[Federal Register Volume 83, Number 201 (Wednesday, October 17, 2018)]
[Notices]
[Pages 52484-52487]
[FR Doc No: 2018-22568]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-2613]

Presenting Quantitative Efficacy and Risk Information in Direct-
to-Consumer Promotional Labeling and Advertisements; Draft Guidance for
Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``Presenting
Quantitative Efficacy and Risk Information in Direct-to-Consumer
Promotional Labeling and Advertisements.'' This draft guidance provides
recommendations for presenting quantitative efficacy and risk
information in direct-to-consumer (DTC) promotional labeling and
advertisements for prescription human drugs and biological products and
prescription animal drugs and in DTC promotional labeling for over-the-
counter (OTC) animal drugs (collectively promotional materials). FDA is
issuing this draft guidance to describe the Agency's recommendations
for how manufacturers, distributers, and packers (collectively firms)
that include quantitative efficacy or risk information about their
drugs in DTC promotional materials can make the language and
presentation more consumer-friendly.

DATES: Submit either electronic or written comments on the draft
guidance by December 17, 2018 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2018-D-2613 for ``Presenting Quantitative Efficacy and Risk
Information in Direct-to-Consumer Promotional Labeling and
Advertisements; Draft Guidance for Industry; Availability.'' Received
comments will be placed in the docket and, except for those submitted
as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002; or the
Office of Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002; or
the Policy and Regulations Staff (HFV-6), Center for Veterinary
Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville,
MD 20855. Send one self-addressed adhesive label to assist that office
in processing your request. See the SUPPLEMENTARY INFORMATION section
for electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Elizabeth Pepinsky, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 3248, Silver Spring, MD 20993-0002, 301-
796-1200; or Stephen Ripley, Center for Biologics Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
71, Rm. 7301, Silver Spring, MD 20993-0002,<PHONE_NUMBER>; or Tom
Moskal, Center for Veterinary Medicine (HFV-216), 7519 Standish Pl.,
Rockville, MD 20855,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Presenting Quantitative Efficacy and Risk Information in
Direct-to-Consumer Promotional Labeling and Advertisements.'' This
draft guidance describes recommendations for how firms that include
quantitative efficacy or risk information about their drugs \1\ in DTC
promotional materials can make the language and presentation more
consumer-friendly. These recommendations apply to DTC promotional
materials covered by this draft guidance regardless of the medium in
which they are presented (e.g., print, electronic, audiovisual,
broadcast).
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    \1\ The term drugs in this guidance refers to prescription human
drugs, including prescription biological products, and prescription
and OTC animal drugs.
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    When describing efficacy and risk information about a drug in
promotional materials, firms generally have flexibility with how they
present this information so long as the presentation is balanced,
truthful, and non-misleading, and complies with other applicable
statutory and regulatory requirements. One consideration for firms as
they develop DTC promotional materials for their drugs is how to best
convey efficacy and risk information in a manner that consumers can
easily understand, including whether to use words, numbers, visual
graphics, or a combination of these elements. FDA understands that
firms may experience challenges in determining how to best present
quantitative efficacy or risk information in their DTC promotional
materials so that consumers can easily comprehend it and use it to form
accurate perceptions about their drugs. For these reasons, FDA is
issuing this

draft guidance to provide recommendations for presenting quantitative
efficacy and risk information in DTC promotional materials and to
encourage firms to follow these recommendations when including such
information in their DTC promotional materials.
    The draft guidance covers the following topics for presenting
quantitative efficacy and risk information in DTC promotional
materials, based on current research findings related to communicating
health information:

 Presenting probability information in terms of absolute
frequencies, percentages, and relative frequencies
 Formatting quantitative efficacy or risk information
 Using visual aids to illustrate quantitative efficacy or risk
information
 Providing quantitative efficacy or risk information for the
treatment group and the control group

    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent FDA's recommendations for ``Presenting
Quantitative Efficacy and Risk Information in Direct-to-Consumer
Promotional Labeling and Advertisements.'' It does not establish any
rights for any person and is not binding on FDA or the public. You can
use an alternative approach if it satisfies the requirements of the
applicable statutes and regulations. This guidance is not subject to
Executive Order 12866.

II. Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-
3520), Federal Agencies must obtain approval from the Office of
Management and Budget (OMB) for each collection of information they
conduct or sponsor. ``Collection of information'' is defined in 44
U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or
requirements that members of the public submit reports, keep records,
or provide information to a third party. Section 3506(c)(2)(A) of the
PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a
60-day notice in the Federal Register concerning each proposed
collection of information before submitting the collection to OMB for
approval. To comply with this requirement, FDA is publishing notice of
the proposed collection of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
    Title: Presenting Quantitative Efficacy and Risk Information in
Direct-to-Consumer Promotional Labeling and Advertisements.
    Description of Respondents: Respondents to this collection of
information are manufacturers, packers, and distributors and their
representatives (firms) of human prescription drugs, including
prescription biological products, and animal prescription and OTC
drugs.
    Burden Estimate: The draft guidance provides recommendations on how
firms should present quantitative efficacy and risk information in
their DTC promotional materials. Accordingly, the draft guidance
recommends a ``third-party disclosure'' that constitutes a ``collection
of information'' under the PRA.
    Specifically, the draft guidance recommends that firms display
quantitative efficacy or risk information in specific numeric formats
(e.g., absolute frequencies or percentages; whole numbers; denominators
with a base of 10) and with appropriate context (e.g., adding absolute
frequency presentations to relative frequency presentations); provides
formatting considerations for illustrating quantitative efficacy or
risk information in a visual aid; and recommends that firms include
quantitative efficacy or risk information about the control group when
it is provided for the treatment group in DTC promotional materials.
    According to FDA data, approximately 40,000 FDA-regulated DTC
promotional materials are prepared by approximately 404 firms annually,
and of these materials, the Agency estimates that approximately 40
percent contain presentations of quantitative efficacy or risk
information. Based on this information, FDA estimates that
approximately 40 percent (160) firms will disseminate 16,000 DTC
promotional materials that contain quantitative efficacy or risk
information annually, and therefore may be subject to the third-party
disclosures. Based on its experience reviewing FDA-regulated
promotional materials for drugs, FDA estimates that it will take firms
approximately 2 hours to make the disclosures recommended in the draft
guidance if they choose to include quantitative efficacy or risk
information in their DTC promotional materials and follow the
recommendations of this guidance.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of
                        Type of information                             Number of     disclosures per    Total annual    Average burden    Total hours
                                                                       respondents       respondent      disclosures     per disclosure
--------------------------------------------------------------------------------------------------------------------------------------------------------
Recommended information to be included when firms disseminate                   160              100           16,000                2           32,000
 promotional materials that contain quantitative efficacy or risk
 information.......................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm, or https://www.regulations.gov.

    Dated: October 11, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-22568 Filed 10-16-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 84, Number 51 (Friday, March 15, 2019)]
[Notices]
[Pages 9515-9516]
[FR Doc No: 2019-04796]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OECA-2014-0102; FRL-9990-82-OEI]

Information Collection Request Submitted to OMB for Review and
Approval; Comment Request; NSPS for Oil and Natural Gas Production and
Natural Gas Transmission and Distribution (Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency (EPA) has submitted an
information collection request (ICR), NSPS for Oil and Natural Gas
Production and Natural Gas Transmission and Distribution (EPA ICR
Number 2437.04, OMB Control Number 2060-0673), to the Office of
Management and Budget (OMB) for review and approval in accordance with
the Paperwork Reduction Act. This is a proposed extension of the ICR,
which is currently approved through March 31, 2019. Public comments
were previously requested, via the Federal Register, on May 30, 2018
during a 60-day comment period. This notice allows for an additional 30
days for public comments. A fuller description of the ICR is given
below, including its estimated burden and cost to the public. An agency
may neither conduct nor sponsor, and a person is not required to
respond to, a collection of information unless it displays a currently
valid OMB control number.

DATES: Additional comments may be submitted on or before April 15,
2019.

ADDRESSES: Submit your comments, referencing Docket ID Number EPA-HQ-
OECA-2014-0102, to: (1) EPA online using www.regulations.gov (our
preferred method), or by email to<EMAIL_ADDRESS>or by mail to:
EPA Docket Center, Environmental Protection Agency, Mail Code 28221T,
1200 Pennsylvania Ave. NW, Washington, DC 20460; and (2) OMB via email
to<EMAIL_ADDRESS>Address comments to OMB Desk Officer
for EPA.
    EPA's policy is that all comments received will be included in the
public docket without change including any personal information
provided, unless the comment includes profanity, threats, information
claimed to be Confidential Business Information (CBI), or other
information whose disclosure is restricted by statute.

