[Federal Register Volume 84, Number 36 (Friday, February 22, 2019)]
[Notices]
[Pages 5737-5739]
[FR Doc No: 2019-03041]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-85152; File Nos. SR-BX-2018-066 and SR-Phlx-2018-83]

Self-Regulatory Organizations; Nasdaq BX, Inc.; Nasdaq PHLX LLC;
Suspension of and Order Instituting Proceedings To Determine Whether To
Approve or Disapprove Proposed Rule Changes To Amend the Exchanges'
Port Fee Schedules

February 15, 2019.

I. Introduction

    On December 20, 2018, Nasdaq BX, Inc. (``BX'') and Nasdaq PHLX LLC
(``Phlx'') (each an ``Exchange,'' and collectively the ``Exchanges'')
each filed with the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act''),\1\ and Rule 19b-4 thereunder,\2\ a
proposed rule change to amend its port fee schedule. Each proposed rule
change was immediately effective upon filing with the Commission
pursuant to Section 19(b)(3)(A) of the Act.\3\ Each proposed rule
change was published for comment in the Federal Register on January 31,
2019.\4\ The Commission has received no comment letters on the proposed
rule changes. Under Section 19(b)(3)(C) of the Act,\5\ the Commission
is hereby: (i) Temporarily suspending the proposed rule changes; and
(ii) instituting proceedings to determine whether to approve or
disapprove the proposed rule changes.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A).
    \4\ See Securities Exchange Act Release Nos. 84965 (December 26,
2018), 84 FR 842 (``BX Notice''); 84967 (December 26, 2018), 84 FR
861 (``Phlx Notice'').
    \5\ 15 U.S.C. 78s(b)(3)(C).
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II. Description of the Proposed Rule Changes

    Equity 7, Section 115 of BX's rules and Equity 7, Section 3 of
Phlx's rules set forth the Exchanges' port fee schedules. These port
fee schedules provided that the fees for specified ports are assessed
on a per port per month basis.
    In their proposals, each Exchange states that it currently assesses
ports fees in two ways. First, for certain port types (i.e., Multicast
TotalView-ITCH, TCP ITCH data feed, DROP, and their corresponding
disaster recovery ports), the Exchange assigns a port only to the MPID
of the customer that requested it.\6\ Even if, as a practical matter,
others also utilize the port, the Exchange only bills the MPID of the
customer that requested the port.\7\ According to the Exchanges, the
requesting customer may then, at its discretion, subsequently bill any
other users for their shared usage of the port.\8\ Second, for other
port types (i.e., OUCH, FIX trading ports (FIX and FIX Lite), RASH, and
their corresponding disaster recovery ports), the Exchange assigns the
port to the MPID of the customer that requested it, as well as to any
other MPIDs that the requester had specified.\9\ In these instances,
the Exchange does not only bill the port-requesting MPID. Instead, the
Exchange assesses a separate monthly fee to each of the MPIDs it
assigned to the port.\10\
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    \6\ See BX Notice, supra note 4, at 842; Phlx Notice, supra note
4, at 861.
    \7\ See BX Notice, supra note 4, at 842; Phlx Notice, supra note
4, at 861.
    \8\ See BX Notice, supra note 4, at 842; Phlx Notice, supra note
4, at 861.
    \9\ See BX Notice, supra note 4, at 842; Phlx Notice, supra note
4, at 861.
    \10\ See BX Notice, supra note 4, at 842; Phlx Notice, supra
note 4, at 861.
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    Each Exchange proposes to reorganize its port fee schedule into two
sections. The first section would provide that, for OUCH, FIX trading
ports (FIX and FIX Lite), RASH, and their corresponding disaster
recovery ports, where a customer has requested that the Exchange assign
more than one MPID to a particular port, the Exchange will assess a
separate monthly fee to each MPID assigned to the port. Each Exchange
also proposes to revise its price formula for these port types from
``$X/port/month'' to ``$X/each MPID assigned to port/month.'' The
second section would provide that, for Multicast TotalView-ITCH
(software-based), TCP ITCH data feed, DROP, DROP disaster recovery, and
trading ports used in test mode, the Exchange will assess the monthly
fee to the single MPID that requested that particular port. For these
ports, each Exchange would maintain its existing price formula of ``$X/
port/month.'' \11\
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    \11\ The second section of each Exchange's amended port fee
schedule would also include the ports for which the Exchange charges
no fee: Data retransmission ports (production and disaster
recovery), disaster recovery ports for Multicast TotalView-ITCH
(software-based), and disaster recovery ports for TCP ITCH data
feed. Moreover, each Exchange proposes to add a parenthetical with
the word ``Glimpse'' next to data retransmission ports to provide
that such ports include access to the ``Glimpse'' product, which
allows a subscriber to replay market data from the current trading
day.
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    Each Exchange represents that its proposal would merely codify the
existing practices of the Exchange with respect to port fees and would
not make any substantive changes to the port fees that the Exchange's
customers have been paying to date.\12\
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    \12\ See BX Notice, supra note 4, at 842-43; Phlx Notice, supra
note 4, at 862. BX also proposes to correct a typographical error in
the port fee schedule. Phlx also proposes to remove an expired fee
waiver from the port fee schedule.
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III. Suspension of the Proposed Rule Changes

    Pursuant to Section 19(b)(3)(C) of the Act,\13\ at any time within
60 days of the date of filing of a proposed rule change pursuant to
Section 19(b)(1) of the Act,\14\ the Commission summarily may
temporarily suspend the change in the rules of a self-regulatory
organization (``SRO'') if it appears to the Commission that such action
is necessary or appropriate in the public interest, for the protection
of investors, or otherwise in furtherance of the purposes of the Act.
As discussed below, the Commission believes a temporary suspension of
the proposed rule changes is necessary and appropriate to allow for
additional analysis of the proposed rule changes' consistency with the
Act and the rules thereunder.
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    \13\ 15 U.S.C. 78s(b)(3)(C).
    \14\ 15 U.S.C. 78s(b)(1).
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    The Commission notes that, in connection with the proposals, each
Exchange states its belief that the existing per port per month
language is accurate, but the language should be more descriptive so as
to avoid confusion as to the circumstances in which a customer will
incur port fees.\15\ Moreover, in describing why its proposal is
consistent with Sections 6(b)(4) and 6(b)(5) of the Act,\16\ each
Exchange relies on the argument that its proposal would clarify and
more fully describe the port fees, codify the Exchange's existing
practices for assessing port fees, avoid potential

