also proposed to conform the definition of ``OTC equity
security'' in Rule 7410 of the OATS rules to the proposed definition in
Rule 6420 and explained that the proposed change will not result in any
change to the scope of securities required to be reported to OATS.
FINRA similarly proposed to eliminate the separate definition of ``OTC
Equity Security'' in FINRA Rule 4560 (Short-Interest Reporting),\23\
explaining that the proposal would ``exclude from the short-interest
record keeping and reporting requirements all restricted equity
securities, such that equity securities that are currently PORTAL
securities would continue to be excepted from the record keeping and
reporting requirements as well as any other restricted equity
securities.'' \24\
---------------------------------------------------------------------------

    \23\ In Amendment No. 1, FINRA stated as follows: ``The proposed
rule change eliminates the separate definition of ``OTC Equity
Security'' in FINRA Rule 4560 (Short-Interest Reporting). Currently,
the PORTAL Rules carve out PORTAL securities from the record keeping
and reporting requirements of Rule 4560. See Rule 6635(d).
Consistent with this existing exclusion for PORTAL securities, FINRA
is proposing to amend Rule 4560 to exclude from the short-interest
record keeping and reporting requirements all restricted equity
securities, such that equity securities that are currently PORTAL
securities would continue to be excepted from the record keeping and
reporting requirements as well as any other restricted equity
securities.''
    \24\ See Amendment No. 1.
---------------------------------------------------------------------------

    As stated in the Notice, FINRA represented that it will announce
the effective date of the proposed rule change in a Regulatory Notice
to be published no later than 60 days following Commission approval.
The effective date will be 30 days following publication of the
Regulatory Notice announcing Commission approval.

IV. Discussion and Commission's Findings

    The Commission has reviewed carefully the proposed rule change and
finds that the proposal is consistent with the Act and the rules and
regulations thereunder applicable to a national securities association,
including the provisions of Section 15A(b)(6) of the Act,\25\ which
requires, among other things, that FINRA rules be designed to prevent
fraudulent and manipulative acts and practices, promote just and
equitable principles of trade, to foster cooperation and coordination
with persons engaged in regulating, clearing, settling, processing
transactions in securities, and, in

general, to protect investors and the public interest.\26\
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    \25\ 15 U.S.C. 78o-3(b)(6).
    \26\ In approving this proposed rule change, the Commission has
considered the proposed rule's impact on efficiency, competition and
capital formation. See 15 U.S.C. 78c(f).
---------------------------------------------------------------------------

    The proposed rule change is intended to address the cessation of
the PORTAL market and clarify the scope of the ORF Rules, as well as
make conforming changes to other FINRA Rules. The Commission believes
that the proposed rule change is reasonably designed to ensure that
FINRA will continue to receive important transaction information with
respect to securities that are traded over-the-counter. In addition,
the Commission believes that the amended definition ``OTC Equity
Security,'' the standardization of that definition throughout FINRA
rules and FINRA's other proposed changes will close gaps and add
clarity with respect to the application of specified FINRA rules to
certain securities.

V. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the Act,
that the proposed rule change (SR-FINRA-2010-003), as modified by
Amendment Nos. 1 and 2, be, and it hereby is, approved.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\27\
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    \27\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Deputy Secretary.
[FR Doc. 2010-10252 Filed 4-30-10; 8:45 am]
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[Federal Register Volume 76, Number 232 (Friday, December 2, 2011)]
[Rules and Regulations]
[Pages 75448-75449]
[FR Doc No: 2011-30940]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2011-0455; Airspace Docket No. 11-AEA-4]

Establishment of Class D and E Airspace; Frederick, MD

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action establishes Class D and E airspace at Frederick,
MD, to accommodate new Area Navigation (RNAV) Global Positioning System
(GPS) Standard Instrument Approach Procedures (SIAPs) at Frederick
Municipal Airport. This action enhances the safety and management of
Instrument Flight Rules (IFR) operations for SIAPs at the airport.

