[Federal Register Volume 76, Number 32 (Wednesday, February 16, 2011)]
[Proposed Rules]
[Pages 8984-8986]
[FR Doc No: 2011-3508]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

44 CFR Part 67

[Docket ID FEMA-2011-0002; Internal Agency Docket No. FEMA-B-1182]

Proposed Flood Elevation Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Proposed rule.

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SUMMARY: Comments are requested on the proposed Base (1% annual-chance)
Flood Elevations (BFEs) and proposed BFE modifications for the
communities listed in the table below. The purpose of this proposed
rule is to seek general information and comment regarding the proposed
regulatory flood elevations for the reach described by the downstream
and upstream locations in the table below. The BFEs and modified BFEs
are a part of the floodplain management measures that the community is
required either to adopt or to show evidence of having in effect in
order to qualify or remain qualified for participation in the National
Flood Insurance Program (NFIP). In addition, these elevations, once
finalized, will be used by insurance agents and others to calculate
appropriate flood insurance premium rates for new buildings and the
contents in those buildings.

DATES: Comments are to be submitted on or before May 17, 2011.

ADDRESSES: The corresponding preliminary Flood Insurance Rate Map
(FIRM) for the proposed BFEs for each community is available for
inspection at the community's map repository. The respective addresses
are listed in the table below.
    You may submit comments, identified by Docket No. FEMA-B-1182, to
Luis Rodriguez, Chief, Engineering Management Branch, Federal Insurance
and Mitigation Administration, Federal Emergency Management Agency, 500
C Street, SW., Washington, DC 20472,<PHONE_NUMBER>, or (e-mail)
<EMAIL_ADDRESS>
FOR FURTHER INFORMATION CONTACT: Luis Rodriguez, Chief, Engineering
Management Branch, Federal Insurance and Mitigation Administration,
Federal Emergency Management Agency, 500 C Street, SW., Washington, DC
20472,<PHONE_NUMBER>, or (e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Federal Emergency Management Agency
(FEMA) proposes to make determinations of BFEs and modified BFEs for
each community listed below, in accordance with section 110 of the
Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR
67.4(a).
    These proposed BFEs and modified BFEs, together with the floodplain
management criteria required by 44 CFR 60.3, are the minimum that are
required. They should not be construed to mean that the community must
change any existing ordinances that are more stringent in their
floodplain management requirements. The community may at any time enact
stricter requirements of its own or

pursuant to policies established by other Federal, State, or regional
entities. These proposed elevations are used to meet the floodplain
management requirements of the NFIP and also are used to calculate the
appropriate flood insurance premium rates for new buildings built after
these elevations are made final, and for the contents in those
buildings.
    Comments on any aspect of the Flood Insurance Study and FIRM, other
than the proposed BFEs, will be considered. A letter acknowledging
receipt of any comments will not be sent.
    National Environmental Policy Act. This proposed rule is
categorically excluded from the requirements of 44 CFR part 10,
Environmental Consideration. An environmental impact assessment has not
been prepared.
    Regulatory Flexibility Act. As flood elevation determinations are
not within the scope of the Regulatory Flexibility Act, 5 U.S.C. 601-
612, a regulatory flexibility analysis is not required.
    Executive Order 12866, Regulatory Planning and Review. This
proposed rule is not a significant regulatory action under the criteria
of section 3(f) of Executive Order 12866, as amended.
    Executive Order 13132, Federalism. This proposed rule involves no
policies that have federalism implications under Executive Order 13132.
    Executive Order 12988, Civil Justice Reform. This proposed rule
meets the applicable standards of Executive Order 12988.

List of Subjects in 44 CFR Part 67

    Administrative practice and procedure, Flood insurance, Reporting
and recordkeeping requirements.

    Accordingly, 44 CFR part 67 is proposed to be amended as follows:

PART 67--[AMENDED]

    1. The authority citation for part 67 continues to read as follows:

    Authority:  42 U.S.C. 4001 et seq.; Reorganization Plan No. 3 of
1978, 3 CFR, 1978 Comp., p. 329; E.O. 12127, 44 FR 19367, 3 CFR,
1979 Comp., p. 376.

Sec.  67.4  [Amended]

    2. The tables published under the authority of Sec.  67.4 are
proposed to be amended as follows:

----------------------------------------------------------------------------------------------------------------
                                                                  * Elevation in feet
                                                                (NGVD)  + Elevation in
                                                                feet (NAVD)
                                       Location of referenced     Depth in feet above
         Flooding source(s)                 elevation**             ground  [caret]        Communities affected
                                                               Elevation in feet (MLLW)
                                                              --------------------------
                                                                Effective     Modified
----------------------------------------------------------------------------------------------------------------
                                       City and Borough of Juneau, Alaska
----------------------------------------------------------------------------------------------------------------
Auke Bay............................  At Smugglers Cove,              None    [caret]25  City and Borough of
                                       approximately 640 feet                             Juneau.
                                       southeast of the
                                       intersection of Fox
                                       Farm Trail and Fritz
                                       Cove Road.
                                      Approximately 550 feet     [caret]25    [caret]27
                                       northeast of the
                                       intersection of Point
                                       Louisa Road and
                                       Glacier Highway.
                                      At the Auke Bay ferry      [caret]22    [caret]29
                                       terminal.
Duck Creek..........................  At the downstream side     [caret]20    [caret]23  City and Borough of
                                       of Radcliffe Road.                                 Juneau.
                                      Approximately 350 feet     [caret]48    [caret]52
                                       upstream of Taku
                                       Boulevard.
East Fork Duck Creek................  Approximately 150 feet     [caret]31    [caret]34  City and Borough of
                                       downstream of Nancy                                Juneau.
                                       Street.
                                      Approximately 200 feet     [caret]31    [caret]34
                                       downstream of Trinity
                                       Drive.
Fritz Cove..........................  At the southern end of          None    [caret]23  City and Borough of
                                       Mendenhall Peninsula.                              Juneau.
                                      Approximately 870 feet          None    [caret]26
                                       south of the
                                       intersection of Fritz
                                       Cove Road and Fox Farm
                                       Trail.
Gastineau Channel, Douglas Island     At the north end of             None    [caret]23  City and Borough of
 Side.                                 Douglas Island,                                    Juneau.
                                       opposite the airport.
                                      At the west end of              None    [caret]25
                                       Douglas Island, west
                                       of North Douglas Road.
                                      At the Paris Creek         [caret]26    [caret]25
                                       confluence.
                                      At the eastern end of      [caret]26    [caret]29
                                       Juneau Island next to
                                       Douglas Marina.
Gastineau Channel, Juneau Side......  Approximately 0.3 mile          None    [caret]25  City and Borough of
                                       southeast of the                                   Juneau.
                                       intersection of
                                       Engineers Cutoff Road
                                       and Mendenhall
                                       Peninsula Road.
                                      Approximately 0.5 mile     [caret]31    [caret]26
                                       southwest of the
                                       intersection of Point
                                       Lena Loop Road and
                                       Towers Road.
                                      At the end of Thane             None    [caret]27
                                       Road, at the Little
                                       Sheep Creek confluence.
                                      Approximately 0.55 mile         None    [caret]28
                                       southeast of the
                                       intersection of Mill
                                       Street and Thane Road.
Jordan Creek........................  Approximately 1,080             None    [caret]25  City and Borough of
                                       feet downstream of                                 Juneau.
                                       Yandukin Drive.
                                      Approximately 0.23 mile    [caret]30    [caret]31
                                       upstream of Egan Drive.
Lemon Creek.........................  Approximately 0.27 mile         None    [caret]23  City and Borough of
                                       downstream of Glacier                              Juneau.
                                       Highway.
                                      Approximately 1.4 miles         None   [caret]106
                                       upstream of Glacier
                                       Highway.
Mendenhall River....................  Approximately 1.14              None    [caret]23  City and Borough of
                                       miles downstream of                                Juneau.
                                       Glacier Highway.
                                      At the upstream side of    [caret]55    [caret]56
                                       Mendenhall Loop Road.