confusion among customers, and would not change the fees that port
users currently pay.\17\ Similarly, in discussing why its proposal
would not impose any burden on competition not necessary or appropriate
in furtherance of the purposes of the Act, each Exchange relies on the
argument that its proposal would merely codify existing practice and
would not change the fees that the Exchange currently charges.\18\
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    \15\ See BX Notice, supra note 4, at 842; Phlx Notice, supra
note 4, at 861.
    \16\ See 15 U.S.C. 78f(b)(4), (5).
    \17\ See BX Notice, supra note 4, at 842-43; Phlx Notice, supra
note 4, at 862.
    \18\ See BX Notice, supra note 4, at 843; Phlx Notice, supra
note 4, at 862.
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    The Commission notes that the Exchanges do not provide other
explanations for why the proposals are consistent with the Act, such as
why it is consistent with the Act to charge a fee for each MPID
assigned to certain port types offered by the Exchange (i.e., OUCH, FIX
trading port, RASH, and corresponding disaster recovery ports), rather
than simply charging one fee per port for all port types. As noted
above, the proposals would amend the Exchanges' price formulas for
these port types from ``$X/port/month'' to ``$X/each MPID assigned to
port/month,'' which reflects that if there are multiple MPIDs assigned
to one of these ports, rather than charging one ``$X/port/month'' fee
for the port, the Exchanges charge a multiple of the ``$X/port/month''
fee for the port (i.e., a separate fee for each MPID assigned).\19\ The
Commission also notes that, while the Exchanges state that the
proposals would reflect their existing practices for assessing port
fees, the Exchanges do not reference previous Exchange rule filings
that explained why their existing practices (i.e., for a subset of the
port types offered, charging a fee for each MPID assigned to the port)
are consistent with the Act.
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    \19\ See supra Section II.
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    When exchanges file proposed rule changes with the Commission, they
are required to provide a statement supporting the proposal's basis
under the Act and the rules and regulations thereunder applicable to
the exchange.\20\ The instructions to Form 19b-4, on which exchanges
file their proposed rule changes, specify that such statement ``should
be sufficiently detailed and specific to support a finding that the
proposed rule change is consistent with [those] requirements.'' \21\
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    \20\ See Form 19b-4 (Item 3 entitled ``Self-Regulatory
Organization's Statement of the Purpose of, and Statutory Basis for,
the Proposed Rule Change'').
    \21\ Id.
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    Among other things, exchange proposed rule changes are subject to
Section 6 of the Act, including Sections 6(b)(4), (5), and (8), which
require the rules of an exchange to: (1) Provide for the equitable
allocation of reasonable fees among members, issuers, and other persons
using the exchange's facilities; \22\ (2) perfect the mechanism of a
free and open market and a national market system, protect investors
and the public interest, and not be designed to permit unfair
discrimination between customers, issuers, brokers, or dealers; \23\
and (3) not impose any burden on competition not necessary or
appropriate in furtherance of the purposes of the Act.\24\
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    \22\ 15 U.S.C. 78f(b)(4).
    \23\ 15 U.S.C. 78f(b)(5).
    \24\ 15 U.S.C. 78f(b)(8).
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    In temporarily suspending the changes to the Exchanges' fee
schedules, the Commission intends to further consider whether the
proposed changes to the Exchanges' port fee schedules are consistent
with the statutory requirements applicable to a national securities
exchange under the Act. In particular, the Commission will consider
whether the proposed rule changes satisfy the standards under the Act
and the rules thereunder requiring, among other things, that an
exchange's rules provide for the equitable allocation of reasonable
fees among members, issuers, and other persons using its facilities;
not permit unfair discrimination between customers, issuers, brokers or
dealers; and do not impose any burden on competition not necessary or
appropriate in furtherance of the purposes of the Act.\25\
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    \25\ See 15 U.S.C. 78f(b)(4), (5), and (8), respectively.
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    Therefore, the Commission finds that it is appropriate in the
public interest, for the protection of investors, and otherwise in
furtherance of the purposes of the Act, to temporarily suspend the
proposed rule changes.\26\
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    \26\ For purposes of temporarily suspending the proposed rule
changes, the Commission has considered the proposed rules' impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
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IV. Proceedings To Determine Whether To Approve or Disapprove the
Proposed Rule Changes

    The Commission is instituting proceedings pursuant to Sections
19(b)(3)(C) \27\ and 19(b)(2)(B) of the Act \28\ to determine whether
the proposed rule changes should be approved or disapproved.
Institution of proceedings does not indicate that the Commission has
reached any conclusions with respect to any of the issues involved.
Rather, the Commission seeks and encourages interested persons to
provide additional comment on the proposed rule changes to inform the
Commission's analysis of whether to approve or disapprove the proposed
rule changes.
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    \27\ 15 U.S.C. 78s(b)(3)(C). Once the Commission temporarily
suspends a proposed rule change, Section 19(b)(3)(C) of the Act
requires that the Commission institute proceedings under Section
19(b)(2)(B) to determine whether a proposed rule change should be
approved or disapproved.
    \28\ 15 U.S.C. 78s(b)(2)(B).
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    Pursuant to Section 19(b)(2)(B) of the Act,\29\ the Commission is
providing notice of the grounds for possible disapproval under
consideration:
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    \29\ 15 U.S.C. 78s(b)(2)(B).
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     Section 6(b)(4) of the Act, which requires that the rules
of a national securities exchange ``provide for the equitable
allocation of reasonable dues, fees, and other charges among its
members and issuers and other persons using its facilities,'' \30\
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    \30\ 15 U.S.C. 78f(b)(4).
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     Section 6(b)(5) of the Act, which requires, among other
things, that the rules of a national securities exchange be designed to
``perfect the mechanism of a free and open market and a national market
system'' and ``protect investors and the public interest,'' and not be
``designed to permit unfair discrimination between customers, issuers,
brokers, or dealers,'' \31\ and
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    \31\ 15 U.S.C. 78f(b)(5).
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     Section 6(b)(8) of the Act, which requires that the rules
of a national securities exchange ``not impose any burden on
competition not necessary or appropriate in furtherance of the purposes
of [the Act].'' \32\
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    \32\ 15 U.S.C. 78f(b)(8).
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    As noted above, the proposals would, among other things, amend the
Exchanges' port fee schedules to provide that certain port fees are
charged on a ``$X/each MPID assigned to port/month'' basis rather than
a ``$X/port/month'' basis.\33\ Also as discussed above, in connection
with the proposals, each Exchange states that its proposal would
clarify and more fully describe the port fees, codify the Exchange's
existing practices for assessing port fees, avoid potential confusion
among customers, and would not change the fees that port users
currently pay.\34\ The Exchanges do not provide other explanations for
why the proposals are consistent with the Act, and do not reference
previous Exchange rule filings that provided such explanations.
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    \33\ See supra Section II.
    \34\ See supra Section III.
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    Under the Commission's Rules of Practice, the ``burden to
demonstrate that a proposed rule change is consistent with the [Act]
and the rules and regulations issued thereunder . . .

is on the [SRO] that proposed the rule change.'' \35\ The description
of a proposed rule change, its purpose and operation, its effect, and a
legal analysis of its consistency with applicable requirements must all
be sufficiently detailed and specific to support an affirmative
Commission finding,\36\ and any failure of an SRO to provide this
information may result in the Commission not having a sufficient basis
to make an affirmative finding that a proposed rule change is
consistent with the Act and the applicable rules and regulations
thereunder.\37\
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    \35\ Rule 700(b)(3), Commission Rules of Practice, 17 CFR
201.700(b)(3).
    \36\ See id.
    \37\ See id.
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    The Commission is instituting proceedings to allow for additional
consideration and comment on the issues raised herein, including as to
whether the proposed rule changes are consistent with the Act, and
specifically, with its requirements that exchange fees be reasonable
and equitably allocated; be designed to perfect the mechanism of a free
and open market and the national market system, protect investors and
the public interest, and not be unfairly discriminatory; and not impose
an unnecessary or inappropriate burden on competition.\38\
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    \38\ See 15 U.S.C. 78f(b)(4), (5), and (8).
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V. Commission's Solicitation of Comments

    The Commission requests written views, data, and arguments with
respect to the concerns identified above as well as any other relevant
concerns. Such comments should be submitted by March 15, 2019. Rebuttal
comments should be submitted by March 29, 2019. Although there do not
appear to be any issues relevant to approval or disapproval which would
be facilitated by an oral presentation of views, data, and arguments,
the Commission will consider, pursuant to Rule 19b-4, any request for
an opportunity to make an oral presentation.\39\
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    \39\ 15 U.S.C. 78s(b)(2). Section 19(b)(2) of the Act grants the
Commission flexibility to determine what type of proceeding--either
oral or notice and opportunity for written comments--is appropriate
for consideration of a particular proposal by an SRO. See Securities
Acts Amendments of 1975, Report of the Senate Committee on Banking,
Housing and Urban Affairs to Accompany S. 249, S. Rep. No. 75, 94th
Cong., 1st Sess. 30 (1975).
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    The Commission asks that commenters address the sufficiency and
merit of the Exchanges' statements in support of the proposals, in
addition to any other comments they may wish to submit about the
proposed rule changes. Interested persons are invited to submit written
data, views, and arguments concerning the proposed rule changes,
including whether the proposed rule changes are consistent with the
Act. Comments may be submitted by any of the following methods:

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-BX-2018-066, SR-Phlx-2018-83, or both on the subject
line.

