[Federal Register: March 19, 2008 (Volume 73, Number 54)]
[Notices]
[Page 14805-14806]
[DOCID:fr19mr08-55]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2008-0172; FRL-8355-2]

Notice of Filing of a Pesticide Petition for Residues of
Pesticide Chemicals in or on Various Commodities

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the initial filing of a pesticide
petition proposing the establishment or modification of regulations for
residues of pesticide chemicals in or on various commodities.

DATES: Comments must be received on or before April 18, 2008.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2008-0172, and the pesticide petition number (PP
8F7317), by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket Facility telephone number is<PHONE_NUMBER>.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2008-0172. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line 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 regulations.gov or e-
mail. The regulations.gov website 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 regulations.gov,
your e-mail address will be automatically captured and included as part
of the comment that is placed in the docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the docket index
available in regulations.gov. To access the electronic docket, go to
http://www.regulations.gov, select ``Advanced Search,'' then ``Docket
Search.'' Insert the docket ID number where indicated and select the
``Submit'' button. Follow the instructions on the regulations.gov
website to view the docket index or access available documents.
Although listed in the index, some information is not publicly
available, e.g., CBI or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy 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 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 (703)
305-5805.

FOR FURTHER INFORMATION CONTACT: Todd Peterson, Biopesticides and
Pollution Prevention Division (7511P), 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. What Should I Consider as I Prepare My Comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through
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:
    i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
    ii. 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.
    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.

    vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period
deadline identified.

II. What Action is the Agency Taking?

    EPA is printing notice of the filing of a pesticide petition
received under section 408 of the Federal Food, Drug, and Cosmetic Act
(FFDCA), 21 U.S.C. 346a, proposing the establishment or modification of
regulations in 40 CFR part 180 for residues of pesticide chemicals in
or on various food commodities. EPA has determined that the pesticide
petition described in this notice contains data or information
regarding the elements set forth in FFDCA section 408(d)(2); however,
EPA has not fully evaluated the sufficiency of the submitted data at
this time or whether the data supports granting of the pesticide
petition. Additional data may be needed before EPA rules on this
pesticide petition.
    Pursuant to 40 CFR 180.7(f), a summary of the petition included in
this notice, prepared by the petitioner, is included in a docket EPA
has created for this rulemaking. The docket for this petition is
available on-line at http://www.regulations.gov.

New Exemption from Tolerance

    PP 8F7317. Stratacor Inc., 1315 South 46th Street, Bldg. 154,
Richmond, CA 94804, proposes to establish an exemption from the
requirement of a tolerance for residues of the insect repellent, [C8-
C10 n-carboxylic acids (octanoic acid, nonanoic acid, and decanoic
acid)], in or on food commodity beef and dairy cattle, and horses.
Because this petition is a request for an exemption from the
requirement of a tolerance without numerical limitations, no analytical
method is required.

List of Subjects

    Environmental protection, Agricultural commodities, Feed additives,
Food additives, Pesticides and pests, Reporting and recordkeeping
requirements.

    Dated: March 7, 2008.
Janet L. Andersen,
Director, Biopesticides and Pollution Prevention Division, Office of
Pesticide Programs.

[FR Doc. E8-5555 Filed 3-18-08; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register Volume 87, Number 29 (Friday, February 11, 2022)]
[Rules and Regulations]
[Page 7964]
[FR Doc No: 2022-03043]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

49 CFR Part 571

Federal Motor Vehicle Safety Standards

CFR Correction

    This rule is being published by the Office of the Federal Register
to correct an editorial or technical error that appeared in the most
recent annual revision of the Code of Federal Regulations.

0
In Title 49 of the Code of Federal Regulations, Parts 400 to 571,
revised as of October 1, 2021, in Sec.  571.108, remove S5.1 and S5.2.

[FR Doc. 2022-03043 Filed 2-10-22; 8:45 am]
BILLING CODE 0099-10-D


[Federal Register Volume 85, Number 159 (Monday, August 17, 2020)]
[Rules and Regulations]
[Pages 49947-49949]
[FR Doc No: 2020-17865]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2020-0717; Product Identifier 2019-CE-038-AD; Amendment
39-21196; AD 2020-16-12]
RIN 2120-AA64

Airworthiness Directives; Pacific Aerospace Limited Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule; request for comments.

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SUMMARY: The FAA is adopting a new airworthiness directive (AD) for
Pacific Aerospace Limited Model 750XL airplanes. This AD results from
mandatory continuing airworthiness information (MCAI) issued by the
aviation authority of another country to identify and correct an unsafe
condition on an aviation product. The MCAI describes the unsafe
condition as inadvertent fuel shut-off to the engine during the
operation of the flaps due to the fuel and flap control levers being
located too closely together. The FAA is issuing this AD to address the
unsafe condition on these products.

DATES: This AD is effective September 8, 2020.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in the AD as of September 8,
2020.
    The FAA must receive comments on this AD by October 1, 2020.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to https://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
    For service information identified in this AD, contact Pacific
Aerospace Limited, Airport Road, Hamilton, Private Bag 3027, Hamilton
3240, New Zealand; telephone: +64 7 843 6144; facsimile: +64 7 843
6134; email<EMAIL_ADDRESS>internet: https://www.aerospace.co.nz. You may view this referenced service information
at the FAA, Airworthiness Products Section, Operational Safety Branch,
901 Locust, Kansas City, Missouri 64106. For information on the
availability of this material at the FAA, call<PHONE_NUMBER>. It is
also available on the internet at https://www.regulations.gov by
searching for Docket No. FAA-2020-0717.

Examining the AD Docket

    You may examine the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2020-
0717; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this AD, the regulatory evaluation, any comments received, and other
information. The street address for Docket Operations is listed above.
Comments will be available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Mike Kiesov, Aerospace Engineer, FAA,
General Aviation & Rotorcraft Section, International Validation Branch,
901 Locust, Room 301, Kansas City, Missouri 64106; telephone: (816)
329-4144; fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    The Civil Aviation Authority (CAA), which is the aviation authority
for New Zealand, has issued AD DCA/750XL/39, dated September 5, 2019
(referred to after this as ``the MCAI''), to correct an unsafe
condition for Pacific Aerospace Limited Model 750XL airplanes. The MCAI
states:

    DCA/750XL/39 with effective date 5 September 2019 is prompted by
the findings of an accident investigation. The report recommended
that an effective lock mechanism should be introduced for the fuel
condition lever in order to prevent inadvertent fuel shut-off to the
engine during the operation of the flaps, as the fuel and flap
control levers are closely located.

    Pacific Aerospace Mandatory Service Bulletin (MSB) PACSB/XL/111
issue 1, dated 18 June 2019 introduces a fuel condition lever
inspection and instructions to adjust the position of the fuel
condition lever to ensure it rests against the left hand side of the
control guide slot when selected to the ground idle position.

You may examine the MCAI on the internet at https://www.regulations.gov
by searching for and locating Docket No. FAA-2020-0717.