FOR FURTHER INFORMATION CONTACT: Patrick Yellin, Monitoring,
Assistance, and Media Programs Division, Office of Compliance, Mail
Code 2227A, Environmental Protection Agency, 1200 Pennsylvania Ave. NW,
Washington, DC 20460; telephone number:<PHONE_NUMBER>; fax number:
(202) 564-0050; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Supporting documents, which explain in
detail the information that the EPA will be collecting, are available
in the public docket for this ICR. The docket can be viewed online at
www.regulations.gov, or in person at the EPA Docket Center, WJC West,
Room 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone
number for the Docket Center is<PHONE_NUMBER>. For additional
information about EPA's public docket, visit: www.epa.gov/dockets.

    Abstract: The New Source Performance Standards (NSPS) for Oil and
Natural Gas Production and Natural Gas Transmission and Distribution
(40 CFR part 60, subpart OOOO) apply to oil and natural gas facilities
that commence construction, modification or reconstruction after August
23, 2011 and on or before September 19, 2015, that are involved in the
extraction and production of oil and natural gas, as well as the
processing, transmission, and distribution of natural gas. The June
2016 final rule established a new subpart (40 CFR 60, subpart OOOOa) to
set new standards for emissions of GHGs and VOCs for affected
facilities in the crude oil and natural gas source category that
commence construction, modification, or reconstruction after September
18, 2015. These amendments also included revisions to improve
implementation of the NSPS subpart OOOO to address issues raised in
administrative reconsideration petitions submitted on both the August
16, 2012 NSPS and the September 13, 2013 amendments. These
implementation improvements did not change the requirements for
operations and equipment covered by the current standards at subpart
OOOO. The information collection requirements of the NSPS (40 CFR 60,
subpart OOOOa) and associated burden are addressed in EPA ICR Number
2523.02. In general, all NSPS standards require initial notifications,
performance tests, and periodic reports by the owners/operators of the
affected facilities. They are also required to maintain records of the
occurrence and duration of any startup, shutdown, or malfunction in the
operation of an affected facility, or any period during which the
monitoring system is inoperative. These notifications, reports, and
records are essential in determining compliance with 40 CFR part 60,
subpart OOOO.
    Form Numbers: None.
    Respondents/affected entities: Oil and natural gas production and
natural gas transmission and distribution facilities.
    Respondent's obligation to respond: Mandatory (40 CFR part 60,
subpart OOOO).
    Estimated number of respondents: 532 (total).
    Frequency of response: Semiannually and annually.
    Total estimated burden: 69,300 hours (per year). Burden is defined
at 5 CFR 1320.3(b).
    Total estimated cost: $9,110,000 (per year), which includes
$1,220,000 in annualized capital/startup and/or operation & maintenance
costs.
    Changes in the Estimates: There is a decrease in the total
estimated respondent burden and total annual O&M as currently
identified in the OMB Inventory of Approved Burdens. The burden
decrease occurred because the standard has been in effect for more than
three years and the requirements are different during initial
compliance (new facilities) as compared to on-going compliance
(existing facilities). Additionally, the adjustment decrease in burden
is due to a decrease in the number of sources subject to 40 CFR 60,
subpart OOOO. Amendments to Subpart OOOO published on June 3, 2016 (81
FR 35824) established new standards for affected facilities in the
crude oil and natural gas source category that commence construction,
modification, or reconstruction after September 18, 2015. Facilities
with new affected sources that would have previously met the
requirements for subpart OOOO must now meet the requirements of 40 CFR
60, subpart OOOOa. The number of existing respondents that are subject
to subpart OOOO is assumed to decrease over time as sources are either
modified (and therefore subject to Subpart OOOOa) or retired. This ICR
reflects the on-going burden and costs for existing facilities.

Courtney Kerwin,
Director, Regulatory Support Division.
[FR Doc. 2019-04796 Filed 3-14-19; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 80, Number 36 (Tuesday, February 24, 2015)]
[Notices]
[Pages 9807-9809]
[FR Doc No: 2015-03663]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-74292; File No. SR-Phlx-2015-14]

Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Notice of
Filing and Immediate Effectiveness of Proposed Rule Change To Amend the
Exchange's Pricing Schedule Under Section VIII With Respect to
Execution and Routing of Orders in Securities Priced at $1 or More per
Share

February 18, 2015.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on February 3, 2015, NASDAQ OMX PHLX LLC (``Phlx'' or ``Exchange'')
filed with the Securities and Exchange Commission (``SEC'' or
``Commission'') the proposed rule change as described in Items I, II,
and III, below, which Items have been prepared by the Exchange. The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend the Exchange's Pricing Schedule
under Section VIII, entitled ``NASDAQ OMX PSX FEES,'' with respect to
execution and routing of orders in securities priced at $1 or more per
share.
    The text of the proposed rule change is available on the Exchange's
Web site at http://nasdaqomxphlx.cchwallstreet.com/, at the principal
office of the Exchange, and at the Commission's Public Reference Room.

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

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

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

1. Purpose
    The purpose of the proposed rule change is to amend certain fees
for order execution and routing applicable to the use of the order
execution and routing services of the NASDAQ OMX PSX System (``PSX'')
by member organizations for all securities traded at $1 or more per
share, as well as clarify that consolidated volume does not include the
date of the annual reconstitution of the Russell Investments Indexes.
    Specifically, the charge to a member organization entering an order
that executes in PSX will increase from: (i) $0.0024 to $0.0026 per
share executed for shares executed in The NASDAQ Stock Market LLC
(``Nasdaq'')-listed securities; (ii) $0.0024 to $0.0025 per share
executed for shares executed in New York Stock Exchange (``NYSE'')-
listed securities; and (iii) $0.0024 to $0.0026 per share executed for
shares in securities listed on exchanges other than Nasdaq or NYSE. The
Exchange believes that these increases better reflect the costs in
providing rebates to members.
    Additionally, the Exchange proposes to clarify that for purposes of
calculating consolidated volume and the extent of a member's trading
activity, expressed as a percentage of, or ratio to, consolidated
volume, the date of the annual reconstitution of the Russell
Investments Indexes (``Russell Reconstitution'') will be excluded from
both total consolidated volume and the member's trading activity. This
change is consistent with the practices of both Nasdaq and the NASDAQ
OMX BX, Inc. (``BX'') exchanges.
    Also, the Exchange proposes to make a few clarifications in the
Exchange's Pricing Schedule. Specifically, in section (a)(2) of ``Order
Execution and Routing in All Securities'' under ``VIII. NASDAQ OMX PSX
FEES'', the Exchange proposes to replace the word ``None'' with
``$0.0000 per share executed at NASDAQ OMX BX''. The Exchange believes
this proposed change will serve to enhance market participant's
understanding that there is no charge for shares executed at BX and
reduce any possible confusion in these instances. Additionally, in this
same section for both XDRK and XCST orders, the first column will
clarify that the amounts in the accompanying column are charges for
executions on a venue other than the NASDAQ OMX PSX System, rather than
the current practice of simply indicating that they are a ``charge or
credit'' to a member organization entering such orders. Finally, the
description of the charge to members entering an XDRK order is changed
to ``$0.0007 per share executed''; and the reference to ``shares
executed at a venue other than NASDAQ OMX BX'' is deleted since an XDRK
order cannot execute at BX. These clarifications are all intended to
reduce confusion and make the fee schedule easier to understand.
2. Statutory Basis
    The Exchange believes that its proposal to amend its Pricing
Schedule is consistent with Section 6(b) of the Act \3\ in general, and
furthers the objectives of Sections 6(b)(4) and (b)(5) of the Act \4\
in particular, in that it is an equitable allocation of reasonable fees
and other charges among Exchange members and other persons using its
facilities, and it does not unfairly discriminate between customers,
issuers, brokers or dealers.
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    \3\ 15 U.S.C. 78f(b).
    \4\ 15 U.S.C. 78f(b)(4) and (5).
---------------------------------------------------------------------------

