MEMORANDUM SUBJECT: Conversion from MTBE blended RFG to ethanol blended RFG FROM: Chris McKenna TO: Docket EPA HQ OAR 2005 0170 DATE: 4/ 24/ 2006 Based on confidential conversations with several large refiners of RFG, all of them have indicated they have converted, or are in the process of converting, all of their terminals to be able to sell RFG blended with ethanol in place of RFG blended with MTBE. These refiners have historically produced MTBE blended RFG for sale at terminals in RFG markets in several states throughout the U. S., including Texas, Virginia, Maryland, Delaware, Pennsylvania, New Jersey, New York and Connecticut.

Chris McKenna


[Federal Register Volume 79, Number 110 (Monday, June 9, 2014)]
[Notices]
[Pages 32938-32939]
[FR Doc No: 2014-13350]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP14-494-000]

National Fuel Gas Supply Corporation; Notice of Request Under
Blanket Authorization

    Take notice that on May 30, 2014, National Fuel Gas Supply
Corporation (National Fuel), 6363 Main Street, Williamsville, New York
14221, filed in Docket No. CP14-494-000, a prior notice request
pursuant to sections 157.205, 157.208 and 157.216 of the Commission's
Regulations under the Natural Gas Act (NGA). National Fuel seeks
authorization to (1) construct and operate approximately 350 feet of 6-
inch diameter pipeline, (2) abandon, in place, approximately 3,430 feet
of 12-inch diameter pipeline, (3) remove approximately 420 feet of 4-
inch diameter bare steel pipeline, and (4) install various auxiliary
facilities in connection with the pipeline abandonment, all located in
National Fuel's existing Summit Storage field in Erie County,
Pennsylvania, all as more fully set forth in the application which is
on file with the Commission and open to public inspection.
    The filing may also be viewed on the Web at http://www.ferc.gov
using the ``eLibrary'' link. Enter the docket number excluding the last
three digits in the docket number field to access the document. For
assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>or toll free at<PHONE_NUMBER>, or TTY,
contact<PHONE_NUMBER>.
    Any questions concerning this application may be directed to
Kenneth E. Webster, Attorney, National Fuel Gas Supply Corporation,
6363 Main Street, Williamsville, NY 14221 or by calling<PHONE_NUMBER>,
fax<PHONE_NUMBER> or at<EMAIL_ADDRESS>    Any person or the Commission's staff may, within 60 days after
issuance of the instant notice by the Commission, file pursuant to Rule
214 of the Commission's Procedural Rules (18 CFR 385.214) a motion to
intervene or notice of intervention and pursuant to Section 157.205 of
the regulations under the NGA (18 CFR 157.205), a protest to the
request. If no protest is filed within the time allowed therefore, the
proposed activity shall be deemed to be authorized effective the day
after the time allowed for filing a protest. If a protest is filed and
not withdrawn within 30 days after the allowed time for filing a
protest, the instant request shall be treated as an application for
authorization pursuant to Section 7 of the NGA.
    Pursuant to section 157.9 of the Commission's rules (18 CFR 157.9),
within 90 days of this Notice, the Commission staff will either:
Complete its environmental assessment (EA) and place it into the
Commission's public record (eLibrary) for this proceeding; or issue a
Notice of Schedule for Environmental Review. If a Notice of Schedule
for Environmental Review is issued, it will indicate, among other
milestones, the anticipated date for the Commission staff's issuance of
the EA for this proposal. The filing of the EA in the Commission's
public record for this proceeding or the issuance of a Notice of
Schedule for Environmental Review will serve to notify federal and
state agencies of the timing for the completion of all necessary
reviews, and the subsequent need to complete all

federal authorizations within 90 days of the date of issuance of the
Commission staff's EA.
    Persons who wish to comment only on the environmental review of
this project should submit an original and two copies of their comments
to the Secretary of the Commission. Environmental commenter's will be
placed on the Commission's environmental mailing list, will receive
copies of the environmental documents, and will be notified of meetings
associated with the Commission's environmental review process.
Environmental commenters will not be required to serve copies of filed
documents on all other parties. However, the non-party commentary, will
not receive copies of all documents filed by other parties or issued by
the Commission (except for the mailing of environmental documents
issued by the Commission) and will not have the right to seek court
review of the Commission's final order.
    The Commission strongly encourages electronic filings of comments,
protests and interventions in lieu of paper using the ``eFiling'' link
at http://www.ferc.gov. Persons unable to file electronically should
submit an original and 5 copies of the protest or intervention to the
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426.

    Dated: June 3, 2014.
Kimberly D. Bose,
Secretary.
[FR Doc. 2014-13350 Filed 6-6-14; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 110 (Thursday, June 10, 2021)]
[Notices]
[Pages 30942-30944]
[FR Doc No: 2021-12199]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2019-E-5338; FDA-2019-E-5346; and FDA-2019-E-5343]

Determination of Regulatory Review Period for Purposes of Patent
Extension; EVENITY

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for EVENITY and is publishing
this notice of that determination as required by law. FDA has made the
determination because of the submission of applications to the Director
of the U.S. Patent and Trademark Office (USPTO), Department of
Commerce, for the extension of a patent which claims that human
biological product.

DATES: Anyone with knowledge that any of the dates as published (see
SUPPLEMENTARY INFORMATION) are incorrect may submit either electronic
or written comments and ask for a redetermination by August 9, 2021.
Furthermore, any interested person may petition FDA for a determination
regarding whether the applicant for extension acted with due diligence
during the regulatory review period by December 7, 2021. See
``Petitions'' in the SUPPLEMENTARY INFORMATION section for more
information.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before August 9, 2021. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of August 9, 2021. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket Nos.
FDA-2019-E-5338; FDA-2019-E-5343; FDA-2019-E-5346, For Determination of
Regulatory Review Period for Purposes of Patent Extension; EVENITY.
Received comments, those filed in a timely manner (see ADDRESSES), will
be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with Sec.  10.20 (21 CFR 10.20) and
other applicable disclosure law. For more information about FDA's
posting of comments to public dockets, see 80 FR 56469, September 18,
2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug product, animal drug product, medical device, food
additive, or color additive) was subject to regulatory review by FDA
before the item was marketed. Under these acts, a product's regulatory
review period forms the basis for determining the amount of extension
an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human biological products, the
testing phase begins when the exemption to permit the clinical
investigations of the biological product becomes effective and runs
until the approval phase begins. The approval phase starts with the
initial submission of an application to market the human biological
product and continues until FDA grants permission to market the
biological product. Although only a portion of a regulatory review
period may count toward the actual amount of extension that the
Director of USPTO may award (for example, half the testing phase must
be subtracted as well as any time that may have occurred before the
patent was issued), FDA's determination of the length of a regulatory
review period for a human biological product will include all of the
testing phase and approval phase as specified in 35 U.S.C.
156(g)(1)(B).
    FDA has approved for marketing the human biologic product EVENITY
(romosozumab-aqqg). EVENITY is indicated for the treatment of
osteoporosis in postmenopausal women at high risk for fracture, defined
as a history of osteoporotic fracture, or multiple risk factors for
fracture; or patients who have failed or are intolerant to other
available osteoporosis therapy. Subsequent to this approval, the USPTO
received patent term restoration applications for EVENITY (U.S. Patent
Nos. 7,592,429; 8,017,120; and 8,440,193) from Amgen Inc., and the
USPTO requested FDA's assistance in determining the patents'
eligibility for patent term restoration. In a letter dated December 23,
2019, FDA advised the USPTO that this human biological product had
undergone a regulatory review period and that the approval of EVENITY
represented the first permitted commercial marketing or use of the
product. Thereafter, the USPTO requested that FDA determine the
product's regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
EVENITY is 4,519 days. Of this time, 3,524 days occurred during the
testing phase of the regulatory review period, while 995 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355(i)) became effective: November
26, 2006. The applicant claims December 8, 2006,

