[Federal Register Volume 86, Number 194 (Tuesday, October 12, 2021)]
[Notices]
[Pages 56745-56746]
[FR Doc No: 2021-22136]

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SECURITIES AND EXCHANGE COMMISSION

[SEC File No. CF 270-291, OMB Control No. 3235-0328]

Proposed Collection; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, 100 F Street NE, Washington, DC
20549-2736

Extension:
    Form ID

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.) (the ``Paperwork Reduction Act''),
the Securities and Exchange Commission (``Commission'') is soliciting
comments on the collection of information summarized below. The
Commission plans to submit this existing collection of information to
the Office of Management and Budget for extension and revisions.
    Form ID (OMB Control No. 3235-0328) must be completed and filed
with the Commission by all individuals, companies, and other
organizations who seek access to file electronically on the
Commission's Electronic Data Gathering, Analysis, and Retrieval system
(``EDGAR''). Those seeking access to file on EDGAR typically include
those who are required to make certain disclosures pursuant to the
federal securities laws. The information provided on Form ID is an
essential part of the security of EDGAR. Form ID is not a public
document because it is used solely for the purpose of screening
applicants and granting access to EDGAR. Form ID must be submitted
whenever an applicant seeks an EDGAR identification number (Central
Index Key or CIK) and/or access codes to file on EDGAR. The Commission
may consider potential technical changes to the EDGAR filer access and
filer account management processes (``potential access changes'') that
include the addition of individual user account credentials as well as
a filer management tool on EDGAR through which filers would manage
their EDGAR accounts. If the potential access changes are implemented,
the Commission anticipates that it would adopt amendments to certain
Commission rules and forms to reflect the potential access changes,
including Form ID. The potential access changes would include a filer
designating on Form ID which of its users would act as filer
administrator(s) to manage the filer's EDGAR account, analogous to the
contact person listed on Form ID who currently receives access codes.
The potential access changes would also include additional data fields
on Form ID related to authorized individuals.\1\
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    \1\ An ``authorized individual'' for purposes of Form ID
notarization process includes, for example, the Chief Executive
Officer, Chief Financial Officer, partner, corporate secretary,
officer, director, or treasurer of a company filer; or for
individual filers, the individual filer or a person with a power of
attorney from the individual filer. See EDGAR Filer Manual, Volume
I, at Section 3.
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    Separately, the Commission may consider potential amendments to
Form ID that would result in a more uniform and secure process for
EDGAR access by requiring applicants that already have a CIK and no
longer have access to EDGAR to apply for access by submitting a new
Form ID, rather than by submitting a manual passphrase update request,
as they do currently.\2\ As part of their Form ID application, such
applicants would continue to provide additional documentation as
currently required by the EDGAR Filer Manual for manual passphrase
update requests.\3\
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    \2\ The manual passphrase update request is submitted by filers
who do not possess access codes for their existing EDGAR accounts
when the contact email address on their existing account is not
accurate. (If the contact email address were accurate, they would be
able to receive a security token to allow them to regain access
without engaging in the manual passphrase update request process.)
    \3\ See EDGAR Filer Manual, Volume I, at Section 4. See also
Adoption of Updated EDGAR Filer Manual, Release No. 33-10948 (Jun.
21, 2021) [86 FR 40308 (Jul. 28, 2021)].
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    For purposes of the Paperwork Reduction Act, we currently estimate
that there are 48,493 Form ID filings annually and that it takes
approximately 0.15 hours per response to prepare for a total of 7,274
annual burden hours. The current burden includes the number of Form ID
filings for filers without CIKs (48,089 filings) and filers with CIKs
who have not filed

electronically on EDGAR (404 filings).\4\ Filers are responsible for
100% of the total burden hours.
---------------------------------------------------------------------------

    \4\ 48,089 filings for users without CIKs + 404 filings for
filers with CIKs who have not yet filed electronically on EDGAR =
48,493 filings.
---------------------------------------------------------------------------

    If the potential access changes and potential Form ID amendments
become effective, for purposes of the Paperwork Reduction Act, we
estimate that the number of Form ID filings would increase
approximately by 7,284 annually \5\ and that the number of hours to
prepare Form ID would increase by 0.15 hours. The current approved
estimate of the annual number of Form ID filings for filers without
CIKs (48,089 filings) and filers with CIKs who have not filed
electronically on EDGAR (404 filings) would stay the same.
---------------------------------------------------------------------------

    \5\ We base this estimate on the average annual number of
filings from filers with CIKs who submitted manual passphrase update
requests for the past three federal fiscal years. ((7,004 filings
per year + 6,871 filings per year + 7,978 filings per year)/3 years)
= average of 7,284 filings per year.
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    Thus, for purposes of the Paperwork Reduction Act, the estimated
total number of annual Form ID filings would increase from 48,493
filings to 55,777 filings.\6\ The estimate of 0.15 hours per response
would increase to 0.30 hours per response. The estimated total annual
burden would increase from 7,274 hours to 16,734 hours.\7\ The estimate
includes the number of filers without CIKs, filers with CIKs who have
not filed electronically on EDGAR, and filers with CIKs who are seeking
to reaccess EDGAR. The estimate that the filers are responsible for
100% of the total burden hours would stay the same.
---------------------------------------------------------------------------

    \6\ 48,493 filings + 7,284 filings = 55,777 filings.
    \7\ 55,777 filings x 0.30 hours/filing = 16,734 hours (rounded
up).
---------------------------------------------------------------------------

    In relation to the potential access changes described above, the
Commission may consider amending Form ID to make technical
modifications and clarifications. We do not believe that these
technical modifications and clarifications to Form ID would make any
substantive modifications to any existing collection of information
requirements or impose any new substantive recordkeeping or information
collection requirements within the meaning of the Paperwork Reduction
Act.
    The estimate of average burden hours is made solely for the
purposes of the Paperwork Reduction Act. The estimate is not derived
from a comprehensive or representative survey or study of the costs of
Commission rules. Complying with this collection of information
requirement is necessary to obtain the benefit of relying on Form ID.
An agency may not conduct or sponsor, and a person is not required to
respond to, a collection of information unless it displays a currently
valid control number.
    Written comments are invited on: (i) Whether this proposed
collection of information is necessary for the proper performance of
the functions of the agency, including whether the information will
have practical utility; (ii) the accuracy of the agency's estimate of
the burden imposed by the collection of information; (iii) ways to
enhance the quality, utility, and clarity of the information collected;
and (iv) ways to minimize the burden of the collection of information
on respondents, including through the use of automated collection
techniques or other forms of information technology. Consideration will
be given to comments and suggestions submitted in writing within 60
days of this publication.
    Please direct your written comments to David Bottom, Director/Chief
Information Officer, Securities and Exchange Commission, c/o Cynthia
Roscoe, 100 F Street NE, Washington, DC 20549 or send an email to:
[email protected].

    Dated: October 6, 2021.
J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2021-22136 Filed 10-8-21; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 77, Number 189 (Friday, September 28, 2012)]
[Notices]
[Pages 59622-59624]
[FR Doc No: 2012-23833]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0977]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Regulations Restricting the Sale and Distribution of
Cigarettes and Smokeless Tobacco To Protect Children and Adolescents

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on regulations restricting the
sale and distribution of cigarettes and smokeless tobacco to protect
children and adolescents.