Unnamed Tributary to Duck Creek.....  At the downstream side          None    [caret]42  City and Borough of
                                       of El Camino Street.                               Juneau.
                                      At the upstream side of         None    [caret]46
                                       Mendenhall Loop Road.
----------------------------------------------------------------------------------------------------------------
* National Geodetic Vertical Datum.
+ North American Vertical Datum.
 Depth in feet above ground.
[caret] Mean Lower Low Water.
** BFEs to be changed include the listed downstream and upstream BFEs, and include BFEs located on the stream
 reach between the referenced locations above. Please refer to the revised Flood Insurance Rate Map located at
 the community map repository (see below) for exact locations of all BFEs to be changed.

Send comments to Luis Rodriguez, Chief, Engineering Management Branch, Federal Insurance and Mitigation
 Administration, Federal Emergency Management Agency, 500 C Street, SW., Washington, DC 20472.

                                                    ADDRESSES
City and Borough of Juneau
Maps are available for inspection at 155 South Seward Street, Juneau, AK 99801.

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

(Catalog of Federal Domestic Assistance No. 97.022, ``Flood
Insurance.'')

    Dated: February 7, 2011.
Sandra K. Knight,
Deputy Federal Insurance and Mitigation Administrator, Mitigation,
Department of Homeland Security, Federal Emergency Management Agency.
[FR Doc. 2011-3508 Filed 2-15-11; 8:45 am]
BILLING CODE 9110-12-P


[Federal Register: November 20, 2008 (Volume 73, Number 225)]
[Rules and Regulations]
[Page 70276]
[DOCID:fr20no08-13]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520

[Docket No. FDA-2008-N-0039]

Oral Dosage Form New Animal Drugs; Amprolium; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Correcting amendments.

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SUMMARY: The Food and Drug Administration (FDA) is correcting a
document amending the animal drug regulations to reflect approval of a
supplemental new animal drug application (NADA) that appeared in the
Federal Register of August 6, 2008 (73 FR 45610). FDA is correcting a
paragraph designating the sponsors of approved applications for oral
dosage forms of amprolium. This correction is being made to improve the
accuracy of the animal drug regulations.

DATES: This rule is effective November 20, 2008.

FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for
Veterinary Medicine (HFV-6), Food and Drug Administration, 7519
Standish Pl., Rockville, MD 20855,<PHONE_NUMBER>, e-mail:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: For reasons set forth in this preamble, FDA
is correcting 21 CFR part 520 as follows:

List of Subjects in 21 CFR Part 520

    Animal drugs.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under the
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR part 520 is
corrected by making the following amendment:

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 520 continues to read as
follows:

    Authority: 21 U.S.C. 360b.

Sec.  520.100  [Corrected]

0
2. In Sec.  520.100(b)(2), remove ``Nos. 051311 and 066104'' and add in
its place ``No. 66104''.

    Dated: October 17, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8-27646 Filed 11-19-08; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register: July 27, 2010 (Volume 75, Number 143)]
[Notices]
[Page 43981-43983]
[DOCID:fr27jy10-89]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2009-0332; FRL-8838-6]

Methyl Parathion; Rescision of Previously Issued Order and
Issuance of Revised Cancellation Order for Certain Pesticide
Registrations

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces EPA's rescision of a previously issued
cancellation order and provides a revised cancellation order,
voluntarily requested by the registrants and accepted by the Agency, of
products containing methyl parathion, pursuant to section 6(f)(1) of
the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), as
amended. This revised cancellation order rescinds a July 16, 2010
Federal Register Notice which incorrectly stated the effective date of
the cancellations of the product registrations listed in Table 1 of
Unit II. This order correctly identifies the effective dates of
cancellation for the affected product registrations. In addition, this
order clarifies the existing

stocks provisions. These are the last products containing this
pesticide registered for use in the United States. In the April 28,
2010 Federal Register Notice of Receipt of Requests from the
registrants listed in Table 2 of Unit II. to voluntarily cancel all
these product registrations, EPA indicated that it would issue an order
implementing the cancellations, unless the Agency received substantive
comments within the 30 day comment period that would merit its further
review of these requests, or unless the registrants withdrew their
requests. The Agency received two comments on the notice but none
merited the denial or the further review of the requests. Further, the
registrants did not withdraw their requests. Accordingly, EPA hereby
issues in this notice a cancellation order granting the requested
cancellations. Any distribution, sale, or use of the products subject
to this cancellation order is permitted only in accordance with the
terms of this order, including any existing stocks provisions.

