[Federal Register: August 3, 2010 (Volume 75, Number 148)]
[Rules and Regulations]
[Page 45478-45480]
[DOCID:fr03au10-3]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2010-0706]
RIN 1625-AA00

Safety Zone; Transformers 3 Movie Filming, Chicago River,
Chicago, IL

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing two separate temporary safety
zones on the Chicago River near Chicago, Illinois. These zones are
intended to restrict vessels from a portion of the Chicago River due to
the filming of a major motion picture, Transformers 3. These temporary
safety zones are necessary to protect the surrounding public and
vessels from the hazards associated with the different types of stunts
that will be performed during the filming of this movie.

DATES: Effective Date: this rule is effective in the CFR from August 3,
2010 until 9 p.m. on August 8, 2010. This rule is effective with actual
notice for purposes of enforcement beginning 7 a.m. on July 27, 2010.

ADDRESSES: Documents indicated in this preamble as being available in
the docket are part of docket USCG-2010-0706 and are available online
by going to http://www.regulations.gov, inserting USCG-2010-0706 in the
``Keyword'' box, and then clicking ``search.'' They are also available
for inspection or copying at the Docket Management Facility (M-30),
U.S. Department of Transportation, West Building Ground floor, Room
W12-140, 1200 New Jersey Avenue SE., Washington DC 20590, between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary rule, contact or email BM1 Adam Kraft, U.S. Coast Guard
Sector Lake Michigan, at<PHONE_NUMBER> or<EMAIL_ADDRESS>If you
have questions on viewing the docket, call Renee V. Wright, Program
Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Regulatory Information

    The Coast Guard is issuing this temporary final rule without prior
notice and opportunity to comment pursuant to authority under section
4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when an agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under U.S.C. 553 (b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because the final details for these events
were not submitted to the Coast Guard until July 20, 2010. Based on the
hazards associated with the filming of this major motion picture,
delaying the enactment of this rule to provide for a comment would be
against the public interest. Therefore, there was not enough time to
solicit the public for comments concerning this temporary final rule.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. Delaying the effective date of
this rule would be contrary to the public interest as immediate action
is needed to protect the public from the hazards associated with the
filming of this major motion picture.

Basis and Purpose

    These temporary safety zones are necessary to protect vessels from
the hazards associated with the stunts that will be occurring during
this filming of the major motion picture, Transformers 3. The Captain
of the Port, Sector Lake Michigan, has determined that the stunts
associated with the filming of this motion picture do pose significant
risks to public safety and property. The likely combination of
congested waterways and the stunts that will be performed during the
filming of a major motion picture could easily result in serious
injuries or fatalities.

Discussion of Rule

    The Coast Guard is establishing two temporary safety zones. The
first safety zone will be enforced between 7 a.m. and 9 p.m. on July
27, 2010 and encompasses all U.S. navigable waters of the Chicago River
between the Lakeshore Drive Bridge, 41[deg]53'19'' N, 087[deg]36'51'' W
and the Wabash Street Bridge, 41[deg]53'17'' N, 087[deg]37'36'' W. The
second safety zone will be enforced between 7 a.m. and 9 p.m. on August
8, 2010 and encompasses all U.S. navigable waters of the Chicago River
between the Dearborn Street Bridge, 41[deg]53'14'' N, 087[deg]37'46'' W
and the Wabash Street Bridge, 41[deg]53'17'' N, 087[deg]37'36'' W.
[DATUM: NAD 83].
    All persons and vessels shall comply with the instructions of the
Coast Guard Captain of the Port, Sector Lake Michigan, or his or her
on-scene representative. Entry into, transiting, or anchoring within
the safety zone is prohibited unless authorized by the Captain of the
Port, Sector Lake Michigan, or his or her on-scene representative. The
Captain of the Port, Sector Lake Michigan, or his or her on-scene
representative may be contacted via VHF Channel 16.

Regulatory Analyses

    We developed this rule after considering numerous statutes and
executive orders related to rulemaking. Below we summarize our analyses
based on 13 of these statutes or executive orders.

Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, and does not
require an assessment of potential costs and benefits under section
6(a)(3) of that Order. The Office of Management and Budget has not
reviewed it under that Order.
    Although this regulation will restrict access to the area, the
effect of the rule will not be significant because: The minimal time
that vessels will be restricted from the zone and the zone is an area
where the Coast Guard expects insignificant adverse impact to mariners
from the zones' ten minute or less activation periods.

Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered whether this rule will have a significant economic impact on
a substantial number of small entities. The term ``small entities''
comprises small businesses, not-for-profit organizations that are
independently owned and operated and are not dominant in their fields,
and governmental jurisdictions with populations of less than 50,000.
    The Coast Guard certifies under 5 U. S. C. 605(b) that this rule
will not have a significant economic impact on a substantial number of
small entities.
    This rule will affect the following entities, some of which might
be small entities: The owners or operators of vessels intending to
transit or anchor in a portion of the Chicago River between 7 a.m. and
9 p.m. on July 27, 2010 and August 8, 2010.
    The safety zones will not have a significant economic impact on a
substantial number of small entities for the following reasons: This
rule will only be enforced while unsafe conditions exist. Traffic will
only be prohibited from passing through the

zones when actual filming is being conducted. Traffic will only be
stopped for a short duration not to exceed ten minutes during any one
closure. In the event that these temporary safety zones affect
shipping, commercial vessels may request permission from the Captain of
The Port, Sector Lake Michigan, or his or her on scene representative
to transit through the safety zone. The Coast Guard will give notice to
the public via a Broadcast to Mariners that the regulation is in
effect.

Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we offer to assist small
entities in understanding the rule so that they could better evaluate
its effects on them and participate in the rulemaking process.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

Collection of Information

    This rule calls for no new collection of information under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on State or local
governments and would either preempt State law or impose a substantial
direct cost of compliance on them. We have analyzed this rule under
that Order and have determined that it does not have implications for
federalism.

Unfunded Mandates Reform Act

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

Taking of Private Property

    This rule will not affect a taking of private property or otherwise
have taking implications under Executive Order 12630, Governmental
Actions and Interference with Constitutionally Protected Property
Rights.

Civil Justice Reform

    This rule meets applicable standards in sections 3(a) and 3(b)(2)
of Executive Order 12988, Civil Justice Reform, to minimize litigation,
eliminate ambiguity, and reduce burden.

Protection of Children

    We have analyzed this rule under Executive Order 13045, Protection
of Children from Environmental Health Risks and Safety Risks. This rule
is not an economically significant rule and does not concern an
environmental risk to health or risk to safety that may
disproportionately affect children.

Indian Tribal Governments

    This rule does not have tribal implications under Executive Order
13175, Consultation and Coordination with Indian Tribal Governments,
because it does not have a substantial direct effect on one or more
Indian tribes, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes.

Energy Effects

    We have analyzed this temporary rule under Executive Order 13211,
Actions Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use. We have determined that it is not a ``significant
energy action'' under that order because it is not a ``significant
regulatory action'' under Executive Order 12866 and is not likely to
have a significant adverse effect on the supply, distribution, or use
of energy. The Administrator of the Office of Information and
Regulatory Affairs has not designated it as a significant energy
action. Therefore, it does not require a Statement of Energy Effects
under Executive Order 13211.

Technical Standards

    The National Technology Transfer and Advancement Act (NTTAA) (15
U.S.C. 272 note) directs agencies to use voluntary consensus standards
in their regulatory activities unless the agency provides Congress,
through the Office of Management and Budget, with an explanation of why
using these standards would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., specifications of materials, performance, design, or
operation; test methods; sampling procedures; and related management
systems practices) that are developed or adopted by voluntary consensus
standards bodies. This rule does not use technical standards.
Therefore, we did not consider the use of voluntary consensus
standards.

Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded
this action is one of a category of actions which do not individually
or cumulatively have a significant effect on the human environment.
This rule is categorically excluded, under figure 2-1, paragraph
(34)(g), of the Instruction. This rule involves the establishment of
two safety zones and is therefore categorically excluded under
paragraph 34(g) of the Instruction.
    A final environmental analysis check list and categorical exclusion
determination are available in the docket where indicated under
ADDRESSES.

List of Subjects in 33 CFR Part 165

    Harbors, Marine Safety, Navigation (water), Reporting and record
keeping requirements, Security measures, Waterways.

0
For the reasons discussed in the preamble, the Coast Guard amends 33
CFR Part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

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

    Authority:  33 U.S.C. 1226, 1231; 46 U.S.C. Chapter 701; 50
U.S.C. 191, 195; 33 CFR 1.05-1(g), 6.04-1, 6.04-6, and 160.5; Pub.
L. 107-295, 116 Stat. 2064; Department of Homeland Security
Delegation No. 0170.1.