DATES: Submit either electronic or written comments on the collection
of information by November 27, 2012.

ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
    Regulations Restricting the Sale and Distribution of Cigarettes and
Smokeless Tobacco to Protect Children and Adolescents--21 CFR 1140 (OMB
Control Number 0910-0312)--Renewal
    This is a request for a renewal of OMB approval of the information
collection requirements contained in FDA's regulations for cigarettes
and smokeless tobacco containing nicotine. The regulations that are
codified at 21 CFR Part 1140 (previously codified at 21 CFR Part 897)
are authorized by section 102 of the Family Smoking Prevention and
Tobacco Control Act (Tobacco Control Act) (Pub. L. 111-31). Section 102
of the Tobacco Control Act required FDA to publish a final rule
regarding cigarettes and smokeless tobacco identical in its provisions
to the regulation issued by FDA in 1996 (61 FR 44396, August 28, 1996),
with certain specified exceptions including subpart C (which included
897.24) and 897.32(c) be removed from the reissued rule (section
102(a)(2)(B)). The reissued final rule was published in the Federal
Register on March 19, 2010 (75 FR 13225).
    This collection includes reporting information requirements for
1140.30 (formerly 897.30) which directs persons to notify FDA if they
intend to use a form of advertising that is not addressed in the
regulations. Disclosure requirements for 1140.32 (formerly 897.32)
states that the advertising must use black text on a white background,
but that this particular requirement does not apply to adult
newspapers, magazines, periodicals, or other publications.
Recordkeeping requirements under 1140.32 indicate that competent and
reliable survey evidence is required to determine whether a particular
publication is an ``adult'' publication.
    The requirements are as follows:

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

----------------------------------------------------------------------------------------------------------------
21 CFR 1140.30...........................  Reporting...............................  Directs persons to notify
                                                                                FDA if they intend to use
                                                                                a form of advertising that
                                                                                is not originally
                                                                                described in the March 19,
                                                                                2010, final rule.
21 CFR 1140.32...........................  Disclosure..............................  Requires firms to use black
                                                                                text on white backgrounds
                                                                                in labeling and
                                                                                advertising.
21 CFR 1140.32...........................  Recordkeeping...........................  Firms advertising in
                                                                                ``adult'' magazines or
                                                                                publications may need
                                                                                survey evidence
                                                                                demonstrating that the
                                                                                publication meets the
                                                                                criteria for an ``adult''
                                                                                publication.
----------------------------------------------------------------------------------------------------------------

    For the disclosure and recordkeeping requirements under 1140.32,
FDA has decided to use its discretionary enforcement and has placed
placeholders of 1 burden hour for disclosure and 1 burden hour for
reporting because FDA does not intend to enforce the requirements for
this section for the next 3 years.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of
                           21 CFR Section                               Number of      responses per     Total annual   Average  burden    Total hours
                                                                       respondents       respondent       responses      per  response
--------------------------------------------------------------------------------------------------------------------------------------------------------
1140.30 (Scope of permissible forms of labeling and advertising)...             300                1              300                1              300
                                                                    ------------------------------------------------------------------------------------
    Total..........................................................  ...............  ...............  ...............  ...............             300
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of                      Average  burden
                           21 CFR section                               Number of       records per      Total annual     per record-      Total hours
                                                                      record-keepers   record-keeper       records          keeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
1140.32 (Format and content requirements for labeling and                         1                1                1                1                1
 advertising)......................................................
                                                                    ------------------------------------------------------------------------------------
    Total..........................................................  ...............  ...............  ...............  ...............               1
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

                                               Table 3--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of
                           21 CFR section                               Number of     disclosures per    Total annual   Average  burden    Total hours
                                                                       respondents       respondent      disclosures    per  disclosure
--------------------------------------------------------------------------------------------------------------------------------------------------------
1140.32............................................................               1                1                1                1                1
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    The burden hour estimates for this collection of information were
based on industry-prepared data and information regarding
pharmaceutical advertising and cigarette and smokeless tobacco product
advertising expenditures. The burden collection does not include
reporting burdens associated with providing established names on labels
and statements of intended use because section 102 of the Tobacco
Control Act required that these provisions be struck from the reissued
final rule (previously included in 897.24 and 897.32(c)).
    Section 1140.30 (previously 897.30) requires manufacturers,
distributors, and retailers to observe certain format and content
requirements for labeling and advertising, and requires manufacturers,
distributors, and retailers to notify FDA if they intend to use an
advertising medium that is not listed in the regulations. The concept
of permitted advertising in 1140.30 is sufficiently broad to encompass
most forms of advertising. FDA estimates that approximately 300
respondents will submit an annual notice of alternative advertising,
and the Agency has estimated it should take 1 hour to provide such
notice.
    For the recordkeeping and disclosure requirements, 1140.32
(previously 897.32) requires competent and reliable survey evidence to
establish whether a newspaper, magazine, periodical, or other
publication qualifies as an ``adult'' publication. Section 1140.32 also
requires the use of a black text on a white background for labeling and
advertising. The respondent and hourly burden for recordkeeping and
disclosure under this section (2 burden hours total) reflect
placeholders for the number of manufacturers who would keep records
under this section.
    During the next 3 years, FDA does not intend to enforce the
recordkeeping and disclosure requirements of 1140.32 and has revised
the burden to act as a placeholder in the event FDA exercises its
authority to enforce the requirements of this section in the future.
    FDA estimates that the total time required for this collection of
information is 302 hours.

    Dated: September 21, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-23833 Filed 9-27-12; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 81, Number 114 (Tuesday, June 14, 2016)]
[Notices]
[Pages 38699-38700]
[FR Doc No: 2016-13977]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2576-168]

FirstLight Hydro Generating Company; Notice of Application
Accepted for Filing and Soliciting Comments, Motions To Intervene, and
Protests

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection:
    a. Application Type: Non-project use of project lands and waters.
    b. Project No: 2576-168.
    c. Date Filed: March 4, 2016.
    d. Applicant: FirstLight Hydro Generating Company.
    e. Name of Project: Housatonic River Hydroelectric Project.
    f. Location: The Shepaug Development (Lake Lillinonah) in
Litchfield County, Connecticut.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791a-825r.
    h. Applicant Contact: Howard Person, Plant Manager, 143 West
Street, Suite E, New Milford, CT 06776,<PHONE_NUMBER>.
    i. FERC Contact: Mark Carter,<PHONE_NUMBER><EMAIL_ADDRESS>    j. Deadline for filing comments, motions to intervene, and
protests: July 8, 2016.
    The Commission strongly encourages electronic filing. Please file
motions to intervene, protests, comments, or recommendations using the
Commission's eFiling system at http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit brief comments up to 6,000
characters, without prior registration, using the eComment system at
http://www.ferc.gov/docs-filing/