    The Exchange is proposing modest increases to the charges that a
member organization entering an order that executes in PSX from: (i)
$0.0024 to $0.0026 per share executed for shares executed in Nasdaq-
listed securities; (ii) $0.0024 to $0.0025 per share executed for
shares executed in NYSE-listed securities; and (iii) $0.0024 to $0.0026
per share executed for shares in securities listed on exchanges other
than Nasdaq or NYSE. The Exchange believes that these modest increases
are reasonable because they reflect the Exchange's need to adjust its
credits and fees in response to the costs and benefits provided by the
Exchange. Additionally, these modest increases are reasonable since by
staggering increases, the Exchange is able to offer reduced rates in
some tapes while balancing the need to fund rebates and operational
costs.
    The Exchange believes that the proposed changes are consistent with
an equitable allocation of fees and are not unfairly discriminatory
because they apply to all member organizations that enter orders that
execute in PSX. The Exchange also believes that they are consistent
with equitable allocation of fees and are not unfairly discriminatory
because they apply to all member organizations that enter orders that
execute in PSX.
    The Exchange is also proposing to clarify that for purposes of
calculating consolidated volume and the extent of a member's trading
activity, expressed as a percentage of, or ratio to, consolidated
volume, the date of the Russell Reconstitution will be excluded from
both total consolidated volume and the member's trading activity. The
Exchange believes that this clarification is reasonable because it is
consistent with the practices at both Nasdaq and the BX exchanges and
will reduce confusion concerning the Russell Reconstitution.
    The Exchange believes that the proposed changes are consistent with
an equitable allocation of fees and are not unfairly discriminatory
because trading volumes on the date of the Russell Reconstitution are
generally far in excess of volumes on other days during the month. As a
result, the trading activity of members that are regular daily
participants in PSX, expressed as a percentage of consolidated volume,
is likely to be lower than their percentage of consolidated volume on
other days during the month. Therefore, including the date of the
Russell Reconstitution in calculations of consolidated volume would
likely make it more difficult for members to achieve particular volume
levels during the month. Accordingly, excluding the date of the Russell
Reconstitution from these calculations will diminish the likelihood of
a de facto price increase from occurring because a member is not able
to reach a volume percentage on that date that it typically reaches on
other trading days during the month. Moreover, excluding the date is
very unlikely to result in a price increase for any members, since a
member that was not, on other days during the month, trading in PSX at
volume levels that would allow it to qualify for rebate tiers, would be
unlikely to achieve percentage volume levels on the date of the Russell
Reconstitution that would increase its overall monthly percentage to
the required levels, even if it was very active on that date.
    Finally, the Exchange believes that the remaining changes to the
Pricing Schedule are reasonable because they

are intended to clarify and reduce confusion through the clarification
as to what is a charge or credit, the clarification that there is no
charge for certain orders executed at BX, as well as to clarify through
the removal of unnecessary language that may add confusion to the
Pricing Schedule. The Exchange also believes that these changes are
consistent with an equitable allocation of fees and are not unfairly
discriminatory because they do not impact fees and serve only to
clarify and reduce possible confusion.

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act, as amended.\5\ The Exchange
notes that it operates in a highly competitive market in which market
participants can readily favor competing venues if they deem fee levels
at a particular venue to be excessive, or rebate opportunities
available at other venues to be more favorable. In such an environment,
the Exchange must continually adjust its fees to remain competitive
with other exchanges and with alternative trading systems that have
been exempted from compliance with the statutory standards applicable
to exchanges. Because competitors are free to modify their own fees in
response, and because market participants may readily adjust their
order routing practices, the Exchange believes that the degree to which
fee changes in this market may impose any burden on competition is
extremely limited. In this instance, the modest increases to the
charges assessed are intended to allow the Exchange to help offset its
costs in providing rebates to members. Because there are numerous
competitive alternatives to PSX, it is likely the Exchange would lose
market share and money as a result of changes if they do not reflect
costs.
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    \5\ 15 U.S.C. 78f(b)(8).
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C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    No written comments were either solicited or received.

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

    Pursuant to Section 19(b)(3)(A)(ii) of the Act,\6\ the Exchange has
designated this proposal as establishing or changing a due, fee, or
other charge imposed by the self-regulatory organization on any person,
whether or not the person is a member of the self-regulatory
organization, which renders the proposed rule change effective upon
filing.
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78s(b)(3)(A)(ii).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings to
determine whether the proposed rule should be approved or disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-Phlx-2015-14 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-Phlx-2015-14. This file
number should be included on the subject line if email is used.
    To help the Commission process and review your comments more
efficiently, please use only one method. The Commission will post all
comments on the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments,
all written statements with respect to the proposed rule change that
are filed with the Commission, and all written communications relating
to the proposed rule change between the Commission and any person,
other than those that may be withheld from the public in accordance
with the provisions of 5 U.S.C. 552, will be available for Web site
viewing and printing in the Commission's Public Reference Room on
official business days between the hours of 10:00 a.m. and 3:00 p.m.
Copies of such filing also will be available for inspection and copying
at the principal offices of the Exchange. All comments received will be
posted without change; the Commission does not edit personal
identifying information from submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-Phlx-2015-14, and should be submitted on
or before March 17, 2015.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\7\
---------------------------------------------------------------------------

    \7\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Brent J. Fields,
Secretary.
[FR Doc. 2015-03663 Filed 2-23-15; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 77, Number 129 (Thursday, July 5, 2012)]
[Proposed Rules]
[Pages 39657-39658]
[FR Doc No: 2012-16312]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R10-OAR-2012-0380; FRL-9693-9]

Approval and Promulgation of Air Quality Implementation Plans;
Washington; Determination of Clean Data for the 2006 24-Hour Fine
Particulate Standard for the Tacoma, Pierce County Nonattainment Area

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: EPA is proposing to determine that the Tacoma, Pierce County
nonattainment area (hereafter referred to as ``Tacoma, Pierce County''
or ``the area'') for the 2006 24-hour fine particulate matter
(PM2.5) National Ambient Air Quality Standard (NAAQS) has
clean data for the 2006 24-hour PM2.5 NAAQS. This proposed
determination is based upon quality-assured, quality-controlled, and
certified ambient air monitoring data showing that the area has
monitored attainment of the 2006 PM2.5 NAAQS based on the
2009-2011 data available in EPA's Air Quality System (AQS) database. If
this proposed determination is made final, the requirements for the
area to submit an attainment demonstration, associated reasonably
available control measures (RACM), a reasonable further progress plan
(RFP), contingency measures, and other planning State Implementation
Plans (SIPs) related to attainment of the standard shall be suspended
for so long as the area continues to meet the 2006 24-hour
PM2.5 NAAQS. This action is being taken under the Clean Air
Act (CAA).

DATES: Written comments must be received on or before August 6, 2012.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R10-
OAR-2012-0380, by any of the following methods:
     www.regulations.gov: Follow the on-line instructions for
submitting comments.
     Email<EMAIL_ADDRESS>     Mail: Jeff Hunt, EPA Region 10, Office of Air, Waste and
Toxics (AWT-107), 1200 Sixth Avenue, Suite 900, Seattle, WA 98101.
     Hand Delivery/Courier: EPA Region 10, 1200 Sixth Avenue,
Suite 900, Seattle, WA 98101. Attention: Jeff Hunt, Office of Air,
Waste and Toxics, AWT-107. Such deliveries are only accepted during
normal hours of operation, and special arrangements should be made for
deliveries of boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-R10-OAR-
2012-0112. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
www.regulations.gov, including any personal information provided,
unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through www.regulations.gov or email. The
www.regulations.gov Web site is an ``anonymous access'' system, which
means EPA will not know your identity or contact information unless you
provide it in the body of your comment. If you send an email comment
directly to EPA without going through www.regulations.gov your email
address will be automatically captured and included as part of the
comment that is placed in the public docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, is not placed on the Internet and will be
publicly available only in hard copy. Publicly available docket
materials are available either electronically in www.regulations.gov or
in hard copy during normal business hours at the Office of Air, Waste
and Toxics, EPA Region 10, 1200 Sixth Avenue, Seattle, WA 98101.

FOR FURTHER INFORMATION CONTACT: Jeff Hunt at telephone number: (206)
553-0256, email address<EMAIL_ADDRESS>or the above EPA, Region 10
address.

SUPPLEMENTARY INFORMATION: Throughout this document whenever ``we,''
``us,'' or ``our'' is used, we mean EPA.
    The following outline is provided to aid in locating information in
this preamble.

I. What action is EPA taking?
II. What is the effect of this action?
III. What is the background for this action?
IV. What is EPA's analysis of the relevant air quality data?
V. What is EPA's proposed action?
VI. Statutory and Executive Order Reviews

I. What action is EPA taking?

    EPA is proposing to determine that the area has clean data for the
2006 24-hour PM2.5 NAAQS. This determination is based upon
quality-assured, quality-controlled, and certified ambient air
monitoring data showing that the area has monitored attainment of the
2006 PM2.5 NAAQS based on 2009-2011 monitoring data.

II. What is the effect of this action?

    If this determination is made final, under the provisions of EPA's
PM2.5 implementation rule (40 CFR 51.1004(c)), the
requirements for the area to submit an attainment demonstration,
associated RACM, RFP plan, contingency measures, and any other planning
SIP requirements related to attainment of the 2006 24-hour
PM2.5 NAAQS would be suspended for so long as the area
continues to meet this NAAQS. Furthermore, as described below, a final
clean data determination would not be equivalent to a redesignation of
the area to attainment for the 2006 24-hour PM2.5 NAAQS.
    If EPA subsequently determines that the area is in violation of the
2006 24-hour PM2.5 NAAQS, the basis for the suspension of
the specific requirements, set forth at 40 CFR 51.1004(c), would no
longer exist and the area would thereafter have to address the
pertinent requirements.
    The proposed clean data determination that the air quality data
shows attainment of the 2006 24-hour PM2.5 NAAQS is not
equivalent to the redesignation of the area to attainment. This
proposed action, if finalized, will not constitute a redesignation to
attainment under section 107(d)(3) of the CAA, because we would not yet
have an approved maintenance plan for the area as required under
section 175A of the CAA, nor a determination that the area has met the
other requirements for redesignation. The designation status of the
area would remain nonattainment for the 2006 PM2.5 NAAQS
until such time as EPA determines that the area meets the CAA
requirements for redesignation to attainment.