Related Service Information Under 1 CFR Part 51

    The FAA reviewed Pacific Aerospace Mandatory Service Bulletin
PACSB/XL/111, Issue 1, dated June 18, 2019. The service information
contains procedures for inspecting and adjusting the position of the
fuel condition lever relative to the control guide, which assists in
prevention of inadvertent movement of the power lever into the cutoff
position if ground idle is selected. This service information is
reasonably available because the interested parties have access to it
through their normal course of business or by the means identified in
the ADDRESSES section.

FAA's Determination and Requirements of the AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with this State of Design Authority, it has
notified the FAA of the unsafe condition described in the MCAI and
service information referenced above. The FAA is issuing this AD
because it evaluated all information provided by the State of Design
Authority and determined the unsafe condition exists and is likely to
exist or develop on other products of the same type design.

FAA's Determination of the Effective Date

    An unsafe condition exists that requires the immediate adoption of
this AD. The FAA has found that the risk to the flying public justifies
waiving notice and comment prior to adoption of this rule because of
several reported engine failures on these airplanes due to inadvertent
movement of the power lever into the cutoff position if ground idle is
selected. Engine failure could result in loss of airplane control. The
risk assessment received by the FAA, and reconfirmed in July of 2020,
indicates that urgent action is required. Therefore, the FAA finds good
cause that notice and opportunity for prior public comment are
impracticable. In addition, for the reason stated above, the FAA finds
that good cause exists for making this amendment effective in less than
30 days.

Comments Invited

    This AD is a final rule that involves requirements affecting flight
safety and was not preceded by notice and an opportunity for public
comment. However, the FAA invites you to send any written data, views,
or arguments about this final rule. Send your comments to an address
listed under the ADDRESSES section. Include the Docket Number FAA-2020-
0717 and Product Identifier 2019-CE-038-AD at the beginning of your
comments. The FAA will consider all comments received by the closing
date and may amend this final rule because of those comments.
    Except for Confidential Business Information (CBI) as described in
the following paragraph, and other information as described in 14 CFR
11.35, the FAA will post all comments received, without change, to
https://www.regulations.gov, including any personal information you
provide. The FAA will also post a report summarizing each substantive
verbal contact we receive about this final rule.

Confidential Business Information

    CBI is commercial or financial information that is both customarily
and actually treated as private by its owner. Under the Freedom of
Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public
disclosure. If your comments responsive to this AD contain commercial
or financial information that is customarily treated as private, that
you actually treat as private, and that is relevant or responsive to
this AD, it is important that you clearly designate the submitted
comments as CBI. Please mark each page of your submission containing
CBI as ``PROPIN.'' The FAA will treat such marked submissions as
confidential under the FOIA, and they will not be placed in the public
docket of this AD. Submissions containing CBI should be sent to Mike
Kiesov, Aerospace Engineer, FAA, Small Airplane Standards Branch, 901
Locust, Room 301, Kansas City, Missouri 64106. Any commentary that the
FAA receives which is not specifically designated as CBI will be placed
in the public docket for this rulemaking.

Costs of Compliance

    The FAA estimates that this AD will affect 22 products of U.S.
registry. The FAA also estimates that it will take 1 work-hour per
product to comply with the inspection requirement of this AD. The
average labor rate is $85 per work-hour.
    Based on these figures, the FAA estimates the cost of this AD on
U.S. operators to be $1,870, or $85 per product.
    In addition, the FAA estimates that any necessary follow-on actions
will take 4 work-hours and require parts costing $20, for a cost of
$360 per product. The FAA has no way of determining the number of
products that may need these actions.
    According to the manufacturer, some of the costs of this AD may be
covered under warranty, thereby reducing the cost impact on affected
individuals. The FAA does not control warranty coverage for affected
individuals. As a result, the FAA has included all costs in our cost
estimate.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    The FAA is issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: General requirements.
Under that section, Congress charges the FAA with promoting safe flight
of civil aircraft in air commerce by prescribing regulations for
practices, methods, and procedures the Administrator finds necessary
for safety in air commerce. This regulation is within the scope of that
authority because it addresses an unsafe condition that is likely to
exist or develop on products identified in this rulemaking action.

Regulatory Flexibility Act

    The requirements of the Regulatory Flexibility Act (RFA) do not
apply when an agency finds good cause pursuant to 5 U.S.C. 553 to adopt
a rule without prior notice and comment. Because FAA has determined
that it has good cause to adopt this rule without notice and comment,
RFA analysis is not required.

Regulatory Findings

    The FAA determined that this AD will not have federalism
implications under Executive Order 13132. This AD will not have a
substantial direct effect 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.
    For the reasons discussed above, I certify that this AD:

    (1) Is not a ``significant regulatory action'' under Executive
Order 12866, and
    (2) Will not affect intrastate aviation in Alaska.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive:

2020-16-12 Pacific Aerospace Limited: Amendment 39-21196; Docket No.
FAA-2020-0717; Product Identifier 2019-CE-038-AD.

(a) Effective Date

    This airworthiness directive (AD) becomes effective September 8,
2020.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Pacific Aerospace Limited Model 750XL
airplanes, serial numbers 101 through 216, 220, 8001, and 8002,
certificated in any category.

(d) Subject

    Air Transport Association of America (ATA) Code 76: Engine
Controls.

(e) Reason

    This AD was prompted by inadvertent fuel shut-off to the engine
during the operation of the flaps, due to the fuel and flap control
levers being located too closely together. The FAA is issuing this
AD to adjust the position of the fuel condition lever relative to
the control guide, which will prevent inadvertent movement of the
power lever into the cutoff position if ground idle is selected and
result in engine failure and loss of airplane control.

(f) Actions and Compliance

    Unless already done, within the next 30 days after September 8,
2020 (the effective date of this AD), inspect the position of the
fuel condition lever by following the Accomplishment Instructions,
paragraph 2(1), of Pacific Aerospace Mandatory Service Bulletin
PACSB/XL/111, Issue 1, dated June 18, 2019 (MSB PACSB/XL/111). If
the fuel condition lever is not positioned against the left side of
the control guide slot in the ground idle position, before further
flight, adjust the fuel condition level position by following the
Accomplishment Instructions, paragraph 2(3), of MSB PACSB/XL/111.

(g) Alternative Methods of Compliance (AMOCs)

    The Manager, Small Airplane General Aviation & Rotorcraft
Section, International Validation Branch, FAA, has the authority to
approve AMOCs for this AD, if requested using the procedures found
in 14 CFR 39.19. Send information to ATTN: Mike Kiesov, Aerospace
Engineer, FAA, General Aviation & Rotorcraft Section, International
Validation Branch, 901 Locust, Room 301, Kansas City, Missouri
64106; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>Before using any approved AMOC on any airplane
to which the AMOC applies, notify your appropriate principal
inspector (PI) in the FAA Flight Standards District Office (FSDO),
or lacking a PI, your local FSDO.

(h) Related Information

    Refer to mandatory continuing airworthiness information (MCAI)
CAA AD No. DCA/750XL/39, dated September 5, 2019, for related
information. You may examine the MCAI on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-
2020-0717.