ecomment.asp. You must include your name and contact information at the
end of your comments. For assistance, please contact FERC Online
Support at<EMAIL_ADDRESS>(866) 208-3676 (toll free), or
(202) 502-8659 (TTY). In lieu of electronic filing, please send a paper
copy to: Secretary, Federal Energy Regulatory Commission, 888 First
Street NE., Washington, DC 20426. The first page of any filing should
include docket number P-2576-168.
    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 whose name appears on 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.
    k. Description of Request: FirstLight Hydro Generating Company
proposes to permit the expansion of West Cove Marina from the existing
25 boat slips to a total of 136 boat slips distributed across 8 docks,
as well as construction of a new gasoline dock to replace the existing
gasoline dock. Although the majority of the site has been previously
developed, minor earthwork would be performed to install the 8 concrete
pads for connecting the docks to shore.
    l. Locations of the Application: A copy of the application is
available for inspection and reproduction at the Commission's Public
Reference Room, located at 888 First Street NE., Room 2A, Washington,
DC 20426, or by calling<PHONE_NUMBER>. This filing may also be viewed
on the Commission's Web site at http://www.ferc.gov using the
``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. You may also
register online at http://www.ferc.gov/docs-filing/esubscription.asp to
be notified via email of new filings and issuances related to this or
other pending projects. For assistance, call 1-866-208-3676 or email
<EMAIL_ADDRESS>for TTY, call<PHONE_NUMBER>. A copy is
also available for inspection and reproduction at the address in item
(h) above. Agencies may obtain copies of the application directly from
the applicant.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Comments, Protests, or Motions to Intervene: Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214, respectively. In determining the appropriate action to take, the
Commission will consider all protests or other comments 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 comments,
protests, or motions to intervene must be received on or before the
specified comment date for the particular application.
    o. Filing and Service of Documents: Any filing must (1) bear in all
capital letters the title ``COMMENTS'', ``PROTEST'', or ``MOTION TO
INTERVENE'' as applicable; (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 commenting, protesting or intervening; and (4) otherwise comply
with the requirements of 18 CFR 385.2001 through 385.2005. All
comments, motions to intervene, or protests must set forth their
evidentiary basis. Any filing made by an intervenor 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
385.2010.

    Dated: June 8, 2016.
Kimberly D. Bose,
Secretary.
[FR Doc. 2016-13977 Filed 6-13-16; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register: December 23, 2005 (Volume 70, Number 246)]
[Notices]
[Page 76285-76286]
[DOCID:fr23de05-71]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-8014-7]

Proposed National Pollutant Discharge Elimination System (NPDES)
General Permit for Stormwater Discharges From Industrial Activities--
Extension of Comment Period

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice; extension of comment period.

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SUMMARY: On December 1, 2005 (70 FR 72116) EPA noticed the availability
of the proposed National Pollutant Discharge Elimination System (NPDES)
General Permit for Stormwater Discharges from Industrial Activities and
requested comments on the draft by January 16, 2006. The purpose of
this notice is to extend this comment period to February 16, 2006.

DATES: Comments on the proposed general permit must be postmarked by
February 16, 2006.

ADDRESSES: Submit your comments, identified by Docket ID No. OW-2005-
0007 by one of the following methods:
     http://www.regulations.gov: Follow the on-line

instructions for submitting comments.
     E-mail<EMAIL_ADDRESS>    Mail: Water Docket, Environmental Protection Agency, Mailcode:
4101T, 1200 Pennsylvania Ave., NW., Washington, DC 20460. Please
include a total of three copies.
    Hand Delivery: EPA Docket Center, EPA West, Room B102, 1301
Constitution Ave., NW., Washington, DC 20004. Such deliveries are only
accepted during the Docket's normal hours of operation, and special
arrangements should be made for deliveries of boxed information.
    Instructions: Direct your comments to Docket ID No. OW-2005-0007.
EPA's policy is that all comments received will be included in the
public docket without change and may be made available online at http://www.regulations.gov
, including any personal information provided,

unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through http://www.regulations.gov or e-mail. The http://www.regulations.gov Web site is an ``anonymous

access'' system, which means EPA will not know your identity or contact
information unless you provide it in the body of your comment. If you
send an e-mail comment directly to EPA without going through http://www.regulations.gov
 your e-mail address will be automatically captured

and included as part of the comment that is placed in the public docket
and made available on the Internet. If you submit an electronic
comment, EPA recommends that you include your name and other contact
information in the body of your comment and with any disk or CD-ROM you
submit. If EPA cannot read your comment due to technical difficulties
and cannot contact you for clarification, EPA may not be able to
consider your comment. Electronic files should avoid the use of special
characters, any form of encryption, and be free of any defects or
viruses. For additional information about EPA's public docket visit the
EPA Docket Center homepage at http://www.epa.gov/epahome/dockets.htm.

For additional instructions on submitting comments, go to Unit I.B of
the SUPPLEMENTARY INFORMATION section of the document.
    Docket: All documents in the docket are listed in the http://www.regulations.gov
 index. Although listed in the index, some

information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in http://www.regulations.gov or in hard copy at the Water Docket, EPA/

DC, EPA West, Room B102, 1301 Constitution Ave., NW., Washington, DC
20004. This Docket Facility is open from 8 a.m. to 4:30 p.m., Monday
through Friday, excluding legal holidays. The Docket telephone number
is<PHONE_NUMBER>. The Public Reading Room is open from 8:30 a.m. to
4:30 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Public Reading Room is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Jenny Molloy, Office of Wastewater
Management, Office of Water, EPA Headquarters at tel.:<PHONE_NUMBER> or
e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does This Action Apply to Me?

    If you have questions regarding the applicability of this action to
a particular entity, consult the person listed in the preceding FOR
FURTHER INFORMATION CONTACT section.

B. What Should I Consider as I Prepare My Comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through
http://www.regulations.gov or e-mail. Clearly mark the part or all of

the information that you claim to be CBI. For CBI information in a disk
or CD ROM that you mail to EPA, mark the outside of the disk or CD ROM
as CBI and then identify electronically within the disk or CD ROM the
specific information that is claimed as CBI). In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for Preparing Your Comments. When submitting comments,
remember to:
     Identify the rulemaking by docket number and other
identifying information (subject heading, Federal Register date and
page number).
     Follow directions--The agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
     Explain why you agree or disagree; suggest alternatives
and substitute language for your requested changes.
     Describe any assumptions and provide any technical
information and/or data that you used.
     If you estimate potential costs or burdens, explain how
you arrived at your estimate in sufficient detail to allow for it to be
reproduced.
     Provide specific examples to illustrate your concerns, and
suggest alternatives.
     Explain your views as clearly as possible.
     Make sure to submit your comments by the comment period
deadline identified.

C. What Action Is Being Taken?

    The comment period for the proposed general permit for Stormwater
Discharges from Industrial Activities is being extended for 30 days
until February 16, 2006, at the request of Waterkeeper Alliance,
Natural Resources Defense Council, Friends of Grays Harbor, Amigos
Bravos: Friends of Wild Rivers, National Mining Association, Idaho
Mining Association, Hecla Mining Company, The Colorado Mining
Association, Idaho Association of Commerce & Industry, and Arizona
Mining Association. After the close of

the public comment period, EPA will issue a final permit decision. This
decision will not be made until after all public comments have been
considered and appropriate changes made to the permit. Responses to
comments will be included in the final permit decision.

    Authority: Clean Water Act, 33 U.S.C. 1251 et seq.