III. What is the background for this action?

    The 2006 PM2.5 NAAQS set forth at 40 CFR 50.13 became
effective on December 18, 2006 (71 FR 61144) and promulgated a 24-hour
standard of 35 micrograms per cubic meter ([micro]g/m\3\) based on a 3-
year average of the 98th percentile of 24-hour concentration. On
December 14, 2009 (74 FR 58688), EPA made designation determinations,
as required by CAA section 107(d)(1), for the 2006 24-hour
PM2.5 NAAQS. As part of that action, Tacoma, Pierce County
(partial county designation) became designated as nonattainment for the
2006 24-hour PM2.5 NAAQS.

IV. What is EPA's analysis of the relevant air quality data?

    EPA has reviewed the ambient air monitoring data for
PM2.5, consistent with the requirements contained in 40 CFR
part 50, as recorded in the EPA Air Quality System (AQS) database for
the Tacoma, Pierce County, 2006 24-hour PM2.5 nonattainment
area. All data considered have been recorded in the AQS data base,
certified as meeting quality assurance requirements, and determined to
have met data completeness requirements. On the basis of that review,
EPA has concluded that this area attained the 2006 24-hour
PM2.5 NAAQS during the 2009-2011 monitoring period. Under
EPA regulations at 40 CFR 50.7: ``The 24-hour primary and secondary
PM2.5 standards are met when the 98th percentile 24-hour
concentration, as determined in accordance with appendix N of this
part, is less than or equal to 35 [mu]g/m\3\.'' The following table
shows the design values (the metrics calculated in accordance with 40
CFR part 50, appendix N, for determining compliance with the NAAQS) for
the 2006 24-hour PM2.5 NAAQS for the years 2009-2011.
Because the 2009-2011 design value at the Federal Reference Method
monitor, Tacoma South L Street, is equal to the 2006 24-hour
PM2.5 NAAQS of 35 [mu]g/m\3\, EPA is proposing to determine
that the area has monitored attainment for this NAAQS.

             2009-2011 Daily Average Concentrations in the Tacoma, Pierce County Nonattainment Area
----------------------------------------------------------------------------------------------------------------
                                                                                2009-11 Design
                                Monitor name                                     Monitor ID     values ([micro]g/
                                                                                m\3\)
----------------------------------------------------------------------------------------------------------------
Tacoma South L Street \1\...................................................         530530029                35
Tacoma Tide flats--2301 Alexander Ave \2\...................................         530530031                24
Puyallup 5722 66th Ave E \2\................................................         530530022                21
Puyallup South Hill \2\.....................................................         530531018                22
----------------------------------------------------------------------------------------------------------------
\1\ The Tacoma South L Street site is the Federal Reference Method (FRM) monitor used for determining compliance
  with the 2006 PM2.5 NAAQS. PM2.5 AQS data and information is available as part of EPA's AirTrends Site at:
  http://www.epa.gov/airtrends/values.html. More recent 2011 data is included as part of the docket for this
  action.
\2\ The three additional monitors located in the nonattainment area listed above are neither Federal Reference
  Method nor Federal Equivalent Method (FEM) monitors but are included to provide supplementary information.
  Detailed information on how EPA calculated the design values for these monitors is included in the docket for
  this action.

V. What is EPA's proposed action?

    EPA is proposing to determine that the Tacoma, Pierce County area
has clean data for the 2006 24-hour PM2.5 NAAQS. As provided
in 40 CFR 51.1004(c), if EPA finalizes this determination, it will
suspend the requirements for the area to submit an attainment
demonstration, associated RACM, RFP, contingency measures, and any
other planning SIP requirements related to the attainment of the 2006
PM2.5 NAAQS, so long as the area continues to meet the
standard. EPA is soliciting public comments on the issues discussed in
this document. These comments will be considered before taking final
action.

VI. Statutory and Executive Order Reviews

    This action proposes to make an attainment determination based on
air quality data and would not, if finalized, impose any additional
requirements. For that reason, this proposed action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this proposed rulemaking that the Tacoma, Pierce
County PM2.5 nonattainment area has clean data for the 2006
24-hour PM2.5 standard does not impose substantial direct
costs on tribal governments or preempt tribal law as specified by
Executive Order 13175 (65 FR 67249, November 9, 2000).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Particulate
matter, Reporting and recordkeeping requirements.

    Authority: 42 U.S.C. 7401 et seq.

    Dated: June 19, 2012.
Julie M. Hagensen,
Acting Regional Administrator, Region 10.
[FR Doc. 2012-16312 Filed 7-3-12; 8:45 am]
BILLING CODE 6560-50-P


COMPANY FEDERAL REGISTER DOCUMENT SUBMISSION TEMPLATE  (7/1/2006)

EPA Registration Division contact: [Michael Walsh,<PHONE_NUMBER>]

INSTRUCTIONS:  Please utilize this outline in preparing tolerance
petition documents.  In cases where the outline element does not apply
please insert “NA-Remove” and maintain the outline.  The comment
notes that appear on the left margin represent hidden typesetting codes
designed to expedite the processing of the Federal Register document.
Please do not remove or alter these comment notes or change the margins,
font, or format in your document. Simply replace the instructions that
appear in italics and brackets, i.e., “[insert company name],” with
the information specific to your action.]

TEMPLATE:

[BASF Corporation]

[Petition Number: 4F82867F7260]

	EPA has received a pesticide petition ([7 insert petition numberF7260])
from [BASF Corporation], [P.O. Box 13528, Research Triangle Park, NC
27709] proposing, pursuant to section 408(d) of the Federal Food, Drug,
and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180.

	1. by establishing a tolerance for residues of

	[metaflumizone] in or on the raw agricultural commodity [crop group
11-10: pome fruit crop group] at [0.04] parts per million (ppm), [crop
group 12-12: stone fruit crop group] at [0.04] ppm, and updating
existing crop groups to [crop group 10-10: citrus fruits group] at
[0.04] ppm and [crop group 14-12: tree nuts group] at [0.04] ppm.  EPA
has determined that the petition contains data or information regarding
the elements set forth in section 408 (d)(2) of the FDDCA; however, EPA
has not fully evaluated the sufficiency of the submitted data at this
time or whether the data supports granting of the petition. Additional
data may be needed before EPA rules on the petition.

A. Residue Chemistry

	1. Plant metabolism. [In three plant metabolism studies (cabbage,
tomato and cotton), the major component of the residue was
metaflumizone.  The major degradate was the ketone, M320I04 and an
oxidized and cyclized metabolite, M320I23, was present in lesser
amounts.  These four compounds were defined as the residues of concern
and were incorporated into an analytical method.  In the confined
rotational crop studies plant uptake was very limited and the residues
were a mixture of minor and polar components.]

	2. Analytical method. [BASF Analytical Method No. 531/0 was developed
to determine residues of metaflumizone and its metabolites M320I04 and
M320I23 in crop matrices.  In this method, residues of metaflumizone are
extracted from plant matrices with methanol/water (70:30; v/v) and then
partitioned into dichloromethane.  For oily matrices, the residues are
extracted with a mixture of isohexane/acetonitrile (1:1; v/v).  The
final determination of metaflumizone and its metabolites is performed by
LC/MS/MS.]

	3. Magnitude of residues. [A full set of citrus, grape, and tree nut
field trial data were submitted to the EPA in 2011 which resulted in
residues less than the limit of detection (LOD) in/on samples harvested
5 days after a single application at 0.004 lbs ai/acre (1x).  Residues
were also <LOD in/on grape and orange RACs harvested 5 days after a
single application at 0.02 lbs ai/acre (5x).  BASF proposed the
translation of the citrus, grape, and tree nut metaflumizone residue
data to pome fruit and stone fruit.

A metaflumizone granular product is currently registered for soil
application as a fire ant bait to citrus, tree nuts, and grapes at 4 x
0.001 lbs ai/acre (retreatment interval (RTI) = 4 weeks; preharvest
interval (PHI) = 5 days).  Spot application to fire ant mounds is also
registered at 0.00008 lbs ai/mound (RTI = 4 weeks; PHI = 5 days).  Based
on the citrus, grape and tree nut field trial and processing data, limit
of quantitation (LOQ) tolerances (0.04 ppm) in/on citrus, grape, and
tree nuts were established for the combined residues metaflumizone (e-
and z-isomers) and M320I04 (D345540, T. Bloem, 26-Jan-2010).

An adequate field rotational crop study was also submitted which
resulted in <LOQ residues in lettuce, radish roots/tops, and wheat
forage/hay/straw/grain planted 30 days after the last of four broadcast
foliar applications (2 lb ai/gal SC) to tomato at 0.26 lb ai/acre (n=2;
RTI = 6-8 days; 260x; D308394, T. Bloem, 30-Nov-2005).