as the date the investigational new drug application (IND) became
effective. However, FDA records indicate that the IND effective date
was November 26, 2006, which was 30 days after FDA receipt of the IND.
    2. The date the application was initially submitted with respect to
the human biological product under section 351 of the Public Health
Service Act (42 U.S.C. 262): July 19, 2016. FDA has verified the
applicant's claim that the biologics license application (BLA) for
EVENITY (BLA 761062) was initially submitted on July 19, 2016.
    3. The date the application was approved: April 9, 2019. FDA has
verified the applicant's claim that BLA 761062 was approved on April 9,
2019.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its applications for patent extension,
this applicant seeks 1,550 days, 1,575 days or 1,827 days of patent
term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in Sec.  60.30 (21 CFR 60.30), any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must comply with all the requirements
of Sec.  60.30, including but not limited to: Must be timely (see
DATES), must be filed in accordance with Sec.  10.20, must contain
sufficient facts to merit an FDA investigation, and must certify that a
true and complete copy of the petition has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42,
1984.) Petitions should be in the format specified in 21 CFR 10.30.
    Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: June 3, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-12199 Filed 6-9-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 86, Number 31 (Thursday, February 18, 2021)]
[Notices]
[Page 10130]
[FR Doc No: 2021-03319]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4580-DR; Docket ID FEMA-2021-0001]

Connecticut; Major Disaster and Related Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This is a notice of the Presidential declaration of a major
disaster for the State of Connecticut (FEMA-4580-DR), dated January 12,
2021, and related determinations.

DATES: The declaration was issued January 12, 2021.

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 January 12, 2021, 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 Connecticut resulting from Tropical Storm Isaias on August 4,
2020, 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 Connecticut.
    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, Robert V. Fogel, of FEMA is
appointed to act as the Federal Coordinating Officer for this major
disaster.
    The following areas of the State of Connecticut have been
designated as adversely affected by this major disaster:

    Fairfield, Hartford, Litchfield, Middlesex, New Haven, New
London, Tolland, and Windham Counties and the Mashantucket Pequot
Indian Tribe and Mohegan Tribe of Indians for Public Assistance.
    All areas within the State of Connecticut 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.

Robert J. Fenton,
Senior Official Performing the Duties of the Administrator, Federal
Emergency Management Agency.
[FR Doc. 2021-03319 Filed 2-17-21; 8:45 am]
BILLING CODE 9111-23-P


 Data Requirement:PMRA Data Code:9.8.4 (TGAI) or 9.8.6 (EP)                         EPA DP Barcode:420822                         OECD Data Point:IIA 8.12 (TGAI) and IIIA <IP_ADDRESS> (EP)                         EPA Guideline:850.4150

Test material:  Dacthal Flowable Herbicide (DCPA)Purity:54.0% Common name:   Chemical name:IUPAC: CAS name:   CAS No.:   1861-32-1 Synonyms:  DCPA Primary Reviewer:Teresa NelisSignature:   Environmental Scientist, CDM/CSS-Dynamac JVDate: 12/22/16

Secondary Reviewer:  Teri MyersSignature:   Senior Scientist, CDM/CSS-Dynamac JVDate:   12/22/16

Primary Reviewer:Christina M. WendelSignature:  EPA/OPP/EFED/ERB2/Biologist Date: 12/02/2021

Secondary Reviewer(s): Michael WagmanSignature:  EPA/OPP/EFED/ERB2/Senior ScientistDate: 11/30/2021

Reference/Submission No.: {.....................}

Company Code {............}[For PMRA] Active Code{............}[For PMRA]  Use Site Category:{............}[For PMRA] EPA PC Code 078701

Date Evaluation Completed: 02-12-2021

CITATION:  Sindermann, A.B., Porch, J.R, Krueger, H.O. and K.H. Martin, K.H. 2013. Dacthal: A Toxicity Test to Determine the Effects of the Test Substance on Vegetative Vigor of Ten Species of Plants. Final Report. Unpublished study performed by Wildlife International, Easton, Maryland. Study sponsored by Amvac Chemical Corporation. Los Angeles, California. Wildlife International Project Number 246P-106. Study completed December 6, 2013.

This Data Evaluation Record may have been altered by the Environmental Fate and Effects Division subsequent to signing by CDM/CSS-Dynamac JV personnel

EXECUTIVE SUMMARY:

The effect of Dacthal Flowable Herbicide (DCPA) on the vegetative vigor of monocot (corn, Zea mays; onion, Allium cepa; ryegrass, Lolium perenne; and wheat, Triticum aestivum) and dicot (cabbage, Brassica oleracea; lettuce, Lactuca sativa; oilseed rape, Brassica napus; soybean, Glycine max; sugarbeet, Beta vulgaris; and tomato, Lycopersicon esculentum) crops was studied at nominal concentrations of 0 (negative control), 0.66, 1.3, 2.6, 5.2, and 10.5 lb ai/A.

Treatment levels were analytically confirmed in the dosing solutions at each application rate. The measured concentrations of DCPA were <0.089 (<LOQ, negative control), 0.61, 1.23, 2.52, 4.98, and 10.2 lb a.i./A for onion, ryegrass, soybean, sugarbeet, and tomato, and <0.089 (<LOQ, negative control), 0.61, 1.24, 2.53, 5.08, 10.2 lb a.i./A for cabbage, corn, lettuce, oilseed rape, and wheat.

The growth medium used in the seedling emergence test was a loamy sand made from kaolinite clay, industrial quartz sand and peat (loamy fine sand, pH 7.2, organic carbon 0.56%). On day 21 the surviving plants per pot were recorded and cut at soil level for measuring the plant height and dry weight.

Negative control survival was 100%. There were no significant inhibitions in seedling survival in any species tested compared to the negative control (p>0.05).

There were no significant inhibitions in seedling height in any species tested compared to the negative control (p>0.05).         There were no significant inhibitions in dry weight for any species tested except for soybean. Significant inhibitions in soybean dry weight were 19 and 20% at the 4.98 and 10.2 lb a.i./A treatment levels, respectively, compared to the negative control (Dunnett's test, p<0.05).

Based on the reviewer's results, the most sensitive monocot could not be determined due to lack of toxicity. Inhibitions did not approach 25% and there were no statistically significant effects for any monocot tested. Therefore, the IC25 was visually estimated as >10.2 lb a.i./A, the highest tested application rate, and the NOAEC was 10.2 lb a.i./A for all tested monocot species. The most sensitive dicot was soybean, based on dry weight, with NOAEC and extrapolated IC25 values of 2.52, and 11.9 lb a.i./A, respectively (with 20% effects at the 10.2 lb a.i./A, highest test level); however, the IC25 value and confidence intervals were outside the tested range of concentrations and should be interpreted with caution.

Based on the phytotoxicity rating system used by the study author, there were no to slight effects in all species.  Soybean and sugarbeet phytotoxic effects included chlorosis, necrosis and leaf curl, and the effects were dose-related.

Maximum Labeled Rate: Not reported

Monocot    Most sensitive monocot:Could not be determined due to lack of toxicity        EC50/IC50: >10.2 lb a.i./A95% C.I.: N/A    EC25/IC25: >10.2 lb a.i./A95% C.I.: N/A    EC05/IC05: N/A95% C.I.: N/A    NOAEC: 10.2 lb a.i./A    LOAEC: >10.2 lb a.i./A    Slope: N/A95% C.I.: N/A

Dicot    Most sensitive dicot:   Soybean, based on dry weight*        EC50/IC50: >10.2 lb a.i./A 95% C.I.: N/A    EC25/IC25: 11.9 lb a.i./A95% C.I.: 5.96-20.1 lb a.i./A    EC05/IC05: 2.72 lb a.i./A95% C.I.: N/A-5.56 lb a.i./A    NOAEC: 2.52 lb a.i./A    LOAEC: 4.98 lb a.i./A    Slope: N/A95% C.I.: N/A    *Some endpoints and/or confidence intervals are outside the tested range of concentrations and should be interpreted with caution.