DATES: The cancellations are effective December 31, 2012.

FOR FURTHER INFORMATION CONTACT: Kelly Ballard, Pesticide Re-evaluation
Division (7508P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>; e-
mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

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

B. How Can I Get Copies of this Document and Other Related Information?

    EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2009-0332. 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 Bldg.), 2777 S. Crystal Dr., Arlington,
VA. The hours of operation of this Docket Facility are from 8:30 a.m.
to 4 p.m., Monday through Friday, excluding legal holidays. The Docket
Facility telephone number is<PHONE_NUMBER>.

II. What Action is the Agency Taking?

    This revised cancellation order rescinds a July 16, 2010 Federal
Register Notice (75 FR 41482) which incorrectly stated the effective
date of the cancellations of the product registrations listed in Table
1 of Unit II and issues a revised order for the cancellation of methyl
parathion products. This order correctly identifies the effective dates
of cancellation for the affected product registrations. In addition,
this order clarifies the existing stocks provisions.
    The cancellation order for methyl parathion products, issued in the
Federal Register on July 16, 2010 is rescinded. This notice announces
the cancellations as requested by registrants, of methyl parathion
products registered under section 3 of FIFRA. These registrations are
listed in sequence by registration number in Table 1 of this unit.

             Table 1.--Methyl Parathion Product Cancellations
------------------------------------------------------------------------
          EPA Registration Number                   Product Name
------------------------------------------------------------------------
4787-33                                     Cheminova Methyl Parathion
                                             Technical
------------------------------------------------------------------------
67760-43                                    Cheminova Methyl Parathion 4
                                             EC
------------------------------------------------------------------------
70506-193                                   PENNCAP-M Microencapsulated
                                             Insecticide
------------------------------------------------------------------------

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

               Table 2.--Registrants of Cancelled Products
------------------------------------------------------------------------
            EPA Company Number                Company Name and  Address
------------------------------------------------------------------------
4787                                        Cheminova A/S
                                            1600 Wilson Boulevard,
                                            Suite 700
                                            Arlington, VA 22209
------------------------------------------------------------------------
67760                                       Cheminova, Inc.
                                            1600 Wilson Boulevard,
                                            Suite 700
                                            Arlington, VA 22209
------------------------------------------------------------------------
70506                                       United Phosphorus
                                            630 Freedom Business Center,
                                            Suite 402
                                            King of Prussia, PA 19406
------------------------------------------------------------------------

III. Summary of Public Comments Received and Agency Response to
Comments

    EPA received two comments from the general public. The first
comment was from the Independent Scientific Research Advocates, and
refers to the toxicity issues of organophosphates as a class of
chemicals, and does not specifically refer to this cancellation action
for methyl parathion. The second comment was from the USA Rice
Federation, and notes the concern over the loss of methyl parathion.
USA Rice would like EPA to expedite a replacement chemical for methyl
parathion, and would support the expedition. The Agency does not
believe that the comments submitted during the comment period merit
further review for the purpose of this order or for a denial of the
requests for voluntary cancellation.

 IV. Cancellation Order

    Pursuant to FIFRA section 6(f), EPA hereby approves the requested
cancellations of methyl parathion registrations identified in Table 1
of Unit II. Accordingly, the Agency hereby orders that the product
registrations identified in Table 1 of Unit II. are canceled. The
effective date of the cancellations that are subject of this notice is
December 31, 2012. Any distribution, sale, or use of existing stocks of
the products identified in Table 1 of Unit II. in a manner inconsistent
with any of the provisions for disposition of existing stocks set forth
in Unit VI. will be a violation of FIFRA.

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

    Section 6(f)(1) of FIFRA provides that a registrant of a pesticide
product may at any time request that any of its pesticide registrations
be canceled or amended to terminate one or more uses. FIFRA further
provides that, before acting on the request, EPA must publish

a notice of receipt of any such request in the Federal Register.
Thereafter, following the public comment period, the EPA Administrator
may approve such a request. The notice of receipt for this action was
published for comment on April 28, 2010 (75 FR 22402-22404) (FRL-8822-
6). The comment period closed on May 28, 2010.

VI. Provisions for Disposition of Existing Stocks

     Existing stocks are those stocks of registered pesticide products
which are currently in the United States and which were packaged,
labeled, and released for shipment prior to the effective date of the
action. The existing stocks provision for the products subject to this
order is specified in the Memorandum of Agreement between the EPA and
registrants listed in Table 2 (www.regulations.gov_EPA-HQ-OPP-2009-
0010). The existing stocks provision is as follows: All sale,
distribution and use of existing stocks of manufacturing-use products
imported into the United States shall be prohibited as of December 31,
2012. In addition, as of December 31, 2012, all sale, distribution, and
use of existing stocks of manufacturing-use products shall be
prohibited unless the sale, distribution, or use is for purposes of
export consistent with section 17 of FIFRA or for proper disposal.
Registrants are prohibited from selling or distributing end-use
products as of December 31, 2012, except for end-use products intended
for export consistent with the requirements of section 17 of FIFRA, or
for proper disposal. Persons other than the registrants are permitted
to sell or distribute end-use products prior to August 31, 2013. All
sale and distribution of end-use products shall be prohibited as of
August 31, 2013, except for export consistent with section 17 of FIFRA
or for proper disposal. Additionally, all use of existing stocks of the
end-use products shall be prohibited as of December 31, 2013, except
for products intended for export consistent with the requirements of
section 17 of FIFRA or proper disposal. Finally, as of the effective
date of this cancellation order, any permitted use of existing stocks
is expressly conditioned upon such use being consistent with the terms
of the previously approved labeling on or that accompanied the
cancelled product.

List of Subjects

    Environmental protection, Pesticides and pests.