Paper Comments

     Send paper comments in triplicate to Brent J. Fields,
Secretary, Securities and Exchange Commission, 100 F Street NE,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-BX-2018-066, SR-Phlx-
2018-83, or both. This file number should be included on the subject
line if email is used. To help the Commission process and review your
comments more efficiently, please use only one method. The Commission
will post all comments on the Commission's internet website (http://www.sec.gov/rules/sro.shtml). Copies of the submissions, all subsequent
amendments, all written statements with respect to the proposed rule
changes that are filed with the Commission, and all written
communications relating to the proposed rule changes between the
Commission and any person, other than those that may be withheld from
the public in accordance with the provisions of 5 U.S.C. 552, will be
available for website viewing and printing in the Commission's Public
Reference Room, 100 F Street NE, Washington, DC 20549 on official
business days between the hours of 10:00 a.m. and 3:00 p.m. Copies of
the filings also will be available for inspection and copying at the
principal office of the Exchange. All comments received will be posted
without change. Persons submitting comments are cautioned that we do
not redact or edit personal identifying information from comment
submissions. You should submit only information that you wish to make
available publicly. All submissions should refer to File Number SR-BX-
2018-066, SR-Phlx-2018-83, or both and should be submitted on or before
March 15, 2019. Rebuttal comments should be submitted by March 29,
2019.

VI. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(3)(C) of the
Act,\40\ that File Numbers SR-BX-2018-066 and SR-Phlx-2018-83 be and
hereby are, temporarily suspended. In addition, the Commission is
instituting proceedings to determine whether the proposed rule changes
should be approved or disapproved.
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    \40\ 15 U.S.C. 78s(b)(3)(C).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\41\
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    \41\ 17 CFR 200.30-3(a)(57), (58).
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Eduardo A. Aleman,
Deputy Secretary.
[FR Doc. 2019-03041 Filed 2-21-19; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 83, Number 148 (Wednesday, August 1, 2018)]
[Rules and Regulations]
[Pages 37440-37443]
[FR Doc No: 2018-16470]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2018-0150; FRL-9980-39]

Titanium dioxide; Exemption From the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation amends the exemption from the requirement of a
tolerance for residues of titanium dioxide (CAS Reg. No. 13463-67-7)
when used as an inert ingredient in pesticide formulations applied to
growing crops to allow for use as a carrier. SciReg. Inc., on behalf of
Bayer CropScience Biologics GmbH, submitted a petition to EPA under the
Federal Food, Drug, and Cosmetic Act (FFDCA), requesting establishment
of an exemption from the requirement of a tolerance. This regulation
eliminates the need to establish a maximum permissible level for
residues of titanium dioxide resulting from this use.

DATES: This regulation is effective August 1, 2018. Objections and
requests for hearings must be received on or before October 1, 2018,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2018-0150, 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 protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
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 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-2018-0150 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
October 1, 2018. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (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-2018-0150, 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. Petition for Exemption

    In the Federal Register of May 18, 2018 (83 FR 23247) (FRL-9976-
87), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C.
346a, announcing the filing of a pesticide petition (PP IN-11085) by
SciReg. Inc., on behalf of Bayer CropScience Biologics GmbH, Lukaswiese
4, 23970 Wismar, Germany. The petition requested that the 40 CFR
180.920 exemption from the requirement of a tolerance for residues of
titanium dioxide (CAS Reg. No. 13463-67-7) be amended to allow for use
as a carrier when used as an inert ingredient in pesticide formulations
applied to growing crops only. That document referenced a summary of
the petition prepared by SciReg. Inc., on behalf of Bayer CropScience
Biologics GmbH, the petitioner, which is available in the docket,
http://www.regulations.gov. There were no comments received in response
to the notice of filing.

III. Inert Ingredient Definition

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

IV. Aggregate Risk Assessment and Determination of Safety

    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the tolerance is ``safe.'' Section 408(b)(2)(A)(ii) of FFDCA defines
``safe'' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.'' This includes exposure through
drinking water and in residential settings, but does not include
occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure of infants and children to the
pesticide chemical residue in establishing a tolerance and to ``ensure
that there is a reasonable certainty that no harm will result to
infants and children from aggregate exposure to the pesticide chemical
residue. . . .''
    EPA establishes exemptions from the requirement of a tolerance only
in those cases where it can be clearly demonstrated that the risks from
aggregate exposure to pesticide chemical residues under reasonably
foreseeable circumstances will pose no appreciable risks to human
health. In order to determine the risks from aggregate exposure to
pesticide inert ingredients, the Agency considers the toxicity of the
inert in conjunction with possible exposure to residues of the inert
ingredient through food, drinking water, and through other exposures
that occur as a result of pesticide use in residential settings. If EPA
is able to determine that a finite tolerance is not necessary to ensure
that there is a reasonable certainty that no harm will result from
aggregate exposure to the inert ingredient, an exemption from the
requirement of a tolerance may be established.
    Consistent with FFDCA section 408(c)(2)(A), and the factors
specified in FFDCA section 408(c)(2)(B), 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 titanium dioxide including
exposure resulting from the exemption established by this action. EPA's
assessment of exposures and risks associated with titanium dioxide
follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered their
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.
    The available toxicity studies on titanium dioxide via the oral
route of exposure clearly demonstrate a lack of toxicity. The several
studies in mice, rats, dogs, cats, rabbits and other species of varying
durations do not indicate toxicity, even at very high doses (e.g.,
50,000 ppm or 2,500 mg/kg/day dietary exposure for two years in rats).
There are no studies on the dermal toxicity of titanium dioxide and
there is no expected toxicity via the dermal route of exposure because
as an insoluble solid material, titanium dioxide is not absorbed via
the skin.
    The available inhalation studies indicate that the primary toxicity
of titanium dioxide is due to deposition of the inhaled particles.
Although these studies suggest equivocal evidence of carcinogenicity
due to prolonged exposure to titanium dioxide particles, EPA has
determined that these effects are not relevant for assessing risk from
exposure to titanium dioxide when used as an inert ingredient in
pesticide formulations based on the following. First, tumors were only
observed in two of the available studies and only in one species. In
one study, those tumors were only observed in rats continually exposed
to ultrafine particles of titanium dioxide. In the second study, tumors
were only observed from exposure to fine particles of titanium dioxide
at extremely high concentrations (250 mg/m\3\), in which the animals
experienced overloading of lung clearance, with chronic inflammation
resulting in lung tumors. All but one of the tumors in the second study
were subsequently reclassified as non-neoplastic or non-cancerous in
nature. No tumors were observed in studies involving mice.
    The titanium dioxide used in pesticide formulations is considered
pigmentary grade, not ultrafine or nanoscale. Consequently, the tumors
observed from exposure to ultrafine particles of titanium dioxide are
not relevant for assessing exposure to the type of titanium dioxide
used in pesticide formulations. Following the reclassification of the
tumors observed in the second inhalation study, EPA does not consider
these effects to be strong evidence of carcinogenicity from exposure to
fineparticle-sized titanium dioxide. Further, EPA does not expect any
reasonably foreseeable uses of titanium dioxide in pesticide
formulations that might result in residential exposures that would
approach the levels of exposure necessary to elicit the effects seen in
the available inhalation study. The levels at which effects were
observed in that study greatly exceed any reasonable