Table 1 (Tier II studies).  Summary of most sensitive parameters by species (lb ai/A). Species Endpoint NOEC EC05/IC05 EC25/IC25 EC50/IC50 Cabbage None 10.2 NC >10.2 >10.2 Corn None 10.2 >10.2 >10.2 >10.2 Lettuce None 10.2 NC >10.2 >10.2 Oilseed Rape None 10.2 NC >10.2 >10.2 Onion None 10.2 NC >10.2 >10.2 Ryegrass None 10.2 NC >10.2 >10.2 Soybean1* Dry Weight 2.52 2.72 11.9 >10.2 Sugarbeet None 10.2 NC >10.2 >10.2 Tomato None 10.2 >10.2 >10.2 >10.2 Wheat None 10.2 NC >10.2 >10.2 NC  -  not calculable *Endpoints and/or confidence intervals are outside the tested range of concentrations and should be interpreted with caution. 1Significant inhibitions in soybean dry weight were <25%; and were 19 and 20% at the 4.98 and the 10.2 lb a.i./A treatment levels, respectively, compared to the negative control (Dunnett's test, p<0.05).

This study is scientifically sound and is classified as acceptable.

I. MATERIALS AND METHODS   GUIDELINE FOLLOWED:  This study was conducted in compliance with Series 850-Ecological Effects Test Guidelines, OCSPP Number 850.4150: Vegetative Vigor (2012). The reviewer evaluated the study methods according to EPA Ecological Effects Test Guidelines, OCSPP Guideline 850.4150: Vegetative Vigor (January 2012).                                The physico-chemical properties of the test material were not reported. This is a minor deficiency. Soil CEC and % moisture were not reported. This is a minor deficiency. A range-finding study was conducted, but only the summary results were reported in Appendix 16 of the study report, and some details were not provided in the data summary tables that were provided in the Appendix.           The deficiencies did not have an impact on the acceptability of this study.        COMPLIANCE: Signed and dated GLP, Quality Assurance and Data Confidentiality statements were provided.  This study was conducted in compliance with Good Laboratory Practice Standards as published by U.S. Environmental Protection Agency (40 CFR Part 160), August 1989; OECD Principles of Good Laboratory Practice (ENV/MC/CHEM (98) 17); and Japan MAFF, 59 NohSan, Notification No. 6283, Agricultural Production Bureau, 1 October 1999. As noted, periodic analyses of well water and soil for potential contaminants were not performed according to GLP but were performed using a certified laboratory and standard U.S. EPA analytical methods. Characterization of the reference substance and the stability of the reference substance under conditions of storage at the test site were determined before the completion of the study in accordance with GLP, however, characterization was conducted after test initiation.        A. MATERIALS:

   1. Test Material       DCPA (Dacthal Flowable Herbicide)           Description: Off-white liquid              Lot No./Batch No.: BT2242030              Purity: 54.0%

      Stability of compound        under test conditions:Recovery of test substance in spray solutions ranged from 92-97% (n=18); matrix fortified sample recoveries ranged from 99-100%. Stability (verification) of the test material was reported to be 92.7 to 96.4% of nominal concentrations.       (OECD recommends chemical stability in water and light)

      Storage conditions of        test chemicals: At ambient room conditions, out of direct sunlight.

Table 2.  Physical/chemical properties of DCPA. Parameter Values Comments Water solubility at 20˚C Not reported

Vapor pressure Not reported

UV absorption Not reported

pKa Not reported

Kow Not reported

       2. Test organism:

      Monocotyledonous species: Corn (Zea mays, Poaceae; Nothstine Dent); Onion (Allium cepa, Liliaceae; Yellow Granex Hybrid 33); Ryegrass (Lolium perenne, Poaceae; Gator 3 Perennial); and Wheat (Triticum aestivum, Poaceae; Glenn Hard Red Spring). EPA recommends four monocots in two families, including corn.       Dicotyledonous species: Cabbage (Brassica oleracea, Brassicaceae; Late Flat Dutch); Lettuce (Lactuca sativa, Asteraceae; Summertime); Oilseed Rape (Brassica napus, Brassicaceae; Dwarf Essex); Soybean (Glycine max, Fabaceae; Maverick); Sugarbeet (Beta vulgaris, Chenopodiaceae; 38WVR0852); and Tomato (Lycopersicon esculentum, Solanaceae; Rutgers). EPA recommends six dicots in four families, including soybean and a root crop.        OECD recommends a minimum of three species selected for testing, at least one from each of the following categories: Category 1: ryegrass, rice, oat, wheat, and sorghum; Category 2: mustard, rape, radish, turnip, and Chinese cabbage; Category 3: vetch, mung bean, red clover, fenugreek, lettuce, and cress.       Seed source: Corn, Wheat and Oilseed Rape from Johnny's Selected Seeds, Winslow ME; Onion from Park Seed Company, Greenwood, SC; Ryegrass, Cabbage and Tomato from Meyer Seed, Baltimore, MD;; Lettuce from Sustainable Seed Company, Covelo, CO; Soybean from Missouri Foundation Seeds, Columbia, MO; and Sugarbeet from Betaseed, Inc., Moorhead, MN.         Prior seed treatment/sterilization: None.        Historical % germination of seed: Corn (94%), Onion (98%), Ryegrass (90%), Wheat (94%), Cabbage (85%), Lettuce (98%), Oilseed Rape (96%), Soybean (91%), Sugarbeet (98%), and Tomato (90%). Seed storage, if any: Not reported.

   B. STUDY DESIGN:

      1. Experimental Conditions

         a. Limit test: None.                     b. Range-finding study: A preliminary non-GLP range-finding test evaluating the effects of Dacthal on the height, plant condition and fresh weight was conducted exposing corn, onion, ryegrass, wheat, cabbage, lettuce, oilseed rape, soybean, sugarbeet, and tomato to nominal application rates of 0.016, 0.08, 0.4, 2, and 10 lb a.i./A, and a control. The results are presented in Appendix 16 (pg. 155-164). Fresh weight inhibitions maximum of 87% were observed; and height inhibitions were a maximum of 32% were observed both for onion. Very limited information is provided in the study report, only data summary tables in Appendix 16.

         c. Definitive Study           Table 3:  Experimental Parameters  -  Vegetative Vigor. Parameters Vegetative Vigor

Details Remarks

Criteria Duration of the test 21 days

Recommended test duration is 14-21 days. OECD recommends that the test be terminated no sooner than 14 days after 50 percent of the control seedlings have emerged Number of seeds/plants/species/ replicate Six pots (replicates) with 5 seeds per replicate

Five plants per replicate are recommended. Number of plants retained after thinning Up to 3 seeds were planted in each pot. One day prior to application, seedlings were thinned to one plant per pot, if necessary. Seedlings were randomly assigned to test groups prior to application. Number of replicates Control: Adjuvant control: Treated:

6 N/A 6

Four replicates per dose should be used. OECD recommends a minimum of four replicates per treatment Test concentrations (lb ai/A) Nominal:

Measured:

0 (negative control), 0.66, 1.3, 2.6, 5.2, and 10.5 lb a.i./A

Onion, ryegrass, soybean, sugarbeet, and tomato: <0.089 (<LOQ, negative control), 0.61, 1.23, 2.52, 4.98, and 10.2 lb a.i./A

Cabbage, corn, lettuce, oilseed rape, and wheat: <0.089 (<LOQ, negative control), 0.61, 1.24, 2.53, 5.08, 10.2 lb a.i./A The study author reported nominal application rates of 0 (negative control), 0.88, 1.8, 3.5, 7.0 and 14 pt/A. Spray solutions were prepared in well water purified by reverse osmosis (R/O).  Negative control group was sprayed with reverse osmosis water only.