(i) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference of the service information listed in this
paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) Pacific Aerospace Mandatory Service Bulletin PACSB/XL/111,
Issue 1, dated June 18, 2019.
    (ii) [Reserved]
    (3) For Pacific Aerospace Limited service information identified
in this AD, contact Pacific Aerospace Limited, Airport Road,
Hamilton, Private Bag 3027, Hamilton 3240, New Zealand; phone: +64
7843 6144; fax: +64 7843 6134; email<EMAIL_ADDRESS>
internet: https://www.aerospace.co.nz.
    (4) You may view this service information at the FAA,
Airworthiness Products Section, Operational Safety Branch, 901
Locust, Kansas City, Missouri 64106. For information on the
availability of this material at the FAA, call<PHONE_NUMBER>. It is
also available on the internet at https://www.regulations.gov by
searching for locating Docket No. FAA-2020-0717.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, email<EMAIL_ADDRESS>or go to: https://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on August 5, 2020.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2020-17865 Filed 8-14-20; 8:45 am]
BILLING CODE 4910-13-P


Comment Info: =================

General Comment:Mr. Zeller,

As an American citizen and veteran of the US Navy - Submarine Electronics and Computer Field I am also writing to you as an individual consumer to request an extension of the comment period for the Food and Drug Administration's ("FDA") Proposed Rule Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking and Prevention and Tobacco Control Act (the "Proposed Rule") published at 79 Fed. Reg. 23,142 and Federal Register No. 2014-09491. On behalf of myself, I am requesting that the comment period for the Proposed Rule be extended by the FDA for an additional 105 days, from its current 75-day period, to 180 days.

The Proposed Rule raises a number of significant issues and questions that are important and relevant to me, as a consumer of products that are proposed for regulation under the Proposed Rule. The Proposed Rule asks about a hundred different questions I might want to respond to. I want to provide my thoughts and comments on many of these issues, but my time to devote to researching and providing thoughtful comments on these important questions is limited. I have already spent many hours researching and dissecting these issues, but they take time. I know that the FDA took many years to even come up with the Proposed Rule, so I do not think it is at all unreasonable to allow the public a mere six months to comment on it. This is our only opportunity, as consumers, to provide our feedback.

I feel incredibly strongly about e-cigarettes as a alternative to tobacco and the chemical additives and compounds found in combustible cigarettes. Quite simply, I firmly believe that they saved my life and many more Americans. I wish to provide you with my personal story, as well as science- and evidence-based responses to your questions so that you can take my comment into account. I realize that the FDA has the authority under 21 CFR 10.40 to extend this time frame and that the FDA has exercised this authority on numerous occasions in the past. I would therefore ask that you do so here, so that all stakeholders have the opportunity to provide their comments on this proposed regulation.

I appreciate your consideration of my request and am happy to discuss this issue with you further.


[Federal Register: October 22, 2009 (Volume 74, Number 203)]
[Rules and Regulations]
[Page 54483-54485]
[DOCID:fr22oc09-9]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2009-0870]
RIN 1625-AA00

Safety Zone; Waters Surrounding M/V Guilio Verne and Barge Hagar
for the Transbay Cable Laying Project, San Francisco Bay, CA

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary moving safety zone
in the navigable waters of San Francisco Bay surrounding the Motor
Vessel (M/V) Guilio Verne and barge Hagar while engaged in cable laying
operations. Unauthorized persons or vessels are prohibited from
entering into, transiting through, or remaining in the safety zone
without permission of the Captain of the Port or his designated
representative. This safety zone is necessary to protect persons and
property from hazards associated with the cable laying operations.

DATES: This temporary final rule is effective from 12 a.m. on October
22, 2009, until 11:59 p.m. on December 1, 2009. This temporary final
rule is enforceable with actual notice by Coast Guard personnel
beginning October 7, 2009.

ADDRESSES: Documents indicated in this preamble as being available in
the docket are part of docket USCG-2009-0870 and are available online
by going to http://www.regulations.gov, inserting USCG-2009-0870 in the
``Keyword'' box, and then clicking ``Search.'' They are also available
for inspection or copying at the Docket Management Facility (M-30),
U.S. Department of Transportation, West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590, between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary rule, call Lieutenant Junior Grade Simone Mausz, U.S. Coast
Guard Sector San Francisco, at<PHONE_NUMBER> or e-mail at
<EMAIL_ADDRESS>If you have questions on viewing the docket,
call Renee V. Wright, Program Manager, Docket Operations, telephone
202-366-9826.

SUPPLEMENTARY INFORMATION:

Regulatory Information

    The Coast Guard is issuing this temporary final rule without prior
notice and opportunity to comment pursuant to authority under section
4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because the event would occur before the
rulemaking process would be completed. The safety zone is necessary to
protect the safety of persons and property in the area from the dangers
posed by the offloading of heavy equipment. Delaying the effective date
of the safety zone would expose members of the public to those dangers,
and would be contrary to the public interest.
    For the same reasons, the Coast Guard also finds under 5 U.S.C.
553(d)(3) that good cause exists for making this rule effective less
than 30 days after publication in the Federal Register. Any delay in
the effective date of this rule would expose members of the public to
the dangers associated with offloading heavy equipment.

Background and Purpose

    The Transbay Cable Laying project is necessary to deliver
electrical current from a decommissioned power plant in Pittsburg, CA
to a power plant in San Francisco to provide the city with energy. This
rule is necessary for the safety of the public and vessels transiting
to other berths during the offload of this cargo. This rule prohibits
entry of any vessel or person into the safety zone without specific
authorization from the Captain of the Port or his designated
representative.

Discussion of Rule

    This temporary moving safety zone will remain in effect from 12
a.m. October 7, 2009 through 11:59 p.m. December 1, 2009 and includes
all waters extending from the surface area to the sea floor within
1,000 feet of the vessel and barge.
    The effect of the temporary moving safety zone will be to restrict
navigation in the vicinity of the cable laying operations while the
cable is being deployed and buried. Except for persons or vessels
authorized by the Coast Guard Patrol Commander, no person or vessel may
enter or remain in the restricted area. These regulations are needed to
keep spectators and vessels a safe distance away from the vessel to
ensure the safety of participants, spectators, and transiting vessels.

Regulatory Analyses

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

Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, and does not
require an assessment of potential costs and benefits under section
6(a)(3) of that Order. The Office of Management and Budget has not
reviewed it under that Order.
    Although this rule restricts access to the waters encompassed by
the temporary moving safety zone, the effect of this rule will not be
significant because vessels will be able to safely transit around the
area and the local waterway users will be notified via public Broadcast
Notice to Mariners to ensure the temporary moving safety zone will
result in minimum impact. The entities most likely to be affected are
pleasure craft engaged in recreational activities.

Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered whether this rule would have a significant economic impact
on a substantial number of small entities. The term ``small entities''
comprises small businesses, not-for-profit organizations that are
independently owned and operated and are not dominant in their fields,
and governmental jurisdictions with populations of less than 50,000.
    The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will
not have a significant economic impact on a substantial number of small
entities.
    This rule may affect owners and operators of pleasure craft engaged
in recreational activities and sightseeing. This rule will not have a
significant economic impact on a substantial number of small entities
for several reasons: (i) Vessel traffic can pass safely around the
area; (ii) vessels engaged in recreational activities and sightseeing
have ample space outside of the effected portion of the San Francisco
Bay to engage in these activities; (iii) this rule will encompass only
a small portion of

the waterway for a limited period of time; and, (iv) the maritime
public will be advised in advance of this safety zone via Broadcast
Notice to Mariners.

Assistance for Small Entities

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

Collection of Information

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

Federalism

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

Unfunded Mandates Reform Act

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

Taking of Private Property

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

Civil Justice Reform

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

Protection of Children

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

Indian Tribal Governments

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

Energy Effects

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

Technical Standards

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

Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023.1 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded
this action is one of a category of actions which do not individually
or cumulatively have a significant effect on the human environment.
This rule is categorically excluded, under figure 2-1, paragraph
(34)(g), of the Instruction because the rule involves establishing a
safety zone. An environmental analysis checklist and a categorical
exclusion determination are available in the docket where indicated
under ADDRESSES.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

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

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

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

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

0
2. Add temporary Sec.  165-T11-243 to read as follows:

Sec.  165-T11-243  Safety Zone; Transbay Cable Laying Project, San
Francisco Bay, CA.

    (a) Location. The following area is a temporary moving safety zone:
All waters of San Francisco Bay up to Pittsburg, CA, from surface to
bottom, within 1,000 feet of the M/V Guilio Verne and the barge Hagar.
    (b) Definitions. As used in this section, designated representative
means a Coast Guard Patrol Commander, including a Coast Guard coxswain,
petty officer, or other officer operating a Coast Guard vessel and a
Federal, State, or local officer

designated by or assisting the Captain of the Port San Francisco (COTP)
in the enforcement of the safety zone.
    (c) Regulations. (1) Under the general regulations in Sec.  165.23,
entry into, transiting, or anchoring within this safety zone is
prohibited unless authorized by the COTP or the COTP's designated
representative.
    (2) The safety zone is closed to all vessel traffic, except as may
be permitted by the COTP or the COTP's designated representative.
    (3) Vessel operators desiring to enter or operate within the safety
zone must contact the COTP or the COTP's designated representative to
obtain permission to do so. Vessel operators given permission to enter
or operate in the temporary moving safety zone must comply with all
directions given to them by the COTP or the COTP's designated
representative. Persons and vessels may request permission to enter the
safety zone on VHF-16 or through the 24-hour Command Center at
telephone<PHONE_NUMBER>.
    (d) Effective period. This section is effective from 12 a.m. on
October 7, 2009 through 11:59 p.m. on December 1, 2009.

    Dated: October 6, 2009.
P.M. Gugg,
Captain, U.S. Coast Guard, Captain of the Port San Francisco.
[FR Doc. E9-25393 Filed 10-21-09; 8:45 am]

BILLING CODE 4910-15-P


[Federal Register Volume 85, Number 158 (Friday, August 14, 2020)]
[Notices]
[Pages 49649-49650]
[FR Doc No: 2020-17812]

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

[ER-FRL-9052-3]

Environmental Impact Statements; Notice of Availability

    Responsible Agency: Office of Federal Activities, General
Information<PHONE_NUMBER> or https://www.epa.gov/nepa.

Weekly receipt of Environmental Impact Statements (EIS) Filed August 3,
2020, 10 a.m. EST Through August 10, 2020, 10 a.m. EST Pursuant to 40
CFR 1506.9.

Notice

    Section 309(a) of the Clean Air Act requires that EPA make public
its comments on EISs issued by other Federal agencies. EPA's comment
letters on EISs are available at: https://cdxnodengn.epa.gov/cdx-enepa-public/action/eis/search.

EIS No. 20200163, Draft Supplement, BR, CA, B.F. Sisk Dam Raise and
Reservoir Expansion Project Environmental Impact Report/Supplemental
Environmental Impact Statement, Comment Period Ends: 09/28/2020,
Contact: Casey Arthur<PHONE_NUMBER>.
EIS No. 20200164, Final Supplement, USFS, ND, Northern Great Plains
Management Plans Revision Final Supplemental Environmental Impact
Statement for Oil and Gas Leasing, Review Period Ends: 10/01/2020,
Contact: Macario Herrera<PHONE_NUMBER>.
EIS No. 20200165, Draft, USFS, ID, Stibnite Gold Project, Comment
Period Ends: 09/28/2020, Contact: Brian Harris<PHONE_NUMBER>.
EIS No. 20200166, Final, BLM, AK, Willow Master Development Plan Final
Environmental Impact

Statement, Review Period Ends: 09/14/2020, Contact: Racheal Jones 907-
290-0307.
EIS No. 20200167, Final, TVA, TN, Gallatin Impoundment Closure, Review
Period Ends: 09/14/2020, Contact: Elizabeth Smith<PHONE_NUMBER>.

    Dated: August 11, 2020.
Cindy S. Barger,
Director, NEPA Compliance Division, Office of Federal Activities.
[FR Doc. 2020-17812 Filed 8-13-20; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 88, Number 147 (Wednesday, August 2, 2023)]
[Notices]
[Page 50899]
[FR Doc No: 2023-16344]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4710-DR; Docket ID FEMA-2023-0001]

Alabama; Major Disaster and Related Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This is a notice of the Presidential declaration of a major
disaster for the State of Alabama (FEMA-4710-DR), dated May 5, 2023,
and related determinations.

DATES: The declaration was issued May 5, 2023.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter
dated May 5, 2023, the President issued a major disaster declaration
under the authority of the Robert T. Stafford Disaster Relief and
Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the ``Stafford
Act''), as follows:

    I have determined that the damage in certain areas of the State
of Alabama resulting from severe storms, straight-line winds, and
tornadoes during the period of March 24 to March 27, 2023, is of
sufficient severity and magnitude to warrant a major disaster
declaration under the Robert T. Stafford Disaster Relief and
Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the ``Stafford
Act''). Therefore, I declare that such a major disaster exists in
the State of Alabama.
    In order to provide Federal assistance, you are hereby
authorized to allocate from funds available for these purposes such
amounts as you find necessary for Federal disaster assistance and
administrative expenses.
    You are authorized to provide Public Assistance in the
designated areas and Hazard Mitigation throughout the State.
Consistent with the requirement that Federal assistance be
supplemental, any Federal funds provided under the Stafford Act for
Public Assistance and Hazard Mitigation will be limited to 75
percent of the total eligible costs.
    Further, you are authorized to make changes to this declaration
for the approved assistance to the extent allowable under the
Stafford Act.