DATES: Effective 0901 UTC, February 9, 2012. The Director of the
Federal Register approves this incorporation by reference action under
title 1, Code of Federal Regulations, part 51, subject to the annual
revision of FAA Order 7400.9 and publication of conforming amendments

FOR FURTHER INFORMATION CONTACT: Rich Horrocks, Operations Support
Group, Eastern Service Center, Federal Aviation Administration, P.O.
Box 20636, Atlanta, Georgia 30320; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

History

    On August 12, 2011, the FAA published in the Federal Register a
notice of proposed rulemaking (NPRM) to establish Class D and E
airspace for the new Frederick Municipal Airport, Frederick, MD (76 FR
50156) Docket No. FAA-2011-0455. Interested parties were invited to
participate in this rulemaking effort by submitting written comments on
the proposal to the FAA. No comments were received. Class D and E
airspace designations are published in Paragraphs 5000, 6002 and 6004,
respectively, of FAA Order

7400.9V dated August 9, 2011, and effective September 15, 2011, which
is incorporated by reference in 14 CFR 71.1. The Class D and E airspace
designations listed in this document will be published subsequently in
the Order.

The Rule

    This amendment to Title 14, Code of Federal Regulations (14 CFR)
part 71 establishes Class D airspace extending upward from the surface
to 2,800 feet MSL within a 5-mile radius of Frederick Municipal
Airport. Class E surface area airspace, within a 5-mile radius of the
airport and Class E airspace designated as an extension to Class D
surface area. Controlled airspace is necessary for the new RNAV GPS
standard instrument approach procedures developed for the airport and
for continued safety and management of IFR operations at Frederick
Municipal Airport, Frederick, MD.
    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current, is
non-controversial and unlikely to result in adverse or negative
comments. It, therefore, (1) is not a ``significant regulatory action''
under Executive Order 12866; (2) is not a ``significant rule'' under
DOT Regulatory Policies and Procedures (44 FR 11034; February 26,
1979); and (3) does not warrant preparation of a Regulatory Evaluation
as the anticipated impact is so minimal. Since this is a routine matter
that will only affect air traffic procedures and air navigation, it is
certified that this rule, when promulgated, will not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. 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.
    This rulemaking is promulgated under the authority described in
Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the
FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it establishes controlled airspace at Frederick Municipal Airport,
Frederick, MD.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

    In consideration of the foregoing, the Federal Aviation
Administration amends 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for part 71 continues to read as follows:

    Authority: 49 U.S.C. 106(g); 40103, 40113, 40120; E.O. 10854, 24
FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of Federal Aviation
Administration Order 7400.9V, Airspace Designations and Reporting
Points, dated August 9, 2011, and effective September 15, 2011, is
amended as follows:

Paragraph 5000 Class D airspace.

* * * * *

AEA MD D Frederick, MD [NEW]

Frederick Municipal Airport, MD
    (Lat. 39[deg]25'03'' N., long. 77[deg]22'28'' W.)

    That airspace extending from the surface up to and including
2,800 feet MSL within a 5-mile radius of Frederick Municipal
Airport. This Class D airspace area is effective during specific
dates and times established in advance by a Notice to Airmen. The
effective date and time will thereafter be continuously published in
the Airport/Facility Directory.

Paragraph 6002 Class E airspace designated as surface areas.

* * * * *

AEA MD E2 Frederick, MD [NEW]

Frederick Municipal Airport, MD
    (Lat. 39[deg]25'03'' N., long. 77[deg]22'28'' W.)

    That airspace extending from the surface up to and including
2,800 feet MSL within a 5-mile radius of the Frederick Municipal
Airport. This Class E airspace area is effective during specific
dates and times established in advance by a Notice to Airmen. The
effective date and time will thereafter be continuously published in
the Airport/Facility Directory.

Paragraph 6004 Class E airspace designated as an extension to a
Class D surface area.

* * * * *

AEA MD E4 Frederick, MD [NEW]

Frederick Municipal Airport, MD
    (Lat. 39[deg]25'03'' N., long. 77[deg]22'28'' W.)