Measured application rates and conversions are provided in Appendix 1 below.

Five test concentrations should be used with a dose range of 2X or 3X progression

OECD recommends three concentrations, preferably with application rates equivalent to 0.0 (control), 1.0, 10.0 and 100 mg substance per kg of oven-dried soil. Method and interval of analytical verification

LOQ: LOD: Samples of the dosing solutions were analyzed by Agilent Series 1100 High Performance Liquid Chromatograph, YMC-Pack ODS-AM column (150mm) with an Agilent 1100 Series Variable Wavelength Detector (220nm). 0.089 lb a.i./A N/A Samples for verification of the spray mixture were collected on September 5 and 6, 2013 and were found to be 92.7 to 96.4% of nominal concentrations (Table 1 in study report; pg. 21). Adjuvant (type, percentage, if used) N/A

Test container (pot) Size/Volume Material: (glass/polystyrene)

11 cm diameter by 10 cm depth Plastic

Non-porous containers should be used. OECD recommends that non-porous plastic or glazed pot be used. Growth facility Greenhouse

Method/depth of seeding Corn, onion, wheat and soybean: 20mm depth All others: 10mm depth

Test material application Application time including the plant growth stage

Number of applications

Application interval

Method of application

Onion, 2 leaf stage; corn, cabbage, lettuce, 2-4 leaf stage; wheat, 3 leaf stage; sugarbeet, oilseed rape, soybean, tomato, 3-4 leaf stage; ryegrass, 5-8 leaf stage

1

N/A- single application

The test material was applied at 200L/ha using a DeVries Research Track sprayer with a Teejet 8002E nozzle, 20 psi, applied 41 cm from the soil surface. Calibrations of sprayer system indicated actual spraying rates of 201-202 L/ha.

Details of soil used Geographic location Depth of soil collection Soil texture    %  sand    %  silt    %  clay pH:

% organic carbon CEC Moisture at 1/3 atm (%)

N/A N/A Loamy fine sand 89 3 8 7.2 (in water) 6.7 (in 0.01 M CaCl2) 0.56% Not reported Not reported  Soil was a mixture of kaolinite clay, industrial quartz sand and peat with crushed limestone added to buffer pH. Organic matter 0.96% A sample of soil representative of that used in this study was sent to Agvise Laboratories, Inc., in Northwood, ND, for analysis of the particle size distribution and organic matter content of the soil. The soil used for plant studies are periodically screened for pesticides and metals. No analytes were measured at levels that were expected to have an impact on the study. Although the complete reports were filed in the archives at EAG Laboratories the results of these analyses were not provided in the study report for reference.

Soil mixes containing sandy loam, loam, or clay loam soil with no greater than 2% organic matter are preferable. Glass beads, rock wool, and 100% acid washed sand are not preferred. OECD prefers the soil to be sieved (0.5 cm) to remove coarse fragments. Carbon content should not exceed 1.5% (3% organic matter). Fine particles (under 20um) makeup should be between 10 and 20%. The recommended pH is between 5.0 and 7.5. Details of nutrient medium, if used

N/A

Watering regime and schedules Water source/type:

Volume applied: Interval of application: Method of application:

Laboratory well water purified by reverse osmosis (R/O). Not specified. As needed. The plants were bottom watered every, one to three days, as needed. The days on which watering occurred are listed in Appendix 5 (pgs. 63-64) of the study report. The well water used for plant studies are periodically screened for pesticides and metals. No analytes were measured at levels that were expected to have an impact on the study. Although the reports were filed in the archives at EAG Laboratories the results of these analyses were not provided in the study report for reference.

EPA prefers that bottom watering be utilized for vegetative vigor studies so that the chemical is not leached out of the soil during the test. Any pest control method/fertilization, if used A slow release fertilizer was added to soil before planting.

Test conditions

Temperature: Photoperiod:

Light intensity and quality:

Relative humidity:

Temperature: Photoperiod:

Light intensity and quality:

Relative humidity: Onion, sugarbeet, soybean, tomato and ryegrass: Mean 23.09, range 16.06-35.34˚C 16L:8D  Natural sunlight supplemented with artificial light.   Mean 14.0, range 12.4-16.7 moles PAR

Mean 66.22, range 29.51-93.20%

Cabbage, oilseed rape, lettuce, wheat and corn:  Mean 24.26, range 16.98-34.91˚C 16L:8D  Natural sunlight supplemented with artificial light.   Mean 14.0, range 10.8-17.0 moles PAR

Mean 62.63, range 28.36-91.50% Environmental conditions are summarized in Appendix 5 (pgs. 63-64) of the study report.

EPA prefers that the cold vs warm loving plants be tested in two separate groups to optimize plant growth.

OECD prefers that the temperature, humidity and light conditions be suitable for maintaining normal growth of each species for the test period. Reference chemical (if used) Name: Concentrations:

N/A

Other parameters, if any None

   2. Observations:

Table 4:  Observation Parameters - Vegetative Vigor. Parameters Vegetative Vigor

Details Remarks Parameters measured (e.g., number of germinated seeds, emerged seedlings, plant height, dry weight or other endpoints) - Survival - Height - Mean dry weight - Phytotoxicity

Measurement technique for each parameter  Phytotoxicity was visually determined. Height was measured to the apical meristem or the tip of the longest leaf.  Mean plant weight was estimated by cutting plant at soil surface and measuring the total dry weight per replicate divided by number of plants weighed following oven drying.

Observation intervals  Each pot was inspected weekly (days 7, 14, & 21) and phytotoxicity assessments performed.  Plant height and dry weight were recorded at study termination (day 21).

Other observations, if any N/A

Were raw data included? Yes

Phytotoxicity rating system, if used 0- No effect; 10-30- Slight effect; 40-60- Moderate effect; 70-90- Severe effect; 100 = death of entire plant. Frans, Robert E. and Ronald E. Talbert. 1977. Design of Field Experiments and the Measurement and Analysis of Plant Responses, pp. 15-23, in B. Truelove, ed., Research Methods in Weed Science. Southern Weed Science Society, Auburn University, Alabama

II. RESULTS and DISCUSSION:

   A. INHIBITORY EFFECTS:

Vegetative Vigor:

      Negative control survival was 100%. The study author found no significant inhibitions in survival in any species tested compared to the negative control. The reviewer did not find significant inhibitions in survival in any species tested (p>0.05).

      The study author and reviewer did not find significant inhibitions in height in any species tested compared to the negative control (p>0.05).               The study author found significant inhibition in soybean dry weight, but not in any other species tested compared to the negative control. Significant inhibitions in soybean dry weight were 19 and 20% at the 5.2 and 10.5 lb ai/A treatment levels, respectively, compared to the negative control (Dunnett's test, p<0.05). The reviewer also found significant inhibitions in soybean dry weight of 19 and 20% at the 4.98 and the 10.2 lb a.i./A treatment levels, respectively, compared to the negative control (Dunnett's test, p<0.05).