0
2. Add Sec.  165.T09-0706 to read as follows

Sec.  165.T09-0706  Safety Zone; Transformers 3 Movie Filming, Chicago
River, Chicago, IL

    (a) Safety Zones. (1) The first safety zone encompasses all U.S.
navigable waters of the Chicago River between the

Lakeshore Drive Bridge, 41[deg]53'19'' N, 087[deg]36'51'' W and the
Wabash Street Bridge, 41[deg]53'17'' N, 087[deg]37'36'' W.
    (i) Date. July 27, 2010.
    (2) The second safety zone encompasses all U.S. navigable waters of
the Chicago River between the Dearborn Street Bridge, 41[deg]53'14'' N,
087[deg]37'46'' W and the Wabash Street Bridge, 41[deg]53'17'' N,
087[deg]37'36''W. [DATUM: NAD 83].
    (i) Date. August 8, 2010.
    (b) Enforcement period. The first safety zone will be enforced
between 7 a.m. to 9 p.m. on July 27, 2010. The second safety zone will
be enforced between 7 a.m. to 9 p.m. on August 8, 2010. The Captain of
the Port, Sector Lake Michigan, or the on-scene representative may
suspend and restart the enforcement of the safety zone at anytime
within the stated enforcement times.
    (c) Regulations. (1) In accordance with the general regulations in
section 165.23 of this part, entry into, transiting, or anchoring
within this safety zone is prohibited unless authorized by the Captain
of the Port, Sector Lake Michigan, or his or her on-scene
representative.
    (2) This safety zone is closed to all vessel traffic, except as may
be permitted by the Captain of the Port, Sector Lake Michigan, or his
or her on-scene representative.
    (3) The ``on-scene representative'' of the Captain of the Port,
Sector Lake Michigan, is any Coast Guard commissioned, warrant or petty
officer who has been designated by the Captain of the Port, Sector Lake
Michigan, to act on his or her behalf. The on-scene representative of
the Captain of the Port, Sector Lake Michigan, will be on land in the
vicinity of the safety zone and will have constant communications with
the Chicago Marine Unit vessels that will be on-scene as the
enforcement vessels.
    (4) Vessel operators desiring to enter or operate within the safety
zone shall contact the Captain of the Port, Sector Lake Michigan, or
his or her on-scene representative to obtain permission to do so. The
Captain of the Port, Sector Lake Michigan, or his or her on-scene
representative may be contacted via VHF Channel 16. Vessel operators
given permission to enter or operate in the safety zone must comply
with all directions given to them by the Captain of the Port, Sector
Lake Michigan, or his or her on-scene representative.

    Dated: July 21, 2010.
L. Barndt,
Captain, U.S. Coast Guard, Captain of the Port, Sector Lake Michigan.
[FR Doc. 2010-18960 Filed 8-2-10; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register: April 22, 2010 (Volume 75, Number 77)]
[Notices]
[Page 21064-21069]
[DOCID:fr22ap10-124]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-61927; File No. SR-FINRA-2010-012]

Self-Regulatory Organizations; Financial Industry Regulatory
Authority, Inc.; Notice of Filing of Proposed Rule Change To Amend
FINRA Rule 8312 (FINRA BrokerCheck Disclosure)

April 16, 2010.
    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 March 30, 2010, the Financial Industry Regulatory Authority, Inc.
(``FINRA'') 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 FINRA. 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

    FINRA is proposing to amend FINRA Rule 8312 (FINRA BrokerCheck
Disclosure) to (1) expand the information released through BrokerCheck,
both in terms of scope and time disclosed; and (2) establish a process
to dispute the accuracy of (or update) information disclosed through
BrokerCheck.
    The text of the proposed rule change is available on FINRA's Web
site at http://www.finra.org, at the principal office of FINRA, on the
Commission's Web site at http://www.sec.gov, 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, FINRA 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. FINRA 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 proposed rule change amends FINRA Rule 8312, which pertains to
FINRA's BrokerCheck program. As described in more detail below, the
proposed rule change would (1) expand the information released through
BrokerCheck, both in terms of scope and time disclosed; and (2)
establish a process to dispute the accuracy of (or update) information
disclosed through BrokerCheck.
I. Expansion of Information Released through BrokerCheck
    FINRA established BrokerCheck (then known as the Public Disclosure
Program) in 1988 to provide the public with information on the
professional background, business practices, and conduct of FINRA
members and their associated persons. In 1990, with FINRA's support,
Congress passed legislation requiring FINRA to establish and maintain a
toll-free telephone number to respond to inquiries about members and
associated persons. In 1998, FINRA began providing certain
administrative information, such as registration and employment
history, online via FINRA's Web site. FINRA again amended its rules
pertaining to BrokerCheck in 2000 to establish a two-year period for
disclosure of information about persons formerly registered with a
FINRA member, increase the amount of information disclosed to investors
through BrokerCheck, and refine the report delivery process. In 2007,
FINRA expanded the types of information made available through
BrokerCheck, made BrokerCheck more user friendly, introduced an
educational component of the BrokerCheck report and Web site, and
provided a compilation of selected data of FINRA members. Last year,
FINRA expanded BrokerCheck to permanently make publicly available in
BrokerCheck certain information about former associated persons of a
member who were the subject of a final regulatory action.
    As the above discussion demonstrates, FINRA has regularly assessed
the scope and utility of the information provided to the public through
BrokerCheck and, as a result, has made numerous changes to improve the
program. Last year, in addressing the public comment letters submitted
to the Commission in connection with its most recent BrokerCheck
expansion proposal, FINRA noted that it would continue to evaluate all
aspects of the BrokerCheck program and consider whether greater
disclosure of information through BrokerCheck should be made in the
future.\3\ FINRA believes that such regular evaluation of the program
is important due to FINRA's statutory obligation to make information
available to the public, as well as the prominence that BrokerCheck has
attained as an investor protection service.\4\
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    \3\ See Letter to Elizabeth M. Murphy, Secretary, Commission,
from Richard E. Pullano, Associate Vice President and Chief Counsel,
Registration and Disclosure, FINRA, dated October 15, 2009, in
response to comments received regarding Securities Exchange Act
Release No. 60462 (August 7, 2009), 74 FR 41470 (August 17, 2009)
(Notice of Filing File No. SR-FINRA-2009-050). See also discussion
of comments in Securities Exchange Act Release No. 61002 (November
13, 2009), 74 FR 61193 (November 23, 2009) (Order Approving File No.
SR-FINRA-2009-050).
    \4\ Approximately 18.5 million records were viewed last year on
BrokerCheck, and the program is routinely mentioned in news articles
and investor education materials as a premier tool for researching
investment professionals. The Commission has also recognized
BrokerCheck as a valuable tool for the public in deciding, among
other things, whether to do business with an industry member. See
Securities Exchange Act Release No. 61002 (November 13, 2009), 74 FR
61193 (November 23, 2009) (Order Approving File No. SR-FINRA-2009-
050).
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    Late last year, FINRA evaluated the BrokerCheck program, including
the fundamental policies governing the disclosure of information
through the program, as well as the types, the length of availability,
and the value to the public of the information that is disclosed via
BrokerCheck. Additionally, FINRA considered the role that BrokerCheck
plays as an investor protection service and the significant shift in
the financial services landscape that has occurred during the past few
years and continues to this day.
    Based on the results of its evaluation, FINRA has determined that
further expansion of the BrokerCheck program is warranted. As such,
FINRA is proposing to amend FINRA Rule 8312 to (1) expand the
BrokerCheck disclosure period for former associated persons of a member
to ten years from two years; (2) permanently make publicly available in
BrokerCheck certain information about former associated persons of a
member if any of the following applies, as reported to the Central
Registration Depository (``CRD'' or ``Web CRD'') on a uniform
registration form: (i) The person was convicted of or pled guilty or
nolo contendere to a crime; (ii) the person was the subject of a civil
injunction in connection with investment-related activity or a civil
court finding of involvement in a violation of any investment-related
statute or regulation; or (iii) the person was named as a respondent or
defendant in an investment-related, consumer-initiated arbitration or
civil litigation which alleged that the person was involved in a sales
practice violation and which resulted in an arbitration award or civil
judgment against the person; and (3) make publicly available in
BrokerCheck all historic customer complaints that were archived after
the implementation of Web CRD. FINRA has concluded that these
proposals, as described in more detail below, are a logical extension
of the BrokerCheck program that will help protect investors and other
users of BrokerCheck, and make BrokerCheck a more effective tool in
combating fraud across the financial services sector.

Expansion of the BrokerCheck Disclosure Period for Former Registered
Persons

    Currently, as described in FINRA Rule 8312, BrokerCheck provides
certain information regarding current associated persons and persons
who were associated with a member within the preceding two years (i.e.,
a two year ``post-registration disclosure period'').\5\

This information is derived from the uniform registration forms.\6\
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    \5\ BrokerCheck also provides public access to certain
information about formerly associated persons, regardless of when
they were associated with a member, if they were the subject of a
final regulatory action as defined in Form U4 that has been reported
to CRD via a uniform registration form. As discussed below, FINRA
also is proposing to broaden the scope of information made
permanently available to the public via BrokerCheck.
    \6\ The uniform registration forms are Form BD (Uniform
Application for Broker-Dealer Registration), Form BDW (Uniform
Request for Broker-Dealer Withdrawal), Form BR (Uniform Branch
Office Registration Form), Form U4 (Uniform Application for
Securities Industry Registration or Transfer), Form U5 (Uniform
Termination Notice for Securities Industry Registration), and Form
U6 (Uniform Disciplinary Action Reporting Form).
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    When FINRA proposed implementing the two year post-registration
disclosure period over a decade ago, it noted that such a disclosure
period was appropriate because it generally coincides with the period
in which an individual can return to the industry without being
required to requalify by examination and the initial period in which an
individual remains subject to FINRA's jurisdiction.\7\ Since that time,
the purpose of BrokerCheck has broadened from helping investors make
informed choices about the individuals and firms with which they may
wish to do business to also include providing the public with access to
information about formerly registered persons who, although no longer
in the securities industry in a registered capacity, may work in other
investment-related industries or may seek to attain other positions of
trust with potential investors and about whom investors may wish to
learn relevant information. Consequently, FINRA believes that the
reasons initially set forth for the two year post-registration
disclosure period are no longer as compelling as when the disclosure
period was initially established.
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    \7\ See Securities Exchange Act Release No. 42402 (February 7,
2000), 65 FR 7582 (February 15, 2000) (Order Approving File No. SR-
NASD-99-45).
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    Therefore, FINRA is proposing to expand the post-registration
disclosure period to ten years from two years. FINRA believes that a
ten year post-registration disclosure period is now more reasonable
since it may take individuals some time after leaving the securities
industry to establish themselves in another investment-related industry
or to attain other positions of trust with potential investors. A ten
year post-registration disclosure period will provide investors and
other users of BrokerCheck with a longer period of time to consider
relevant and important information about such formerly registered
individuals. FINRA believes that a ten year post-registration
disclosure period will accomplish this goal without unduly burdening or
infringing on the reputational or privacy interests of those
individuals whose FINRA registrations have terminated.