    Dated: July 20, 2010.
Richard P. Keigwin, Jr.,
Director, Pesticide Re-evaluation Division, Office of Pesticide
Programs.
[FR Doc. 2010-18380 Filed 7-26-10; 8:45 am]
BILLING CODE 6560-50-S


[Federal Register Volume 81, Number 231 (Thursday, December 1, 2016)]
[Rules and Regulations]
[Pages 86581-86586]
[FR Doc No: 2016-28873]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2015-0412; FRL-9950-89]

Quizalofop Ethyl; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
quizalofop ethyl in or on crayfish and rice grain. Nissan Chemical
Industries, Ltd. requested these tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective December 1, 2016. Objections and
requests for hearings must be received on or before January 30, 2017,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2015-0412, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m.,

Monday through Friday, excluding legal holidays. The telephone number
for the Public Reading Room is<PHONE_NUMBER>, and the telephone number
for the OPP Docket is<PHONE_NUMBER>. Please review the visitor
instructions and additional information about the docket available at
http://www.epa.gov/dockets.

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

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

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

    You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. To access the OCSPP
test guidelines referenced in this document electronically, please go
to http://www.epa.gov/test-guidelines-pesticides-and-toxic-substances.

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2015-0412 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
January 30, 2017. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2015-0412, by one of
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of August 26, 2015 (80 FR 51759) (FRL-9931-
74), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
5F8367) by Lewis and Harrison, LLC, 122 C St. NW., Suite 505,
Washington, DC 20001 (on behalf of Nissan Chemical Industries, Ltd., 7-
1, 3-chome, Kanda-Nishiki-cho, Chiyoda-ku, Tokyo 101-0054, Japan). The
petition requested that 40 CFR 180.441 be amended by establishing
tolerances for residues of the herbicide quizalofop-p-ethyl ester,
ethyl-(R)-(2-(4-((6-chloroquinoxalin-2-yl)oxy)phenoxy)propanoate), and
its acid metabolite quizalofop-P, R-(2-(4-((6-quinoxalin-2-
yl)oxy)phenoxy)propanoic acid, and the S enantiomers of both the ester
and the acid, all expressed as quizalofop-P-ethyl ester, in or on
crayfish at 0.04 parts per million (ppm) and rice, grain at 0.05 ppm.
That document referenced a summary of the petition prepared by Nissan
Chemical Industries, Ltd., the registrant, which is available in the
docket, http://www.regulations.gov. There were no comments received in
response to the notice of filing.
    Based upon review of the data supporting the petition, EPA changed
the tolerance expression for rice grain and corrected the commodity
definition for crayfish. The reasons for these changes are explained in
Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

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

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children.
    Quizalofop ethyl is a 50/50 racemic mixture of R- and S-
enantiomers. Quizalofop-P-ethyl, the purified R-

enantiomer, is the pesticidally-active isomer. Since the toxicological
profiles of quizalofop ethyl and quizalofop-P-ethyl are similar, the
available toxicity studies are adequate to support both compounds. For
the purposes of this final rule, both quizalofop ethyl and quizalofop-
P-ethyl are collectively referred to as ``quizalofop ethyl''.
    Quizalofop ethyl has very low acute toxicity via the oral, dermal,
and inhalation routes of exposure, is not an eye or skin irritant, and
is not a skin sensitizer. There were no adverse effects observed in the
oral toxicity studies that could be attributable to a single-dose
exposure.
    Repeated-dose toxicity studies indicate the liver as the target
organ, as evidenced by increased liver weights and histopathological
changes. Following oral administration, quizalofop ethyl is rapidly
excreted via urine and feces. In the subchronic oral toxicity rat
study, effects of decreased body weight gains, increased liver weight,
and centrilobular liver cell enlargement were observed. In the
subchronic oral toxicity dog study, an increased incidence of
testicular atrophy was observed. In the combined chronic toxicity/
carcinogenicity study in rats, an increased incidence of centrilobular
liver cell enlargement was observed in both sexes and mild anemia in
males.
    No dermal toxicity effects were observed in the subchronic dermal
toxicity rabbit study at up to the limit dose. Subchronic inhalation
toxicity is assumed to be equivalent to oral toxicity. In the chronic
oral toxicity dog study, no toxicity effects were observed at the
highest dose tested (HDT).
    In the rat and rabbit developmental toxicity studies, maternal
effects including decreased body weight gains and food consumption were
observed; no developmental effects were observed at up to the HDT. In
the two-generation reproduction toxicity study in rats, maternal
effects including decreased body weight and body weight gains were
observed at the same dose level that resulted in prenatal and postnatal
effects (decreased percentage of pups born alive and decreased pup
weights).
    Although tumors were observed in male and female mice after
exposure to quizalofop, the overall evidence for carcinogenicity is
weak, as discussed in supporting documents. Additionally, the point of
departure used for establishing the chronic reference dose for
quizalofop is significantly lower (30X) than the dose that induced
tumors in male and female mice. EPA has determined that quantification
of cancer risk using a non-linear approach would adequately account for
all chronic toxicity, including carcinogenicity, which could result
from exposure to quizalofop ethyl.
    Quizalofop ethyl does not show evidence of neurotoxicity, based on
no evidence of neurotoxicity or neuropathology in the available
toxicology studies. There was also no evidence of adverse effects on
the functional development of pups observed in the rat reproduction
toxicity study. Quizalofop ethyl showed no evidence of immunotoxicity.
    Specific information on the studies received and the nature of the
adverse effects caused by quizalofop ethyl as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document, ``Quizalofop-P-ethyl. Human Health
Risk Assessment in Support of the Proposed New Use on Rice'' in docket
ID number EPA-HQ-OPP-2015-0412.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which the NOAEL and the LOAEL are identified.
Uncertainty/safety factors (UF) are used in conjunction with the POD to
calculate a safe exposure level--generally referred to as a population-
adjusted dose (PAD) or a reference dose (RfD)--and a safe margin of
exposure (MOE). For non-threshold risks, the Agency assumes that any
amount of exposure will lead to some degree of risk. Thus, the Agency
estimates risk in terms of the probability of an occurrence of the
adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www.epa.gov/pesticides-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
    A summary of the toxicological endpoints for quizalofop ethyl used
for human risk assessment is shown in Table 1 of this unit.