      Based on the study author's results, the most sensitive monocot and dicot could not be determined due to lack of toxicity. The study author determined the NOER and LOER for soybean dry weight was 2.6 and 10.5 lb ai/A, respectively, but no treatment related reductions were greater than 25% for any endpoint or any species.              Based on the phytotoxicity rating system used by the study author, there were none to slight effects in all species.  Soybean and sugarbeet phytotoxic effects included chlorosis, necrosis and leaf curl, and the effects were dose-related.        B. REPORTED STATISTICS BY THE STUDY AUTHOR:             Plant shoot height, shoot dry weight and percent survival means were determined. Parametric assumptions for normal distribution and homogeneity of variance were tested. If appropriate, effects of treatment were evaluated with an ANOVA, and the treatment groups were compared to controls with a Dunnett's test. When assumptions were not met, statistical results were still accepted due to the robust nature of the Dunnett's test. A probability of less than 0.05 was considered statistically significant. Results of the Dunnett's test were used to help establish the NOER. Statistical analyses also included the determination of effect rates (ERX estimates) and their confidence limits, if necessary. ER25 and ER50 estimates were calculated when reductions in test endpoints among one or more treatment groups were at least 25% or 50%, respectively, relative to control means. Where reductions in treatment groups were less than 25% or 50% compared to the control, the ER25 or ER50 values were considered to be greater than the highest treatment group. All statistical computations were performed on a personal computer using SAS version 8. Nominal concentrations were used for all analyses.     Table 5: Effect of DCPA on 21-Day Vegetative Vigor Species Results summary for height (lb ai/A)

height (cm) NOEC ER05 95%CI ER25 95%CI ER50 95%CI slope 95%CI Cabbage 27-28.7 10.5 ND N/A >10.5 N/A >10.5 N/A N/A N/A Corn 88.4-94.6 10.5 ND N/A >10.5 N/A >10.5 N/A N/A N/A Lettuce 19.4-20.4 10.5 ND N/A >10.5 N/A >10.5 N/A N/A N/A Oilseed Rape 36-38.3 10.5 ND N/A >10.5 N/A >10.5 N/A N/A N/A Onion 28.7-31 10.5 ND N/A >10.5 N/A >10.5 N/A N/A N/A Ryegrass 30.5-33.3 10.5 ND N/A >10.5 N/A >10.5 N/A N/A N/A Soybean 64.1-72.2 10.5 ND N/A >10.5 N/A >10.5 N/A N/A N/A Sugarbeet 30.2-31.5 10.5 ND N/A >10.5 N/A >10.5 N/A N/A N/A Tomato 52.5-56.4 10.5 ND N/A >10.5 N/A >10.5 N/A N/A N/A Wheat 57.6-60 10.5 ND N/A >10.5 N/A >10.5 N/A N/A N/A ND- Not determined. NC- Not calculable.

Table 5a: Effect of DCPA on 21-Day Vegetative Vigor Species Results summary for biomass (lb ai/A)

weight (g) NOEC ER05 95%CI ER25 95%CI ER50 95%CI slope 95%CI Cabbage 4.56-5.17 10.5 ND N/A >10.5 N/A >10.5 N/A N/A N/A Corn 3.87-4.44 10.5 ND N/A >10.5 N/A >10.5 N/A N/A N/A Lettuce 4.37-5.02 10.5 ND N/A >10.5 N/A >10.5 N/A N/A N/A Oilseed Rape 4.56-5.01 10.5 ND N/A >10.5 N/A >10.5 N/A N/A N/A Onion 0.177-0.21 10.5 ND N/A >10.5 N/A >10.5 N/A N/A N/A Ryegrass 0.875-1.01 10.5 ND N/A >10.5 N/A >10.5 N/A N/A N/A Soybean1 3.89-5.06 2.6 ND N/A >10.5 N/A >10.5 N/A N/A N/A Sugarbeet 2.69-3.08 10.5 ND N/A >10.5 N/A >10.5 N/A N/A N/A Tomato 5.68-6.32 10.5 ND N/A >10.5 N/A >10.5 N/A N/A N/A Wheat 1.59-1.84 10.5 ND N/A >10.5 N/A >10.5 N/A N/A N/A ND- Not determined. NC- Not calculable. 1 Significant decrease in soybean dry weight, inhibition of 19 and 20% at the 5.2 and 10.5 lb ai/A treatment levels, respectively, compared to the negative control (Dunnett's test, p<0.05).

Table 5b:  Effect of DCPA on 21-Day Vegetative Vigor Species Results summary for survival (lb ai/A)

% NOEC ER05 95%CI ER25 95%CI ER50 95%CI slope 95%CI Cabbage 100 10.5 ND N/A >10.5 N/A >10.5 N/A N/A N/A Corn 100 10.5 ND N/A >10.5 N/A >10.5 N/A N/A N/A Lettuce 100 10.5 ND N/A >10.5 N/A >10.5 N/A N/A N/A Oilseed Rape 100 10.5 ND N/A >10.5 N/A >10.5 N/A N/A N/A Onion 100 10.5 ND N/A >10.5 N/A >10.5 N/A N/A N/A Ryegrass 97-100 10.5 ND N/A >10.5 N/A >10.5 N/A N/A N/A Soybean 97-100 10.5 ND N/A >10.5 N/A >10.5 N/A N/A N/A Sugarbeet 100 10.5 ND N/A >10.5 N/A >10.5 N/A N/A N/A Tomato 97-100 10.5 ND N/A >10.5 N/A >10.5 N/A N/A N/A Wheat 100 10.5 ND N/A >10.5 N/A >10.5 N/A N/A N/A ND- Not determined. NC- Not calculable.

Plant Injury Index* Control Cabbage Corn Lettuce Oilseed Rape Onion Ryegrass Soybean Sugarbeet Tomato  Wheat Formulation Blank 0-8 0-2 0-14 0-10 0-10 0-18 0-26 0-28 0-22 0-20 0-4 N/A *0- No effect; 10-30- Slight effect; 40-60- Moderate effect; 70-90- Severe effect; 100 = death of entire plant.

   C. VERIFICATION OF STATISTICAL RESULTS BY THE REVIEWER:

   All analyses were conducted comparing treated to the negative control. These analyses were conducted using CETIS version <IP_ADDRESS> and backend settings approved for use by EFED on 10/20/15.   Data for each endpoint were tested to determine if their distributions were normal and if their variances were homogeneous using Shapiro-Wilk's and Levene's tests, respectively. Data that satisfied these assumptions were subjected to Dunnett's and William's tests, and data that did not satisfy these assumptions were subjected to the non-parametric Mann-Whitney U and Jonckheere's tests. Linear (survival) and non-linear (height and dry weight) regression models were used to interpret EC/ICx values. Measured concentrations were used for all analyses.

Table 6:  Effect of DCPA on 21-Day Vegetative Vigor Species Results summary for height (lb ai/A)

height (cm) NOEC IC05 95%CI IC25 95%CI IC50 95%CI slope 95%CI Cabbage* 27-28.7 10.2 11.1 N/A-17.6 >10.2 N/A >10.2 N/A N/A N/A Corn 88.4-94.6 10.2 >10.2 N/A >10.2 N/A >10.2 N/A N/A N/A Lettuce 19.4-20.4 10.2 >10.2 N/A >10.2 N/A >10.2 N/A N/A N/A Oilseed Rape* 36-38.3 10.2 >10.2 N/A >10.2 N/A >10.2 N/A N/A N/A Onion 28.7-31 10.2 8.98 N/A-30.6 >10.2 N/A >10.2 N/A N/A N/A Ryegrass 30.5-33.3 10.2 NC N/A >10.2 N/A >10.2 N/A N/A N/A Soybean 64.1-72.2 10.2 NC N/A >10.2 N/A >10.2 N/A N/A N/A Sugarbeet 30.2-31.5 10.2 >10.2 N/A >10.2 N/A >10.2 N/A N/A N/A Tomato 52.5-56.4 10.2 >10.2 N/A >10.2 N/A >10.2 N/A N/A N/A Wheat** 57.6-60 10.2 30.2 6720-0.26 0.109 30.3-0.000166 0.0000199 28.4-N/A N/A N/A ND- Not determined. NC- Not calculable. *Endpoint and/or confidence limits are outside the tested range of concentrations and should be interpreted with caution. **Wheat height showed an inverse dose response.