    Dated: December 20, 2005.
James Hanlon,
Director, Office of Wastewater Management.
[FR Doc. E5-7778 Filed 12-22-05; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register: February 22, 2008 (Volume 73, Number 36)]
[Notices]
[Page 9842]
[DOCID:fr22fe08-113]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-57336; File No. SR-Amex-2007-36]

Self-Regulatory Organizations; American Stock Exchange LLC; Order
Approving a Proposed Rule Change, as modified by Amendment No. 1, to
Eliminate a Volume Add-on to Amex Options Specialist Financial
Requirements

I. Introduction

    On April 10, 2007, the American Stock Exchange LLC (``Amex'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\ a
proposal to amend its rules to eliminate a volume add-on to Amex
options specialist financial requirements. The Amex filed Amendment No.
1 to the proposal on December 12, 2007. The proposed rule change, as
modified by Amendment No. 1, was published for comment in the Federal
Register on January 14, 2008.\3\ The Commission received no comments
regarding the proposed rule change, as amended. This order approves the
proposed rule change.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act of 1934 Release No. 34-57106
(January 4, 2008), 73 FR 2291.
---------------------------------------------------------------------------

II. Description of the Proposal

    The Amex proposes to amend Rule 950-ANTE(h). Rule 950-ANTE(h)
currently requires an option specialist to maintain minimum tentative
net capital in the amount of $1,000,000 plus $25,000 for each option
issue (option class) in excess of the initial twenty-five issues in
which the specialist is registered. The amendment would eliminate the
$25,000 add-on for each option class in excess of the initial twenty-
five option classes.

III. Discussion

    The Commission finds that the proposed rule change, as amended, is
consistent with the requirements of the Act and the rules and
regulations under the Act applicable to a national securities
exchange.\4\ In particular, the Commission finds that the proposal is
consistent with section 6(b)(5) of the Act,\5\ which requires, among
other things, that the rules of a national securities exchange be
designed to prevent fraudulent and manipulative acts and practices, to
promote just and equitable principles of trade, to remove impediments
to and perfect the mechanism of a free and open market and a national
market system, and, in general, to protect investors and the public
interest.
---------------------------------------------------------------------------

    \4\ In approving this proposed rule change, the Commission has
considered the impact on efficiency, competition, and capital
formation of the proposed rule change. See 15 U.S.C. 78c(f).
    \5\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    Amex member firms are subject to both the Amex and the Commission's
net capital rule.\6\ The multiple listing of options across markets, as
well as quoting obligations of registered options traders, remote
registered options traders, and supplemental registered options traders
now provides multiple sources of liquidity in each options class, which
diminishes the role and need to highly capitalize any one liquidity
provider. Therefore, the benefits of requiring Amex options specialists
to maintain net capital beyond the Commission's net capital rule have
been greatly reduced. Reducing the amount of capital required to be
held under the Amex net capital rule also would allow options
specialists to use funds previously maintained to meet Amex net capital
requirements for other purposes, lowering their cost of business and
helping to ensure that they can continue to function as options
specialists on the Exchange.
---------------------------------------------------------------------------

    \6\ Rule 15c3-1 under the Act (17 CFR 240.15c3-1).
---------------------------------------------------------------------------

IV. Conclusion

    It is therefore ordered, pursuant to section 19(b)(2) of the
Act,\7\ that the proposed rule change (SR-Amex-2007-36), as modified by
Amendment No. 1, be, and hereby is, approved.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\8\
---------------------------------------------------------------------------

    \8\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Deputy Secretary.
[FR Doc. E8-3254 Filed 2-21-08; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register Volume 81, Number 23 (Thursday, February 4, 2016)]
[Rules and Regulations]
[Pages 5916-5917]
[FR Doc No: 2016-02099]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2016-0057]

Drawbridge Operation Regulation; James River, Isle of Wight and
Newport News, VA

AGENCY: Coast Guard, DHS.

ACTION: Notice of deviation from drawbridge regulation.

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

SUMMARY: The Coast Guard has issued a temporary deviation from the
operating schedule that governs the James River Bridge (US17) across
the James River, mile 5.0, at Isle of Wight and Newport News, VA. The
deviation is necessary to perform bridge maintenance and repairs. This
deviation allows the bridge to remain in the closed-to-navigation
position.

DATES: This deviation is effective from 5 a.m. on February 7, 2016 to 7
p.m. on February 14, 2016.

ADDRESSES: The docket for this deviation, [USCG-2016-0057] is available
at http://www.regulations.gov. Type the docket number in the ``SEARCH''
box and click ``SEARCH''. Click on Open Docket Folder on the line
associated with this deviation.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary deviation, call or email Hal R. Pitts, Bridge Administration
Branch Fifth District, Coast Guard, telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Virginia Department of Transportation,
that owns and operates the James River Bridge (US17), has requested a
temporary deviation from the current operating regulations to perform
repairs to the aerial electrical cable connecting the north tower to
the south tower. The bridge is a vertical lift draw bridge and has a
vertical clearance in the closed position of 60 feet above mean high
water.
    The current operating schedule is open on signal as set out in 33
CFR 117.5. Under this temporary deviation, the bridge will remain in
the closed-to-

navigation position from 5 a.m. to 7 p.m. from February 7, 2016 through
February 14, 2016. During this temporary deviation, the bridge will
operate per 33 CFR 117.5 from 7 p.m. to 5 a.m.
    The James River is used by a variety of vessels including deep
draft ocean-going vessels, U.S. government vessels, small commercial
vessels, recreational vessels and tug and barge traffic. The Coast
Guard has carefully coordinated the restrictions with waterway users.
    Vessels able to pass through the bridge in the closed position may
do so at any time. The bridge will not be able to open for emergencies
and there is no immediate alternate route for vessels to pass. The
Coast Guard will also inform the users of the waterways through our
Local and Broadcast Notices to Mariners of the change in operating
schedule for the bridge so that vessel operators can arrange their
transit to minimize any impact caused by the temporary deviation.
    In accordance with 33 CFR 117.35(e), the drawbridge must return to
its regular operating schedule immediately at the end of the effective
period of this temporary deviation. This deviation from the operating
regulations is authorized under 33 CFR 117.35.

    Dated: January 28, 2016.
Hal R. Pitts,
Bridge Program Manager, Fifth Coast Guard District.
[FR Doc. 2016-02099 Filed 2-3-16; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register: September 20, 2006 (Volume 71, Number 182)]
[Rules and Regulations]
[Page 54922-54928]
[DOCID:fr20se06-12]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0613.; FRL-8089-2]

Etofenprox; Pesticide Tolerances for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes time-limited tolerances for
residues of etofenprox (2-[ethoxyphenyl]-2-methylpropyl-3-phenoxy
benzyl ether) in or on rice grain and rice straw. This action is
associated with an emergency exemption under section 18 of the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizing use of
the pesticide on rice. This regulation establishes a maximum
permissible level for residues of etofenprox in these food commodities.
The tolerances expire and are revoked on December 31, 2009.