    The Federal Emergency Management Agency (FEMA) hereby gives notice
that pursuant to the authority vested in the Administrator, under
Executive Order 12148, as amended, Kevin A. Wallace, Sr., of FEMA is
appointed to act as the Federal Coordinating Officer for this major
disaster.
    The following areas of the State of Alabama have been designated as
adversely affected by this major disaster:

    Chambers, Colbert, Coosa, Elmore, Lauderdale, Macon, Marion,
Morgan, Randolph, and Tallapoosa Counties for Public Assistance.
    All areas within the State of Alabama are eligible for
assistance under the Hazard Mitigation Grant Program.
    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households In Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050, Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

Deanne Criswell,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2023-16344 Filed 8-1-23; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 86, Number 169 (Friday, September 3, 2021)]
[Notices]
[Page 49529]
[FR Doc No: 2021-19075]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Numbers: RP21-1055-000.
    Applicants: Colorado Interstate Gas Company, L.L.C.
    Description: Compliance filing: Operational Purchase and Sales
Report 2021 to be effective N/A.
    Filed Date: 8/27/21.
    Accession Number: 20210827-5060.
    Comment Date: 5 p.m. ET 9/8/21.

    Docket Numbers: RP21-1056-000.
    Applicants: Tres Palacios Gas Storage LLC.
    Description: Compliance filing: Informational Filing Re MBR
Authority, Compliance Dkt. Nos. CP07-90-000 et al. to be effective N/A.
    Filed Date: 8/27/21.
    Accession Number: 20210827-5072.
    Comment Date: 5 p.m. ET 9/8/21.

    Docket Numbers: RP21-1057-000.
    Applicants: Northern Border Pipeline Company.
    Description: Sec.  4(d) Rate Filing: NBPL--TC eConnects
Implementation to be effective 10/1/2021.
    Filed Date: 8/27/21.
    Accession Number: 20210827-5163.
    Comment Date: 5 p.m. ET 9/8/21.

    Docket Numbers: RP21-1059-000.
    Applicants: Northwest Pipeline LLC.
    Description: Sec.  4(d) Rate Filing: 2021 Winter Fuel Filing to be
effective 10/1/2021.
    Filed Date: 8/30/21.
    Accession Number: 20210830-5036.
    Comment Date: 5 p.m. ET 9/13/21.

    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    The filings are accessible in the Commission's eLibrary system
(https://elibrary.ferc.gov/idmws/search/fercgensearch.asp) by querying
the docket number.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: August 30, 2021.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2021-19075 Filed 9-2-21; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 57 (Monday, March 27, 2017)]
[Rules and Regulations]
[Pages 15133-15135]
[FR Doc No: 2017-05945]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 100

[Docket No. USCG-2017-0217]
RIN 1625-AA08

Special Local Regulation; Wy-Hi Rowing Regatta; Detroit River,
Trenton Channel; Wyandotte, MI

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a special local regulation for
certain waters of the Detroit River, Trenton Channel, Wyandotte, MI.
This action is necessary and is intended to ensure safety of life on
navigable waters to be used for a rowing event immediately prior to,
during, and immediately after this event. This regulation requires
vessels to maintain a minimum speed for safe navigation and
maneuvering.

DATES: This temporary final rule is effective from 7:30 a.m. until 5
p.m. on May 6, 2017.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to http://www.regulations.gov, type USCG-
2017-0217 in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rule.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary rule, call or email Tracy Girard, Prevention Department,
Sector Detroit, Coast Guard; telephone<PHONE_NUMBER>, or email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of Proposed Rulemaking
Sec.  Section
COTP Captain of the Port
U.S.C. United States Code

II. Background Information and Regulatory History

    The Coast Guard is issuing this temporary rule without prior notice
and opportunity to comment pursuant to authority under section 4(a) of
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because doing so would be impracticable. The
final details of this rowing event was not known to the Coast Guard
with sufficient time for the Coast Guard until there was insufficient
time remaining before the event to publish an NPRM.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 33 U.S.C.
1231. The Captain of the Port Detroit (COTP) has determined that the
likely combination of recreation vessels, commercial vessels, and an
unknown number of spectators in close proximity to a youth rowing
regatta along the water pose extra and unusual hazards to public safety
and property. Therefore, the COTP believes a Special Local Regulation
around the event location is needed to help minimize risks to safety of
life and property during this event.

IV. Discussion of the Rule

    This rule establishes a temporary special local regulation from
7:30 a.m. until 5 p.m. on May 6, 2017. In light of the aforementioned
hazards, the COTP has determined that a special local regulation is
necessary to protect spectators, vessels, and participants. The special
local regulation will encompass the following waterway: All waters of
the Detroit River, Trenton Channel between the following two lines
going from bank-to-bank: The first line is drawn directly across the
channel from position 42[deg]11.0' N., 083[deg]09.4' W. (NAD 83); the
second line, to the north, is drawn directly across the channel from
position 42[deg]11.7' N., 083[deg]08.9' W. (NAD 83).
    An on-scene representative of the COTP or event sponsor
representatives may permit vessels to transit the area when no race
activity is occurring. The on-scene representative may be present on
any Coast Guard, state or local law enforcement vessel assigned to
patrol the event. Vessel operators desiring to transit through the
regulated area must contact the Coast Guard Patrol Commander to obtain
permission to do so. The COTP or his designated on-scene representative
may be contacted via VHF Channel 16.
    The COTP or his designated on-scene representative will notify the
public of the enforcement of this rule by all appropriate means,
including a Broadcast Notice to Mariners and Local Notice to Mariners.

V. Regulatory Analyses

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

A. Regulatory Planning and Review

    E.O.s 12866 (``Regulatory Planning and Review'') and 13563
(``Improving Regulation and Regulatory Review'') direct agencies to
assess the costs and benefits of available regulatory alternatives and,
if regulation is necessary, to select regulatory approaches that
maximize net benefits including potential economic, environmental,
public health and safety effects, distributive impacts, and equity.
E.O. 13563 emphasizes the importance of quantifying both costs and
benefits, of reducing costs, of harmonizing rules, and of promoting
flexibility. Executive Order 13771 (``Reducing Regulation and
Controlling Regulatory Costs''), directs agencies to reduce regulation
and control regulatory costs and provides that ``for every one new
regulation issued, at least two prior regulations be identified for
elimination, and that the cost of planned regulations be prudently
managed and controlled through a budgeting process.''
    The Office of Management and Budget (OMB) has not designated this
rule a significant regulatory action under section 3(f) of Executive
Order 12866. Accordingly, the Office of Management and Budget (OMB) has
not reviewed it.
    As this rule is not a significant regulatory action, this rule is
exempt from the requirements of Executive Order 13771. See OMB's
Memorandum titled ``Interim Guidance Implementing Section 2 of the
Executive Order of January 30, 2017 titled `Reducing

Regulation and Controlling Regulatory Costs' '' (February 2, 2017).
    This regulatory action determination is based on the size,
location, duration, and time-of-year of the special local regulation.
Vessel traffic will be able to safely transit around this special local
regulation zone which will impact a small designated area of the
Detroit River from 7:30 a.m. to 5 p.m. May 6, 2017. Moreover, the Coast
Guard will issue Broadcast Notice to Mariners via VHF-FM marine channel
16 about the special local regulation and the rule allows vessels to
seek permission to enter the area.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule
will not have a significant economic impact on a substantial number of
small entities.
    While some owners or operators of vessels intending to transit the
special local regulation may be small entities, for the reasons stated
in section V.A above, this rule will not have a significant economic
impact on any vessel owner or operator.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
contact the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

C. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect 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. We have analyzed this rule under that Order and have
determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this rule does not have tribal implications under Executive
Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it does not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes. If
you believe this rule has implications for federalism or Indian tribes,
please contact the person listed in the FOR FURTHER INFORMATION CONTACT
section above.