Based on the field trial, processing, and rotational crop data and
provided the pome fruit and stone fruit application scenarios are
identical to the citrus, grape, and tree nut application scenario, the
ChemSAC concluded that the proposed translation is acceptable.]

B. Toxicological Profile

	1. Acute toxicity.  [Based on the available acute toxicity data,
metaflumizone and its formulated product do not pose acute toxicity
risks.  For metaflumizone:

Oral LD50                 Rat	      LD50 > 5000 mg/kg b.w.
category IV  TC \l5 "

Oral LD50                 Mouse	      LD50 > 5000 mg/kg b.w.
category IV

Dermal LD50            Rat	      LD50 > 5000 mg/kg b.w.        category
IV

Inhalation LC50       Rat	      > 5.2 mg/L
category IV

Eye Irritation           Rabbit	      Not irritating
     category IV

Skin Irritation          Rabbit	      Not irritating
     category IV

Skin Sensitization    Guinea pig   Not sensitizing (Maximization Test)]

	2. Genotoxicty. [In a battery of three in vitro and two in vivo
mutagenicity assays consisting of all required end-points (point
mutation, chromosomal damage, and DNA damage and repair), the
weight-of-the-evidence for metaflumizone indicates a lack of potential
genotoxicity.

Specifically, for the battery of three in vitro mutagenicity assays with
metaflumizone, no positive responses were observed for increased
revertant frequencies with and without metabolic activation [bacterial
reverse mutation assay] or for increased mutant frequencies with and
without metabolic activation [HGPRT locus assay].  Although there was a
positive result for a statistically increased number of structurally
aberrant metaphases in the chromosomes, which indicates clastogenic
potential under in vitro conditions, this result was only observed
without metabolic activation [cytogenicity study with V79 cells.

Importantly, the potential biological significance of this apparent
chromosome damage observed in vitro only without metabolic activation,
was evaluated in vivo using the mouse micronucleus assay.  Testing in
the in vivo micronucleus study with NMRI mice was conducted at a high
dose level (2000 mg/kg b.w.) that demonstrated clinical symptoms of
toxicity, including piloerection and poor general state, in 5 of 5
animals.  No significant or dose-related increases in chromosomal damage
were observed in this in vivo test, indicating that metaflumizone does
not cause chromosomal aberrations in intact animals.

Moreover, it has also been recognized by U.S. EPA that more weight
should be placed on in vivo systems than in vitro systems as expressed
in the Agency’s weight-of-evidence for genotoxic evaluation of a
chemical included in the "Guidelines for Mutagenicity Risk Assessment"
(Federal Register, September 24, 1986, Vol. 51: 34006-34012).  Thus, the
negative in vivo results (non-clastogenicity for chromosomal
aberrations) observed in the mouse micronucleus assay and the rat
hepatocytes assay, should override the positive results obtained in the
in vitro assay only without metabolic activation.  Furthermore, it has
been noted that in vitro systems may simulate abnormal physiological
conditions from prolonged exposure to a chemical in the absence of S-9
metabolic activation [Brusick, D.J. (editor) 1987. Genotoxicity Produced
in Cultured Mammalian Cell Assay by Treatment Conditions. Mutation
Research, Vol. 189, No.1: 1-69] and [Sofuni, T. 1993. Japanese
Guidelines for Mutagenicity Testing. Environmental and Molecular
Mutagenesis, Vol. 21, No.1: 2-7].  Consequently, based on the
weight-of-the-evidence presented above, metaflumizone does not pose a
genotoxic concern.]

	3. Reproductive and developmental toxicity. [Potential reproductive
toxicity of metaflumizone was investigated in a two-generation
reproduction toxicity study in Wistar rats by oral gavage
administration.  Originally, the highest dose tested by oral gavage was
75 mg/kg b.w../day, which induced both excessive maternal toxicity (very
high incidences of poor general health in females during premating,
gestation, and lactation; and statistically decreased food consumption,
body weights, and body weight gain) as well as excessive developmental
toxicity (statistically impaired pup body weights and body weight gain),
which altogether resulted in high pup mortality.  Consequently, a
meaningful assessment of the potential reproductive toxicity of the test
compound at this excessively toxic dose level was not possible.
Thereafter, for the next two successive parental generations of rats,
which were originally derived from the parents treated at 75 mg/kg
b.w./day, the highest dose tested was 50 mg/kg b.w./day.

Subsequently, the NOAEL for parental toxicity was 20 mg/kg b.w./day,
based on the following effects for females at 50 mg/kg b.w./day (highest
dose tested for two consecutive generations) -- increased incidences of
poor general health in females during premating, gestation, and
lactation; 3 of 25 dams with complete litter losses; and statistically
significantly reduced body weights during premating, gestation, and
lactation.

The NOAEL for offspring/pup toxicity was 20 mg/kg b.w./day, based on a
slight increased incidence of pup mortality at 50 mg/kg b.w./day.
Whereas the NOAEL for fertility in this study was 50 mg/kg b.w./day
(highest dose tested for two generations), the NOAEL for reproductive
performance was considered to be 20 mg/kg b.w./day, based on 3 of 25
dams with complete litter losses, of which 2 of these 3 dams had
indications of poor nursing for their first generation of pups.  It is
noteworthy that because most of the pup mortality was due to poor
nursing in only 2 of 25 dams, this finding may be considered to be
incidental.  Importantly, no comparable impairment of reproductive
performance occurred for the succeeding parental generation treated by
oral gavage administration at 50 mg/kg b.w./day.

In a developmental (teratology) toxicity study in the Wistar rat, the
results indicated that the NOAEL for maternal toxicity was 40 mg/kg
b.w./day, based on statistically decreased food consumption and body
weight gains at 120 mg/kg b.w./day (highest dose tested).  The NOAEL for
fetal (prenatal)/developmental toxicity was 120 mg/kg b.w./day (highest
dose tested).  In addition, there were no indications of any teratogenic
effects in the rat fetuses at 120 mg/kg b.w./day (highest dose tested).
Therefore, metaflumizone is considered to be neither a developmental
toxicant nor a teratogenic agent in the rat.

In a developmental (teratology) toxicity study in the Himalayan rabbit,
the results indicated that the NOAEL for maternal toxicity was 100 mg/kg
b.w./day, based on several clinical symptoms of toxicity (including
ataxia and poor general state) occurring in 4 of 25 does at 300 mg/kg
b.w./day, for which 2 of these 4 does had abortions prior to being
sacrificed early, with a third doe at 300 mg/kg b.w./day being
sacrificed moribund.  Similarly, the NOAEL for fetal (prenatal) /
developmental toxicity was 100 mg/kg b.w./day, based on slightly
decreased mean fetal body weights as well as an increased rate for a
certain skeletal variation, namely incomplete ossification of
sternabrae.  Because developmental toxicity was only observed at dose
levels that were maternally toxic, metaflumizone is not selectively
toxic to the fetal rabbit.

Lastly, in this rabbit developmental toxicity study, there were no
indications of any teratogenic effects in the rabbit fetuses at 300
mg/kg b.w./day (highest dose tested).  Therefore, metaflumizone is not
teratogenic in the rabbit.

Neurotox?

An acute dietary endpoint was not established for the general
population, including infants and children, since an endpoint of concern
(effect) attributable to a single dose was not identified in the
database.  Studies considered for this endpoint included the acute
neurotoxicity study for which a LOAEL was not observed.

An acute dietary endpoint was established for females 13-149 years old
based on a developmental effect observed in the rabbit developmental
toxicity study that can be potentially due to a single dose of
metaflumizone.  The effects consisted of an absent subclavian artery in
the offspring at the LOAEL of 300 mg/kg b.w./day metaflumizone (NOAEL =
100 mg/kg b.w./day).  A combined uncertainty factor (UF) of 300 was
applied to account for interspecies and intraspecies extrapolation (100)
and a 3X FQPA safety factor of 3 was retained because the rabbit
developmental toxicity study was performed via oral gavage dosing,
resulting in an ARfD of 0.33 04 mg/kg b.w./day.]

	4. Subchronic toxicity. [In the Sprague-Dawley rat, treatment by oral
gavage with metaflumizone for a subchronic duration (90-day timepoint in
the chronic toxicity/carcinogenicity study) resulted in reduced food
consumption and/or decreased mean body weight and/or body weight gains
in males and females at 300 mg/kg b.w./day and in increased incidences
of hepatocellular centrilobular hypertrophy in the livers of males at
300 mg/kg b.w./day.  Under the conditions of the study, the NOAEL for
oral administration of metaflumizone for 90 days was 60 mg/kg b.w./day.

In the beagle dog, treatment by oral gavage with metaflumizone for a
subchronic duration (90-day timepoint in the chronic toxicity study)
resulted in reduced body weight gain and/or decreased food consumption
in several dogs at 30 mg/kg b.w./day and slightly decreased mean MCHC at
30 mg/kg b.w./day.  Under the conditions of the study, the NOAEL for
oral administration of metaflumizone for 90 days was 12 mg/kg b.w./day.