     Table 1--Summary of Toxicological Doses and Endpoints for Quizalofop Ethyl for Use in Human Health Risk
                                                   Assessment
----------------------------------------------------------------------------------------------------------------
                                        Point of departure and
          Exposure/scenario               uncertainty/safety     RfD, PAD, LOC for risk         Study and
                                               factors                 assessment         toxicological effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (all populations)......       No hazard attributable to a single-dose exposure was identified.
                                      --------------------------------------------------------------------------
Chronic dietary (all populations)....  NOAEL = 0.9 mg/kg/day..  Chronic RfD = 0.009 mg/  Combined Chronic
                                       UFA = 10x..............   kg/day.                  Toxicity/
                                       UFH = 10x..............  cPAD = 0.009 mg/kg/day.   Carcinogenicity Rat
                                       FQPA SF = 1x...........                            Study
                                                                                LOAEL = 3.7 mg/kg/day
                                                                                based on mild anemia
                                                                                in males and increased
                                                                                number of liver masses
                                                                                and centrilobular
                                                                                enlargement of the
                                                                                liver in both sexes
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. mg/kg/day =
  milligram/kilogram/day. NOAEL = no-observed-adverse-effect-level. PAD = population adjusted dose (a = acute, c
  = chronic). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human
  (interspecies). UFH = potential variation in sensitivity among members of the human population (intraspecies).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to quizalofop ethyl, EPA considered exposure under the
petitioned-for tolerances as well as all existing quizalofop ethyl
tolerances in 40 CFR 180.441. EPA assessed dietary exposures from
quizalofop ethyl in food as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a one-day or single exposure. No such effects were
identified in the toxicological studies for quizalofop ethyl;
therefore, a quantitative acute dietary exposure assessment is
unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 2003-2008
National Health and Nutrition Examination Survey, What We Eat in
America (NHANES/WWEIA). As to residue levels in food, EPA incorporated
tolerance-level residues, 100 percent crop treated (PCT) for all
commodities, and default processing factors for all processed
commodities except sunflower oil.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that quizalofop ethyl does not pose a cancer risk to humans.
Therefore, a dietary exposure assessment for the purpose of assessing
cancer risk is unnecessary.
    iv. Anticipated residue and percent crop treated (PCT) information.
EPA did not use anticipated residue and/or PCT information in the
dietary assessment for quizalofop ethyl. Tolerance level residues and/
or 100 PCT were assumed for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for quizalofop ethyl in drinking water. These simulation
models take into account data on the physical, chemical, and fate/
transport characteristics of quizalofop ethyl. Further information
regarding EPA drinking water models used in pesticide exposure
assessment can be found at http://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    Based on the Modified Tier 1 Rice Model and Pesticide Root Zone
Model Ground Water (PRZM GW) model, the estimated drinking water
concentrations (EDWCs) of quizalofop ethyl for chronic exposures for
non-cancer assessments are estimated to be 127 parts per billion (ppb)
for surface water and 89 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For chronic dietary risk
assessment, the water concentration value of 127 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). Quizalofop ethyl is
not registered for any specific use patterns that would result in
residential exposure.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
    EPA has not found quizalofop ethyl to share a common mechanism of
toxicity with any other substances, and quizalofop ethyl does not
appear to produce a toxic metabolite produced by other substances. For
the purposes of this tolerance action, therefore, EPA has assumed that
quizalofop ethyl does not have a common mechanism of toxicity with
other substances. For information regarding EPA's efforts to determine
which chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's Web site at http://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the Food Quality
Protection Act Safety Factor (FQPA SF). In applying this provision, EPA
either retains the default value of 10X, or uses a different additional
safety factor when reliable data available to EPA support the choice of
a different factor.
    2. Prenatal and postnatal sensitivity. As summarized in Unit
III.A., results from the rat and rabbit developmental toxicity and the
two-generation rat reproduction toxicity studies indicated no
qualitative or quantitative evidence of increased susceptibility in
developing fetuses or in the offspring following prenatal and/or
postnatal exposure to quizalofop ethyl.
    3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X. That decision is based on the following
findings:
    i. The toxicity database for quizalofop ethyl is complete.
    ii. There is no indication that quizalofop ethyl is a neurotoxic
chemical and there is no need for a developmental neurotoxicity study
or additional UFs to account for neurotoxicity.
    iii. There is no qualitative or quantitative evidence that
quizalofop ethyl results in increased susceptibility in in utero rats
or rabbits in the prenatal developmental studies or in young rats in
the two-generation reproduction study.
    iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100 PCT and tolerance-level residues. EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to quizalofop ethyl in drinking water. These
assessments will not underestimate the exposure and risks posed by
quizalofop ethyl.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists. Since there are no residential uses for quizalofop
ethyl, the aggregate risk assessment only includes exposure estimates
from dietary consumption of food and drinking water.
    1. Acute risk. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary

consumption of food and drinking water. No adverse effect resulting
from a single-dose exposure was identified and no acute dietary
endpoint was selected. Therefore, quizalofop ethyl is not expected to
pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
quizalofop ethyl from food and water will utilize 97% of the cPAD for
all infants less than 1 year old, the population group receiving the
greatest exposure.
    3. Short- and intermediate-term risk. Short- and intermediate-term
aggregate exposure takes into account short- and intermediate-term
residential exposure plus chronic exposure to food and water
(considered to be a background exposure level). Because there are no
residential uses, quizalofop ethyl is not expected to pose short- or
intermediate-term risk.
    4. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, quizalofop ethyl is not expected to pose a cancer risk to
humans.
    5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to quizalofop ethyl residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodologies (Modified Meth-147, liquid
chromatography-mass spectrometry/mass spectrometry (LC-MS/MS) for plant
commodities including rice; Modified BASF Method Number D1416 (LC-MS/
MS) for crustaceans; and AMR-515-86, AMR-623-86, AMR-627-86, AMR-845-
87, and AMR-846-87, all High Performance Liquid Chromotography (HPLC)
methods using ultraviolet detection for livestock commodities) are
available to enforce the tolerance expression.
    The methods may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level. The Codex has not
established a MRL for quizalofop ethyl.