Expansion of BrokerCheck To Permanently Include Additional Information

    As previously mentioned, currently under FINRA Rule 8312,
BrokerCheck generally provides information about individuals who are
registered with FINRA or who were associated with a member within the
preceding two years. Last year, BrokerCheck was expanded to permanently
make publicly available in BrokerCheck certain information about former
associated persons of a member who were the subject of a final
regulatory action as defined in Form U4 that has been reported to CRD
via a uniform registration form.\8\ This change was designed to allow
the public to access information about formerly registered persons who
may work in other investment-related industries or may otherwise seek
to attain positions of trust with potential investors.
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    \8\ See Securities Exchange Act Release No. 61002 (November 13,
2009), 74 FR 61193 (November 23, 2009) (Order Approving File No. SR-
FINRA-2009-050).
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    As a result of its evaluation of the BrokerCheck program, FINRA now
believes that BrokerCheck should permanently make publicly available
additional information about certain former associated persons of a
member. FINRA is proposing to permanently make publicly available in
BrokerCheck certain information about former associated persons of a
member \9\ if any of the following applies, as reported to CRD on a
uniform registration form: (1) The person was convicted of or pled
guilty or nolo contendere to a crime; \10\ (2) the person was the
subject of a civil injunction in connection with investment-related
activity or a civil court finding of involvement in a violation of any
investment-related statute or regulation; \11\ or (3) the person was
named as a respondent or defendant in an investment-related, consumer-
initiated arbitration or civil litigation which alleged that the person
was involved in a sales practice violation and which resulted in an
arbitration award or civil judgment against the person.\12\ FINRA is
proposing to provide through BrokerCheck information concerning any
such disclosure event(s),\13\ as well as certain administrative
information (e.g., employment and registration history) and information
as to qualification examinations passed by these formerly registered
individuals. FINRA is also proposing to make available the most
recently submitted comment, if any, provided by the person, presuming
the comment is in the form and in accordance with the procedures
established by FINRA and relates to the information provided through
BrokerCheck.\14\ Other disclosure matters that may be disclosed
pursuant to FINRA Rule 8312 for associated persons and during the post-
registration period (e.g., reportable customer complaints or Historic
Complaints, criminal charges, terminations, bankruptcies, liens) would
continue not to be disclosed after the post-registration period
expires.
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    \9\ The proposal will apply only to those individuals registered
with FINRA on or after August 16, 1999, which is the date that Web
CRD was implemented. Since FINRA launched the Web CRD system, it has
used the information in the Web CRD database to generate BrokerCheck
reports. Such information is available in a Web-based format and
therefore can be easily used to generate BrokerCheck reports.
Although the Web CRD database contains information regarding all
persons that have been registered with FINRA since the
implementation of the Legacy CRD system (the predecessor to Web CRD)
in 1981, certain data limitations apply to the information available
for some individuals who were no longer registered at the time Web
CRD was established. Therefore, the proposal will not apply to those
individuals whose FINRA registration terminated prior to August 16,
1999.
    \10\ This information is currently elicited by Questions
14A(1)(a) and 14B(1)(a) on Form U4 and Questions 7C(1) and 7C(3) on
Form U5.
    \11\ This information is currently elicited by Questions
14H(1)(a) and 14H(1)(b) on Form U4.
    \12\ This information is currently elicited by Question
14I(1)(b) on Form U4 and Question 7E(1)(b) on Form U5.
    \13\ Under the proposed rule change, FINRA will provide
information regarding any of the enumerated disclosure events that
is reported on Form U6 even if the event has not been reported by an
individual on Form U4 or Form U5, as referenced above, because, for
example, the individual was not registered at the time the event was
reported.
    \14\ The proposed information to be disclosed permanently (i.e.,
administrative information, examination information and the most
recently submitted comment) mirrors the information currently
disclosed permanently with respect to any formerly registered person
who is the subject of a final regulatory action.
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    FINRA believes that this proposal will allow the public access to
relevant and important information about formerly registered persons
who, although no longer in the securities industry in a registered
capacity, may work in other investment-related industries or may seek
to attain other positions of trust with potential investors and about
whom investors may wish to learn relevant information. FINRA believes
that this information should be included on a permanent basis, rather
than for only ten years following the termination of an individual's
FINRA registration,

because, like final regulatory actions (which are included permanently
in BrokerCheck), each of the disclosure events that is proposed to be
permanently included in BrokerCheck constitutes a final disposition. In
addition, in most circumstances, these disclosure events allow the
subject person an opportunity to present arguments to an impartial
fact-finder about the allegations prior to such final disposition.
Furthermore, much of the information that would be subject to release
pursuant to the proposal may be available through other public sources.
For example, information regarding arbitration awards is available on
FINRA's Arbitration Awards Online database,\15\ and information
regarding civil and criminal proceedings is provided to the public via
numerous state Web sites.
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    \15\ See http://finraawardsonline.finra.org/.
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Disclosure of Historic Complaints

    Pursuant to FINRA Rule 8312, Historic Complaints are customer
complaints that were reported on a uniform registration form that are
more than two years old and that have not been settled or adjudicated
and customer complaints, arbitrations, or litigations that have been
settled for an amount less than the specified dollar amount (identified
on the customer complaint question) and are therefore no longer
reportable on a uniform registration form. Currently, FINRA Rule 8312
provides that Historic Complaints be displayed in BrokerCheck only
after the following conditions have been met: (1) A matter became a
Historic Complaint on or after March 19, 2007; (2) the most recent
Historic Complaint or currently reported customer complaint,
arbitration or litigation is less than ten years old; and (3) the
person has a total of three or more currently disclosable regulatory
actions, currently reported customer complaints, arbitrations or
litigations, or Historic Complaints (subject to the limitation that
they became Historic Complaints on or after March 19, 2007), or any
combination thereof. Unless all three conditions are met, a person's
Historic Complaints are not disclosed through BrokerCheck.\16\
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    \16\ In addition, even if a person meets the criteria
established for disclosing Historic Complaints, only those Historic
Complaints that became Historic Complaints after March 19, 2007,
will be displayed through BrokerCheck.
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    FINRA established the ``three or more'' standard for the release of
Historic Complaints so as to allow public investors ``to determine for
themselves whether a particular associated person has demonstrated a
pattern of conduct over the years and the significance, if any, they
should attach to the Historic Complaint information.'' \17\ Following
its recent evaluation of the BrokerCheck program, however, FINRA no
longer believes that such a standard is prudent. In this regard, FINRA
is concerned that the standard may discourage public investors from
making a qualitative assessment of a current or former associated
person based on all of the potentially relevant information available
regarding that individual. FINRA believes that, rather than allowing
public investors to determine for themselves whether an individual has
demonstrated a pattern of conduct, the standard may actually suggest to
investors that any individual who meets the standard has in fact
demonstrated a pattern of (mis)conduct (i.e., three events constitutes
a pattern of conduct, otherwise the rule would not have established
such a threshold). FINRA is also concerned that the standard, along
with the current date limitation for Historic Complaints that are
eligible for display, may limit the ability of public investors to
place Historic Complaints in the appropriate context or to otherwise
accurately evaluate a current or former associated person's entire
record.
---------------------------------------------------------------------------

    \17\ See Securities Exchange Act Release No. 51915 (June 23,
2005), 70 FR 37880, 37884 (June 30, 2005) (Notice of Filing File No.
SR-NASD-2003-168).
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    Therefore, FINRA is proposing to amend FINRA Rule 8312 to eliminate
the conditions set forth in the rule that must be met before Historic
Complaints will be displayed in BrokerCheck. Eliminating these
conditions will result in the disclosure of all Historic Complaints via
BrokerCheck that became non-reportable after the implementation of Web
CRD on August 16, 1999.\18\
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    \18\ FINRA is proposing to limit the Historic Complaints
eligible for display in BrokerCheck to those that became non-
reportable after the implementation of Web CRD in 1999, because the
Web CRD system (unlike Legacy CRD) contains the specific reason that
a matter was archived. Therefore, FINRA will be able to determine
whether a matter was archived because it was no longer reportable on
a uniform registration form (and therefore qualifies as a Historic
Complaint) or whether it was archived for a different reason (e.g.,
the matter was filed in error).
---------------------------------------------------------------------------