dose for toxicity testing and any likely residential exposure levels.
Moreover, when used as an inert in pesticide formulations, titanium
dioxide will be bound to other materials, with no significant
inhalation exposure to titanium dioxide particles themselves.
    This position is consistent with the National Institute of
Occupational Health and Safety's (NIOSH) recent assessment that
ultrafine but not fine titanium dioxide would be considered a
``potential occupational carcinogen.'' The NIOSH Current Intelligence
Bulletin ``Occupational Exposure to Titanium Dioxide'' concludes that
``[t]he lung tumors observed in rats after exposure to 250 mg/m\3\ of
fine TiO2 [titanium dioxide] were the basis for the original
NIOSH designation of TiO2 as a ``potential occupational
carcinogen.'' However, because this dose is considered to be
significantly higher than currently accepted inhalation toxicology
practice, NIOSH concluded that the response at such a high dose should
not be used in making its hazard identification.'' NIOSH concluded that
the data is insufficient to classify fine titanium dioxide as a
potential occupational carcinogen.
    Because the predominant form of titanium dioxide used commercially,
and the form used as an inert ingredient in pesticide formulations, is
pigment grade, which is not in the ultrafine or nanoscale particle size
range but rather in the fine particle size range, EPA concludes that
carcinogenicity is not a concern from exposure to titanium dioxide
resulting from its use as an inert ingredient in pesticide
formulations.
    Specific information on the studies received and the nature of the
adverse effects caused by titanium dioxide 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 final rule
published in the Federal Register of July 27, 2012 (77 FR 44151) (FRL-
9354-6) and in the Agency's risk assessment which can be found at
http://www.regulations.gov in document ``Titanium Dioxide; Human Health
Risk Assessment and Ecological Effects Assessment to Support Proposed
Exemption from the Requirement of a Tolerance When used as an Inert
Ingredient in Pesticide Formulations'' in docket ID number EPA-HQ-OPP-
2018-0150.

B. Toxicological Points of Departure/Levels of Concern

    Because the available data indicate no toxicity via the oral route
of exposure, no endpoint of concern for that route of exposure has been
identified in the available database. This conclusion is in agreement
with the conclusion of the World Health Organization (WHO) Committee on
Food Coloring Materials that no Acceptable Daily Intake (ADI) need be
set for the use of titanium dioxide based on the range of acute, sub-
acute, and chronic toxicity assays, all showing low mammalian toxicity.
Similarly, no significant toxicity of titanium dioxide is expected via
the dermal route of exposure, so no endpoint was identified.
    Because the effects seen in inhalation studies occurred at doses
above the levels at which pesticide exposure is expected and for
particle sizes that are different from the size of titanium dioxide
used in pesticide formulations, the Agency has concluded that those
risks are not relevant for assessing risk from pesticide exposure and
therefore, did not identify an endpoint for assessing inhalation
exposure risk.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to titanium dioxide, EPA considered exposure under the
proposed exemption from the requirement of a tolerance and all other
existing exemptions from the requirement of a tolerance for residues of
titanium dioxide. EPA assessed dietary exposures from titanium dioxide
in food as follows:
    Residues of titanium dioxide are exempt from the requirement of a
tolerance when used as an inert ingredient in many different
circumstances: When used in pesticide formulations applied to growing
crops as a pigment/coloring agent in plastic bags used to wrap growing
bananas or colorant on seeds for planting (40 CFR 180.920); when used
in pesticide formulations applied to animals (40 CFR 180.930); when
used as a UV protectant in microencapsulated formulations of the
insecticide lambda-cyhalothrin at no more than 3.0% by weight (40 CFR
180.1195); when used as a UV stabilizer in pesticide formulations of
napropamide at no more than 5% of the product formulation (40 CFR
180.1195); when used in pesticide placed at entrance to bee hives
intended to control varroa mites in hive at a maximum of 0.1% wt/wt (40
CFR 180.1195); and when used in anthraquinone pesticide formulations at
a maximum of 45% wt/wt (40 CFR 180.1195). Titanium dioxide is also
approved for use as a colorant in food (21 CFR 73.575).
    Although dietary exposure may be expected from use of titanium
dioxide in pesticide formulations applied to bee hives and on other
crops (as well as from other non-pesticidal sources), a quantitative
exposure assessment for titanium dioxide was not conducted because no
endpoint of concern was identified in the database.
    2. Dietary exposure from drinking water. Since a hazard endpoint of
concern was not identified for the acute and chronic dietary
assessment, a quantitative dietary exposure risk assessment for
drinking water was not conducted, although exposures from drinking
water may be expected from use on food crops.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., textiles (clothing and diapers), carpets, swimming
pools, and hard surface disinfection on walls, floors, tables).
    Titanium dioxide may be used in non-pesticide products such as
paints, printing inks, paper and plastic products around the home. It
has also been approved for use in drugs (21 CFR 73.1575) and in
cosmetics (21 CFR 73.2575 and 73.3126). Additionally, titanium dioxide
may be used as an inert ingredient in pesticides that include
residential uses; however based on the discussion in Unit IV.B., a
quantitative residential exposure assessment for titanium dioxide was
not conducted.
    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.''
    Because titanium dioxide does not have a toxic mode of action or a
mechanism of toxicity, this provision does not apply.

D. Safety Factor for Infants and Children

    Due to titanium dioxide's low potential hazard and the lack of a
hazard endpoint, it was determined that a quantitative risk assessment
using safety factors applied to a point of departure protective of an
identified hazard endpoint is not appropriate for titanium dioxide. For
the same reasons that a quantitative risk assessment based on a safety
factor approach is not appropriate for titanium dioxide, an FQPA SF is
not needed to protect the safety of infants and children.

E. Aggregate Risks and Determination of Safety

    Taking into consideration all available information on titanium
dioxide, EPA has determined that there is a reasonable certainty that
no harm to any population subgroup will result from aggregate exposure
to titanium dioxide under reasonable foreseeable circumstances.
Therefore, the exemption from tolerance under 40 CFR 180.920 for
residues of titanium dioxide, when used as an inert ingredient in
pesticide formulations is safe under FFDCA section 408.

V. Analytical Enforcement Methodology

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

VI. Conclusions

    Therefore, EPA is amending the exemption from the requirement of a
tolerance in 40 CFR 180.920 for residues of titanium dioxide (CAS Reg.
No. 13463-67-7) when used as an inert ingredient (carrier) in pesticide
formulations.

VII. Statutory and Executive Order Reviews

    This action establishes an exemption from the requirement of a
tolerance 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); Executive Order 13045, entitled ``Protection of
Children from Environmental Health Risks and Safety Risks'' (62 FR
19885, April 23, 1997); or Executive Order 13771, entitled ``Reducing
Regulations and Controlling Regulatory Costs'' (82 FR 9339, February 3,
2017). 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 exemption in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
    This 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).

VIII. 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: July 11, 2018.
Michael L. Goodis,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

0
2. In Sec.  180.920, revise the inert ingredient ``Titanium dioxide
(CAS Reg. No. 13463-67-7)'' in the table to read as follows:

Sec.  180.920  Inert ingredients used pre-harvest; exemptions from the
requirement of a tolerance.

* * * * *

----------------------------------------------------------------------------------------------------------------
           Inert ingredients                      Limits                                Uses
----------------------------------------------------------------------------------------------------------------

                                                  . . . . . . .
Titanium dioxide (CAS Reg. No. 13463-   .........................  Pigment, colorant, carrier.
 67-7).