C. Revisions to Petitioned-For Tolerances

    EPA changed the proposed tolerance expression for rice grain from
the detection of ``quizalofop-P-ethyl and its acid metabolite
quizalofop-P, and the S enantiomers of both the ester and the acid, all
expressed as quizalofop-P-ethyl ester'' to ``quizalofop ethyl residues
convertible to 2-methoxy-6-chloroquinoxaline, expressed as the
stoichiometric equivalent of quizalofop ethyl'' to match the expression
of the other existing plant commodities since the same common moiety
analytical method is used for enforcement. EPA also changed the
proposed commodity name from ``crayfish'' to the correct definition of
``fish-shellfish, crustacean''.

V. Conclusion

    Therefore, tolerances are established for residues of quizalofop
ethyl in or on fish-shellfish, crustacean at 0.04 ppm and rice, grain
at 0.05 ppm.

VI. Statutory and Executive Order Reviews

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

VII. Congressional Review Act

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

List of Subjects in 40 CFR Part 180

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

    Dated: November 10, 2016.
Michael Goodis,
Acting Director, Registration Division, Office of Pesticide Programs.
    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

0
2. In Sec.  180.441:
0
a. Add alphabetically the commodity in the table in paragraph (a)(1).
0
b. Add paragraph (a)(3).
    The additions read as follows:

Sec.  180.441  Quizalofop ethyl; tolerances for residues.

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

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

                                * * * * *
Rice, grain............................................            0.05

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

* * * * *
    (3) Tolerances are established for residues of the herbicide
quizalofop-P-ethyl, including its metabolites and degradates, in or on
the commodities in the following table. Compliance with the tolerance
levels specified in the following table is to be determined by
measuring quizalofop ethyl and quizalofop acid, expressed as the
stoichiometric equivalent of quizalofop ethyl, in or on the commodity.

------------------------------------------------------------------------
                                                            Parts per
                       Commodity                             million
------------------------------------------------------------------------
Fish-shellfish, crustacean.............................            0.04
------------------------------------------------------------------------

* * * * *

[FR Doc. 2016-28873 Filed 11-30-16; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 76, Number 35 (Tuesday, February 22, 2011)]
[Notices]
[Pages 9861-9862]
[FR Doc No: 2011-3899]

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

DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2000-7363; FMCSA-2000-7918; FMCSA-2006-24015; FMCSA-
25246]

Qualification of Drivers; Exemption Applications; Vision

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of renewal of exemptions; request for comments.

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

SUMMARY: FMCSA announces its decision to renew the exemptions from the
vision requirement in the Federal Motor Carrier Safety Regulations for
9 individuals. FMCSA has statutory authority to exempt individuals from
the vision requirement if the exemptions granted will not compromise
safety. The Agency has concluded that granting these exemption renewals
will provide a level of safety that is equivalent to, or greater than,
the level of safety maintained without the exemptions for these
commercial motor vehicle (CMV) drivers.

DATES: This decision is effective March 7, 2011. Comments must be
received on or before March 24, 2011.

ADDRESSES: You may submit comments bearing the Federal Docket
Management System (FDMS) numbers: FMCSA-2000-7363; FMCSA-2000-7918;
FMCSA-2006-24015; FMCSA-25246, using any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the on-line instructions for submitting
comments.
    Mail: Docket Management Facility; U.S. Department of
Transportation, 1200 New Jersey Avenue, SE., West Building Ground
Floor, Room W12-140, Washington, DC 20590-0001.
     Hand Delivery or Courier: West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue, SE., Washington, DC, between 9 a.m.
and 5 p.m., Monday through Friday, except Federal Holidays.
     Fax: 1-202-493-2251.
    Instructions: Each submission must include the Agency name and the
docket number for this notice. Note that DOT posts all comments
received without change to http://www.regulations.gov, including any
personal information included in a comment. Please see the Privacy Act
heading below.
    Docket: For access to the docket to read background documents or
comments, go to http://www.regulations.gov at any time or Room W12-140
on the ground level of the West Building, 1200 New Jersey Avenue, SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The Federal Docket Management System (FDMS) is
available 24 hours each day, 365 days each year. If you want
acknowledgment that we received your comments, please include a self-
addressed, stamped envelope or postcard or print the acknowledgement
page that appears after submitting comments on-line.
    Privacy Act: Anyone may search the electronic form of all comments
received into any of our dockets by the name of the individual
submitting the comment (or of the person signing the comment, if
submitted on behalf of an association, business, labor union, etc.).
You may review DOT's Privacy Act Statement for the FDMS published in
the Federal Register on January 17, 2008 (73 FR 3316), or you may visit
http://edocket.access.gpo.gov/2008/pdf/E8-785.pdf.

FOR FURTHER INFORMATION CONTACT: Dr. Mary D. Gunnels, Director, Medical
Programs,<PHONE_NUMBER><EMAIL_ADDRESS>FMCSA, Department of
Transportation, 1200 New Jersey Avenue, SE., Room W64-224, Washington,
DC 20590-0001. Office hours are from 8:30 a.m. to 5 p.m. Monday through
Friday, except Federal holidays.

SUPPLEMENTARY INFORMATION:

Background

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may renew an exemption
from the vision requirements in 49 CFR 391.41(b)(10), which applies to
drivers of CMVs in interstate commerce, for a two-year period if it
finds ``such exemption would likely achieve a level of safety that is
equivalent to, or greater than, the level that would be achieved absent
such exemption.'' The procedures for requesting an exemption (including
renewals) are set out in 49 CFR part 381.