DATES: This regulation is effective September 20, 2006. Objections and
requests for hearings must be received on or before November 20, 2006,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2006-0613. All documents in the
docket are listed on the regulations.gov website. Although listed in
the index, some information is not publicly available, e.g.,
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Certain other material, such as
copyrighted material, is not placed on the Internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available either in the electronic docket at http://www.regulations.gov
, or, if only available in hard copy, at the Office

of Pesticide Programs (OPP) Regulatory Public Docket in Rm. S-4400, One
Potomac Yard (South Building), 2777 S. Crystal Drive Arlington, VA. The
hours of operation of this Docket Facility are from 8:30 a.m. to 4
p.m., Monday

through Friday, excluding legal holidays. The Docket telephone number
is<PHONE_NUMBER>.

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

I. General Information

A. Does this Action Apply to Me?

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

 B. How Can I Access Electronic Copies of this Document?

    In addition to accessing an electronic copy of this Federal
Register document through the electronic docket at http://www.regulations.gov
, you may access this Federal Register document

electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr. You may also access a

frequently updated electronic version of 40 CFR part 180 through the
Government Printing Office's pilot e-CFR site at http://www.gpoaccess.gov/ecfr
.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. You must file your objection or
request a hearing on this regulation in accordance with the
instructions provided in 40 CFR part 178. To ensure proper receipt by
EPA, you must identify docket ID number EPA-HQ-OPP-2006-0613 in the
subject line on the first page of your submission. All requests must be
in writing, and must be mailed or delivered to the Hearing Clerk on or
before November 20, 2006.
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit your copies, identified by docket ID
number EPA-HQ-OPP-2006-0613, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.

Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket telephone number is<PHONE_NUMBER>.

II. Background and Statutory Findings

    EPA, on its own initiative, in accordance with sections 408(e) and
408 (l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21
U.S.C. 346a(e) and (l)(6), is establishing tolerances for residues of
the insecticide etofenprox (2-[ethoxyphenyl]-2-methylpropyl-3-phenoxy
benzyl ether) or on rice grain at 0.01 parts per million (ppm) and rice
straw at 0.02 ppm. These tolerances expire and are revoked on December
31, 2009. EPA will publish a document in the Federal Register to remove
the revoked tolerance from the Code of Federal Regulations (CFR).
    Section 408(l)(6) of the FFDCA requires EPA to establish a time-
limited tolerance or exemption from the requirement for a tolerance for
pesticide chemical residues in food that will result from the use of a
pesticide under an emergency exemption granted by EPA under section 18
of FIFRA. Such tolerances can be established without providing notice
or period for public comment. EPA does not intend for its actions on
section 18 related tolerances to set binding precedents for the
application of section 408 of the FFDCA and the new safety standard to
other tolerances and exemptions. Section 408(e) of the FFDCA allows EPA
to establish a tolerance or an exemption from the requirement of a
tolerance on its own initiative, i.e., without having received any
petition from an outside party.
    Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of the FFDCA defines ``safe'' to mean that ``there is
a reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of the FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
    Section 18 of the FIFRA authorizes EPA to exempt any Federal or
State agency from any provision of FIFRA, if EPA determines that
``emergency conditions exist which require such exemption.'' This
provision was not amended by the Food Quality Protection Act of 1996
(FQPA). EPA has established regulations governing such emergency
exemptions in 40 CFR part 166.

III. Emergency Exemption for Etofenprox on Rice and FFDCA Tolerances

    The Applicant asserts that the current emergency situation with
respect to weevil management has arisen primarily from the continuing,
and probably increasing, practice of cultivating crawfish in ponds in
close proximity to rice fields in southern Louisiana. The great
majority of crawfish ponds (at least 75%) are close enough to rice
fields to be affected by the management practices used in rice. All of
the insecticides currently registered for use against the

rice water weevil in Louisiana are toxic to crawfish. The use of
etofenprox for weevil control has one significant advantage over
currently used liquid products in that it is formulated as a granular
and thus there is far less potential for drift. The Applicant states
that the estimated economic loss if no effective weevil controls are
available is over 8 million dollars.
    EPA has authorized under FIFRA section 18 the use of etofenprox on
rice for control of rice water weevil (Lissorhoptrus oryzophilus) in
Louisiana. After having reviewed the submission, EPA concurs that
emergency conditions exist for this State.
    As part of its assessment of this emergency exemption, EPA assessed
the potential risks presented by residues of etofenprox in or on rice
grain and rice straw. In doing so, EPA considered the safety standard
in section 408(b)(2) of the FFDCA, and EPA decided that the necessary
tolerance under section 408(l)(6) of the FFDCA would be consistent with
the safety standard and with FIFRA section 18. Consistent with the need
to move quickly on the emergency exemption in order to address an
urgent non-routine situation and to ensure that the resulting food is
lawful, EPA is issuing these tolerances without notice and opportunity
for public comment as provided in section 408(l)(6) of the FFDCA.
Although these tolerances expire and are revoked on December 31, 2009,
under section 408(l)(5) of the FFDCA, residues of the pesticide not in
excess of the amounts specified in these tolerances remaining in or on
rice grain or rice straw after that date will not be unlawful, provided
the pesticide is applied in a manner that was lawful under FIFRA, and
the residues do not exceed a level that was authorized by these
tolerances at the time of that application. EPA will take action to
revoke these tolerances earlier if any experience with, scientific data
on, or other relevant information on this pesticide indicate that the
residues are not safe.
    Because these time-limited tolerances are being approved under
emergency conditions, EPA has not made any decisions about whether
etofenprox meets EPA's registration requirements for use on rice or
whether permanent tolerances for this use would be appropriate. Under
these circumstances, EPA does not believe that these tolerances serve
as a basis for registration of etofenprox by a State for special local
needs under FIFRA section 24(c). Nor do these tolerances serve as the
basis for any State other than Louisiana to use this pesticide on this
crop under section 18 of FIFRA without following all provisions of
EPA's regulations implementing FIFRA section 18 as identified in 40 CFR
part 166. For additional information regarding the emergency exemption
for etofenprox, contact the Agency's Registration Division at the
address provided under FOR FURTHER INFORMATION CONTACT.

IV. Aggregate Risk Assessment and Determination of Safety

    EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 of the FFDCA and a complete
description of the risk assessment process, see http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm
.

    Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed
the available scientific data and other relevant information in support
of this action. EPA has sufficient data to assess the hazards of
etofenprox and to make a determination on aggregate exposure,
consistent with section 408(b)(2) of the FFDCA, for time-limited
tolerances for residues of etofenprox in or on rice grain at 0.01 ppm
and rice straw at 0.02 ppm. EPA's assessment of the dietary exposures
and risks associated with establishing the tolerances follows.