For a subchronic (90-day) dermal toxicity study conducted with
metaflumizone in Wistar rats, the results support a NOAEL of 100 mg/kg
b.w./day, based on decreased food consumption (females) and decreased
body weight gain in males and females at 300 mg/kg b.w./day, the next
highest dose tested.  Several microscopic changes were observed in
female animals at 300 mg/kg b.w./day and above, but these morphologic
changes were regarded to be indirect effects of the impaired body weight
gain.

For a subacute (28-day) inhalation toxicity study conducted with
metaflumizone in Wistar rats, the results support a NOAEL of 0.03 mg/L,
based on decreased food consumption (females) and decreased body weight
/ body weight gain (females) and several microscopic changes in the
respiratory tract at 0.10 mg/L, the next highest dose tested.  Several
microscopic changes in non-respiratory tract tissues were observed in
animals at these two dose levels, but these morphologic changes were
regarded to be indirect effects of the impaired body weight / body
weight gain.

Testing for metaflumizone’s potential immunotoxicity, two studies were
conducted, namely “28-Day Oral Immunotoxicity Study [by
Thymic-Dependent Antibody Response (TDAR) Assay] in the Female Wistar
Rat”  and  “28-Day Oral Immunotoxicity Study [by Natural Killer (NK)
Cell Assay] in the Female Wistar Rat.”   Results from both studies
indicate a lack of immunotoxic potential for metaflumizone (BAS 320 I)
up to the highest dose tested (HTD).  Both Study Reports have been
submitted to U.S. EPA (in 2011).

	5. Chronic toxicity. [In the Sprague-Dawley rat, treatment by oral
gavage with metaflumizone for a 2-year chronic duration resulted in
dose-related increased incidences of hepatocellular centrilobular
hypertrophy in the livers of males and females at 60 mg/kg b.w./day and
at 300/200 mg/kg b.w./day and hepatocellular basophilic alteration in
males at 60 and 300 mg/kg b.w./day.  [NOTE:  Beginning the first day of
Week 3, the dose level of the high-dose females was lowered from 300 to
200 mg/kg b.w./day, due to an adverse effect of -71% decreased body
weight gain as compared to controls.]

Therefore, the no-observable-adverse-effect-level (NOAEL) for systemic
toxicity following oral administration of metaflumizone for 24 months to
Sprague-Dawley rats was 30 mg/kg b.w./day for males and females.
Importantly, treatment with metaflumizone to rats for 2 years resulted
in no test substance-related neoplastic findings, and therefore, the
NOAEL for oncogenicity was 300/200 mg/kg b.w./day (highest dose tested).

In the CD-1 mouse, treatment by oral gavage with metaflumizone for an
18-month chronic duration resulted in a treatment-related increased
incidence of increased brown pigment in the spleens of male and female
animals administered 1000 mg/kg b.w./day (highest dose tested), as
compared to controls.  Under the conditions of the study, the NOAEL for
systemic toxicity following oral administration of metaflumizone for 18
months to CD-1 mice was 250 mg/kg b.w./day (the next highest dose
tested) for males and females.  Importantly, treatment with
metaflumizone to mice for 18 months resulted in no test
substance-related neoplastic findings, and therefore, the NOAEL for
oncogenicity was 1000 mg/kg b.w./day (highest dose tested).

In the beagle dog, treatment via gelatin capsules with metaflumizone for
a 12-month chronic duration resulted in reduced body weight gain and/or
decreased food consumption in several dogs at 30 mg/kg b.w./day and
slightly decreased mean MCHC at 30 mg/kg b.w./day.  Under the conditions
of the study, the NOAEL for oral administration of metaflumizone for 12
months was 12 mg/kg b.w./day.

Threshold Effect.  For estimated chronic exposure, the calculation of
the chronic reference dose (chronic RfD) is based on the results of the
chronic toxicity studies in the rat, mouse, and dog, and the
two-generation reproduction study in the rat.  For metaflumizone, the
lowest NOAEL for chronic toxic effects is 12 mg/kg b.w./day from the
12-month dog study.  A safety factor of 100 and an additional FQPA
safety factor of 3 was applied to the NOAEL to account for the higher
absorption observed with dietary exposures, resulting in a chronic RfD
of 0.04 mg/kg b.w./day.

Non-Threshold Effect.  Since there were no test substance-related
neoplastic findings following long-term treatment with metalfumizone to
mice for 18 months or to rats for 24 months, the NOAEL for oncogenicity
in both studies was established at the respective highest doses tested.
Therefore, metaflumizone should be classified as "not likely to be a
human carcinogen."]

	6. Animal metabolism. [In the rat, goat and hen metabolism studies, the
majority of the dose was rapidly excreted in the feces.  The low levels
that were absorbed were distributed throughout various tissues.
Metaflumizone was the major component of the extractable residues in all
tissues, milk, eggs and is the only residue of concern.  Metabolism of
metaflumizone occurs by hydroxylation and conjugation on either of the
phenyl rings or at the ethylene bridge and are the major routes of
detoxification.  Cleavage of the semicarbazide bond to yield M320I04
also occurs, usually with accompanying conjugation.  The only residue of
concern is metaflumizone.]

	7. Metabolite toxicology. [Toxicity of the metabolites of metaflumizone
with potential exposure to humans was concurrently evaluated during
toxicity testing of the parent except for the metabolite M320I23 that
was not observed in the rat metabolism study.  The Z-isomer (M320I02) of
metaflumizone was evaluated in additional toxicity tests to confirm no
differences between the minor Z-isomer component and metaflumizone with
a 9 to 1 E-isomer to Z-isomer ratio, respectively.  The results show no
toxicological concerns:

Toxicity Studies with the metabolite M320I23 of metaflumizone

(a)  Acute Toxicity Study with Metabolite M 320I023

The metabolite M 320I023 of metaflumizone demonstrates low acute
toxicity via the oral route of exposure in the rat.

Oral LD50  > 2000 mg/kg b.w. (category III).

(b)  Subchronic Toxicity Study with Metabolite M 320I023

In the Sprague-Dawley rat, treatment by oral gavage with metabolite M
320I023 of metaflumizone for a subchronic (90-day) duration resulted in
systemic toxicity effects of increased relative liver weights (females)
and increased incidences of liver hepatocellular centrilobular
hypertrophy in males and females at 1000 mg/kg b.w./day (highest dose
tested), as compared to controls.  Under the conditions of the study,
the NOAEL for oral administration of the metabolite M 320I023 of
metaflumizone for 90 days was 200 mg/kg b.w./day (next highest dose
tested) in males and females.

(c)  Mutagenicity/Genotoxicity Studies with Metabolite M 320I023

In a battery of three in vitro and one in vivo mutagenicity assays
consisting of all required end-points (point mutation, chromosomal
damage, and DNA damage and repair), the weight-of-the-evidence for the
metabolite M 320I023 (parent ketone) of metaflumizone insecticide
indicates a lack of potential genotoxicity.

Specifically, for the battery of three in vitro mutagenicity assays with
metabolite M 320I023 of metaflumizone, no positive responses were
observed for increased revertant frequencies with and without metabolic
activation [bacterial reverse mutation assay] or for increased mutant
frequencies with and without metabolic activation [HGPRT locus assay].
Although there was a positive result for a statistically increased
number of structurally aberrant metaphases in the chromosomes, which
indicates clastogenic potential under in vitro conditions, this result
was only observed with metabolic activation [cytogenicity study with V79
cells].

Importantly, the potential biological significance of this apparent
chromosome damage observed in vitro only with metabolic activation, was
evaluated in vivo using the mouse micronucleus assay.  Testing in this
in vivo micronucleus study with NMRI mice was conducted at a high dose
level (2000 mg/kg b.w.), that demonstrated no clinical symptoms of
toxicity but which represents the limit dose for this assay.  No
significant or dose-related increases in in vivo chromosomal damage were
observed, indicating that the metabolite M 320I023 of metaflumizone does
not cause chromosomal aberrations in intact animals.

Moreover, it has also been recognized by U.S. EPA that more weight
should be placed on in vivo systems than in vitro systems as expressed
in the Agency’s weight-of-evidence for genotoxic evaluation of a
chemical included in the "Guidelines for Mutagenicity Risk Assessment"
(Federal Register, September 24, 1986, Vol. 51: 34006-34012).  Thus, the
negative in vivo results (non-clastogenicity for chromosomal
aberrations) observed in the mouse micronucleus assay should override
the positive results obtained in the in vitro assay only with metabolic
activation.  Furthermore, it has been noted that in vitro systems may
simulate abnormal physiological conditions [Brusick, D.J. (editor) 1987.
Genotoxicity Produced in Cultured Mammalian Cell Assay by Treatment
Conditions. Mutation Research, Vol. 189, No.1: 1-69].  Additionally, it
has been reported in the literature that S-9 metabolic activation does
not often have adequate cofactors for activating detoxifying mechanisms
found in the whole animal system [Ashby, J. 1983. The unique role of
rodents in the detection of possible human carcinogens and mutagens.
Mutation Research, Vol. 115: 117-213] [Galloway, S.M. 1994. Chromosome
Aberrations Induced In Vitro:  Mechanisms. Delayed Expression, and
Intriguing Questions.  Environmental and Molecular Mutagenesis, Vol. 23,
Supplement 24: 44-53].  Consequently, based on the
weight-of-the-evidence presented above, the metabolite M 320I023 of
metaflumizone does not pose a genotoxic concern.