Exemption Decision

    This notice addresses 9 individuals who have requested renewal of
their exemptions in accordance with FMCSA procedures. FMCSA has
evaluated these 9 applications for renewal on their merits and decided
to extend each exemption for a renewable two-year period. They are:

David S. Carman
Thomas G. Danclovic
Glen T. Garrabrant
Alan L. Johnston
James E. Menz
Dennis I. Nelson
Rance A. Powell
Shannon E. Rasmussen
Henry L. Walker

    The exemptions are extended subject to the following conditions:
(1) That each individual has a physical examination every year (a) by
an ophthalmologist or optometrist who attests that the vision in the
better eye continues to meet the standard in 49 CFR 391.41(b)(10), and
(b) by a medical examiner who attests that the individual is otherwise
physically qualified under 49 CFR 391.41; (2) that each individual
provides a copy of the ophthalmologist's or optometrist's report to the
medical examiner at the time of the annual medical examination; and (3)
that each individual provide a copy of the annual medical certification
to the employer for retention in the driver's qualification file and
retains a copy of the certification on his/her person while driving for
presentation to a duly authorized Federal, State, or local enforcement
official. Each exemption will be valid for two years unless rescinded
earlier by FMCSA. The exemption will be rescinded if: (1) The person
fails to comply with the terms and conditions of the exemption; (2) the
exemption has resulted in a lower level of safety than was maintained
before it was granted; or (3) continuation of the exemption would not
be consistent with the goals and objectives of 49 U.S.C. 31136(e) and
31315.

Basis for Renewing Exemptions

    Under 49 U.S.C. 31315(b)(1), an exemption may be granted for no
longer than two years from its approval date and may be renewed upon
application for additional two year periods. In accordance with 49
U.S.C. 31136(e) and 31315, each of the 9 applicants has satisfied the
entry conditions for obtaining an exemption from the vision
requirements (65 FR 45817; 65 FR 66286; 65 FR 77066; 66 FR 13825; 68 FR
10300; 70 FR 7546; 71 FR 14566; 71 FR 30227; 72 FR 180; 72 FR 7111; 72
FR 9397; 73 FR 27014; 74 FR 6211; 74 FR 6212). Each of these 9
applicants has requested renewal of the exemption and has submitted
evidence showing that the vision in the better eye continues to meet
the standard specified at 49 CFR 391.41(b)(10) and that the vision
impairment is stable. In addition, a review of each record of safety
while driving with the respective vision deficiencies over the past two
years indicates each applicant continues to meet the vision exemption
standards. These factors provide an adequate basis for predicting each
driver's ability to continue to drive safely in interstate commerce.
Therefore, FMCSA concludes that extending the exemption for each
renewal applicant for a period of two years is likely to achieve a
level of safety equal to that existing without the exemption.

Request for Comments

    FMCSA will review comments received at any time concerning a
particular driver's safety record and determine if the continuation of
the exemption is consistent with the requirements at 49 U.S.C. 31136(e)
and 31315. However, FMCSA requests that interested parties with
specific data concerning the safety records of these drivers submit
comments by March 24, 2011.
    FMCSA believes that the requirements for a renewal of an exemption
under 49 U.S.C. 31136(e) and 31315 can be satisfied by initially
granting the renewal and then requesting and evaluating, if needed,
subsequent comments submitted by interested parties. As indicated
above, the Agency previously published notices of final disposition
announcing its decision to exempt these 9 individuals from the vision
requirement in 49 CFR 391.41(b)(10). The final decision to grant an
exemption to each of these individuals was made on the merits of each
case and made only after careful consideration of the comments received
to its notices of applications. The notices of applications stated in
detail the qualifications, experience, and medical condition of each
applicant for an exemption from the vision requirements. That
information is available by consulting the above cited Federal Register
publications.
    Interested parties or organizations possessing information that
would otherwise show that any, or all, of these drivers are not
currently achieving the statutory level of safety should immediately
notify FMCSA. The Agency will evaluate any adverse evidence submitted
and, if safety is being compromised or if continuation of the exemption
would not be consistent with the goals and objectives of 49 U.S.C.
31136(e) and 31315, FMCSA will take immediate steps to revoke the
exemption of a driver.

    Issued on: February 10, 2011.
Larry W. Minor,
Associate Administrator, Office of Policy.
[FR Doc. 2011-3899 Filed 2-18-11; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register Volume 80, Number 220 (Monday, November 16, 2015)]
[Proposed Rules]
[Pages 70727-70728]
[FR Doc No: 2015-28910]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 62

[EPA-R05-OAR-2015-0701; FRL-9936-95-Region 5]

Air Plan Approval; Michigan; Sewage Sludge Incinerators State
Plan and Small Municipal Waste Combustors Negative Declaration for
Designated Facilities and Pollutants

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve

Michigan`s State Plan to control air pollutants from Sewage Sludge
Incinerators (SSI). The Michigan Department of Environmental Quality
submitted the State Plan on September 21, 2015, following the required
public process. The State Plan is consistent with the Emission
Guidelines promulgated by EPA on March 21, 2011. This approval means
that EPA finds that the State Plan meets applicable Clean Air Act
requirements for subject SSI units. Once effective, this approval also
makes the State Plan Federally enforceable. EPA is also announcing that
we have received from Michigan a negative declaration for Small
Municipal Waste Combustors (SMWC). The Michigan Department of
Environmental Quality submitted on July 27, 2015 a negative declaration
certifying that there are no SMWC units currently operating in the
state of Michigan.

DATES: Comments must be received on or before December 16, 2015.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R05-
OAR-2015-0071, by one of the following methods:
    1. www.regulations.gov: Follow the on-line instructions for
submitting comments.
    2. Email<EMAIL_ADDRESS>    3. Fax:<PHONE_NUMBER>.
    4. Mail: Jacqueline Nwia, Acting Chief, Toxics and Global
Atmosphere Section, Air Toxics and Assessment Branch (AT-18J), U.S.
Environmental Protection Agency, 77 West Jackson Boulevard, Chicago,
Illinois 60604.
    5. Hand Delivery: Jacqueline Nwia, Acting Chief, Toxics and Global
Atmosphere Section, Air Toxics and Assessment Branch (AT-18J), U.S.
Environmental Protection Agency, 77 West Jackson Boulevard, Chicago,
Illinois 60604. Such deliveries are only accepted during the Regional
Office normal hours of operation, and special arrangements should be
made for deliveries of boxed information. The Regional Office official
hours of business are Monday through Friday, 8:30 a.m. to 4:30 p.m.
excluding Federal holidays.
    Please see the direct final rule which is located in the Rules
section of this Federal Register for detailed instructions on how to
submit comments.