A. Toxicological Endpoints

    The dose at which no adverse effects are observed (the NOAEL) from
the toxicology study identified as appropriate for use in risk
assessment is used to estimate the toxicological endpoint. However, the
lowest dose at which adverse effects of concern are identified (the
LOAEL) is sometimes used for risk assessment if no NOAEL was achieved
in the toxicology study selected. An uncertainty factor (UF) is applied
to reflect uncertainties inherent in the extrapolation from laboratory
animal data to humans and in the variations in sensitivity among
members of the human population as well as other unknowns. An UF of 100
is routinely used, 10X to account for interspecies differences and 10X
for intra species differences.
    For dietary risk assessment (other than cancer) the Agency uses the
UF to calculate an acute or chronic reference dose (acute RfD or
chronic RfD) where the RfD is equal to the NOAEL divided by the
appropriate UF (RfD = NOAEL/UF). Where an additional safety factor (SF)
is retained due to concerns unique to the FQPA, this additional factor
is applied to the RfD by dividing the RfD by such additional factor.
The acute or chronic Population Adjusted Dose (aPAD or cPAD) is a
modification of the RfD to accommodate this type of FQPA SF.
    For non-dietary risk assessments (other than cancer) the UF is used
to determine the level of concern (LOC). For example, when 100 is the
appropriate UF (10X to account for interspecies differences and 10X for
intraspecies differences) the LOC is 100. To estimate risk, a ratio of
the NOAEL to exposures (margin of exposure (MOE) = NOAEL/exposure) is
calculated and compared to the LOC.
    The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify carcinogenic risk. The Q*
approach assumes that any amount of exposure will lead to some degree
of cancer risk. A Q* is calculated and used to estimate risk which
represents a probability of occurrence of additional cancer cases
(e.g., risk is expressed as 1 x 10\6\ or one in a million). Under
certain specific circumstances, MOE calculations will be used for the
carcinogenic risk assessment. In this non-linear approach, a ``point of
departure'' is identified below which carcinogenic effects are not
expected. The point of departure is typically a NOAEL based on an
endpoint related to cancer effects though it may be a different value
derived from the dose response curve. To estimate risk, a ratio of the
point of departure to exposure (MOEcancer = point of
departure/exposures) is calculated. A summary of the toxicological
endpoints for etofenprox used for human risk assessment is shown in the
following Table:

                                Doses and Toxicological Endpoints for Etofenprox
----------------------------------------------------------------------------------------------------------------
                                          Dose Used in Risk
                                             Assessment,          FQPA SF and Level of
          Exposure/Scenario                 Interspecies,           Concern for Risk     Study and Toxicological
                                         Intraspecies and any          Assessment                Effects
                                            Traditional UF
----------------------------------------------------------------------------------------------------------------
Acute Dietary (females 13-49 years of  Not selected             NA                       No toxicological
 age)                                                                                endpoint attributable
                                                                                to a single exposure
                                                                                was identified in the
                                                                                available toxicology
                                                                                studies.
----------------------------------------------------------------------------------------------------------------
Acute Dietary (General population      Not selected             NA                       No toxicological
 including infants and children)                                                          endpoint attributable
                                                                                to a single exposure
                                                                                was identified in the
                                                                                available toxicology
                                                                                studies.
----------------------------------------------------------------------------------------------------------------
Chronic Dietary (All populations)      NOAEL = 3.7 mg/kg/day    FQPA SF = 1x cPAD =      Combined Chronic
                                       Chronic RfD = 0.037 mg/  Chronic RfD/Special       Toxicity/
                                        kg/day.                  FQPA SF = 0.037 mg/kg/   Carcinogenicity Study
                                                                 day.                     in Rat (MRID No.
                                                                                40449707)
                                                                                LOAEL = 25.5 mg/kg/day
                                                                                based on increased
                                                                                thyroid weights.
                                                                                Related to increased
                                                                                liver weights and
                                                                                histopathology changes
                                                                                in liver and thyroid
                                                                                that occurred at the
                                                                                higher dose.
----------------------------------------------------------------------------------------------------------------
Incidental Oral Short-Term (1 - 30     NOAEL =100 mg/kg/day     LOC for MOE = 100        Developmental Toxicity
 days)                                 UF = 100...............                            in Rabbit (MRID No.
                                                                                45210602)
                                                                                LOAEL = 300 mg/kg/day
                                                                                based on decreased
                                                                                body weights, body
                                                                                weight gains, and food
                                                                                consumption (maternal
                                                                                toxicity).
----------------------------------------------------------------------------------------------------------------
Incidental Oral Intermediate-Term (1 - NOAEL = 20 mg/kg/day UF  LOC for MOE = 100        Subchronic Oral
  6 months)                             = 100                                             Toxicity in Rat (MRID
                                                                                No. 40449703)
                                                                                LOAEL = 120 mg/kg/day
                                                                                based on decreased
                                                                                body weight gain,
                                                                                increased liver and
                                                                                thyroid weights with
                                                                                corresponding
                                                                                histopathology,
                                                                                changes in hematology
                                                                                and clinical
                                                                                chemistry.
----------------------------------------------------------------------------------------------------------------
Dermal (All durations)                 NA                       NA                       No systemic toxicity
                                                                                was identified in the
                                                                                dermal 28-day study;
                                                                                Highest Dose Tested
                                                                                was 1,000 mg/kg/day.
----------------------------------------------------------------------------------------------------------------
Inhalation (All durations)             NOAEL =10.6 mg/kg/day    LOC for MOE = 100        13-Week Inhalation
                                       UF = 100...............  Residential............   Toxicity in Rat (MRID
                                                                LOC for MOE = 100......   No. 40449705)
                                                                Occupational...........  LOAEL = 52.3 mg/kg/day
                                                                                based on organ weight
                                                                                changes and
                                                                                histopathological
                                                                                changes in liver,
                                                                                adrenals and thyroid.
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)       Classification: ``Not likely to be carcinogenic to humans at doses that
                                                     do not alter rat thyroid hormone homeostasis.''
----------------------------------------------------------------------------------------------------------------
UF = uncertainty factor, FQPA SF = Any additional safety factor retained due to concerns unique to the FQPA,
  NOAEL = no observed adverse effect level, LOAEL = lowest observed adverse effect level, PAD = population
  adjusted dose (a = acute, c = chronic) RfD = reference dose, MOE = margin of exposure, LOC = level of concern,
  NA = Not Applicable

B. Exposure Assessment

    1. Dietary exposure from food and feed uses. Risk assessments were
conducted by EPA to assess dietary exposures from etofenprox in food as
follows:
    i. Acute exposure. Acute dietary risk assessments are performed for
a food-use pesticide if a toxicological study has indicated the
possibility of an effect of concern occurring as a result of a one day
or single exposure. An acute risk assessment was not performed. No
toxicological endpoint attributable to a single (acute) dietary
exposure was identified.
    ii. Chronic exposure.In conducting this chronic dietary risk
assessment the Dietary Exposure Evaluation Model (DEEM\TM\) analysis
evaluated the individual food consumption as reported by respondents in
the USDA 1994-1996 nationwide Continuing Surveys of Food Intake by
Individuals (CSFII) and accumulated exposure to the chemical for each
commodity. The following assumptions were made for the chronic exposure
assessments: The concentration of etofenprox in rice commodities is
assumed at tolerance level and 100 percent of rice grown is assumed to
be treated.
    iii. Cancer. Etofenprox has been classified as, ``Not likely to be
carcinogenic to humans at doses that do not alter rat thyroid hormone
homeostasis.'' In 1989, the EPA classified etofenprox as a ``Group C
Possible Human Carcinogen'' based on thyroid tumors in rats. In 1996
the EPA evaluated additional information submitted by the registrant,
Mitsui Toatsu, regarding the carcinogenic potential of etofenprox. Its
objective was to demonstrate a threshold mechanism for the thyroid
tumors in rats. In 2005, an additional 4-week dietary investigative
study on thyroid function and hepatic microsomal enzyme induction in
rats was reviewed by the EPA. In 2005, the Agency considered if the
additional study along with the previously submitted data provided
sufficient information to support re-evaluation of etofenprox's
carcinogenicity status. In consideration of these new data, and in
accordance with the EPA Final Guidelines for Carcinogen Risk
Assessment, etofenprox was classified as ``Not likely to be