                                                  . . . . . . .
----------------------------------------------------------------------------------------------------------------

[FR Doc. 2018-16470 Filed 7-31-18; 8:45 a.m.]
 BILLING CODE 6560-50-P


[Federal Register Volume 76, Number 193 (Wednesday, October 5, 2011)]
[Rules and Regulations]
[Pages 61587-61592]
[FR Doc No: 2011-25704]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2011-0053; FRL-8884-2]

Prothioconazole; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes tolerances for residues of
prothioconazole in or on multiple commodities which are identified and
discussed later in this document. Bayer CropScience requested these
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective October 5, 2011. Objections and
requests for hearings must be received on or before December 5, 2011,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2011-0053. All documents in the
docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is
not publicly available, e.g., Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, is not placed on the
Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket Facility telephone number is (703)
305-5805.

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

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to those
engaged in the following activities:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather to
provide a guide for readers regarding entities likely to be affected by
this action. Other types of entities not listed in this unit could also
be affected. The North American Industrial Classification System
(NAICS) codes have been provided to assist you and others in
determining whether this action might apply to certain entities. If you
have any questions regarding the applicability of this action to a
particular entity, consult the person listed under FOR FURTHER
INFORMATION CONTACT.

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

    You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at http://ecfr.gpoaccess.gov/cgi/t/text/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-2011-0053 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
December 5, 2011. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket. Information not marked confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA without prior notice. Submit a copy of
your non-CBI objection or hearing request, identified by docket ID
number EPA-HQ-OPP-2011-0053, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is<PHONE_NUMBER>.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of March 29, 2011 (76 FR 17375) (FRL-8867-
4), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of pesticide petitions (PPs
0F7714 and 0F7715) by Bayer CropScience, P.O. Box 12014, 2 T.W.
Alexander Drive, Research Triangle Park, NC 27709. The petition
requested that 40 CFR 180.626 be amended by establishing tolerances for
residues of the fungicide prothioconazole, 2-[2-(1-chlorocyclopropyl)-
3-(2-chlorophenyl-2-hydroxypropyl]-1,2-dihydro-3H-1,2,4-triazole-3-
thione and its desthio metabolite, in or on the raw or processed
agricultural commodity rice,

grain at 0.25 parts per million (ppm); rice, hulls at 1.0 ppm; alfalfa,
forage and alfalfa, hay at 0.02 ppm and potato, tuber at 0.02 ppm (PP
0F7714). In a separate petition (PP 0F7715) Bayer CropScience also
proposed use of the currently established tolerances for residues of
prothioconazole, 2-[2-(1-chlorocyclopropyl)-3-(2-chlorophenyl-2-
hydroxypropyl]-1,2-dihydro-3H-1,2,4-triazole-3-thione and its desthio
metabolite, in or on the raw agricultural commodities pea and bean,
dried shelled, except soybean, subgroup 6C; soybean, forage; soybean,
hay; soybean, seed; rice, seed to support the use of prothioconazole as
a seed treatment on these crops. That notice referenced a summary of
the petitions prepared by Bayer CropScience, the registrant, which is
available in the docket, http://www.regulations.gov. There were no
comments received in response to the notice of filing.
    Based upon review of the data supporting the petition, EPA has
determined that it is appropriate to modify the existing grain crop
groups rather than establish separate rice grain and rice straw
tolerances. The rice grain tolerance will now be covered by the
modified tolerance of 0.35 ppm for grain, cereal group 15, except sweet
corn and sorghum. Likewise, the rice straw tolerance will now be
covered by the modified tolerance of 5.0 ppm for grain, cereal, forage,
fodder, and straw, group 16, except sorghum; straw. Also, the EPA is
establishing a tolerance for rice hulls at 0.90 ppm, instead of the
proposed tolerance of 1.0 ppm. The reasons for these changes are
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 section 408(b)(2)(D) of FFDCA, and the factors
specified in section 408(b)(2)(D) of FFDCA, 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 prothioconazole
including exposure resulting from the tolerances established by this
action. EPA's assessment of exposures and risks associated with
prothioconazole 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.
    Prothioconazole has low acute toxicity by oral, dermal, and
inhalation routes. It is not a dermal sensitizer, or a skin or eye
irritant. Prothioconazole's metabolite, prothioconazole-desthio, also
has low acute toxicity by oral, dermal, and inhalation routes. It is
not a dermal sensitizer, or a skin irritant, but it is a slight eye
irritant. The subchronic and chronic studies show that the target
organs at the lowest observable adverse effects level (LOAEL) include
the liver, kidney, urinary bladder, thyroid and blood. In addition, the
chronic studies showed body weight and food consumption changes, and
toxicity to the lymphatic and GI systems.
    Prothioconazole and its metabolites may be developmental toxicants,
producing effects including malformations in the conceptus at levels
equal to or below maternally toxic levels in some studies; particularly
those studies conducted using prothioconazole-desthio. Reproduction
studies in the rat with prothioconazole and prothioconazole-desthio
suggest that these chemicals may not be reproductive toxicants. Acute
and subchronic neurotoxicity studies were conducted in the rat using
prothioconazole. A developmental neurotoxicity study was conducted in
the rat using prothioconazole-desthio.
    The available data show that the prothioconazole-desthio metabolite
produces toxicity at lower dose levels in subchronic, developmental,
reproductive, and neurotoxicity studies as compared with
prothioconazole and the two additional metabolites that were tested.
    The available carcinogenicity and/or chronic studies in the mouse
and rat, using both prothioconazole and prothioconazole-desthio, show
no increase in tumor incidence. Therefore, EPA has concluded that
prothioconazole and its metabolites are not carcinogenic, and are
classified as ``Not likely to be Carcinogenic to Humans'' according to
the 2005 Cancer Guidelines.
    Specific information on the studies received and the nature of the
adverse effects caused by prothioconazole as well as the no-observed-
adverse-effect-level (NOAEL) and the LOAEL from the toxicity studies
are discussed in the final rule published in the Federal Register of
May 28, 2010 (75 FR 29910) (FRL-8828-6).