FOR FURTHER INFORMATION CONTACT: Margaret Sieffert, Environmental
Engineer, Environmental Protection Agency, Region 5, 77 West Jackson
Boulevard (AT-18J), Chicago, Illinois 60604,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In the Rules section of this Federal
Register, EPA is approving through a direct final rulemaking Michigan's
State Plan for control of air pollutants from SSI sources, and is
amending 40 CFR part 62 to reflect the State's submittal of the
negative declaration as a direct final rule without prior proposal
because the Agency views this as a noncontroversial submittal and
anticipates no adverse comments. A detailed rationale for the approval
is set forth in the direct final rule. If no adverse comments are
received in response to this rule, no further activity is contemplated.
If EPA receives adverse comments, we will withdraw the direct final
rule and will address all public comments in a subsequent final rule
based on this proposed rule. EPA will not institute a second comment
period. Any parties interested in commenting on this action should do
so at this time. Please note that if EPA receives adverse comment on an
amendment, paragraph, or section of this rule, and if that provision
can be severed from the remainder of the rule, EPA may adopt as final
those provisions of the rule that are not the subject of an adverse
comment. For additional information, see the direct final rule which is
located in the Rules section of this Federal Register.

    Dated: October 29, 2015.
Susan Hedman,
Regional Administrator, Region 5.
[FR Doc. 2015-28910 Filed 11-13-15; 8:45 am]
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[Federal Register Volume 83, Number 28 (Friday, February 9, 2018)]
[Notices]
[Pages 5785-5786]
[FR Doc No: 2018-02667]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0369]

Product-Specific Guidances; Draft and Revised Draft Guidances for
Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of additional draft and revised draft product-specific
guidances. The guidances provide product-specific recommendations on,
among other things, the design of bioequivalence (BE) studies to
support abbreviated new drug applications (ANDAs). In the Federal
Register of June 11, 2010, FDA announced the availability of a guidance
for industry entitled ``Bioequivalence Recommendations for Specific
Products'' that explained the process that would be used to make
product-specific guidances available to the public on FDA's website.
The guidances identified in this notice were developed using the
process described in that guidance.

DATES: Submit either electronic or written comments on the draft
guidance by April 10, 2018 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

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

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2007-D-0369 for ``Product-Specific Guidances; Draft and Revised
Draft Guidances for Industry.'' Received comments will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For

more information about FDA's posting of comments to public dockets, see
80 FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidances to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance documents.

FOR FURTHER INFORMATION CONTACT: Xiaoqiu Tang, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 4730, Silver Spring, MD 20993-0002, 301-
796-5850.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of June 11, 2010 (75 FR 33311), FDA
announced the availability of a guidance for industry entitled
``Bioequivalence Recommendations for Specific Products'' that explained
the process that would be used to make product-specific guidances
available to the public on FDA's website at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.
    As described in that guidance, FDA adopted this process as a means
to develop and disseminate product-specific guidances and provide a
meaningful opportunity for the public to consider and comment on those
guidances. Under that process, draft guidances are posted on FDA's
website and announced periodically in the Federal Register. The public
is encouraged to submit comments on those recommendations within 60
days of their announcement in the Federal Register. FDA considers any
comments received and either publishes final guidances or publishes
revised draft guidances for comment. Guidances were last announced in
the Federal Register on October 20, 2017. This notice announces draft
product-specific guidances, either new or revised, that are posted on
FDA's website.

II. Drug Products for Which New Draft Product-Specific Guidances Are
Available

    FDA is announcing the availability of new draft product-specific
guidances for industry for drug products containing the following
active ingredients:

                       Table 1--New Draft Product-
                  Specific Guidances for Drug Products
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Alcaftadine.
Amitriptyline hydrochloride; Chlordiazepoxide.
Amphetamine sulfate.
Barium sulfate (multiple Reference Listed Drugs).
Betamethasone dipropionate.
Bimatoprost (multiple Reference Listed Drugs).
Bupivacaine.
Buprenorphine hydrochloride.
Cabozantinib S-malate (multiple Reference Listed Drugs).
Crisaborole.
Desonide.
Doxycycline hyclate.
Fluocinonide.
Hydrocortisone valerate.
Ixazomib citrate.
Ketoconazole.
Leuprolide acetate; Norethindrone acetate.
Levetiracetam.
Levocetirizine dihydrochloride.
Loteprednol etabonate.
Mebendazole.
Naldemedine tosylate.
Naproxen sodium; Pseudoephedrine hydrochloride.
Niraparib tosylate.
Olopatadine hydrochloride.
Prasterone.
Rucaparib camsylate.
Safinamide mesylate.
Simvastatin; Sitagliptin phosphate.
Soybean oil (multiple Reference Listed Drugs).
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III. Drug Products for Which Revised Draft Product-Specific Guidances
Are Available

    FDA is announcing the availability of revised draft product-
specific guidances for industry for drug products containing the
following active ingredients:

                     Table 2--Revised Draft Product-
                  Specific Guidances for Drug Products
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Aspirin; omeprazole.
Cysteamine bitartrate.
Daclatasvir dihydrochloride.
Dexlansoprazole (multiple Reference Listed Drugs).
Esomeprazole magnesium (multiple Reference Listed Drugs).
Felbamate (multiple Reference Listed Drugs).
Fluconazole.
Gatifloxacin.
Gentamicin sulfate.
Ketorolac tromethamine.
Lansoprazole.
Loteprednol etabonate.
Morphine sulfate.
Naloxegol oxalate.
Oxycodone.
Pantoprazole sodium.
Potassium citrate.
Sulfamethoxazole; Trimethoprim.
Triamcinolone acetonide.
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    For a complete history of previously published Federal Register
notices related to product-specific guidances, go to https://www.regulations.gov and enter Docket No. FDA-2007-D-0369.
    These draft guidances are being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). These draft guidances,
when finalized, will represent the current thinking of FDA on, among
other things, the product-specific design of BE studies to support
ANDAs. They do not establish any rights for any person and are not
binding on FDA or the public. You can use an alternative approach if it
satisfies the requirements of the applicable statutes and regulations.
This guidance is not subject to Executive Order 12866.

IV. Electronic Access

    Persons with access to the internet may obtain the draft guidances
at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or
https://www.regulations.gov.

    Dated: February 5, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-02667 Filed 2-8-18; 8:45 am]
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