Table 6a: Effect of DCPA on 21-Day Vegetative Vigor Species Results summary for biomass (lb ai/A)

weight (g) NOEC IC05 95%CI IC25 95%CI IC50 95%CI slope 95%CI Cabbage 4.56-5.17 10.2 >10.2 N/A >10.2 N/A >10.2 N/A N/A N/A Corn 3.87-4.44 10.2 >10.2 N/A >10.2 N/A >10.2 N/A N/A N/A Lettuce 4.37-5.02 10.2 >10.2 N/A >10.2 N/A >10.2 N/A N/A N/A Oilseed Rape 4.56-5.01 10.2 >10.2 N/A >10.2 N/A >10.2 N/A N/A N/A Onion 0.177-0.21 10.2 NC N/A >10.2 N/A >10.2 N/A N/A N/A Ryegrass* 0.875-1.01 10.2 ND N/A ND N/A ND N/A N/A N/A Soybean1* 3.89-5.06 2.52 2.72 N/A-5.56 11.9 5.96-20.1 >10.2 N/A N/A N/A Sugarbeet* 2.69-3.08 10.2 ND N/A >10.2 N/A >10.2 N/A N/A N/A Tomato 5.68-6.32 10.2 >10.2 N/A >10.2 N/A >10.2 N/A N/A N/A Wheat 1.59-1.84 10.2 >10.2 N/A >10.2 N/A >10.2 N/A N/A N/A ND- Not determined. NC- Not calculable. *Endpoint and/or confidence limits are outside the tested range of concentrations and should be interpreted with caution. 1 Significant decrease in soybean dry weight, inhibition of 19 and 20% at the 4.98 and the 10.2 lb ai/A treatment levels, respectively, compared to the negative control (Dunnett's test, p<0.05). Table 6b:  Effect of DCPA on 21-Day Vegetative Vigor Species Results summary for survival (lb ai/A)

% NOEC EC05 95%CI EC25 95%CI EC50 95%CI slope 95%CI Cabbage 100 10.2 >10.2 N/A >10.2 N/A >10.2 N/A N/A N/A Corn 100 10.2 >10.2 N/A >10.2 N/A >10.2 N/A N/A N/A Lettuce 100 10.2 >10.2 N/A >10.2 N/A >10.2 N/A N/A N/A Oilseed Rape 100 10.2 >10.2 N/A >10.2 N/A >10.2 N/A N/A N/A Onion 100 10.2 >10.2 N/A >10.2 N/A >10.2 N/A N/A N/A Ryegrass 97-100 10.2 >10.2 N/A >10.2 N/A >10.2 N/A N/A N/A Soybean 97-100 10.2 >10.2 N/A >10.2 N/A >10.2 N/A N/A N/A Sugarbeet 100 10.2 >10.2 N/A >10.2 N/A >10.2 N/A N/A N/A Tomato 97-100 10.2 >10.2 N/A >10.2 N/A >10.2 N/A N/A N/A Wheat 100 10.2 >10.2 N/A >10.2 N/A >10.2 N/A N/A N/A ND- Not determined. NC- Not calculable.

Plant Injury Index* Control Cabbage Corn Lettuce Oilseed Rape Onion Ryegrass Soybean Sugarbeet Tomato  Wheat Formulation Blank 0-8 0-2 0-14 0-10 0-10 0-18 0-26 0-28 0-22 0-20 0-4 N/A *0- No effect; 10-30- Slight effect; 40-60- Moderate effect; 70-90- Severe effect; 100 = death of entire plant.    Most sensitive monocot:Could not be determined due to lack of toxicity        EC50/IC50: >10.2 lb a.i./A95% C.I.: N/A    EC25/IC25: >10.2 lb a.i./A95% C.I.: N/A    EC05/IC05: N/A95% C.I.: N/A    NOAEC: 10.2 lb a.i./A    Slope: N/A95% C.I.: N/A        Most sensitive dicot:   Soybean, based on dry weight*        EC50/IC50: >10.2 lb a.i./A95% C.I.: N/A    EC25/IC25: 11.9 lb a.i./A95% C.I.: 5.96-20.1 lb a.i./A    EC05/IC05: 2.72 lb a.i./A95% C.I.: N/A-5.56 lb a.i./A    NOAEC: 2.52 lb a.i./A    LOAEC: 4.98 lb a.i./A    Slope: N/A95% C.I.: N/A    *Some endpoints and/or confidence intervals are outside the range of concentrations and should be interpreted with caution.        D.  STUDY DEFICIENCIES:        The physico-chemical properties of the test material were not reported. This is a minor deficiency. Soil CEC and % moisture were not reported. This is a minor deficiency. A range-finding study was conducted, but only the summary results were reported in Appendix 16 of the study report, and some details were not provided in the data summary tables that were provided in the Appendix.

   E.  REVIEWER'S COMMENTS:             The reviewer and study author results were in agreement for monocots, but not for dicots. Both the study author and reviewer's most sensitive monocot could not be determined due to lack of toxicity. Significant inhibitions in this study did not approach 25% for any monocot species. Therefore, the IC25 was visually estimated as >10.2 lb a.i./A, the highest tested application rate, and the NOAEC was 10.2 lb a.i./A. Based on the study author's results, the most sensitive dicot could not be determined due to lack of toxicity. The study author determined the NOER and LOER for soybean dry weight was 2.6 and 10.5 lb a.i./A, respectively, but concluded the reductions were not treatment related and significant inhibitions did not approach 25% for any endpoint and any species. The reviewer found the most sensitive dicot was soybean, based on dry weight, with NOAEC and IC25 values of 2.52 and 11.9 lb a.i./A, respectively; however, the IC25 value and confidence intervals were outside the tested range of concentrations and should be interpreted with caution. The reviewer's results are presented in the Executive Summary and Conclusions sections of this DER.              The in-life portion of this study was initiated on September 5, 2013 and completed on September 26, 2013 for onion, sugarbeet, soybean, ryegrass, and tomato; and initiated on September 6, 2013 and completed on September 27, 2013 for cabbage, oilseed rape, lettuce, wheat, and corn. Dry weight measurements were completed on September 30, 2013.            F.  CONCLUSIONS:              This study is scientifically sound and is classified as acceptable. The most sensitive monocot species could not be determined due to lack of toxicity. Therefore, the IC25 was visually estimated as >10.2 lb a.i./A, the highest tested application rate, and the NOAEC was 10.2 lb a.i./A for all tested monocot species. The most sensitive dicot was soybean, based on dry weight, with NOAEC and extrapolated IC25 values of 2.52, and 11.9 lb a.i./A, respectively (with 20% effects at the 10.2 lb a.i./A, highest test level); however, the IC25 value and confidence intervals were outside the tested range of concentrations and should be interpreted with caution.         Most sensitive monocot and EC25/IC25: None; the IC25 was visually estimated as >10.2 lb a.i./A, the highest tested application rate for all tested monocot species. Most sensitive dicot and EC25/IC25:  Soybean (based on dry weight, 11.9 lb a.i./A; extrapolated, with 20% effects at the 10.2 lb a.i./A, highest test level)

III.  REFERENCES:

U.S. Environmental Protection Agency. 2012. Series 850- Ecological Effects Test Guidelines, OCSPP Number 850.4150: Vegetative Vigor.

Frans, Robert E. and Ronald E. Talbert. 1977. Design of Field Experiments and the Measurement and Analysis of Plant Responses. Pages 15-23 in B. Truelove, ed. Research Methods in Weed Science. Southern Weed Science Society, Auburn University, Alabama.

SAS Institute, Inc. 1999. SAS Proprietary Software Version 8, Gary, NC, SAS Institute, Inc.