E. Unfunded Mandates Reform Act

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

F. Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that
this action is one of a category of actions that do not individually or
cumulatively have a significant effect on the human environment. This
rule involves a special local regulation lasting nine hours that will
limit entry to a designated area. It is categorically excluded from
further review under paragraph 34(h) of Figure 2-1 of the Commandant
Instruction. An environmental analysis checklist supporting this
determination and a Categorical Exclusion Determination are available
in the docket where indicated under ADDRESSES. We seek any comments or
information that may lead to the discovery of a significant
environmental impact from this rule.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places or vessels.

List of Subjects in 33 CFR Part 100

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

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 100 as follows:

PART 100--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 100 continues to read as follows:

    Authority: 3 U.S.C. 1233.

0
2. Add Sec.  100.T09-0217 to read as follows:

Sec.  100.T09-0217   Special local regulation; Wy-Hi Rowing Regatta;
Detroit River, Trenton Channel, Wyandotte, MI.

    (a) Location. A regulated area is established to encompass the
following waterway: All waters of the Detroit River, Trenton Channel
between the following two lines going from bank-to-bank: The first line
is drawn directly across the channel from position 42[deg]11.0' N.,
083[deg]09.4' W. (NAD 83); the second line, to the north, is drawn
directly across the channel from position 42[deg]11.7' N.,
083[deg]08.9' W. (NAD 83).
    (b) Enforcement period. This section is effective and will be
enforced from 7:30 a.m. until 5 p.m. on May 6, 2017.
    (c) Regulations. (1) Vessels transiting through the regulated area
are to maintain the minimum speeds for safe navigation.
    (2) Vessel operators desiring to operate in the regulated area must

contact the Coast Guard Patrol Commander to obtain permission to do so.
The Captain of the Port Detroit (COTP) or his on-scene representative
may be contacted via VHF Channel 16 or at<PHONE_NUMBER>. Vessel
operators given permission to operate within the regulated area must
comply with all directions given to them by the COTP or his on-scene
representative.
    (3) The ``on-scene representative'' of the COTP Detroit is any
Coast Guard commissioned, warrant or petty officer or a Federal, State,
or local law enforcement officer designated by or assisting the Captain
of the Port Detroit to act on his behalf.
    (4) Vessel operators shall contact the COTP Detroit or his on-scene
representative to obtain permission to enter or operate within the
special local regulation. The COTP Detroit or his on-scene
representative may be contacted via VHF Channel 16 or at<PHONE_NUMBER>.
Vessel operators given permission to enter or operate in the regulated
area must comply with all directions given to them by the COTP Detroit
or his on-scene representative.

    Dated: March 20, 2017.
Scott B. Lemasters,
Commander, U.S. Coast Guard, Captain of the Port Detroit.
[FR Doc. 2017-05945 Filed 3-24-17; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register: July 17, 2006 (Volume 71, Number 136)]
[Rules and Regulations]
[Page 40431-40436]
[DOCID:fr17jy06-13]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 174

[EPA-HQ-OPP-2006-0553; FRL-8076-6]

Bacillus Thuringiensis Cry2Ab2 Protein and the Genetic Material
Necessary for Its Production in Corn in or on All Corn Commodities;
Temporary Exemption From the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes a temporary exemption from the

requirement of a tolerance for residues of the Bacillus Thuringiensis
Cry2Ab2 protein and the genetic material necessary for its production
in corn on field corn, sweet corn, and popcorn when applied/used as a
plant-incorporated protectant. Monsanto Company submitted a petition to
EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended
by the Food Quality Protection Act of 1996 (FQPA), requesting the
temporary/tolerance exemption. This regulation eliminates the need to
establish a maximum permissible level for residues of Bacillus
Thuringiensis Cry2Ab2 protein and the genetic material necessary for
its production in corn. The temporary tolerance exemption will expire
on June 30, 2009.

DATES: This regulation is effective July 17, 2006. Objections and
requests for hearings must be received on or before September 15, 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-2006-0553. All documents in the
docket are listed in the index for the docket. Although listed in the
index, some information is not publicly available, e.g., Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available in the electronic docket at http://www.regulations.gov, or,

if only available in hard copy, at the OPP Regulatory Public Docket in
Rm. S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive,
Arlington, VA. The Docket Facility is open 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: Mike Mendelsohn, Biopesticides and
Pollution Prevention Division (7511P), 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 174 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-2006-0553 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 September 15, 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-2006-0553, 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

    In the Federal Register of May 26, 2006 (Volume 71 FR 30400) (FRL-
8066-7), EPA issued a notice pursuant to section 408(d)(3) of the
FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide
tolerance petition (PP 5G7005) by Monsanto Company, 800 North Lindbergh
Blvd., St. Louis, MO 63167. The petition requested that 40 CFR part 174
be amended by establishing a temporary exemption from the requirement
of a tolerance for residues of Bacillus thuringiensis Cry2Ab2 protein
and the genetic material necessary for its production in corn. This
notice included a summary of the petition prepared by the petitioner
Monsanto Company. One comment was received in response to the notice of
filing. The commenter objected to an exemption from the requirement of
a tolerance, stated that she does not favor genetically engineered
corn, and stated that such corn should be labeled. The Agency
understands the commenter's concerns and recognizes that some
individuals believe that genetically modified crops and food should be
banned completely. Pursuant to its authority under the FFDCA, EPA
conducted a comprehensive assessment of the Cry2Ab2 protein and the
genetic material necessary for its production in

corn, including a review of acute oral toxicity data on the Cry2Ab2
protein, amino acid sequence comparisons to known toxins and allergens,
as well as data demonstrating that the Cry2Ab2 protein is rapidly
degraded by gastric fluid in vitro, is not glycosylated, and is present
in low levels in corn tissue, and has concluded that there is a
reasonable certainty that no harm will result from dietary exposure to
this protein as expressed in genetically modified corn. Thus, under the
standard in FFDCA section 408(b)(2), a tolerance exemption is
appropriate. The labeling of food is under the jurisdiction of the Food
and Drug Administration (FDA).
    Section 408(c)(2)(A)(i) of the FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the exemption is ``safe.'' Section 408(c)(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. Pursuant to section 408(c)(2)(B), in
establishing or maintaining in effect an exemption from the requirement
of a tolerance, EPA must take into account the factors set forth in
section 408(b)(2)(C), which require 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....''
Additionally, section 408(b)(2)(D) of the FFDCA requires that 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 performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. First, EPA determines the
toxicity of pesticides. Second, EPA examines exposure to the pesticide
through food, drinking water, and through other exposures that occur as
a result of pesticide use in residential settings.