    That airspace extending from the surface within 3.2 miles either
side of the 036[deg] bearing from the airport extending from the 5-
mile radius to 7.6 miles northeast of the airport. This Class E
airspace area is effective during specific dates and times
established in advance by a Notice to Airmen. The effective date and
time will thereafter be continuously published in the Airport/
Facility Directory.

    Issued in College Park, Georgia, on November 21, 2011.
Mark D. Ward,
Manager, Operations Support Group, Eastern Service Center, Air Traffic
Organization.
[FR Doc. 2011-30940 Filed 12-1-11; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 79, Number 129 (Monday, July 7, 2014)]
[Notices]
[Pages 38360-38361]
[FR Doc No: 2014-15797]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2014-0055; Notice 1]

Harley-Davidson Motor Company, Inc., Receipt of Petition for
Decision of Inconsequential Noncompliance

AGENCY: National Highway Traffic Safety Administration (NHTSA),
Department of Transportation (DOT).

ACTION: Receipt of Petition.

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SUMMARY: Harley-Davidson Motor Company, Inc. (Harley-Davidson) has
determined that certain model year (MY) 2009-2014 Harley-Davidson FL
Touring family motorcycles do not fully comply with paragraph S6.1.3 of
Federal Motor Vehicle Safety Standard (FMVSS) No. 108, Lamps,
reflective devices, and associated equipment. Harley-Davidson has filed
an appropriate report dated April 7, 2014, pursuant to 49 CFR part 573,
Defect and Noncompliance Responsibility and Reports.

DATES: The closing date for comments on the petition is August 6, 2014.

ADDRESSES: Interested persons are invited to submit written data,
views, and arguments on this petition. Comments must refer to the
docket and notice number cited at the beginning of this notice and be
submitted by any of the following methods:
     Mail: Send comments by mail addressed to: U.S. Department
of Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590.
     Hand Deliver: Deliver comments by hand to: U.S. Department
of Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590. The
Docket Section is open on weekdays from 10 a.m. to 5 p.m. except
Federal Holidays.
     Electronically: Submit comments electronically by: Logging
onto the Federal Docket Management System (FDMS) Web site at http://www.regulations.gov/. Follow the online instructions for submitting
comments. Comments may also be faxed to<PHONE_NUMBER>.
    Comments must be written in the English language, and be no greater
than 15 pages in length, although there is no limit to the length of
necessary attachments to the comments. If comments are submitted in
hard copy form, please ensure that two copies are provided. If you wish
to receive

confirmation that your comments were received, please enclose a
stamped, self-addressed postcard with the comments. Note that all
comments received will be posted without change to http://www.regulations.gov, including any personal information provided.
    Documents submitted to a docket may be viewed by anyone at the
address and times given above. The documents may also be viewed on the
Internet at http://www.regulations.gov by following the online
instructions for accessing the dockets. DOT's complete Privacy Act
Statement is available for review in the Federal Register published on
April 11, 2000, (65 FR 19477-78).
    The petition, supporting materials, and all comments received
before the close of business on the closing date indicated below will
be filed and will be considered. All comments and supporting materials
received after the closing date will also be filed and will be
considered to the extent possible. When the petition is granted or
denied, notice of the decision will be published in the Federal
Register pursuant to the authority indicated below.

SUPPLEMENTARY INFORMATION:

I. Harley-Davidson's Petition

    Pursuant to 49 U.S.C. 30118(d) and 30120(h) (see implementing rule
at 49 CFR part 556), Harley-Davidson submitted a petition for an
exemption from the notification and remedy requirements of 49 U.S.C.
Chapter 301 on the basis that this noncompliance is inconsequential to
motor vehicle safety.
    This notice of receipt of Harley-Davidson's petition is published
under 49 U.S.C. 30118 and 30120 and does not represent any agency
decision or other exercise of judgment concerning the merits of the
petition.

II. Vehicles Involved

    Affected are approximately 343,680 MY 2009-2014 Harley-Davidson FL
Touring family motorcycles manufactured between June 10, 2008 and March
25, 2014.