APPENDIX 1. APPLICATION RATE CONVERSIONS from EXCEL FILE


[Federal Register Volume 83, Number 108 (Tuesday, June 5, 2018)]
[Rules and Regulations]
[Pages 25891-25894]
[FR Doc No: 2018-11427]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2017-1099; Product Identifier 2017-NM-093-AD; Amendment
39-19296; AD 2018-11-08]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for certain
The Boeing Company Model 767-200 and -300 series airplanes. This AD was
prompted by a report of two cracks at a certain frame inner chord. This
AD requires a detailed inspection for any material review board (MRB)
filler installed in the area from the frame web to the stub-beam
fitting at certain stations to determine if the filler extends above
the frame-to-stub-beam joint, and applicable on-condition actions. We
are issuing this AD to address the unsafe condition on these products.

DATES: This AD is effective July 10, 2018.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of July 10,
2018.

ADDRESSES: For service information identified in this final rule,
contact Boeing Commercial Airplanes, Attention: Contractual & Data
Services (C&DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA
90740-5600; telephone<PHONE_NUMBER>; internet https://www.myboeingfleet.com. You may view this service information at the
FAA, Transport Standards Branch, 2200 South 216th St., Des Moines, WA.
For information on the availability of this material at the FAA, call
206-231-3195. It is also available on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-
1099.

Examining the AD Docket

    You may examine the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-
1099; 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 final rule, the regulatory evaluation, any comments received, and
other information. The address for Docket Operations (phone: 800-647-
5527) is Docket Operations, U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Wayne Lockett, Aerospace Engineer,
Airframe Section, FAA, Seattle ACO Branch, 2200 S. 216th St., Des
Moines, WA 98198; phone and fax:<PHONE_NUMBER>; email:
[email protected].

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 by adding an AD that would apply to certain The Boeing Company
Model 767-200 and -300 series airplanes. The NPRM was published in the
Federal Register on December 6, 2017 (82 FR 57552). The NPRM was
prompted by a report of a crack on the transition radius of the station
(STA) 883.5 frame inner chord and an additional crack indication at a
fastener hole in the frame inner chord common to a material review
board (MRB) filler that extended above the frame-to-stub-beam joint.
The NPRM proposed to require a detailed inspection for any MRB filler
installed in the area from the frame web to the stub-beam fitting at
certain stations to determine if the filler extends above the frame-to-
stub-beam joint, and applicable on-condition actions.
    We are issuing this AD to detect and correct cracking of the frame
inner chord, which could result in the inability of one or more
overwing stub frames between STA 808 and STA 933, each a principal
structural element, to sustain limit loads; this condition could
adversely affect the structural integrity of the airplane.

Comments

    We gave the public the opportunity to participate in developing
this final rule. The following presents the comments received on the
NPRM and the FAA's response to each comment. Boeing concurred with the
NPRM.

Effect of Winglets on Accomplishment of the Proposed Actions

    Aviation Partners Boeing stated that accomplishing the Supplemental
Type Certificate (STC) ST01920SE does not affect the actions specified
in the NPRM.
    We concur with the commenter. We have redesignated paragraph (c) of
the proposed AD as paragraph (c)(1) of this AD and added paragraph
(c)(2) to this AD to state that installation of STC ST01920SE does not
affect the ability to accomplish the actions required by this AD.
Therefore, for airplanes on which STC ST01920SE is installed, a
``change in product'' alternative method of compliance (AMOC) approval
request is not necessary to comply with the requirements of 14 CFR
39.17.

Request To Confirm Intent of Compliance Time

    Paragraph (h)(1) of the proposed AD allowed operators to substitute
``the effective date of this AD'' for ``the original issue date of
Requirements Bulletin 767-53A0278 RB.'' United Airlines noted that this
wording is different from that of recent NPRMs, where the AD effective
date is the sole compliance date. United added that the proposed
wording suggested that the operator can choose to use either the AD
effective date or the original issue date of the RB when determining
the compliance timeline. United requested that we clarify the intent of
the provision of paragraph (h)(1) of the proposed AD.
    We agree with the commenter. We have revised paragraph (h)(1) of
this AD to specify use of the effective date of this AD in determining
the compliance time.

Conclusion

    We reviewed the relevant data, considered the comments received,
and determined that air safety and the public interest require adopting
this final rule with the changes described previously and minor
editorial changes. We have determined that these minor changes:
     Are consistent with the intent that was proposed in the
NPRM for addressing the unsafe condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM.
    We also determined that these changes will not increase the
economic burden on any operator or increase the scope of this final
rule.

Related Service Information Under 1 CFR Part 51

    We reviewed Boeing Alert Requirements Bulletin 767-53A0278 RB,
dated June 30, 2017. This service information describes procedures for
a detailed inspection for any MRB filler installed in the area from the
frame web to the stub-beam fitting on the left and right side at STA
859.5, 883.5, and 903.5 to determine if the filler extends above the
frame-to-stub-beam joint, and applicable on-condition actions. The
applicable on-condition actions include repetitive surface high
frequency eddy current inspections and repair for cracking in the frame
inner chord around the end fastener common to each affected MRB filler.
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.

Costs of Compliance

    We estimate that this AD affects 51 airplanes of U.S. registry. We
estimate the following costs to comply with this AD:

                                      Estimated Costs for Required Actions
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per       Cost on U.S.
                   Action                        Labor cost       Parts cost        product         operators
----------------------------------------------------------------------------------------------------------------
Detailed Inspection.........................  20 work-hours x              $0           $1,700          $86,700
                                              $85 per hour =
                                                      $1,700
----------------------------------------------------------------------------------------------------------------

    We estimate the following costs to do any necessary on-condition
actions that would be required. We have no way of determining the
number of aircraft that might need these on-condition actions:

                                   Estimated Costs of On-Condition Inspections
----------------------------------------------------------------------------------------------------------------
                  Labor cost                      Parts cost                    Cost per product
----------------------------------------------------------------------------------------------------------------
3 work-hours x $85 per hour = $255 per                     $0   $255 per inspection cycle.
 inspection cycle.
----------------------------------------------------------------------------------------------------------------

    We have received no definitive data that would enable us to provide
cost estimates for the on-condition repairs specified in this AD.

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.
    We are 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.
    This AD is issued in accordance with authority delegated by the
Executive Director, Aircraft Certification Service, as authorized by
FAA Order 8000.51C. In accordance with that order, issuance of ADs is
normally a function of the Compliance and Airworthiness Division, but
during this transition period, the Executive Director has delegated the
authority to issue ADs applicable to transport category airplanes and
associated appliances to the Director of the System Oversight Division.

Regulatory Findings

    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,
    (2) Is not a ``significant rule'' under DOT Regulatory Policies and
Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

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 (AD):

2018-11-08 The Boeing Company: Amendment 39-19296; Docket No. FAA-
2017-1099; Product Identifier 2017-NM-093-AD.

(a) Effective Date

    This AD is effective July 10, 2018.

(b) Affected ADs

    None.

(c) Applicability

    (1) This AD applies to The Boeing Company Model 767-200 and -300
series airplanes, as identified in Boeing Alert Requirements
Bulletin 767-53A0278 RB, dated June 30, 2017, certificated in any
category.
    (2) Installation of Supplemental Type Certificate (STC)
ST01920SE (http://rgl.faa.gov/Regulatory_and_Guidance_Library/rgstc.nsf/0/59027F43B9A7486E86257B1D006591EE?OpenDocument&Highlight=st01920se)
does not affect the ability to accomplish the actions required by
this AD. Therefore, for airplanes on which STC ST01920SE is
installed, a ``change in product'' alternative method of compliance
(AMOC) approval request is not necessary to comply with the
requirements of 14 CFR 39.17.