Therefore, as indicated from the results of the mammalian toxicity
studies as well as the mutagenicity assays, metabolite M 320I023 of
metaflumizone does not demonstrate more adverse toxicity when compared
to metaflumizone.

Toxicity Studies with the Z-Isomer of metaflumizone

(a)  Acute Toxicity Study with Z-Isomer

The Z-isomer of metaflumizone demonstrates low acute toxicity via the
oral route of exposure in the rat.

Oral LD50 > 5000 mg/kg b.w. (category IV).

(b)  Subchronic Toxicity Study with Z-Isomer

In the Sprague-Dawley rat, treatment by oral gavage with the Z-isomer of
metaflumizone for a subchronic (90-day) duration resulted in impaired
body weight gain only in females at the mid-dose (300 mg/kg b.w./day)
and the high-dose (1000 mg/kg b.w./day), as compared to controls.
Several microscopic changes were observed in female animals at these two
dose levels, but all morphologic changes were regarded to be indirect
effects of the impaired body weight gain.  Under the conditions of the
study, the NOAEL for oral administration of the Z-isomer of
metaflumizone for 90 days was 1000 mg/kg b.w./day (highest dose tested)
in males and 100 mg/kg b.w./day (lowest dose tested) in females.

(c)  Mutagenicity/Genotoxicity Study with Z-Isomer

In an in vitro mutagenicity assay with the Z-isomer of metaflumizone,
there were no positive responses observed for increased revertant
frequencies with and without metabolic activation [bacterial reverse
mutation assay].

Therefore, as indicated from the results of the mammalian toxicity
studies as well as the mutagenicity assay, the minor isomer of
metaflumizone, namely the Z isomer, does not demonstrate more adverse
toxicity when compared to metaflumizone.]

	8. Endocrine disruption. [Data from the reproduction / developmental
toxicity and short-and long-term repeated dose toxicity studies with
metaflumizone in the rat, rabbit, mouse, or dog, do not suggest any
endocrine disruption activity.  This information is based on the absence
of any treatment-related effects from the histopathological examination
of reproductive organs as well as a low level of concern for possible
effects on fertility, reproductive performance, or any other aspect of
reproductive function, or on growth and development of the offspring.]

C. Aggregate Exposure

	1. Dietary exposure.

Food. [

A dietary exposure analysis was conducted for all registered uses of
Metaflumizone at the tolerance values of 0.04 ppm, tomato at the pending
tolerance value of 0.6 ppm (including paste at 1.2 ppm), pepper and
eggplant at the pending tolerance values of 1.5 ppm, and pome fruit and
citrus fruit at the proposed tolerance values of 0.04 ppm.

Acute Dietary Food Exposure:  The Health Effects Division (HED) of EPA
has determined that there are no toxic effects attributable to a single
dose of metaflumizone for the general populations including infants and
children.  Therefore, a quantitative acute dietary exposure and risk
assessment for these sub-populations is not required.

An acute dietary assessment was conducted to evaluate the potential risk
due to acute dietary exposure to females 13 – 49 years old.  The ARfD
for metaflumizone is 1.0 mg/kg bw/day.  The FQPA safety factor for
metaflumizone has been set to 3; therefore, the aPAD is 0.33 mg/kg
bw/day.  The tier 1 acute dietary exposure estimate was based on
established and proposed tolerance values in crops (including tomato
paste), 100 percent crop treated values and experimental and default
concentration/processing factors.  Residues in fish/shellfish were
included based on the Aquatic Bioaccumulation Model (KABAM) piscivorous
fish residue estimate for fish/shellfish.   The Dietary Exposure
Evaluation Module (DEEM-FCID) software, version 3.14 updated with the
USDA NHANES 2-day food consumption data for 2003-2008 and the EPA Food
Commodity Ingredient Database (FCID) as of February 2012 was used for
the assessment.  Drinking water exposure was included in the dietary
exposure analysis.  Tolerances for meat, milk, egg, and poultry are not
required.

The exposure estimate for the metaflumizone acute dietary assessment was
well below U.S. EPA’s level of concern (See table below).  The
estimated acute dietary exposure for females 13 – 49 years old was 1.6
%.  Additional refinements such as the use of anticipated residues and
predicted percent crop treated would further reduce the estimated acute
dietary exposure.

Table 1. Summary of Acute Dietary Exposure and Risk for Metaflumizone
Considering Crop Group 11-10: Pome Fruit Group, Crop Group 12-12: Stone
Fruit Group, Crop Group 10-10: Citrus Fruits Group, Crop Group 14-12:
Tree Nuts Group, Grape, Tomato, Bell Pepper, Eggplant, and Drinking
Water.

Population	Exposure Estimate	%aPAD

Subgroups	(mg/kg b.w./day)

Females (13-49 years old)	0.00535	1.60

aPAD = acute population adjusted dose (aPAD = 0.33 mg/kg bw/day)

Chronic Dietary Food Exposure:

A tier 1 dietary exposure assessment was conducted for all
sub-populations including infants and children.  The ADI for
metaflumizone is 0.12 mg/kg bw/day.  The FQPA safety factor for
metaflumizone has been set to 3; therefore, the cPAD is 0.04 mg/kg
bw/day.  The tier 1 chronic dietary exposure estimates were based on
established and proposed tolerance values in crops (including tomato
paste), 100 percent crop treated values and experimental and default
concentration/processing factors. Residues in fish/shellfish were
included based on the Aquatic Bioaccumulation Model (KABAM) piscivorous
fish residue estimate for fish/shellfish.   The Dietary Exposure
Evaluation Module (DEEM-FCID) software, version 3.14 updated with the
USDA NHANES 2-day food consumption data for 2003-2008 and the EPA Food
Commodity Ingredient Database (FCID) as of February 2012 was used for
the assessment.  Drinking water exposure was included in the dietary
exposure analysis.  Tolerances for meat, milk, egg, and poultry are not
required.

Exposure estimates for the metaflumizone chronic dietary assessments
were well below U.S. EPA’s level of concern (See table below.  The
most highly exposure exposed sub-group was children 1-2 years old and
the exposure accounted for 6.9% of the cPAD.  Additional refinements
such as the use of anticipated residues and predicted percent crop
treated would further reduce the estimated chronic dietary exposure.

Table 2.  Summary of Chronic Dietary Exposure and Risk for Metaflumizone
Considering Crop Group 11-10: Pome Fruit Group, Crop Group 12-12: Stone
Fruit Group, Crop Group 10-10: Citrus Fruits Group, Crop Group 14-12:
Tree Nuts Group, Grape, Tomato, Bell Pepper, Eggplant, and Drinking
Water.

Population	Exposure Estimate	%cPAD

Subgroups	(mg/kg b.w./day)

U.S. Population	0.00152	3.8

All Infants (< 1 year old)	0.00081	2.0

Children (1-2 years old)	0.00277	6.9

Children (3-5 years old)	0.00152	6.0

Children (6-12 years old)	0.00081	4.1

Youth (13-19 years old)	0.00277	2.7

Females (13-49 years old)	0.00152	3.7

Adults (20-49 years old)	0.00081	3.8

Adults (50+ years old)	0.00277	3.2

cPAD = chronic  population adjusted dose (cPAD = 0.04 mg/kg bw/day)]

	ii. Drinking Water. [The estimated drinking water concentrations
(EDWCs) used in this assessment were from the HED human health
assessment of metaflumizone, December 21, 2011.  PRZM-EXAMS modeling
resulted in the highest surface water values.  The model was run using
the fly bait application scenario to turf to represent application to
use sites such as recreational facilities and outdoor recreational areas
including parks, picnic grounds, and camp grounds (26 x 0.0137 lb
ai/acre; yielded the highest EDWCs).  The acute and chronic surface
water EDWCs were 1.14 and 0.597 ppb, respectively.  The acute and
chronic ground water EDWC was 2.1 x 10-3 ppb.  The drinking water
exposure was included in the dietary assessment.   ]

	2. Non-dietary exposure. [

Metaflumizone is registered in the U.S. for use as a fire ant bait and a
fly bait.  This These uses can result in residential exposure.  The EPA
HED has evaluated these uses and determined the exposure.  The exposure
and MOE values for these uses were estimated using EPA’s 2012
Residential SOPs. in the below tables are from the HED document December
21, 2011.   The MOE values were calculated using the a short-term dermal
NOAEL = of 100 mg ai/kg bw/day and short-term incidential oral NOAEL =
of 20 mg ai/kg bw/day.  The calculated MOEs for all homeowner adult and
toddler infant exposures are greater than 100 and therefore do not
exceed EPA’s level of concern.