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 prothioconazole used
for human risk assessment is discussed in Unit III.B. of the final rule
published in the Federal Register of May 28, 2010 (75 FR 29910) (FRL-
8828-6).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to prothioconazole and its metabolites and/or degradates, EPA
considered exposure under the petitioned-for tolerances as well as all
existing prothioconazole tolerances in 40 CFR 180.626. EPA assessed
dietary exposures from prothioconazole 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.
    In estimating acute dietary exposure, EPA used food consumption
information from the United States Department of Agriculture (USDA)
1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by
Individuals (CSFII). As to residue levels in food, EPA conducted a
moderately refined acute dietary exposure assessment. Empirical
processing factors, average field trial residues (since all of the
plant commodities included in this assessment are blended food forms,
except sweet corn), and livestock commodity residues derived from
feeding studies and a reasonably balanced dietary burden (RBDB) were
incorporated into the moderately refined acute assessment. The
assessment also assumed 100 percent crop treated (PCT). Since no
observed effects would be attributable to a single dose exposure for
the general U.S. population (including infants and children), females
13-49 years of age was the only population subgroup included in the
acute assessment.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 1994-1996
and 1998 CSFII. As to residue levels in food, EPA conducted a
moderately refined chronic dietary exposure assessment. Empirical
processing factors, average field trial residues, and livestock
commodity residues derived from feeding studies and a reasonably
balanced dietary burden (RBDB) were incorporated into the chronic
assessment; 100 PCT was assumed.
    iii. Cancer. EPA determines whether quantitative cancer exposure
and risk assessments are appropriate for a food-use pesticide based on
the weight of the evidence from cancer studies and other relevant data.
Cancer risk is quantified using a linear or non-linear approach. If
sufficient information on the carcinogenic mode of action is available,
a threshold or non-linear approach is used and a cancer RfD is
calculated based on an earlier non-cancer key event. If carcinogenic
mode of action data are not available, or if the mode of action data
determines a mutagenic mode of action, a default linear cancer slope
factor approach is utilized.
    Based on the data summarized in Unit III.A., EPA has concluded that
prothioconazole is ``Not Likely to be Carcinogenic to Humans.''
Therefore, a dietary exposure assessment for the purpose of assessing
cancer risk is unnecessary.
    iv. Anticipated residue and percent crop treated (PCT) 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. Average
residues and 100 PCT were assumed for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for prothioconazole in drinking water. These simulation
models take into account data on the physical, chemical, and fate/
transport characteristics of prothioconazole. 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 Pesticide Root Zone Model/Exposure Analysis Modeling
System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-
GROW) models, the estimated drinking water concentrations (EDWCs) of
prothioconazole for the acute dietary risk assessment, the estimated
surface water concentration value of 94.7 parts per million (ppb) was
used to assess the contribution to drinking water. For the chronic
dietary risk assessment, the estimated surface water concentration
value of 84.3 ppb was used to assess the contribution to drinking
water. Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model.
    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).
    Prothioconazole is not registered for any specific use patterns
that would result in residential exposure.
    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.''
    Prothioconazole is a member of the triazole-containing class of
pesticides. Although conazoles act similarly in plants (fungi) by
inhibiting ergosterol biosynthesis, there is not necessarily a
relationship between their pesticidal activity and their mechanism of
toxicity in mammals. Structural similarities do not constitute a common
mechanism of toxicity. Evidence is needed to establish that the
chemicals operate by the same, or essentially the same, sequence of
major biochemical events. In conazoles, however, a variable pattern of
toxicological responses is found. Some are hepatotoxic and
hepatocarcinogenic in mice. Some induce thyroid tumors in rats. Some
induce developmental, reproductive, and neurological effects in
rodents. Furthermore, the conazoles produce a diverse range of
biochemical events including altered cholesterol levels, stress
responses, and altered DNA methylation. It is not clearly understood
whether these biochemical events are directly connected to their
toxicological outcomes. Thus, there is currently no evidence to
indicate that conazoles share common mechanisms of toxicity and EPA is
not following a cumulative risk approach based on a common mechanism of
toxicity for the conazoles. For information regarding EPA's procedures
for cumulating effects from substances found to have a common mechanism
of toxicity, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.
    Prothioconazole is a triazole-derived pesticide. Triazole-derived
pesticides can form the common metabolite, 1,2,4-triazole and three
triazole conjugates (triazole alanine, triazole acetic acid, and
triazolylpyruvic acid). To support existing tolerances and to establish
new tolerances for triazole-derivative pesticides, including
prothioconazole, EPA conducted a human health risk

assessment for exposure to 1,2,4-triazole, triazole alanine, and
triazole acetic acid resulting from the use of all current and pending
uses of any triazole-derived fungicide. The risk assessment is a highly
conservative, screening-level evaluation in terms of hazards associated
with common metabolites (e.g., use of a maximum combination of
uncertainty factors) and potential dietary and non-dietary exposures
(i.e., high end estimates of both dietary and non-dietary exposures).
In addition, the Agency retained the additional 10X FQPA safety factor
(SF) for the protection of infants and children. The assessment
included evaluations of risks for various subgroups, including those
comprised of infants and children. The Agency's risk assessment can be
found in the propiconazole reregistration docket at http://www.regulations.gov, docket ID number EPA-HQ-OPP- 2005-0497 and an
update to assess the addition of the commodities included in this
action may be found in docket ID number EPA-HQ-OPP-2010-0621 in the
document titled ``Common Triazole Metabolites: Updated Aggregate Human
Health Risk Assessment to Address Tolerance Petitions for
Metconazole.''

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 Food Quality
Protection Act Safety Factor (FQPA 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 evidence of
increased susceptibility following prenatal/or postnatal exposure in:
    i. Rat developmental toxicity studies with prothioconazole as well
as its prothioconazole-desthio and sulfonic acid K salt metabolites.
    ii. Rabbit developmental toxicity studies with prothioconazole-
desthio.
    iii. A rat developmental neurotoxicity study with prothioconazole-
desthio; and
    iv. Multi-generation reproduction studies in the rat with
prothioconazole-desthio. Effects include skeletal structural
abnormalities, such as cleft palate, deviated snout, malocclusion,
extra ribs, and developmental delays. Available data also show that the
skeletal effects such as extra ribs are not completely reversible after
birth in the rat, but persist as development continues.
    Although increased susceptibility was seen in these studies, the
Agency concluded that there is a low concern and no residual
uncertainties for prenatal and/or postnatal toxicity effects of
prothioconazole because:
     Developmental toxicity NOAELs and LOAELs from prenatal
exposure are well characterized after oral and dermal exposure;
     The off-spring toxicity NOAELs and LOAELs from postnatal
exposures are well characterized; and
     The NOAEL for the fetal effect malformed vertebral body
and ribs is used for assessing acute risk of females 13 years and older
and, because it is lower than the NOAELs in other developmental
studies, is protective of all potential developmental effects.
    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 prothioconazole is complete, including
required functional immunotoxicity testing. The EPA began requiring
functional immunotoxicity testing of all food and non-food use
pesticides on December 26, 2007.
    ii. There is an acceptable battery of neurotoxicity studies
including a developmental neurotoxicity study. Although offspring
neurotoxicity was found, characterized by peripheral nerve lesions in
the developmental neurotoxicity studies on prothioconazole-desthio, the
increase was seen only in the highest dose group at 105 mg/kg/day, was
not considered treatment related, and a clear NOAEL was established for
this study.
    iii. Although increased susceptibility was seen in the
developmental and reproduction studies, the Agency concluded that there
is a low concern and no residual uncertainties for prenatal and/or
postnatal toxicity effects of prothioconazole for the reasons explained
in Unit III.D.2.
    iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessment is moderately refined
utilizing empirical processing factors, 100 PCT, average crop field
trial residue levels, and livestock maximum residues. Results from
ruminant feeding studies and poultry metabolism studies were used to
determine the maximum residue levels for livestock commodities. The
crop field trials were performed using maximum application rates and
minimum pre-harvest intervals. Although the Agency is requiring
extended confirmatory storage stability data; interim storage stability
data do not indicate that residue concentrations decline and therefore
the assessment should not underestimate risk from dietary exposure. EPA
made conservative (protective) assumptions in the ground water and
surface water modeling used to assess exposure to prothioconazole in
drinking water. These assessments will not underestimate the exposure
and risks posed by prothioconazole.