    This proposed change will allow investors and other users of
BrokerCheck to determine for themselves the significance, if any, they
should attach to the Historic Complaints on an individual's record
based on all available customer complaint information and to put such
complaints in the appropriate context based on the entire BrokerCheck
record for the individual.\19\ Additionally, FINRA believes that the
proposed change will allow investors seeking to do business with
investment professionals--whether associated persons of securities
firms or advisers--to have similar information available to them.\20\
---------------------------------------------------------------------------

    \19\ In conjunction with the implementation of the proposed rule
change, FINRA will revise the educational component of BrokerCheck
with respect to Historic Complaints to help readers view these
disclosures in the appropriate context and give them the appropriate
weight when evaluating an associated person.
    \20\ The Investment Adviser Public Disclosure-Individual
(``IAPD-I'') database (currently scheduled to be deployed in June
2010) will provide to the public registration and licensing
information on natural persons who are registered as investment
advisers with the states. IAPD-I will disclose all Historic
Complaints that became non-reportable after the individual first
became registered through the Investment Adviser Registration
Depository (``IARD'') system. Accordingly, IAPD-I will include
Historic Complaints that became Historic Complaints on or after
March 18, 2002, which is the date IARD was established for
investment adviser representative registration. As a result, when
IAPD-I is deployed, BrokerCheck and IAPD-I may disclose slightly
different information regarding Historic Complaints of those
financial services professionals that are dually registered as
brokers and investment advisers.
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II. BrokerCheck Dispute Process
    The proposed changes described above will result in BrokerCheck
disclosing additional information about current and former associated
persons. This underscores the need for a formalized process for
disputing the accuracy of (or updating) information displayed through
BrokerCheck. FINRA recognizes, for example, that there may be an
increased possibility that information disclosed through BrokerCheck
for former associated persons may have become inaccurate (i.e., a
disposition reported previously may have changed). Additionally,
Congress amended Section 15A(i) of the Exchange Act with the enactment
of the Military Personnel Financial Services Protection Act to require
FINRA, as a registered securities association, to adopt rules
establishing an administrative process for disputing the accuracy of
information provided through BrokerCheck in response to inquiries
regarding ``registration information'' \21\ on its members and their
associated persons. Therefore, FINRA is proposing to codify its current
process for disputing the accuracy of (or

updating) information disclosed through BrokerCheck.\22\
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    \21\ For purposes of Section 15A(i), ``registration
information'' is defined to mean ``the information reported in
connection with the registration or licensing of brokers and dealers
and their associated persons, including disciplinary actions,
regulatory, judicial, and arbitration proceedings, and other
information required by law, or exchange or association rule, and
the source and status of such information.''
    \22\ While the dispute process will be available to currently,
as well as formerly, registered individuals, FINRA anticipates that
most disputes will be brought by the latter because a mechanism
already exists for currently registered individuals to update
information (i.e., through the filing of an amended Form U4).
---------------------------------------------------------------------------

    Under FINRA's current dispute process, FINRA staff occasionally
receives telephonic and written inquiries from persons subject to
BrokerCheck who believe that information disclosed about them through
BrokerCheck is inaccurate. Upon the receipt of such an inquiry, FINRA
staff typically reviews the alleged inaccuracy and, if appropriate,
contacts the entity that reported the information to determine whether
the information is accurate. Once it has obtained all of the available
pertinent information, FINRA staff determines whether the information
is still accurate or whether the information should be modified or
removed from BrokerCheck. FINRA is proposing to enhance and codify this
process, which will allow individuals and firms to dispute the accuracy
of information being displayed through BrokerCheck. The dispute process
will be available both for challenges alleging the information was
incorrect when filed and challenges asserting that the information has
become incorrect due to events subsequent to filing.
    FINRA is proposing to establish a dispute process under which only
an ``eligible party'' would be able to dispute the accuracy of
information disclosed in that party's BrokerCheck report. An eligible
party would consist of any current member, any former member (subject
to a condition discussed below), and any associated person of a member
or person formerly associated with a member for whom a BrokerCheck
report is available. Regarding former members, the proposal would
require that a dispute be submitted by a natural person who served as
the former member's Chief Executive Officer, Chief Financial Officer,
Chief Operating Officer, Chief Legal Officer or Chief Compliance
Officer, or individual with similar status or function, as identified
on Schedule A of Form BD at the time the former member ceased being
registered with FINRA. This requirement on the submission of disputes
by former member firms is intended to ensure that only authorized
representatives of former firms are able to submit disputes.
    To dispute the accuracy of BrokerCheck information, an eligible
party would be required to submit a written notice to FINRA, in such
manner and format that FINRA may require, identifying the information
that the party alleges is inaccurate and providing an explanation as to
the reason the information is believed to be inaccurate. Additionally,
the eligible party would be required to submit with the written notice
all available supporting documentation (if any exists).
    After receiving the written notice, FINRA would determine whether
the dispute is eligible for investigation. To be eligible for
investigation, the dispute would need to pertain only to factual
information and not to information that is subjective in nature or a
matter of interpretation. For example, a dispute involving allegations
made in a customer complaint or a firm's determination that a customer
complaint is required to be reported would not be eligible for
investigation.
    FINRA would presume that a dispute involving factual information is
eligible for investigation. Nevertheless, the proposed rule change
would specifically identify in Supplementary Material to FINRA Rule
8312 the following non-exhaustive list of situations as ineligible for
investigation, even if they may involve factual information:
    (a) A dispute that involves information that was previously
disputed under this process and that does not contain any new or
additional evidence;
    (b) a dispute that is brought by an individual or entity that is
not an eligible party;
    (c) a dispute that does not challenge the accuracy of information
contained in a BrokerCheck report but only provides an explanation of
such information;
    (d) a dispute that constitutes a collateral attack on or otherwise
challenges the allegations underlying a previously reported matter such
as a regulatory action, customer complaint, arbitration, civil
litigation or termination;
    (e) a dispute that consists of a general statement contesting
information in a BrokerCheck report with no accompanying explanation;
and
    (f) a dispute that involves information contained in CRD that is
not disclosed through BrokerCheck.
    If FINRA determines that a dispute is eligible for investigation,
FINRA would add a general notation to the eligible party's BrokerCheck
report stating that the eligible party has disputed certain information
included in the report.\23\ The notation would be removed from the
eligible party's BrokerCheck report upon resolution of the dispute by
FINRA. If FINRA determines that a request is not eligible for
investigation, it would notify the eligible party of this determination
in writing, including a brief description of the reason for the
determination. A determination by FINRA that a dispute is not eligible
for investigation would not be subject to appeal.
---------------------------------------------------------------------------

    \23\ In those circumstances where a dispute involves a court
order to expunge information from BrokerCheck, FINRA would, as it
does today, prevent the disputed information from being displayed
via BrokerCheck while FINRA evaluates the matter.
---------------------------------------------------------------------------

    If a dispute is deemed eligible for investigation, FINRA would
evaluate the written notice and supporting documentation submitted by
the eligible party. If FINRA determines that the written notice and
documentation submitted is sufficient to update, modify or remove the
information that is the subject of the request, FINRA would make the
appropriate change. For example, if an eligible party disputed a
criminal conviction being displayed through BrokerCheck and submitted a
valid court order expunging the matter, FINRA would remove any
information referencing the criminal conviction from BrokerCheck. If,
however, the written notice and supporting documentation do not include
sufficient information upon which FINRA can make a determination, FINRA
would, under most circumstances, contact the entity that reported the
information to CRD (i.e., a firm, other regulator, or FINRA department,
defined in the proposed rule change as a ``reporting entity'') and
request that this reporting entity verify that the information is
accurate.\24\ Where a reporting entity other than FINRA is involved,
FINRA would defer to that reporting entity regarding the accuracy of
the information provided to FINRA and disclosed through
BrokerCheck.\25\ If the reporting entity acknowledges that the
information is not accurate, FINRA would update, modify or remove the
information, as appropriate, based on the information

provided by the reporting entity. If the reporting entity verifies the
accuracy of the information or the reporting entity no longer exists or
is unable to verify the accuracy of the information, FINRA would not
change the information.\26\
---------------------------------------------------------------------------

    \24\ FINRA would not contact the reporting entity if the entity
is unlikely to have information regarding the disputed information.
For example, if the previously mentioned eligible party disputing a
criminal conviction failed to provide a valid court order, FINRA
would not contact the securities firm that reported the conviction
since the firm is unlikely to have the court order in its
possession.
    \25\ If the reporting entity obtained its information from a
third party (e.g., a firm reported to CRD that an associated
individual had declared bankruptcy based on information from a
consumer reporting agency), FINRA would not contact the third party
(in this example, the consumer reporting agency) to try to verify
the accuracy of the information. The reporting entity would have the
responsibility of verifying the accuracy of the information it
received from the third party.
    \26\ The principle guiding FINRA's proposed approach is that
because information in BrokerCheck is derived from the information
filed on the uniform registration forms, it is presumed accurate as
filed. FINRA expects that the dispute process will be used
principally to address genuine filing errors, which FINRA expects to
be rare, or those instances where an event displayed through
BrokerCheck has a changed disposition subsequent to it being filed
on a uniform registration form.
---------------------------------------------------------------------------