Table 3.  Summary of Residential and Recreational Post-Application
Exposure and Risks from use of Fire Ant Bait.

Fire Ant Bait

Population and activity	Route of Exposure	Dose (mg/kg bw/day)	MOE

Adult -- Residential Handler	Dermal	0.00012	833,000

	Inhalation	0.000000013	185,000,000

	Combined	--	ARI = 7,973

Adult – Residential Post-application	Dermal	0.00008	1,250,000

Adult – Golfer Post-application	Dermal	5.90E-06	16,900,000

Adolescent – Golfer Post-application	Dermal	6.86E-06	14,600,000

Children (1 to <2 year olds) –

Post-application	Dermal	0.00016	625,000

	Incidental oral hand-to-mouth	1.50E-06	13,000,000

	Incidental oral object-to-mouth	4.00E-07	50,000,000

	Combined oral h-t-m and dermal	--	ARI = 5479

Table 4.  Summary of Recreational Post-Application Exposure and Risks
from use of Metaflumizone Fly Bait.

Fly Bait

Population and activity	Route of Exposure	Dose (mg/kg bw/day)	MOE

Adult – Post-application	Dermal	0.00117	86,000

Children (1 to <2 years old) – Post-application	Dermal	0.00229	44,000

	Incidental oral hand-to-mouth	0.0000210	950,000

	Incidental oral object-to-mouth	0.0000013	15,000,000

	Combined oral hand-to-mouth and dermal	--	ARI = 384

	3. Aggregate exposure.

[Acute Aggregate Risk:

No acute residential/recreational exposures are expected.  The acute
aggregate risk includes only exposure to females 13-49 years old from
food and water.  The food and drinking water exposure accounts for less
than 1 % aPAD which is below HED’s level of concern.

Short-/Intermediate Term Aggregate Risk:

There is the potential for short-term, non-dietary exposure of children
and adults to metaflumizone from the use as a fire ant bait and a fly
bait.   Therefore, the short-term aggregate exposure includes
residential/recreational exposure, food and water exposure.   The target
MOE for metaflumizone aggregate risk is 100.Because the level of concern
(LOC) for oral exposure is different than the LOC for dermal exposure,
an Aggregate Risk Index (ARI) is used.  An ARI >1 indicates an
acceptable exposure.   In the tables below, the incidental oral exposure
for the hand-to-mouth exposure was aggregated with the dietary and
post-application dermal exposure for both the fire ant and fly bait
uses.

Table 75.  Summary of Short-/Intermediate Term Aggregate Risk from Fire
Ant Bait Use.

	Food + water	Non-dietary oral	Dermal	Aggregate

Population Sub-Group	MOE	MOE	MOE	ARI

US population	13,132	NA	833,000	43.5

Children 1-2	7,228	13,300,000	625,000	24.0

The aggregate MOE values are all greater than the HED level of concern
which indicates that the aggregate use is below HED’s level of
concern.

Table 86.  Summary of Short-/Intermediate Term Aggregate Risk from Fly
Bait Use.

	Food + water	Non-dietary oral	Dermal	Aggregate

Population Sub-Group	MOE	MOE	MOE	ARI

US population	13,100	NA	85,500	41.6

Children 1-2	7,230	952,000	43,700	22.7

The aggregate MOEARI values are all greater than the HED level of
concern1 which indicates that the aggregate use is below HED’s level
of concern acceptable exposures.

Chronic Aggregate Risk:

No chronic residential/recreational exposure is expected.  The chronic
aggregate risk includes only exposure from food and water.  The chronic
food and drinking water exposure for all sub-populations are below
HED’s level of concern.  ]

D. Cumulative Effects>  [Section 408(b)(2)(D)(v) 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.

The EPA is currently developing methodology to perform cumulative risk
assessments.  At this time, there is no available data to determine
whether metaflumizone has a common mechanism of toxicity with other
substances or how to include this pesticide in a cumulative risk
assessment.]

E. Safety Determination

	1. U.S. population. [Using the conservative exposure assumptions
described above and based on the completeness and the reliability of the
toxicity data, BASF has estimated the aggregate exposure to
metaflumizone is well below the EPA’s level of concern.  ]

	2. Infants and children. [All subpopulations based on age were
considered. Infants and children aggregate risk is well below remained
below EPA’s level of concern.  BASF, considering a worst-case
situation, concludes with reasonable certainty that no harm will result
to infants or children from aggregate exposure to metaflumizone
residues.]

F. International Tolerances

	[Maximum residue levels (MRLs) have been established for metaflumizone
by the Codex Alimentarius Commision (CODEX) in potato, tomato, pepper,
eggplant, Brussels sprout, Chinese cabbage, lettuce, and animal
products.  Harmonized EU MRLs have been established for metaflumizone in
potato, tomato, pepper, eggplant, leafy brassica, Brussels sprout,
lettuce and similar and animal products.

Codex (based on parent only)

Potato	0.02

Tomato	0.6

Pepper, inc chili pepper	0.6

Peppers chili, dried	6

Eggplant	0.6

Brussels sprout	0.8

Chinese cabbage	6

Lettuce	7

Swine (all)	0.02

Bovine (meat, kidney, liver, fat, offal)	0.02

Sheep, goat (meat, kidney, liver, fat, offal)	0.02

Milk	0.01

Cream	0.02

EU harmonized (based on parent + M320I04)

Potato	0.05

Tomato	0.6

Pepper, inc chili pepper	1

Eggplant	0.6

Brussels sprout	1

Head cabbage	1

Chinese cabbage	6

Leafy cabbage	10

Lettuce and similar except scarole	10

Swine (all)	0.02

Bovine (meat, kidney, liver, fat, offal)	0.02

Sheep, goat (meat, kidney, liver, fat, offal)	0.02

Poultry (meat, liver, kidney, offal)	0.02

Poultry fat	0.1

Milk and cream	0.02

Eggs	0.02

]


[Federal Register: February 12, 2009 (Volume 74, Number 28)]
[Rules and Regulations]
[Page 6995]
[DOCID:fr12fe09-6]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

49 CFR Part 209

[FRA-2007-28573]
RIN 2130-AB87

Railroad Safety Enforcement Procedures; Enforcement, Appeal and
Hearing Procedures for Rail Routing Decisions

AGENCY: Federal Railroad Administration (FRA), Department of
Transportation (DOT).

ACTION: Final rule; clarification.

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

SUMMARY: On November 26, 2008, FRA published the final rule in this
docket that established procedures to enable railroad carriers to
challenge rail routing decisions made by FRA's Associate Administrator
for Safety. The final rule was published with an immediate effective
date. Under applicable federal statutes, this document did not qualify
for an immediate effective date.

DATES: The applicability date for the final rule published at 73 FR
72194 was January 15, 2009.

FOR FURTHER INFORMATION CONTACT: Lucinda Henriksen, Office of Chief
Counsel, Federal Railroad Administration, 1200 New Jersey Avenue, SE.,
Washington, DC 20590 (telephone<PHONE_NUMBER>).

SUPPLEMENTARY INFORMATION: The final rule in this proceeding, published
on November 26, 2008, indicated that it would be effective upon
publication. See 73 FR 72194. Pursuant to Section 553 of the
Administrative Procedure Act (APA), codified at 5 U.S.C. 553, with
certain exceptions, substantive rules cannot take effect less than 30
days after publication, unless the agency finds good cause for doing so
and provides a written explanation of any good cause found when the
rule is published. FRA provided no justification for the immediate
effective date in the published rule document and, in fact, FRA did not
intend to avail itself of the good cause exception of 5 U.S.C. 553.
    In addition, in accordance with the Congressional Review Act (CRA),
at 5 U.S.C. 801(a)(4), a final rule cannot take effect until the rule
is submitted to Congress in accordance with 5 U.S.C. 801(a)(1). The
rule was submitted to Congress on January 15, 2009.
    According to the procedures established by the Administrative
Committee of the Federal Register under the Federal Register Act (44
U.S.C. Chapter 15), the amendments to the Code of Federal Regulations
(CFR) set out in this final rule were incorporated into the CFR on
November 26, 2008, the effective date of the rule. However, because of
the issues with the APA and the CRA, this rule could not become
applicable or enforceable until January 15, 2009.
    Accordingly, FRA acknowledges that the rule was not effective and
enforceable until January 15, 2009. FRA further notes that because the
rule establishes procedures that have not yet been utilized, neither
the public, nor any regulated entities, were harmed in the interim
period between publication of the rule and January 15, 2009.

    Issued in Washington, DC, on February 6, 2009.
Jo Strang,
Acting Deputy Administrator.
 [FR Doc. E9-3073 Filed 2-11-09; 8:45 am]

BILLING CODE 4910-06-P