III. Toxicological Profile

    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 and considered its validity, completeness and
reliability and the relationship of this information 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.
    Monsanto has submitted acute oral toxicity data demonstrating the
lack of mammalian toxicity at high levels of exposure to the pure
Cry2Ab2 protein. These data demonstrate the safety of the product at a
level well above maximum possible exposure levels that are reasonably
anticipated in the crop. Basing this conclusion on acute oral toxicity
data without requiring further toxicity testing and residue data is
similar to the Agency position regarding toxicity testing and the
requirement of residue data for the microbial Bacillus thuringiensis
products from which this plant-incorporated protectant was derived (See
40 CFR Sec. 158.740(b)(2)(i)). For microbial products, further toxicity
testing and residue data are triggered by significant adverse acute
effects in studies such as the mouse oral toxicity study, to verify the
observed adverse effects and clarify the source of these effects (Tiers
II and III).
    An acute oral toxicity study in mice (MRID 44966602) indicated that
Cry2Ab2 is non-toxic to humans. Three groups of ten male and ten female
mice were dosed by oral gavage with 30, 300, or 1,000 milligrams/
kilogram (mg/kg) bodyweight of microbially-produced Cry2Ab2 protein.
Two negative control groups were also included in the study: Bovine
serum albumin protein control, and a vehicle control (purified water).
Two deaths occurred in control group animals; both deaths were
attributed to gavage injury. All other mice survived the study. Several
animals in both the control and test groups lost weight during the
study, and several abnormalities were observed by gross necropsy in
several animals in both the test and control groups. There were no
significant differences between the test and control groups; therefore,
the Cry2Ab2 protein does not appear to cause any significant adverse
effects at an exposure level of up to 1,000 mg/kg bodyweight.
    When proteins are toxic, they are known to act via acute mechanisms
and at very low dose levels (Sjoblad, Roy D., et al., ``Toxicological
Considerations for Protein Components of Biological Pesticide
Products,'' Regulatory Toxicology and Pharmacology 15, 3-9 (1992)).
Therefore, since no acute effects were shown to be caused by Cry2Ab2,
even at relatively high dose levels, the Cry2Ab2 protein is not
considered toxic. Further, amino acid sequence comparisons showed no
similarities between the Cry2Ab2 protein and known toxic proteins in
protein databases that would raise a safety concern.
    Since Cry2Ab2 is a protein, allergenic potential was also
considered. Currently, no definitive tests for determining the
allergenic potential of novel proteins exist. Therefore, EPA uses a
weight-of-evidence approach where the following factors are considered:
Source of the trait; amino acid sequence similarity with known
allergens; prevalence in food; and biochemical properties of the
protein, including in vitro digestibility in simulated gastric fluid
(SGF) and glycosylation. Current scientific knowledge suggests that
common food allergens tend to be resistant to degradation by heat,
acid, and proteases, may be glycosylated, and can be present at high
concentrations in the food.
    1. Source of the trait. Bacillus thuringiensis is not considered to
be a source of allergenic proteins.
    2. Amino acid sequence. A comparison of the amino acid sequence of
Cry2Ab2 with known allergens showed no significant overall sequence
similarity or identity at the level of eight contiguous amino acid
residues.
    3. Prevalence in food. Expression level analysis indicated that the
protein is present at relatively low levels in corn: Approximately 2.3
[mu]g/g in grain on a dry weight basis. Thus, the expression has been
shown to be in the parts per million range is much lower than the
amounts of allergen protein found in commonly allergenic foods. In
those foods, allergens are major protein components such as seed
storage globulin proteins in nuts and legumes, meat associated proteins
like tropomyosin in fish and shellfish, ovalbumin and ovomucoid in egg
white and lactalbumin and casein in milk. In these cases, the allergens
can be from 10% to 50% of the total protein found whereas the plant-
incorporated protectant (PIP) that is the subject of this tolerance
determination is found in the parts per million range.
    4. Digestibility. The Cry2Ab2 protein was digested within 15
seconds in simulated gastric fluid containing pepsin.
    5. Glycosylation. Cry2Ab2 expressed in corn was shown not to be
glycosylated.
    6. Conclusion. Considering all of the available information, EPA
has concluded that the potential for Cry2Ab2 to be a food allergen is
minimal.

IV. Aggregate Exposures

    In examining aggregate exposure, section 408 of the FFDCA directs
EPA to consider available information concerning exposures from the
pesticide residue in food and all other non-occupational exposures,
including drinking water from ground water or surface water and
exposure through pesticide use in gardens, lawns, or buildings
(residential and other indoor uses).
    The Agency has considered available information on the aggregate
exposure levels of consumers (and major identifiable subgroups of
consumers) to the pesticide chemical residue and to other related
substances. These considerations include dietary exposure under the
tolerance exemption and all other tolerances or exemptions in effect
for the plant-incorporated protectants chemical residue, and exposure
from non-occupational sources. Exposure via the skin or inhalation is
not likely since the plant- incorporated protectant is contained within
plant cells, which essentially eliminates these exposure routes or
reduces these exposure routes to negligible. In addition, even if
exposure can occur through inhalation, the potential for Cry2Ab2 to be
an allergen is low, as discussed above. Although the allergenicity
assessment focuses on potential to be a food allergen, the data also
indicate a low potential for Cry2Ab2 to be an inhalation allergen.
Exposure via residential or lawn use to infants and children is also
not expected because the use sites for the Cry2Ab2 protein is
agricultural. Oral exposure, at very low levels, may occur from
ingestion of processed corn products and, theoretically, drinking
water. However, oral toxicity testing showed no adverse effects.
Furthermore, the expression of the Cry2Ab2 protein in corn kernels has
been shown to be in the parts per million range, which makes the
expected dietary exposure several orders of magnitude lower than the
amount of Cry2Ab2 shown to have no toxicity. Therefore, even if
negligible aggregate exposure should occur, the Agency concludes that
such exposure would result in no harm due to the lack of mammalian
toxicity and low potential for allergenicity demonstrated for the
Cry2Ab2 protein.

V. Cumulative Effects

    Pursuant to FFDCA section 408(b)(2)(D)(v), EPA has considered
available information on the cumulative effects of such residues and
other substances that have a common mechanism of toxicity. These
considerations included the cumulative effects on infants and children
of such residues and other substances with a common mechanism of
toxicity. Because there is no indication of mammalian toxicity from the
plant-incorporated protectant, we conclude that there are no cumulative
effects for the Cry2Ab2 protein.