    Upon making its determination, FINRA would notify the disputing
eligible party in writing that the investigation resulted in a
determination that (1) the information is inaccurate or not accurately
presented and has been updated, modified or deleted; (2) the
information is accurate in content and presentation and no changes have
been made; or (3) the accuracy of the information or its presentation
could not be verified and no changes have been made. A determination by
FINRA regarding a dispute, including a determination to leave unchanged
or to update, modify or delete disputed information, would not be
subject to appeal.\27\
---------------------------------------------------------------------------

    \27\ Although FINRA determinations under the proposed dispute
process would not be subject to appeal, individuals and firms would
continue to have the ability to challenge BrokerCheck information
they believe to be inaccurate through other processes that are
available today (e.g., an arbitration or court proceeding).
---------------------------------------------------------------------------

    As noted above, FINRA will announce the effective date of the
proposed rule change in a Regulatory Notice to be published no later
than 60 days following Commission approval. FINRA will implement the
proposal in phases, with full implementation occurring no later than
180 days following Commission approval.
2. Statutory Basis
    FINRA believes that the proposed rule change is consistent with the
provisions of Section 15A(b)(6) of the Act,\28\ which requires, among
other things, that FINRA rules must be designed to prevent fraudulent
and manipulative acts and practices, to promote just and equitable
principles of trade, and, in general, to protect investors and the
public interest. The proposed rule change, among other things, would
enhance investor protection by expanding the information disclosed to
investors and other users of BrokerCheck.
---------------------------------------------------------------------------

    \28\ 15 U.S.C. 78o-3(b)(6).
---------------------------------------------------------------------------

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

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

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

    Written comments were neither solicited nor received.

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

    Within 35 days of the date of publication of this notice in the
Federal Register or within such longer period (i) as the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding or (ii) as to
which the self-regulatory organization consents, the Commission will:
    (A) By order approve such proposed rule change, or
    (B) institute proceedings to determine whether the proposed rule
change should be 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 e-mail to<EMAIL_ADDRESS>Please include
File Number SR-FINRA-2010-012 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-FINRA-2010-012. This
file number should be included on the subject line if e-mail is used.
To help the Commission process and review your comments more
efficiently, please use only one method. The Commission will post all
comments on the Commission's Internet Web site (http://www.sec.gov/
rules/sro.shtml). Copies of the submission,\29\ all subsequent
amendments, all written statements with respect to the proposed rule
change that are filed with the Commission, and all written
communications relating to the proposed rule change between the
Commission and any person, other than those that may be withheld from
the public in accordance with the provisions of 5 U.S.C. 552, will be
available for Web site viewing and printing in the Commission's Public
Reference Room, 100 F Street, NE., Washington, DC 20549, on official
business days between the hours of 10 a.m. and 3 p.m. Copies of the
filing also will be available for inspection and copying at the
principal office of FINRA. 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-FINRA-2010-012 and should be submitted on or before May 13, 2010.
---------------------------------------------------------------------------

    \29\ The text of the proposed rule change is available on the
Commission's Web site at http://www.sec.gov/rules/sro.shtml.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\30\
---------------------------------------------------------------------------

    \30\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Deputy Secretary.
[FR Doc. 2010-9282 Filed 4-21-10; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 77, Number 221 (Thursday, November 15, 2012)]
[Notices]
[Page 68116]
[FR Doc No: 2012-27731]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 6952-008]

Water Wheel Ranch; Notice of Application Accepted for Filing and
Soliciting Comments, Motions To Intervene, Protests, Recommendations,
and Terms and Conditions

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection.
    a. Type of Application: Amendment of Exemption.
    b. Project No.: 6952-008.
    c. Date filed: December 12, 2011, and supplemented on October 8,
2012.
    d. Applicant: Water Wheel Ranch.
    e. Name of Project: Water Wheel Ranch Hydroelectric Project.
    f. Location: The Water Wheel Ranch Hydroelectric Project would be
located on the North Fork Little Cow Creek in Shasta County,
California. The land on which all the project structures are located is
owned by the applicant.
    g. Filed Pursuant to: Federal Power Act 16 U.S.C. 791a--825r.
    h. Applicant Contact: Mr. Finley McMillan, P.O. Box 130, Round
Mountain, CA 96084. Phone<PHONE_NUMBER>.
    i. FERC Contact: Robert Bell,<PHONE_NUMBER><EMAIL_ADDRESS>    j. Status of Environmental Analysis: This application is ready for
environmental analysis at this time, and the Commission is requesting
comments, reply comments, recommendations, terms and conditions, and
prescriptions.
    k. Deadline for filing responsive documents: All comments, motions
to intervene, protests, recommendations, terms and conditions, and
prescriptions due within 30 days from the issuance date of this notice.
All reply comments filed in response to comments submitted by any
resource agency, Indian tribe, or person, must be filed with the
Commission within 15 days from the issuance date of this notice.
    Comments, protests, and interventions may be filed electronically
via the Internet in lieu of paper; see 18 CFR 385.2001(a)(1)(iii) and
the instructions on the Commission's web site at http://www.ferc.gov/docs-filing/efiling.asp. The Commission strongly encourages electronic
filings.
    The Commission's Rules of Practice and Procedure require all
intervenors filing documents with the Commission to serve a copy of
that document on each person in the official service list for the
project. Further, if an intervenor files comments or documents with the
Commission relating to the merits of an issue that may affect the
responsibilities of a particular resource agency, they must also serve
a copy of the document on that resource agency.
    l. Description of the project: The amended Water Wheel Ranch
Hydroelectric Project would consist of: (1) Relocating powerhouse No.
2, which was destroyed by a forest fire, 850 feet closer to the dam, up
the existing penstock, (2) installing a new 100-foot-long tailrace
which would discharge into Cedar Creek, 1,400 feet upstream of the
current discharge location and (3) appurtenant facilities. The
applicant states there would be no change in project capacity.
    m. This filing is available for review and reproduction at the
Commission in the Public Reference Room, Room 2A, 888 First Street NE.,
Washington, DC 20426. The filing may also be viewed on the web at
http://www.ferc.gov/docs-filing/elibrary.asp using the ``eLibrary''
link. Enter the docket number, P-6952, in the docket number field to
access the document. For assistance, call toll-free 1-866-208-3676 or
email<EMAIL_ADDRESS>For TTY, call<PHONE_NUMBER>. A copy
is also available for review and reproduction at the address in item h
above.
    n. Protests or Motions to Intervene--Anyone may submit a protest or
a motion to intervene in accordance with the requirements of Rules of
Practice and Procedure, 18 CFR 385.210, 385.211, and 385.214. In
determining the appropriate action to take, the Commission will
consider all protests filed, but only those who file a motion to
intervene in accordance with the Commission's Rules may become a party
to the proceeding. Any protests or motions to intervene must be
received on or before the specified deadline date for the particular
application.
    q. All filings must (1) bear in all capital letters the title
``PROTEST'', ``MOTION TO INTERVENE'', ``COMMENTS'', ``REPLY COMMENTS,''
``RECOMMENDATIONS,'' ``TERMS AND CONDITIONS,'' or ``PRESCRIPTIONS;''
(2) set forth in the heading, the name of the applicant and the project
number of the application to which the filing responds; (3) furnish the
name, address, and telephone number of the person protesting or
intervening; and (4) otherwise comply with the requirements of 18 CFR
385.2001 through 385.2005. All comments, recommendations, terms and
conditions or prescriptions must set forth their evidentiary basis and
otherwise comply with the requirements of 18 CFR 4.34(b). Agencies may
obtain copies of the application directly from the applicant. Any of
these documents must be filed by providing the original and seven
copies to: The Secretary, Federal Energy Regulatory Commission, 888
First Street NE., Washington, DC 20426. An additional copy must be sent
to Director, Division of Hydropower Administration and Compliance,
Office of Energy Projects, Federal Energy Regulatory Commission, at the
above address. A copy of any protest or motion to intervene must be
served upon each representative of the applicant specified in the
particular application. A copy of all other filings in reference to
this application must be accompanied by proof of service on all persons
listed in the service list prepared by the Commission in this
proceeding, in accordance with 18 CFR 4.34(b) and 385.2010.

    Dated: November 8, 2012.
Kimberly D. Bose,
Secretary.
[FR Doc. 2012-27731 Filed 11-14-12; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: January 16, 2009 (Volume 74, Number 11)]
[Notices]
[Page 3059-3060]
[DOCID:fr16ja09-105]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0371 (formerly Docket No. 2007D-0125)]

Guidance for Industry: Evidence-Based Review System for the
Scientific Evaluation of Health Claims

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance document entitled ``Guidance for Industry:
Evidence-Based Review System for the Scientific Evaluation of Health
Claims.'' This guidance outlines the agency's approach to the review of
the scientific evidence for health claims that meet the significant
scientific agreement standard (SSA) and qualified health claims.
Elsewhere in this issue of the Federal Register, FDA is announcing the
withdrawal of the guidance documents entitled ``Guidance for Industry
and FDA: Interim Evidence-Based Ranking System for Scientific Data''
and ``Guidance for Industry: Significant Scientific Agreement in the
Review of Health Claims for Conventional Foods and Dietary
Supplements.''

DATES: Submit written or electronic comments on agency guidances at any
time.