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.
    Based on the proposed and existing crop uses for prothioconazole,
dietary aggregate exposures (i.e., food plus drinking water) are
anticipated. There are no residential uses for prothioconazole and,
therefore, no residential exposures are anticipated. Consequently, only
dietary (food plus drinking water) exposures were aggregated for this
assessment.
    1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and
drinking water to prothioconazole will occupy 24% of the aPAD for
females 13-49 years of age, the only population group at risk for acute
effects.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
prothioconazole from food and drinking water will utilize 21% of the
cPAD for the general U.S. population and 62% of the cPAD for all
infants <1 year old, the population group receiving the greatest
exposure.
    3. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies,

prothioconazole is not expected to pose a cancer risk to humans.
    4. 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 prothioconazole residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate liquid chromatography methods with tandem mass
spectrometry detection (LC/MS/MS) are available to enforce the
tolerance expression.
    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>; e-mail 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 U.N. 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 established MRLs for residues of desthio-
prothioconazole in barley at 0.2 ppm; oats, rye, and wheat at 0.05 ppm
each; in the fodder (dry) of cereal grains at 5 ppm; and in the straw
(dry) of cereal grains at 4 ppm. There are currently no established
Mexican MRLs for prothioconazole. Canadian MRLs have been established
for prothioconazole per se in/on several commodities, including barley
(0.35 ppm), wheat (0.07 ppm). Harmonization of the proposed tolerances
with the existing Codex for prothioconazole is not possible at this
time because of differences in tolerance expression and use patterns.
The MRL expression for Codex is prothioconazole-desthio and is thus not
compatible with the U.S. tolerance definition, the sum of
prothiocoanzole and prothioconazole-desthio. EPA generally includes the
parent in all residue definitions for tolerance enforcement, whereas
Codex routinely excludes the parent if it is shown to be a small part
of the actual total residue. Prothioconazole is a minor component of
the total residue on the crops tested. Much of the Codex cereal grain
supervised field trial data are from Europe, where the use pattern is
different resulting in lower measured residues.
    The tolerance definition for plant commodities in Canada was
recently changed and is now harmonized with the U.S. residue
definition. The barley tolerance of Canada agrees with the U.S.
tolerance for cereal grains (except sweet corn, sorghum, and rice) of
0.35 ppm. However, the Canada tolerance for wheat is lower (0.07 ppm)
than the existing U.S. group tolerance. EPA establishes crop group
tolerances, as opposed to individual commodity tolerances, whenever
there are adequate data for the representative commodities of that
group and proposed use. There must be an acceptable range of residues
over all the representative commodities. Wheat falls under this crop
group practice in this case. Canada does not routinely establish animal
feed commodity tolerances, and therefore there are no harmonization
issues with forage, stover, hay, and straw.

C. Revisions to Petitioned-For Tolerances

    The proposed rice grain tolerance level of 0.25 ppm is lower than
the existing tolerance level (0.35 ppm) for grain, cereal group 15,
except rice and sweet corn and sorghum. The existing cereal grain group
15 tolerance excludes rice, but the present evaluation of rice field
trial data allows expansion of that group to include rice. Therefore,
in this action, EPA is revising the existing cereal group to read
grain, cereal group 15 (except sweet corn and sorghum). Likewise, the
rice straw tolerance level is lower than the existing tolerance level
(5.0 ppm) for grain, cereal, forage, fodder, and straw, group 16,
except sorghum and rice straw, and therefore this crop group is being
revised to include rice straw. Also, the submitted data support a
tolerance of 0.90 ppm for rice hulls as determined from the rice to
hull processing factor (from the rice processing study) applied to the
highest average field trial residue, or 4.4 x 0.19 ppm, or 0.9 ppm
instead of the proposed tolerance of 1.0 ppm.

V. Conclusion

    Therefore, tolerances are established for residues of
prothioconazole (2-[2-(1-chlorocylcopropyl)-3-(2-chlorophenyl)-2-
hydroxypropyl]-1,2-dihydro-3H-1,2,4-triazole-3-thion) and its
metabolite prothioconazole-desthio ([alpha]-(1-chlorocyclopropyl)-
[alpha]-[(2-chlorophenyl)methyl]-1H-1,2,4-triazole-1-ethanol), in or on
alfalfa, forage at 0.02 ppm; alfalfa, hay at 0.02 ppm, potato at 0.02
ppm and rice, hulls at 0.90 ppm. The existing tolerance for Grain,
cereal, group 15, except sweet corn, sorghum, and rice is changed to
Grain, cereal, group 15, except sweet corn and sorghum and the existing
tolerance for Grain, cereal, forage, fodder and straw, group 16, except
sorghum and rice; straw is changed to Grain, cereal, forage, fodder and
straw, group 16, except sorghum, straw.
    Further, seed treatment uses on soybean, dried shelled pea and bean
(except soybean) subgroup 6C and rice are covered by existing and
currently established tolerances for these commodities.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this final rule has been
exempted from review under Executive Order 12866, this final rule is
not subject to Executive Order 13211, entitled Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
Protection of Children from Environmental Health Risks and Safety Risks
(62 FR 19885, April 23, 1997). This final rule does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any
special considerations under Executive Order 12898, entitled Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the tolerance in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
    This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or Tribes, nor does this
action alter the

relationships or distribution of power and responsibilities established
by Congress in the preemption provisions of section 408(n)(4) of FFDCA.
As such, the Agency has determined that this action will not have a
substantial direct effect on States or Tribal governments, on the
relationship between the national government and the States or Tribal
governments, or on the distribution of power and responsibilities among
the various levels of government or between the Federal Government and
Indian Tribes. Thus, the Agency has determined that Executive Order
13132, entitled Federalism (64 FR 43255, August 10, 1999) and Executive
Order 13175, entitled Consultation and Coordination with Indian Tribal
Governments (65 FR 67249, November 9, 2000) do not apply to this final
rule. In addition, this final rule does not impose any enforceable duty
or contain any unfunded mandate as described under Title II of the
Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).

VII. Congressional Review Act

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

List of Subjects in 40 CFR Part 180

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

    Dated: September 26, 2011.
Lois Rossi,
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. Section 180.626 is amended by revising the table in paragraph (a)(1)
to read as follows:

Sec.  180.626  Prothioconazole; tolerances for residues.

    (a) * * * (1) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Alfalfa, forage............................................         0.02
Alfalfa, hay...............................................         0.02
Beet, sugar, roots.........................................         0.25
Corn, sweet kernel plus cob with husks removed.............         0.04
Grain, aspirated grain fractions...........................        11
Grain, cereal, forage, fodder and straw, group 16, except           8.0
 sorghum, and rice; forage.................................
Grain, cereal, forage, fodder and straw, group 16, except           7.0
 sorghum, and rice; hay....................................
Grain, cereal, forage, fodder and straw, group 16, except          10
 sorghum, and rice; stover.................................
Grain, cereal, forage, fodder and straw, group 16, except           5.0
 sorghum, straw............................................
Grain, cereal, group 15, except sweet corn and sorghum.....         0.35
Pea and bean, dried shelled, except soybean, subgroup 6C...         0.9
Peanut.....................................................         0.02
Potato.....................................................         0.02
Rapeseed, seed.............................................         0.15
Rice, hulls................................................         0.90
Soybean, forage............................................         4.5
Soybean, hay...............................................        17
Soybean, seed..............................................         0.15
------------------------------------------------------------------------

* * * * *
[FR Doc. 2011-25704 Filed 10-4-11; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 75, Number 67 (Thursday, April 8, 2010)]
[Rules and Regulations]
[Pages 17852-17853]
[FR Doc No: 2010-7803]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2009-0405; Airspace Docket No. 09-ASW-17]

Amendment of Class E Airspace; Altus, OK

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule; correction.

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

SUMMARY: This action corrects the final rule published in the Federal
Register December 29, 2009, amending Class E airspace in the Altus, OK
area. The geographic coordinates were incorrect for the Altus
Localizer. This action corrects that error.

DATES: Effective date 0901 UTC April 8, 2010. The Director of the
Federal Register approves this incorporation by reference action under
1 CFR part 51, subject to the annual revision of FAA Order 7400.9 and
publication of conforming amendments.

FOR FURTHER INFORMATION CONTACT: Scott Enander, Central Service Center,
Operations Support Group, Federal Aviation Administration, Southwest
Region, 2601 Meacham Blvd., Fort Worth, TX 76137; telephone (817) 321-
7716.