carcinogenic to humans at doses that do not alter rat thyroid hormone
homeostasis.'' This decision was based on the following considerations:
    a. Treatment-related thyroid follicular cell tumors were seen in
both male and female rats at 4,900 ppm, which was considered to be
adequate, and not excessive, to assess carcinogenicity;
    b. No treatment-related tumors were seen in male or female mice
when tested at a dose that was considered adequate to assess
carcinogenicity;
    c. There is no mutagenicity concern for etofenprox form in vivo or
in vitro assays;
    d. The non-neoplastic toxicological evidence (i.e., thyroid growth
and thyroid hormonal changes) indicated that etofenprox was inducing a
disruption in the thyroid-pituitary hormonal status; and
    e. Rats are substantially more sensitive than humans to the
development of thyroid follicular cell tumors in response to thyroid
hormone imbalance. The overall weight-of-the-evidence was considered
sufficient to indicate that etofenprox induced thyroid follicular
tumors through an antithyroid mode of action; The quantification of
carcinogenic potential is not applicable. Therefore, no risk
quantification is required.
    2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for etofenprox in drinking water.
Because the Agency does not have comprehensive monitoring data,
drinking water concentration estimates are made by reliance on
simulation or modeling taking into account data on the physical
characteristics of etofenprox. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at http://www.epa.gov/oppefed1/models/water/index.htm.

    Based on the provisional refined rice models (Method A and B) and
SCI-GROW models, the estimated environmental concentrations (EECs) of
etofenprox for chronic exposures are estimated to be 2.5 parts per
billion (ppb) for surface water and 0.002 ppb for ground water.
    The estimated drinking water concentrations (EDWCs) for etofenprox
were directly entered into the dietary exposure model DEEM-FCID\TM\.
For chronic dietary risk assessment, the annual average concentration
of 2.5 ppb was used to assess the contribution to drinking water
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
    Etofenprox is currently registered for use on the following
residential non-dietary sites: Outdoor (yard/patio), spot-on pet
treatment, indoor foggers, and crack and crevice/spot treatment to
control a variety of crawling and flying insect pests. The residential
risk assessment was conducted using the following exposure assumptions:
Average food and drinking water exposures are aggregated with exposures
to toddlers from inhalation and hand-to-mouth activities following the
use of an indoor total-release fogger and hand-to-mouth from contact
with a companion cat treated with the etofenprox spot-on product.
Aggregate assessment for adults combines average food and water
exposures for the total U.S. population with adult handler and post
application inhalation exposures from the use of the indoor total-
release fogger. These residential uses are believed to be the ones most
likely to co-occur (comprehensive flea treatment approach), and also
present the most conservative (worst-case) scenario for potential
aggregate exposures.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of the FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
    Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not made
a common mechanism of toxicity finding as to etofenprox and any other
substances and etofenprox does not appear to produce a toxic metabolite
produced by other substances. For the purposes of this tolerance
action, therefore, EPA has not assumed that etofenprox has a common
mechanism of toxicity with other substances. For information regarding
EPA's efforts to determine which chemicals have a common mechanism of
toxicity and to evaluate the cumulative effects of such chemicals, see
the policy statements released by EPA's Office of Pesticide Programs
concerning common mechanism determinations and procedures for
cumulating effects from substances found to have a common mechanism on
EPA's website at http://www.epa.gov/pesticides/cumulative/.

C. Safety Factor for Infants and Children

    1. In general. Section 408 of the FFDCA provides that EPA shall
apply an additional tenfold margin of safety for infants and children
in the case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the data base on toxicity and exposure
unless EPA determines that a different margin of safety will be safe
for infants and children. Margins of safety are incorporated into EPA
risk assessments either directly through use of a MOE analysis or
through using uncertainty (safety) factors in calculating a dose level
that poses no appreciable risk to humans.
    2. Developmental toxicity studies. A prenatal developmental
toxicity study in rabbits showed no quantitative/qualitative evidence
of increased susceptibility in offspring. In the rabbit study the
developmental effects were seen at doses that resulted in maternal
deaths at the high dose. Additionally, the rabbit developmental study
showed increased abortions, decreased maternal body weights, body
weight gains and food consumption. In the rabbit study, the maternal
LOAEL (300 milligram/kilogram/day (mg/kg/day)) is equal to the
developmental LOAEL. In the 1-generation/developmental study in rats,
increased susceptibility in the offspring was not observed. In the rat
developmental study, the maternal LOAEL was equal to the developmental
LOAEL.
    3. Reproductive toxicity study. The 2-generation reproduction study
in rats did not show evidence of quantitative/qualitative
susceptibility in offspring. In this study rats showed decreased pup
weights, increased thyroid, liver and kidney weights with corresponding
pathological changes in pups, and clinical signs of pups during most of
the lactation period which included body tremors, distended abdomen,
lethargy, unsteady gait, and abnormal movements. However, except for
thyroid weight in female pups, all of these effects occurred at the
highest dose tested (HDT). The effects on organ weights carried over to
the adults of both the F1 and F2 generations with
corresponding centrilobular hepatocyte enlargement and increased
thyroidal epithelial height in the HDT group of the F1
generation. At the high dose, parents (F0) had similar
effects on their organs as the pups: increased liver, thyroid, and
kidney weights with pathological changes in the kidney. The parental
LOAEL was equal to the offspring LOAEL in the 2-generation reproduction
study in rats.

    4. Prenatal and postnatal sensitivity. There is no indication of
increased quantitative/qualitative evidence of susceptibility of the
offspring in the developmental rat or rabbit studies or in the 2-gen
reproduction study in the rat. Developmental effects were seen at doses
that caused maternal toxicity. No developmental effects were seen in
the rat 1-generation/developmental study. In the 2-generation
reproduction toxicity study, there was no evidence of quantitative and
qualitative susceptibility because the presence of toxicity in the
offspring occurred at the level of parental toxicity (increased organs
weights and associated pathological changes occurred in both the pups
and parents). In the developmental neurotoxicity study in rats, the
observed eye abnormalities associated with body injuries could not be
disassociated from possible altered treatment-related maternal behavior
that resulted in injury to the pups.
    5. Conclusion. The toxicology database for etofenprox is
essentially complete. The data are sufficient for endpoint selection
for exposure/risk assessment scenarios and for evaluation of the
requirements under the Food Quality Protection Act (FQPA). Evidence of
quantitative and qualitative susceptibility of offspring were not
observed, and therefore, the FQPA 10x safety factor was reduced to 1x.

D. Aggregate Risks and Determination of Safety

    The Agency currently has two ways to estimate total aggregate
exposure to a pesticide from food, drinking water, and residential
uses. First, a screening assessment can be used, in which the Agency
calculates drinking water levels of comparison (DWLOCs) which are used
as a point of comparison against estimated drinking water
concentrations (EDWCs). The DWLOC values are not regulatory standards
for drinking water, but are theoretical upper limits on a pesticide's
concentration in drinking water in light of total aggregate exposure to
a pesticide in food and residential uses. More information on the use
of DWLOCs in dietary aggregate risk assessments can be found at http://www.epa.gov/oppfead1/
[fxsp0]trac/science/screeningsop.pdf.