ADDRESSES: Submit written requests for single copies of the guidance to
the Office of Nutrition, Labeling, and Dietary Supplements, Center for
Food Safety and Applied Nutrition, (HFS-830), Food and Drug
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740. Send
two self-addressed adhesive labels to assist that office in processing
your requests.
    Submit written comments on the guidance to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Submit electronic comments on the
guidance to http://www.regulations.gov. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance.

FOR FURTHER INFORMATION CONTACT:  Paula R. Trumbo, Center for Food
Safety and Applied Nutrition (HFS-830), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of July 9, 2007 (72 FR 37246), FDA
announced the availability of a draft guidance entitled ``Guidance for
Industry: Evidence-Based Review System for the Scientific Evaluation of
Health Claims.'' The agency considered received comments as it
finalized this guidance. The primary purpose of this guidance is to
provide a description of the scientific evaluation process that FDA
uses in determining the strength of the relationship of a substance to
decreasing the risk of a disease or health-related condition.
    FDA is issuing this guidance document as a level 1 guidance
consistent with FDA's good guidance practices regulation (21 CFR
10.115). This guidance represents the agency's current thinking on the
evaluation of scientific evidence for health claims. It does not create
or confer any rights for or on any person and does not operate to bind
FDA or the public. An alternate approach may be used if such approach
satisfies the requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and

Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collections of information in 21 CFR 101.14 and 101.70 have
been approved under OMB control no. 0910-0381.

III. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.

IV. Electronic Access

    Persons with access to the Internet may obtain the guidance at
http://www.cfsan.fda.gov/guidance.html.

V. References

    The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
(FDA has verified the Web site address, but FDA is not responsible for
any subsequent changes to this Web site after this document publishes
in the Federal Register.)

    1. American Cancer Society, Cancer Facts and Figures, 2004.
    2. The Alpha-Tocopherol, Beta Carotene Cancer Prevention Study
Group, ``The Effect of Vitamin E and Beta Carotene on the Incidence
of Lung Cancer and Other Cancers in Male Smokers, New England
Journal of Medicine, 330:1029-1035, 1994.
    3. Barton S., ``Which Clinical Studies Provide the Best
Evidence? The Best RCT Still Trumps the Best Observational Study,''
British Medical Journal, 321:255-256, 2000.
    4. Cade, J., R. Thompson, V. Burley, et al., ``Development,
Validation and Utilization of Food-Frequency Questionnaires--A
Review, Public Health Nutrition, 5:567-587, 2002.
    5. Federal Judicial Center, Reference Manual on Scientific
Evidence, 2d ed., 2000.
    6. Flegal K.M., ``Evaluating Epidemiological Evidence of the
Effects of Food and Nutrient Exposures,'' American Journal of
Clinical Nutrition, 69:1339S-1344S, 1999.
    7. Greer N., G. Mosser, G. Logan, et al., ``A Practical Approach
to Evidence Grading,'' Joint Commission Journal on Quality
Improvements, 26:700-712, 2000.
    8. Hill A.B., ``The Environment and Disease: Association or
Causation?,'' Proceedings of the Royal Society of Medicine, 58:295-
300, 1965.
    9. Hord N.G. and J.I. Fenton, ``Context is Everything: Mining
the Normal and Preneoplastic Microenvironment for Insights Into the
Diet and Cancer Risk Conundrum,'' Molecular Nutrition and Food
Research, 51:100-106, 2007.
    10. IOM, Institute of Medicine, ``Dietary Supplements: A
Framework for Evaluating Safety,'' National Academies Press,
Washington, DC, 2005.
    11. Kraemer H.C., K.K. Lowe, D.J. Kupfer, To Your Health: How to
Understand What Research Tell Us About Risk, Oxford University
Press, 2005.
    12. Kris-Etherton, P.M. and J. Dietschy, ``Design Criteria for
Studies Examining Individual Fatty Acid Effects on Cardiovascular
Disease Risk Factors: Human and Animal Studies,'' American Journal
of Clinical Nutrition, 1590S-1596S, 1997.
    13. Lichtenstein, A.H. and R.M. Russell, ``Essential Nutrients:
Food or Supplements?'' Journal of American Medical Association,
294:351-358, 2005.
    14. Milner J.A., ``Diet and Cancer: Facts and Controversies,''
Nutrition and Cancer, 56: 216-224, 2006.
    15. National Cancer Institute, Dictionary of Cancer Terms,
http://www.cancer.gov/dictionary.
    16. National Research Council, ``Diet and Health: Implications
for Reducing Chronic Disease Risk,'' National Academy Press,
Washington, DC, 1989.
    17. Omenn, G.S., G.E. Goodman, M.D. Thornquist, et al.,
``Effects of a Combination of Beta Carotene and Vitamin A on Lung
Cancer and Cardiovascular Disease,'' New England Journal of
Medicine, 334:1150-1155, 1996.
    18. Peto, R., R. Doll, J.D. Buckley, et al., ``Can Dietary Beta-
Carotene Materially Reduce Human Cancer Rates?,'' Nature, 290:201-
208, 1981.
    19. Sempos C.T., K. Liu, N.D. Earnst, ``Food and Nutrient
Exposures: What to Consider When Evaluating Epidemiologic Data,''
American Journal of Clinical Nutrition, 69:1330S-1338S, 1999.
    20. Torun B., ``Protein-Energy Malnutrition,'' In: Modern
Nutrition in Health and Disease, Williams and Williams, New York,
2006.
    21. Spilker, B., Guide to Clinical Studies, Raven Press, New
York, 1991.
    22. Subar, A., et al., ``Comparative Validation of the Block,
Willett, and National Cancer Institute Food Frequency
Questionnaires,'' American Journal of Epidemiology, 154:1089-1099,
2001.
    23. Szklo M. and F.J. Nieto, Epidemiology Beyond the Basics,
Aspen Publishing, 2000.
    24. Willett, W.C., ``Overview of Nutritional Epidemiology,''
Nutritional Epidemiology, Oxford University Press, Oxford, 1990.
    25. Willett, W.C., ``Issues in Analysis and Presentation of
Dietary Data,'' In Nutritional Epidemiology, 2d ed., Oxford
University Press, Oxford, 1998.
    26. Wilson, E.B., ``An Introduction to Scientific Research,''
General Publishing Co., Toronto, 1990.

    Dated: January 13, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-957 Filed 1-15-09; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 75, Number 67 (Thursday, April 8, 2010)]
[Rules and Regulations]
[Pages 17851-17852]
[FR Doc No: 2010-7805]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2009-0926; Airspace Docket No. 09-ASW-26]

Amendment of Class E Airspace; Dallas-Fort Worth, TX

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: This action amends Class E airspace in the Dallas-Fort Worth,
TX area. Additional controlled airspace is necessary to accommodate new
Area Navigation (RNAV) Standard Instrument Approach Procedures (SIAP)
at Bridgeport Municipal Airport, Bridgeport, TX. The FAA is taking this
action to enhance the safety and management of Instrument Flight Rule
(IFR) operations at Bridgeport Municipal Airport.

DATES: Effective 0901 UTC, July 29, 2010. The Director of the Federal
Register approves this incorporation by reference action under 1 CFR
Part 51, subject to the annual revision of FAA Order 7400.9 and
publication of conforming amendments.

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

SUPPLEMENTARY INFORMATION:

History

    On November 9, 2009, the FAA published in the Federal Register a
notice of proposed rulemaking to amend Class E airspace for the Dallas-
Fort Worth, TX area (74 FR 57617) Docket No. FAA-2009-0926. Interested
parties were invited to participate in this rulemaking effort by
submitting written comments on the proposal to the FAA. No comments
were received. Class E airspace designations are published in paragraph
6005 of FAA Order 7400.9T signed August 27, 2009, and effective
September 15, 2009, which is incorporated by reference in 14 CFR 71.1.
The Class E airspace designations listed in this document will be
published subsequently in the Order.

The Rule

    This action amends Title 14 Code of Federal Regulations (14 CFR)
part 71 by amending Class E airspace for the Dallas-Fort Worth, TX
area, adding additional controlled airspace extending upward from 700
feet above the surface to accommodate SIAPs at Bridgeport Municipal
Airport, Bridgeport, TX. Adjustments to the geographic coordinates will
be made in accordance with the FAA's National Aeronautical Charting
Office, as well as a name change for McKinney Municipal Airport to
Collin County Regional Airport, McKinney, TX. This action is necessary
for the safety and management of IFR operations. With the exception of
editorial changes and the changes described above, this rule is the
same as that proposed in the NPRM.
    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
Therefore, this regulation: (1) Is not a ``significant regulatory
action'' under Executive Order 12866; (2) is not a ``significant rule''
under DOT Regulatory Policies and Procedures (44 FR 11034; February 26,
1979); and (3) does not warrant preparation of a regulatory evaluation
as the anticipated impact is so minimal. Since this is a routine matter
that will only affect air traffic procedures and air navigation, it is
certified that this rule, when promulgated, will not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the U.S. Code. Subtitle 1, section 106, describes
the authority of the FAA Administrator. Subtitle VII, Aviation
Programs, describes in more detail the scope of the agency's authority.
This rulemaking is promulgated under the authority described in
subtitle VII, part A, subpart I, section 40103. Under that section, the
FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it amends controlled airspace in the Dallas-Fort Worth, TX area.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

0
In consideration of the foregoing, the Federal Aviation Administration
amends 14 CFR part 71 as follows:

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

0
1. The authority citation for 14 CFR part 71 continues to read as
follows:

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

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of the Federal
Aviation Administration Order 7400.9T, Airspace Designations and
Reporting Points, signed August 27, 2009, and effective September 15,
2009, is amended as follows:
* * * * *

Paragraph 6005 Class E airspace areas extending upward from 700
feet or more above the surface.