SUPPLEMENTARY INFORMATION:

History

    On December 29, 2009, the FAA published in the Federal Register a
final rule amending Class E airspace in the Altus, OK area (74 FR
68666, Docket No. FAA-2009-0405). Subsequent to publication, an error
was discovered in the geographic coordinates for the Altus AFB ILS
Runway 17R Localizer. This action corrects the coordinates. Class E
airspace designations are published in paragraph 6005, of FAA Order
7400.9T signed August 27, 2009, and effective September 15, 2009, which
is incorporated by reference in 14 CFR part 71.1.
    In rule FR Doc. E9-30283 published on December 29, 2009, (74 FR
68666) make the following correction:
    On page 68667, in the first column, under Altus AFB ILS Runway 17R
Localizer, remove ``Lat. 34[deg]43[min]15[sec] N., long
99[deg]16[min]26[sec] W.'' and insert ``Lat. 34[deg]38[min]31[sec] N.,
long 99[deg]16[min]26[sec] W.''

    Issued in Fort Worth, Texas, on March 29, 2010.
Walter L. Tweedy,
Acting Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. 2010-7803 Filed 4-7-10; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: October 3, 2005 (Volume 70, Number 190)]
[Notices]
[Page 57585-57586]
[DOCID:fr03oc05-82]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP05-355-001]

Tennessee Gas Pipeline Company; Notice of Amendment

September 23, 2005.
    Take notice that Tennessee Gas Pipeline Company (Tennessee), 1001
Louisiana, Houston, Texas 77002, filed on September 21, 2005, in Docket
No. CP05-355-001, an amendment to its pending application filed on May
16, 2005, in Docket No. CP05-355-000, pursuant to sections 7(c) of the
Natural Gas Act (NGA), to reflect certain changes to its cost
allocation method used to construct its Northeast ConneXion-NY/NJ
Project (Project).
    This amendment is on file with the Commission and open to public
inspection. This filing may be also viewed on the Web at http://www.ferc.gov
 using the ``eLibrary'' link. Enter the docket number

excluding the last three digits in the docket number field to access
the document. For assistance, call<PHONE_NUMBER> or TTY, (202) 208-
3676.
    By this amendment, Tennessee is modifying the capital cost
allocated to the Project from the Compressor Station 325 Project
(Docket No. CP05-42-000), so that the allocation method used for the
Compressor Station 325 capital costs is consistent with the allocation
method used for the Compressor Station 317 capital costs. Tennessee
states that the effect of the change is that the Rate Base for the
Project will decrease by approximately $3 million, and the Cost of
Service will be reduced by $519,000. The proposed monthly recourse rate
will decrease from $15.79 to $14.93 per dekatherm.

    Any questions regarding this application should be directed to
Susan T. Halbach, Senior Counsel, Tennessee Gas Pipeline Company, 1001
Louisiana, Houston, Texas 77002, at<PHONE_NUMBER> or fax (713) 420-
1601.
    There are two ways to become involved in the Commission's review of
this project. First, any person wishing to obtain legal status by
becoming a party to the proceedings for this project should, on or
before the comment date stated below, file with the Federal Energy
Regulatory Commission, 888 First Street, NE., Washington, DC 20426, a
motion to intervene in accordance with the requirements of the
Commission's Rules of Practice and Procedure (18 CFR 385.214 or
385.211) and the Regulations under the NGA (18 CFR 157.10). A person
obtaining party status will be placed on the service list maintained by
the Secretary of the Commission and will receive copies of all
documents filed by the applicant and by all other parties. A party must
submit 14 copies of filings made with the Commission and must mail a
copy to the applicant and to every other party in the proceeding. Only
parties to the proceeding can ask for court review of Commission orders
in the proceeding.
    However, a person does not have to intervene in order to have
comments considered. The second way to participate is by filing with
the Secretary of the Commission, as soon as possible, an original and
two copies of comments in support of or in opposition to this project.
The Commission will consider these comments in determining the
appropriate action to be taken, but the filing of a comment alone will
not serve to make the filer a party to the proceeding. The Commission's
rules require that persons filing comments in opposition to the project
provide copies of their protests only to the party or parties directly
involved in the protest.
    Comments, protests and interventions may be filed electronically
via the Internet in lieu of paper. See, 18 CFR 385.2001(a)(1)(iii) and
the instructions on the Commission's Web site under the ``e-Filing''
link.
    Comment Date: October 14, 2005.

Magalie R. Salas,
Secretary.
[FR Doc. E5-5359 Filed 9-30-05; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register: April 9, 2008 (Volume 73, Number 69)]
[Notices]
[Page 19207]
[DOCID:fr09ap08-38]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 1

April 1, 2008.
    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:
    Docket Numbers: RP08-286-000.
    Applicants: East Tennessee Natural Gas, LLC.
    Description: East Tennessee Natural Gas, LLC submits its Cashout
Report for November 2006 through October 2007.
    Filed Date: 03/28/2008.
    Accession Number: 20080331-0053.
    Comment Date: 5 p.m. Eastern Time on Wednesday, April 09, 2008.

    Docket Numbers: RP08-287-000.
    Applicants: Rockies Express Pipeline LLC.
    Description: Annual Incidental Purchases and Sales Report of
Rockies Express Pipeline LLC.
    Filed Date: 03/28/2008.
    Accession Number: 20080328-5093.
    Comment Date: 5 p.m. Eastern Time on Wednesday, April 09, 2008.

    Docket Numbers: RP08-288-000.
    Applicants: Trailblazer Pipeline Company LLC.
    Description: Trailblazer Pipeline Company LLC submits part of
Trailblazer's FERC Gas Tariff, Fourth Revised Volume 1 tariff and First
Revised Sheet 11.
    Filed Date: 03/28/2008.
    Accession Number: 20080331-0120.
    Comment Date: 5 p.m. Eastern Time on Wednesday, April 09, 2008.

    Docket Numbers: RP08-289-000.
    Applicants: ANR Pipeline Company.
    Description: ANR Pipeline Company submits Fifteenth Revised Sheet
17A and Third Revised Sheet 17B of its FERC Gas Tariff, Second Revised
Volume 1, to become effective May 1, 2008.
    Filed Date: 03/28/2008.
    Accession Number: 20080331-0121.
    Comment Date: 5 p.m. Eastern Time on Wednesday, April 09, 2008.

    Docket Numbers: RP08-296-000.
    Applicants: Horizon Pipeline Company, L.L.C.
    Description: Horizon Pipeline Company, L.L.C.'s Penalty Revenue
Crediting Report.
    Filed Date: 03/28/2008.
    Accession Number: 20080331-5095.
    Comment Date: 5 p.m. Eastern Time on Wednesday, April 09, 2008.

    Docket Numbers: RP96-320-083.
    Applicants: Gulf South Pipeline Company, LP.
    Description: Gulf South Pipeline Company LP submits an amendment to
a negotiated rate letter agreement executed by Gulf South and one of
its customers in relation to the East Texas to Mississippi Expansion
Project etc.
    Filed Date: 03/28/2008.
    Accession Number: 20080331-0122.
    Comment Date: 5 p.m. Eastern Time on Wednesday, April 09, 2008.

    Any person desiring to intervene or to protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214) on or before 5 p.m. Eastern time on the specified comment
date. It is not necessary to separately intervene again in a subdocket
related to a compliance filing if you have previously intervened in the
same docket. Protests will be considered by the Commission in
determining the appropriate action to be taken, but will not serve to
make protestants parties to the proceeding. Anyone filing a motion to
intervene or protest must serve a copy of that document on the
Applicant. In reference to filings initiating a new proceeding,
interventions or protests submitted on or before the comment deadline
need not be served on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://
www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St., NE., Washington, DC 20426.
    The filings in the above proceedings are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive e-mail notification
when a document is added to a subscribed dockets(s). For assistance
with any FERC Online service, please e-mail<EMAIL_ADDRESS>
or call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. E8-7423 Filed 4-8-08; 8:45 am]

BILLING CODE 6717-01-P