VI. Determination of Safety for U.S. Population, Infants and Children

A. Toxicity and Allergenicity Conclusions

    The data submitted and cited regarding potential health effects for
the Cry2Ab2 protein includes the characterization of the expressed
Cry2Ab2 protein in corn, as well as the acute oral toxicity study,
amino acid sequence comparisons to known allergens and toxins, and in
vitro digestibility of the protein. The results of these studies were
used to evaluate human risk, and the validity, completeness, and
reliability of the available data from the studies were also
considered.
    Adequate information was submitted to show that the Cry2Ab2 test
material derived from microbial culture was biochemically and
functionally equivalent to the protein produced by the plant-
incorporated protectant ingredient in corn. Microbially produced
protein was used in the safety studies so that sufficient material for
testing was available.
    The acute oral toxicity data submitted support the prediction that
the Cry2Ab2 protein would be non-toxic to humans. As mentioned above,
when proteins are toxic, they are known to act via acute mechanisms and
at very low dose levels (Sjoblad, Roy D., et al., ``Toxicological
Considerations for Protein Components of Biological Pesticide
Products,'' Regulatory Toxicology and Pharmacology 15, 3-9 (1992)).
Since no treatment-related adverse effects were shown to be caused by
the Cry2Ab2 protein, even at relatively high dose levels, the Cry2Ab2
protein is not considered toxic. Basing this conclusion on acute oral
toxicity data without requiring further toxicity testing and residue
data is similar to the Agency position regarding toxicity and the
requirement of residue data for the microbial Bacillus thuringiensis
products from which this plant-incorporated protectant was derived (See
40 CFR 158.740(b)(2)(i)). For microbial products, further toxicity
testing and residue data are triggered when significant adverse effects
are seen in studies such as the mouse oral toxicity study. Further
studies verify the observed adverse effects and clarify the source of
these effects (Tiers II and III).
    Residue chemistry data were not required for a human health effects
assessment of the subject plant-incorporated protectant ingredients
because of the lack of mammalian toxicity. However, data submitted
demonstrated low levels of the Cry1A.105 in corn tissues.
    Since Cry2Ab2 is a protein, potential allergenicity is also
considered as part of the toxicity assessment. Considering all of the
available information (1) Cry2Ab2 originates from a non-allergenic
source; (2) Cry2Ab2 has no sequence similarities with known allergens;
(3) Cry2Ab2 is not glycosylated; (4) Cry2Ab2 will only be present at
low levels in food; and (5) Cry2Ab2 is rapidly digested in simulated
gastric fluid; EPA has concluded that the potential for Cry2Ab2 to be a
food allergen is minimal.
    Neither available information concerning the dietary consumption
patterns of consumers (and major identifiable subgroups of consumers
including infants and children) nor safety factors that are generally
recognized as appropriate for the use of animal experimentation data
were evaluated. The lack of mammalian toxicity at high levels of
exposure to the Cry2Ab2 protein, as well as the minimal potential to be
a food allergen, demonstrate the safety of the product at levels well
above possible maximum exposure levels anticipated in the crop.
    The genetic material necessary for the production of the plant-
incorporated protectant active ingredient include the nucleic acids
(DNA, RNA) that encode these proteins and regulatory regions. The
genetic material (DNA, RNA), necessary for the production of the
Cry2Ab2 protein has been exempted under the blanket exemption for all
nucleic acids (40 CFR 174.475).

B. Infants and Children Risk Conclusions

    FFDCA section 408(b)(2)(C) provides that EPA shall assess the
available information about consumption patterns among infants and
children, special susceptibility of infants and children to pesticide
chemical residues and the cumulative effects on infants and children of
the residues and other substances with a common mechanism of toxicity.
In addition, FFDCA section 408(b)(2)(C) also 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 database unless

EPA determines that a different margin of safety will be safe for
infants and children.
    In this instance, based on all the available information, the
Agency finds no toxicity for the Cry2Ab2 protein and the genetic
material necessary for its production. Thus, there are no threshold
effects of concern and, as a result, the provision requiring an
additional margin of safety does not apply. Further, the considerations
of consumption patterns, special susceptibility, and cumulative effects
do not apply.

C. Overall Safety Conclusion

    There is a reasonable certainty that no harm will result from
aggregate exposure to the U.S. population, including infants and
children, to the Cry2Ab2 protein and the genetic material necessary for
its production. This includes all anticipated dietary exposures and all
other exposures for which there is reliable information. The Agency has
arrived at this conclusion because, as discussed above, no toxicity to
mammals has been observed, nor any indication of allergenicity
potential for the plant-incorporated protectant.

VII. Other Considerations

A. Endocrine Disruptors

    The pesticidal active ingredient is a protein, derived from a
source that is not known to exert an influence on the endocrine system.
Therefore, the Agency is not requiring information on the endocrine
effects of this plant-incorporated protectant at this time.

B. Analytical Method(s)

    A short description of an enzyme-linked immunosorbent assay for the
detection and quantification of Cry2Ab2 in corn tissue has been
submitted, and a commercially available qualitative
immunochromatographic test strip was shown to detect the Cry2Ab2
protein in corn tissues.

C. Codex Maximum Residue Level

    No Codex maximum residue level exists for the plant-incorporated
protectant Bacillus thuringiensis Cry2Ab2 protein and the genetic
material necessary for its production in corn.

VIII. Statutory and Executive Order Reviews

    This final rule establishes an exemption from the tolerance
requirement under section 408(d) of the FFDCA in response to a petition
submitted to the Agency. The Office of Management and Budget (OMB) has
exempted these types of actions from review under Executive Order
12866, entitled Regulatory Planning and Review (58 FR 51735, October 4,
1993). Because this 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
petition under section 408(d) of the FFDCA, such as the exemption in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply. 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.

IX. 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 174

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

    Dated: June 29, 2006.
James Jones,
 Director Office of Pesticide Programs.

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

PART 174--[AMENDED]

0
1. The authority citation for part 174 continues to read as follows:

    Authority: 7 U.S.C. 136-136y; 21 U.S.C. 346a and 371.

0
2. Section 174.454 is added to subpart W to read as follows:

Sec.  174.454  Bacillus Thuringiensis Cry2Ab2 Protein and the Genetic
Material Necessary for Its Production in Corn.

    Bacillus thuringiensis Cry2Ab2 protein and the genetic material
necessary for its production in corn is exempt from the requirement of
a tolerance when used as plant-incorporated protectant in the food and
feed commodities of field corn, sweet corn and popcorn. Genetic
material necessary for its production means the genetic material which
comprise genetic material encoding the Cry2Ab2 protein and its
regulatory regions. Regulatory regions are the genetic material, such
as promoters, terminators, and enhancers, that control the expression
of the genetic material encoding the Cry2Ab2 protein. This temporary
exemption from the requirement of a tolerance will permit the use of
the food commodities in this paragraph when treated in accordance with
the provisions of the experimental use permit 524-EUP-97 which is being
issued under the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA), as amended (7 U.S.C. 136). This temporary exemption from the
requirement of a tolerance expires and is revoked June 30, 2009;
however, if the experimental use permit is revoked, or if any
experience with or scientific data on this pesticide indicate that the
tolerance is not safe, this temporary exemption from the requirement of
a tolerance may be revoked at any time.
[FR Doc. E6-11249 Filed 7-14-06; 8:45 am]

BILLING CODE 6560-50-S