* * * * *

ASW TX E5 Dallas-Fort Worth, TX [Amended]

Dallas-Fort Worth International Airport, TX
    (Lat. 32[deg]53[min]49[sec] N., long. 97[deg]02[min]17[sec] W.)
McKinney, Collin County Regional Airport, TX
    (Lat. 33[deg]10[min]41[sec] N., long. 96[deg]35[min]26[sec] W.)
Rockwall, Rockwall Municipal Airport, TX
    (Lat. 32[deg]55[min]50[sec] N., long. 96[deg]26[min]08[sec] W.)
Mesquite, Mesquite Metro Airport, TX
    (Lat. 32[deg]44[min]49[sec] N., long. 96[deg]31[min]50[sec] W.)
Mesquite NDB
    (Lat. 32[deg]48[min]34[sec] N., long. 96[deg]31[min]45[sec] W.)
Mesquite Metro ILS Localizer
    (Lat. 32[deg]44[min]03[sec] N., long. 96[deg]31[min]50[sec] W.)
Lancaster, Lancaster Airport, TX
    (Lat. 32[deg]34[min]45[sec] N., long. 96[deg]43[min]09[sec] W.)
Lancaster NDB
    (Lat. 32[deg]34[min]40[sec] N., long. 96[deg]43[min]18[sec] W.)
Point of Origin
    (Lat. 32[deg]51[min]57[sec] N., long. 97[deg]01[min]41[sec] W.)
Fort Worth, Fort Worth Spinks Airport, TX
    (Lat. 32[deg]33[min]55[sec] N., long. 97[deg]18[min]29[sec] W.)
Cleburne, Cleburne Municipal Airport, TX
    (Lat. 32[deg]21[min]14[sec] N., long. 97[deg]26[min]02[sec] W.)
Fort Worth, Bourland Field Airport, TX
    (Lat. 32[deg]34[min]54[sec] N., long. 97[deg]35[min]27[sec] W.)
Granbury, Granbury Regional Airport, TX
    (Lat. 32[deg]26[min]40[sec] N., long. 97[deg]49[min]01[sec] W.)
Weatherford, Parker County Airport, TX
    (Lat. 32[deg]44[min]47[sec] N., long. 97[deg]40[min]57[sec] W.)
Bridgeport, Bridgeport Municipal Airport, TX
    (Lat. 33[deg]10[min]31[sec] N., long. 97[deg]49[min]42[sec] W.)
Decatur, Decatur Municipal Airport, TX
    (Lat. 33[deg]15[min]15[sec] N., long. 97[deg]34[min]50[sec] W.)

    That airspace extending upward from 700 feet above the surface
within a 30-mile radius of Dallas-Fort Worth International Airport,
and within a 6.6-mile radius of Collin County Regional Airport at
McKinney, and within 1.8 miles each side of the 002[deg] bearing
from the Collin County Regional Airport at McKinney extending from
the 6.6-mile radius to 9.2 miles north of the airport, and within a
6.3-mile radius of Rockwall Municipal Airport, and within 1.6 miles
each side of the 010[deg] bearing from the Rockwall Municipal
Airport extending from the 6.3-mile radius to 10.8 miles north of
the airport, and within a 6.5-mile radius of Mesquite Metro Airport,
and within 8 miles east and 4 miles west of the 001[deg] bearing
from the Mesquite NDB extending from the 6.5-mile radius to 19.7
miles north of the airport, and within 1.7 miles each side of the
Mesquite Metro ILS Localizer south course extending from the 6.5-
mile radius to 11.1 miles south of the airport, and within a 6.5-
mile radius of the Lancaster Airport, and within 8 miles west and 4
miles east of the 129[deg] bearing from the Lancaster NDB extending
from the 6.5-mile radius to 16 miles southeast of the NDB, and
within 8 miles northeast and 4 miles southwest of the 144[deg]
bearing from the Point of Origin extending from the 30-mile radius
of Dallas-Fort Worth International Airport to 35 miles southeast of
the Point of Origin, and within a 6.5-mile radius of Fort Worth
Spinks Airport, and within 8 miles east and 4 miles west of the
178[deg] bearing from Fort Worth Spinks Airport extending from the
6.5-mile radius to 21 miles south of the airport, and within a 6.9-
mile radius of Cleburne Municipal Airport, and within 3.6 miles each
side of the 292[deg] bearing from the airport extending from the
6.9-mile radius to 12.2 miles northwest of Cleburne Municipal
Airport, and within a 6.5-mile radius of Fort Worth's Bourland Field
Airport, and within a 6.3-mile radius of Granbury Regional Airport,
and within a 6.3-mile radius of Weatherford's Parker County Airport,
and within 8 miles east and 4 miles west of the 177[deg] bearing
from Parker County Airport extending from the 6.3-mile radius to
21.4 miles south of the airport, and within a 6.3-mile radius of
Bridgeport Municipal Airport, and within 1.6 miles each side of the
040[deg] bearing from Bridgeport Municipal Airport extending from
the 6.3-mile radius to 10.6 miles northeast of the airport, and
within 4 miles each side of the 001[deg] bearing from the Bridgeport
Municipal Airport extending from the 6.3-mile radius to 10.7 miles
north of the airport, and within a 6.3-mile radius of Decatur
Municipal Airport, and within 1.5 miles each side of the 263[deg]
bearing from Decatur Municipal Airport extending from the 6.3-mile
radius to 9.2 miles west of the airport.

    Issued in Fort Worth, Texas, on March 29, 2010.
Walter L. Tweedy,
Acting Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. 2010-7805 Filed 4-7-10; 8:45 am]
BILLING CODE 4910-13-P


<EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE
PETITIONS PUBLISHED IN THE FEDERAL REGISTER  (7/1/2007)>

<EPA Registration Division contact: [insert name and telephone number
with area code]>

<INSTRUCTIONS:  Please utilize this outline in preparing the pesticide
petition.  In cases where the outline element does not apply, please
insert “NA-Remove” and maintain the outline. Please do not change
the margins, font, or format in your pesticide petition. Simply replace
the instructions that appear in green, i.e., “[insert company
name],” with the information specific to your action.>

<TEMPLATE:>

<[Bayer CropScience]>

<[Insert petition number]>

<	EPA has received a pesticide petition ([insert petition number]) from
[Bayer CropScience], [P.O. Box 12014, 2 T.W. Alexander Drive, 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.>

<(Options (pick one)>

<	1. by establishing a tolerance for residues of>

<	>

<	[prothioconazole] in or on the raw agricultural commodity [wheat,
forage] at [8.0] parts per million (ppm).  EPA has determined that the
petition contains data or information regarding the elements set forth
in section 408 (d)(2) of  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 plants, the metabolism of prothioconazole is
adequately understood for purposes of establishing these proposed
tolerances. Prothioconazole was extensively metabolized in plants with
the major residue found in all crops (wheat, peanuts and sugar beets)
being JAU6476-desthio with smaller amounts of various isomers of
JAU6476-hydroxy-desthio, and their conjugates also being found.
Triazolylalanine, triazolylhydroxypropionic acid, and triazolylacetic
acid, metabolites common to the triazole-derivative class of fungicides,
were also found. Based on the above data the residues of concern in
plants are prothioconazole and its metabolite JAU6476-desthio. The  risk
assessment for the common metabolites arising from the
triazole-derivative fungicides is being addressed by the US Triazole
Task Force.  In large animals, the nature of residues is also adequately
understood for purposes of establishing the proposed tolerances. The
residues of concern in edible tissues and milk are prothioconazole, its
metabolites JAU6476-desthio, JAU6476-4-hydroxy, and their conjugates
that can be converted to these three compounds by acid hydrolysis.]>

<	2. Analytical method. [The analytical method for determining residues
of concern in plants extracts residues of prothioconazole and
JAU6476-desthio and converts the prothioconazole  to JAU6476-desthio and
JAU6476-sulfonic acid. Following addition of internal standards the
sample extracts are analyzed by LC/MS/MS. Radiovalidation and
independent laboratory validation have shown that the method adequately
quantifies prothioconazole residues in treated commodities. The
analytical method for analysis of large animal tissues includes
extraction of the residues of concern, followed by addition of an
internal standard to the extract. The extract is then hydrolyzed to
release conjugates, partitioned and analyzed by LC/MS/MS as
prothioconazole, JAU6476-desthio and JAU6476-4-hydroxy. The method for
analysis of milk eliminated the initial extraction step in the tissue
method.]>

<	3. Magnitude of residues. [Magnitude of residue data from foliar
applications of prothioconazole on wheat are currently on file with the
EPA under MRID 46246219 from 54 field trials in the U.S. and Canada.
These data were used to establish the current tolerances for
prothioconazole on wheat forage, grain, hay, and straw at 6.0, 0.07,
4.5, and 5.0 ppm, respectively. Data submitted with this petition are
from 3 additional side-by-side trials. Residues from all trials were
within the current tolerances for all RACs except for one wheat, forage.
Although this trial gave residues in wheat forage slightly higher than
the 6.0 ppm tolerance, they were less than the 6.99 ppm highest residue
used to support the 6.0 ppm tolerance.]>