III. Noncompliance

    Harley-Davidson explains that the noncompliance is that the
location of the rear reflex reflectors on the subject vehicles are
mounted between an average of 0.3'' and 0.7'' below the required 15''
height-above-road surface as required by paragraph S6.1.3 of FMVSS No.
108.

IV. Rule Text

    Paragraph S<IP_ADDRESS> of FMVSS No. 108 requires in pertinent part:

    S<IP_ADDRESS> Each lamp, reflective device, and item of associated
equipment must be securely mounted on a rigid part of the vehicle,
other than glazing, that is not designed to be removed except for
repair, within the mounting location and height limits as specified
in Table I, and in a location where it complies with all applicable
photometric requirements, effective projected luminous lens area
requirements, and visibility requirements with all obstructions
considered.

V. Summary of Harley-Davidson's Analyses

    Harley-Davidson stated its belief that the subject noncompliance is
inconsequential to motor vehicle safety for the following reasons:
     Harley-Davidson had a third-party conduct testing on the
subject motorcycles and reflex reflectors and they exhibited no
reduction in conspicuity as compared to compliant vehicles. The
independent company tested five test heights, for a test range of 11''-
15'' height above-road surface, and all five tests far exceeded the
minimum required values at each of the 10 test points specified in
Table XVI. Due to the substantial safety margin designed into these
reflex reflectors, photometry remained well above the minimums even
when mounted a full 4'' inches below the minimum mounting height.
     Harley-Davidson believes that the lower mounting height of
these reflectors may actually increase conspicuity and motor vehicle
safety compared to fully compliant (higher mounted) reflectors.
     Harley-Davidson notes that the United Nations ECE
regulations specify a minimum mounting height of 9.84'' (240mm). And
further notes that in one study of daytime side vehicle conspicuity of
motorcycles, NHTSA's researchers concluded that the mounting height of
the side reflex reflectors (12 inches vs 15 inches) was an
``insignificant'' factor for vehicle identification distance.
     Harley-Davidson further states that under FMVSS No. 108,
tail lamps and license plate lamps on motorcycles are required to be
illuminated whenever the headlamp is activated. And that since all
Harley-Davidson models are equipped with automatic headlights on (AHO)
functionality, the headlamps and tail lamps are automatically
illuminated when the ignition is in the on position, thus providing
conspicuity during daylight and darkness while the motorcycle is
operating.
    Harley-Davidson also made reference to a withdrawal of rulemaking
regarding a lower height for reflex reflectors.
    Harley-Davidson has additionally informed NHTSA that it has
corrected the noncompliance so that all future production motorcycles
will comply with FMVSS No. 108.
    In summation, Harley-Davidson believes that the described
noncompliance of the subject vehicles is inconsequential to motor
vehicle safety, and that its petition, to exempt Harley-Davidson from
providing recall notification of noncompliance as required by 49 U.S.C.
30118 and remedying the recall noncompliance as required by 49 U.S.C.
30120 should be granted.
    NHTSA notes that the statutory provisions (49 U.S.C. 30118(d) and
30120(h)) that permit manufacturers to file petitions for a
determination of inconsequentiality allow NHTSA to exempt manufacturers
only from the duties found in sections 30118 and 30120, respectively,
to notify owners, purchasers, and dealers of a defect or noncompliance
and to remedy the defect or noncompliance. Therefore, any decision on
this petition only applies to the subject motorcycles that Harley-
Davidson no longer controlled at the time it determined that the
noncompliance existed. However, any decision on this petition does not
relieve vehicle distributors and dealers of the prohibitions on the
sale, offer for sale, or introduction or delivery for introduction into
interstate commerce of the noncompliant vehicles under their control
after Harley-Davidson notified them that the subject noncompliance
existed.

    Authority:  (49 U.S.C. 30118, 30120: delegations of authority at
49 CFR 1.95 and 501.8).

Jeffrey M. Giuseppe,
Acting Director, Office of Vehicle Safety Compliance.
[FR Doc. 2014-15797 Filed 7-3-14; 8:45 am]
BILLING CODE 4910-59-P