    More recently the Agency has used another approach to estimate
aggregate exposure through food, residential and drinking water
pathways. In this approach, modeled surface and ground water EDWCs are
directly incorporated into the dietary exposure analysis, along with
food. This provides a more realistic estimate of exposure because
actual body weights and water consumption from the CSFII are used. The
combined food and water exposures are then added to estimated exposure
from residential sources to calculate aggregate risks. The resulting
exposure and risk estimates are still considered to be high end, due to
the assumptions used in developing drinking water modeling inputs.
    1. Acute risk. An acute risk assessment was not performed. No
toxicological endpoint attributable to a single (acute) dietary
exposure was identified. Therefore, acute risk from etofenprox exposure
to is not expected.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
etofenprox from food and water will utilize < 1% of the cPAD for the
U.S. population, and < 1% of the cPAD for all infants (< 1 year old), the
subpopulation at greatest exposure. Based on the use pattern, chronic
residential exposure to residues of etofenprox is not expected.
Therefore, EPA does not expect the aggregate exposure to exceed 100% of
the cPAD.
    3. Short-term risk. Short-term aggregate exposure takes into
account residential exposure plus chronic exposure to food and water
(considered to be a background exposure level). Etofenprox is currently
registered for use(s) that could result in short-term residential
exposure and the Agency has determined that it is appropriate to
aggregate chronic food and water and short-term exposures for
etofenprox.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that food, water and residential
exposures aggregated result in aggregate MOEs of 960 for adults and 350
for inhalation and 560 for incidental oral for toddlers. These
aggregate MOEs do not exceed the Agency's level of concern for
aggregate exposure to food, water and residential uses. Therefore, EPA
does not expect short-term aggregate exposure to exceed the Agency's
level of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account non-dietary, non-occupational exposure plus chronic
exposure to food and water (considered to be a background exposure
level). Etofenprox is currently registered for use(s) that could result
in intermediate-term residential exposure and the Agency has determined
that it is appropriate to aggregate chronic food and water and
intermediate-term exposures for etofenprox.
    Using the exposure assumptions described in this unit for
intermediate-term exposures, EPA has concluded that food, water, and
residential exposures aggregated result in aggregate MOEs of 960 for
adults and 130 for toddlers. These aggregate MOEs do not exceed the
Agency's level of concern for aggregate exposure to food, water, and
residential uses. Therefore, EPA does not expect intermediate-term
aggregate exposure to exceed the Agency's level of concern.
    5. Aggregate cancer risk for U.S. population. Etofenprox has been
classified as, ``not likely to be carcinogenic to humans at doses that
do not alter rat thyroid hormone homeostasis.'' Therefore, etofenprox
is not expected to pose a cancer risk.
    6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, and to infants and children from aggregate
exposure to etofenprox residues.

V. Other Considerations

A. Analytical Enforcement Methodology

    An adequate enforcement methodology (gas chromatography) is
available to enforce the tolerance expression. The method may be
requested from: Team Leader, Emergency Response Team, Risk Integration,
Minor Use, Emergency Response Branch (7505P) 1200 Pennsylvania Ave.,
NW., Washington, DC 20460; telephone number:<PHONE_NUMBER>; e-mail
address<EMAIL_ADDRESS>
B. International Residue Limits

    Etofenprox is in the CODEX system with a residue definition of
etofenprox (fat soluble), but without an MRL on rice.

VI. Conclusion

    Therefore, time-limited tolerances are established for residues of
etofenprox (2-[ethoxyphenyl]-2-methylpropyl-3-phenoxy benzyl ether), in
or on rice, grain at 0.01ppm and rice, straw at 0.02 ppm.

VII. Statutory and Executive Order Reviews

    This final rule establishes time-limited tolerances under section
408 of the FFDCA. The Office of Management and Budget (OMB) has
exempted these types of actions from review under Executive Order
12866, entitled Regulatory Planning and Review (58 FR 51735, October 4,
1993). Because this rule has been exempted from review under Executive
Order 12866 due to its lack of significance, this rule is not subject
to Executive Order 13211, Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355,
May

22, 2001). This final rule does not contain any information collections
subject to OMB approval under the Paperwork Reduction Act (PRA), 44
U.S.C. 3501 et seq., or impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Public Law 104-4). Nor does it require any
special considerations under Executive Order 12898, entitled Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations (59 FR 7629, February 16, 1994); or OMB review
or any Agency action under Executive Order 13045, entitled Protection
of Children from Environmental Health Risks and Safety Risks (62 FR
19885, April 23, 1997). This action does not involve any technical
standards that would require Agency consideration of voluntary
consensus standards pursuant to section 12(d) of the National
Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law
104-113, section 12(d) (15 U.S.C. 272 note). Since tolerances and
exemptions that are established on the basis of a FIFRA section 18
exemption under section 408 of the FFDCA, such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply. In addition, the Agency has determined that this
action will not have a substantial direct effect on States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government, as specified in Executive Order 13132, entitled Federalism
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to
develop an accountable process to ensure ``meaningful and timely input
by State and local officials in the development of regulatory policies
that have federalism implications.'' ``Policies that have federalism
implications'' is defined in the Executive order to include regulations
that have ``substantial direct effects on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government.'' This final rule directly regulates growers, food
processors, food handlers, and food retailers, not States. This action
does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of the FFDCA. For these same reasons, the Agency
has determined that this rule does not have any ``tribal implications''
as described in Executive Order 13175, entitled Consultation and
Coordination with Indian Tribal Governments (65 FR 67249, November 6,
2000). Executive Order 13175, requires EPA to develop an accountable
process to ensure ``meaningful and timely input by tribal officials in
the development of regulatory policies that have tribal implications.''
``Policies that have tribal implications'' is defined in the Executive
order to include regulations that have ``substantial direct effects on
one or more Indian tribes, on the relationship between the Federal
Government and the Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.''
This rule will not have substantial direct effects on tribal
governments, 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, as specified in
Executive Order 13175. Thus, Executive Order 13175 does not apply to
this rule.

VIII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of this final rule in the Federal Register. This final
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

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

    Dated: September 8, 2006.
James Jones,
Director, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--AMENDED

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

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

0
2. Section 180.620 is added to read as follows:

Sec.  180.620  Etofenprox; tolerances for residues.

     (a) General. [Reserved]
    (b) Section 18 emergency exemptions. Time-limited tolerances are
established for residues of etofenprox (2-[ethoxyphenyl]-2-
methylpropyl-3-phenoxy benzyl ether) in connection with use of the
pesticide under section 18 emergency exemptions granted by EPA. The
tolerances will expire and are revoked on the dates specified in the
following table.

------------------------------------------------------------------------
                                                             Expiration/
                   Commodity                     Parts per    revocation
                                                  million        date
------------------------------------------------------------------------
Rice, grain...................................         0.01     12/31/09
Rice, straw...................................         0.02     12/31/09
------------------------------------------------------------------------

     (c) Tolerances with regional registrations. [Reserved]
     (d) Indirect or inadvertent residues. [Reserved]

[FR Doc. 06-8004 Filed 9-19-06; 8:45 am]

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