<B. Toxicological Profile>

<	1. Acute toxicity.  [Prothioconazole exhibits very low acute oral,
dermal and inhalation toxicity. The acute oral LD50 for prothioconazole
in rats was >6200 mg/kg/day while the dermal LD50 was >2000 mg/kg/day
and the four-hour rat inhalation LC50 >4990 mg/m3. Prothioconazole was
not irritating to the eye or skin of rabbits and did not cause skin
sensitization in guinea pigs.]>

<	2. Genotoxicty. [Prothioconazole is not mutagenic. Slightly positive
and equivocal responses seen in in vitro cytogenetic and UDS assays were
negative in in vivo tests.]>

<	3. Reproductive and developmental toxicity. [Prothioconazole is not
considered a  primary reproductive toxicant in a two-Generation rat
reproduction study. The NOAEL for parental toxicity is 9.7 mg/kg bw/day
and the NOAEL for reproductive and neonatal effects is 95.6 mg/kg
bw/day. In the rat oral developmental toxicity study the fetal NOAEL was
500 mg/kg bw/day and the maternal NOAEL was 80 mg/kg bw/day. A dose
level of 1000 mg/kg bw/day administered to the rat by the dermal route
does not elicit developmental toxicity. In the rabbit, prothioconazole
does not produce developmental toxicity at dose levels exceeding the
maximum tolerated dose. Thus, prothioconazole is not teratogenic in
either the rat or rabbit.]>

<	4. Subchronic toxicity. [90-day feeding studies conducted in rats,
mice, and dogs showed the liver and/or kidney to be the target organs.
In these subchronic studies NOAELs were established at 100 mg/kg/day for
the rat and 25 mg/kg/day for the mouse and dog.]>

<	5. Chronic toxicity. [Prothioconazole is not carcinogenic in either
the rat or the mouse even at dose levels in the rat exceeding the
maximum tolerated dose. The liver and kidney are target organs of
prothioconazole for non-neoplastic toxicity in the rat, mouse and dog.
The lowest NOAEL established on the basis of long-term toxicity studies
is 5 mg/kg bw/day in the rat chronic toxicity/carcinogenicity study and
the dog 52-week toxicity study.]>

<	6. Animal metabolism. [Metabolism and pharmacokinetic studies in the
rat demonstrate that prothioconazole is rapidly absorbed, metabolized
and eliminated. The primary metabolites included JAU6476-desthio, as
well as S- and O-glucuronides of prothioconazole.]>

<	7. Metabolite toxicology. [The major metabolite of prothioconazole in
the rat, plants and large animals is JAU6476-desthio. Therefore, a
comprehensive evaluation of the mammalian toxicity of JAU6476-desthio
has been performed.

The acute oral, dermal, and inhalation toxicity of JAU6476-desthio in
the rat is low (LD50 values: 2806/2506mg/kg [male/female], >5000mg/kg,
4-hour LC50: >5077mg/m3, respectively). It is non-irritating to skin and
only very slightly irritating to eyes and has no cutaneous sensitizing
potential by topical application.

The short and long-term oral toxicity of JAU6476-desthio has been
investigated by dietary administration in the rat, mouse and dog. The
common target organ in all 3 species is the liver. Secondary effects on
the thyroid in the rat and dog were associated with increased hepatic
enzyme induction. In the long term studies, 52 weeks in the rat and 30
weeks in the dog, the NOAEL for the rat and the dog were 1.1 and 10.1
mg/kg bw/day, respectively. JAU6476-desthio is not carcinogenic in
either the rat or the mouse. The NOAEL selected for human risk
assessment is 1.1 mg/kg bw/day established in the combined chronic
toxicity and carcinogenicity study in the rat.

JAU6476-desthio was negative for mutagenicity and genotoxicity in all in
vitro and in vivo studies both with and without metabolic activation.

In a two-generation reproduction study the maternal NOAEL was 2.7 mg/kg
bw/day and the NOAEL for reproductive and neonatal effects 10.0 mg/kg
bw/day. The main targets at the highest dose were dystocia (probably
secondary to hepatic toxicity), decreased pup viability, growth
retardation and low incidence of cleft palates.

In the developmental toxicity studies cleft palates were seen in the rat
and rabbit at the highest dose levels and supernumerary ribs in the rat
at lower dose levels. The oral NOAEL is 1 mg/kg bw/day in the rat and 2
mg/kg/day in the rabbit.

A developmental neurotoxicity study (DNT) in rats was conducted with
JAU6476-desthio as the anticipated dietary exposure is mainly to
JAU6476-desthio and not the parent. No evidence of neurotoxicity was
seen in this study, including no compound-related effects involving
neurobehavioral tests and neuropathology.  Compound-related effects were
limited to overt toxicity and developmental effects which were
consistent with effects seen in other developmental toxicity studies.
The overall NOAEL was 3.6 mg/kg bw/day.]>

<	8. Endocrine disruption. [The toxicology database for prothioconazole
is current and complete.  Studies in this database include evaluation of
the potential effects on carcinogenic, reproduction and development
effects including an evaluation of the pathology of the endocrine organs
following short- or long-term exposure. Prothioconazole is considered
not to have primary endocrine effects.]>

<C. Aggregate Exposure>

<	1. Dietary exposure. [An aggregate risk assessment was conducted for
all registered uses on barley, dried beans and peas (Crop Group 6C),
canola, peanuts, and wheat; the pending uses on soybeans and sugar
beets; plus the proposed increase in the tolerance for wheat forage from
6 ppm to 8 ppm. The acute toxicity endpoint used in the acute assessment
was the NOAEL of 2.0 mg/kg/day from the prothioconazole-desthio rabbit
developmental toxicity study as described in the Agency’s HED risk
assessment memorandum on prothioconazole dated October 13, 2006.
Application of a 1000x uncertainty factor resulted in an acute reference
dose (aRfD) of 0.002 mg/kg/day. The chronic reference dose (cRfD) of
0.001 mg/kg/day resulted from application of a 1000x uncertainty factor
to the NOAEL of 1.1 mg/kg/day from the rat chronic\oncogenicity
prothioconazole-desthio toxicity study.

Results from the acute and chronic dietary exposure assessment described
below demonstrate a reasonable certainty that no harm to the overall
U.S. population or any population subgroup will result from the use of
prothioconazole on the above crops.]>

<	i. Food. [An acute, Tier 2 dietary (food and drinking water) risk
assessment was conducted. For the population subgroup females 13-49
years old, the acute analysis resulted in an exposure of 30.8% of the
aRfD. Results from a chronic, Tier 2 dietary (food) risk assessment
indicated that the most highly exposed population subgroup was all
infants with an exposure equal to 27.8% of the cRfD. Chronic exposure to
the overall U.S. population was 13% of the cRfD.]>

<	ii. Drinking water. [No monitoring data are available for residues of
prothioconazole in drinking water, and EPA has established no health
advisory levels or maximum contaminant levels for residues of
prothioconazole in drinking water. In order to address drinking water,
water was included in the dietary analysis for food. For the population
subgroup females 13-49 years old, the acute analysis resulted in an
exposure of 30.8% of the aRfD. Results from a chronic, Tier 2 dietary
(food) risk assessment indicated that the most highly exposed population
subgroup was all infants with an exposure equal to 27.8% of the cRfD.
Chronic exposure to the overall U.S. population was 13% of the cRfD.]>

<	2. Non-dietary exposure. [Prothioconazole is not registered for
residential uses nor are any registrations pending for such uses.]>

<D. Cumulative Effects>

<	[Prothioconazole is a member of the conazole family of fungicides. The
cumulative effects of the primary common metabolites are being addressed
by the US Triazole Task Force.]>

<E. Safety Determination>

<	1. U.S. population. [In the Agency’s HED risk assessment memorandum
on prothioconazole dated October 13, 2006, it is stated that
quantification of acute risk to the general population including infants
and children is not required. Based on the conservative exposure
assumptions described above and on the completeness of the toxicity
data, it can be concluded that total food and drinking water exposure to
prothioconazole  from all proposed uses will utilize 30.8% of the acute
RfD for females 13-49 years old and 13% of the chronic RfDs for the
overall U.S. population. EPA generally has no concerns for exposures
below 100% of the RfD, because the RfD represents the level at or below
which daily aggregate exposure over a lifetime will not pose appreciable
risks to human health.]>

<	2. Infants and children. [In the Agency’s HED risk assessment
memorandum on prothioconazole dated October 13, 2006, it is stated that
quantification of acute risk to the general population including infants
and children is not required. For acute exposure, the Agency used the
population subgroup females 13-49 years old. In Bayer’s acute
assessment the exposure for females 13-49 years old equaled 30.8% of the
acute RfD. For chronic exposure the most highly exposed population
subgroups (all infants), utilized 27.8% of the chronic RfD. EPA
generally has no concerns for exposures below 100% of the RfD, because
the RfD represents the level at or below which daily aggregate exposure
over a lifetime will not pose appreciable risks to human health.]>

<F. International Tolerances>

<	[Although no Codex MRLs are currently established for prothioconazole,
MRLs for prothioconazole allowing use on wheat are established in
Australia, Belgium, Canada, Czech Republic, Estonia, France, Germany,
Italy, Lithuania, Luxembourg, Netherlands, Poland, Slovakia, and
Switzerland.]>

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