(d) Subject

    Air Transport Association (ATA) of America Code 53, Fuselage.

(e) Unsafe Condition

    This AD was prompted by a report of a crack on the transition
radius of the station (STA) 883.5 frame inner chord and an
additional crack indication at a fastener hole in the frame inner
chord common to a material review board (MRB) filler that extended
above the frame-to-stub-beam joint. We are issuing this AD to detect
and correct cracking of the frame inner chord, which could result in
the inability of one or more overwing stub frames between STA 808
and STA 933, each a principal structural element, to sustain limit
loads; this condition could adversely affect the structural
integrity of the airplane.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Required Actions

    Except as required by paragraph (h) of this AD: At the
applicable times specified in the ``Compliance'' paragraph of Boeing
Alert Requirements Bulletin 767-53A0278 RB, dated June 30, 2017, do
all applicable actions identified in, and in accordance with, the
Accomplishment Instructions of Boeing Alert Requirements Bulletin
767-53A0278 RB, dated June 30, 2017.
    Note 1 to paragraph (g) of this AD: Guidance for accomplishing
the actions required by this AD can be found in Boeing Alert Service
Bulletin 767-53A0278, dated June 30, 2017, which is referred to in
Boeing Alert Requirements Bulletin 767-53A0278 RB, dated June 30,
2017.

(h) Exceptions to Service Information Specifications

    (1) For purposes of determining compliance with the requirements
of this AD: Where Boeing Alert Requirements Bulletin 767-53A0278 RB,
dated June 30, 2017, uses the phrase ``the original issue date of
Requirements Bulletin 767-53A0278 RB,'' this AD requires using ``the
effective date of this AD.''
    (2) Where Boeing Alert Requirements Bulletin 767-53A0278 RB,
dated June 30, 2017, specifies contacting Boeing, this AD requires
repair using a method approved in accordance with the procedures
specified in paragraph (i) of this AD.
    (3) For airplanes identified as Group 1, Configuration 1, in
Boeing Alert Requirements Bulletin 767-53A0278 RB, dated June 30,
2017, that have been modified to a freighter configuration: The
actions specified in Boeing Alert Requirements Bulletin 767-53A0278
RB, dated June 30, 2017, for Group 1, Configuration 2, must be done
instead of the actions for Group 1, Configuration 1, except as
required by paragraph (h)(2) of this AD.
    (4) For airplanes identified as Group 2, Configuration 1, in
Boeing Alert Requirements Bulletin 767-53A0278 RB, dated June 30,
2017, that have been modified to a freighter configuration: The
actions specified in Boeing Alert Requirements Bulletin 767-53A0278
RB, dated June 30, 2017, for Group 2, Configuration 2, must be done
instead of the actions for Group 2, Configuration 1, except as
required by paragraph (h)(2) of this AD.

(i) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Seattle ACO Branch, FAA, has the authority to
approve AMOCs for this AD, if requested using the procedures found
in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request
to your principal inspector or local Flight Standards District
Office, as appropriate. If sending information directly to the
manager of the certification office, send it to the attention of the
person identified in paragraph (j) of this AD. Information may be
emailed to: [email protected].
    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.
    (3) An AMOC that provides an acceptable level of safety may be
used for any repair, modification, or alteration required by this AD
if it is approved by the Boeing Commercial Airplanes Organization
Designation Authorization (ODA) that has been authorized by the
Manager, Seattle ACO Branch, to make those findings. To be approved,
the repair method, modification deviation, or alteration deviation
must meet the certification basis of the airplane, and the approval
must specifically refer to this AD.

(j) Related Information

    For more information about this AD, contact Wayne Lockett,
Aerospace Engineer, Airframe Section, FAA, Seattle ACO Branch, 2200
S. 216th St., Des Moines, WA 98198; phone and fax:<PHONE_NUMBER>;
email: [email protected].

(k) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) 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) Boeing Alert Requirements Bulletin 767-53A0278 RB, dated
June 30, 2017.
    (ii) Reserved.
    (3) For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Contractual & Data Services
(C&DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA 90740-
5600; telephone<PHONE_NUMBER>; internet https://www.myboeingfleet.com.
    (4) You may view this service information at the FAA, Transport
Standards Branch, 2200 South 216th St., Des Moines, WA. For
information on the availability of this material at the FAA, call
206-231-3195.
    (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, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Des Moines, Washington, on May 18, 2018.
Michael Kaszycki,
Acting Director, System Oversight Division, Aircraft Certification
Service.
[FR Doc. 2018-11427 Filed 6-4-18; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 76, Number 220 (Tuesday, November 15, 2011)]
[Rules and Regulations]
[Pages 70649-70651]
[FR Doc No: 2011-29408]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2011-1017]
RIN 1625-AA00

Safety Zone; Department of Defense Exercise, Hood Canal, WA

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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

SUMMARY: The Coast Guard is establishing a temporary safety zone around
vessels involved in a Department of Defense exercise in Hood Canal, WA
that will take place on November 21, 2011. A safety zone is necessary
to ensure the safety of the maritime public during the exercise. The
zone will do so by prohibiting any person or vessel from entering or
remaining in the safety zone unless authorized by the Captain of the
Port.

DATES: This rule is effective from 6 a.m. until 11:59 p.m. on November
21, 2011.

ADDRESSES: Documents indicated in this preamble as being available in
the docket are part of docket USCG-2011-1017 and are available online
by going to http://www.regulations.gov, inserting USCG-2011-1017 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 or email Lieutenant Ian S. Hanna, Waterways
Management Division, Coast Guard Sector Puget Sound; Coast Guard;
telephone<PHONE_NUMBER>, email<EMAIL_ADDRESS>If you
have questions on viewing the docket, call Renee V. Wright, Program
Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Regulatory Information

    The Coast Guard is issuing this temporary final rule without prior
notice and opportunity to comment pursuant to authority under section
4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when 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 it would be contrary to the public
interest, since the event requiring the establishment of this safety
zone would be over before a comment period would end. These Department
of Defense (DOD) vessels have an important and urgent need to perform
this training in order to be ready to protect U.S. persons, assets, and
waters; it would be contrary to the public interest to delay the
exercise to allow for a comment period. Further, publishing an NPRM is
unnecessary as the safety zone is neither burdensome, nor
controversial. The safety zone created is short in duration, and
vessels can transit around it, or through it with permission of the
Captain of the Port (COTP).
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. Good cause exists because the
event would be over before the final rule could be published. These DOD
vessels have an important and urgent need to perform this training in
order to be ready to protect U.S. persons, assets,

and waters; it would be contrary to the public interest to delay this
important exercise to allow for a delayed effective date.

Background and Purpose

    The DOD will be conducting a training exercise in the northern part
of Hood Canal, WA. During the exercise, tactical vessels will be
maneuvering through the Hood Canal from the entrance of Dabob Bay to
Foulweather Bluff. This exercise will include fast moving surface
vessels, smoke machines, and pyrotechnics. This safety zone is being
created to ensure the safety of the maritime public and vessels
participating in the exercise by preventing collisions between
exercising vessels and the maritime public, and by keeping the maritime
public a safe distance away from potentially startling or disorienting
smoke, bright flashes, and loud noises.

Discussion of Rule

    The temporary safety zone established by this rule will prohibit
any person or vessel from entering or remaining within 1000 yards of
any vessel involved in the DOD exercise while such vessel is transiting
Hood Canal, WA between Foul Weather Bluff and the entrance to Dabob
Bay. Members of the maritime public will be able to identify
participating vessels by their gray color and orange Coast Guard stripe
on the hull. The COTP may be also assisted in the enforcement of the
zones by other federal, state, or local agencies.

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, as
supplemented by Executive Order 13563, Improving Regulation and
Regulatory Review, and does not require an assessment of potential
costs and benefits under section 6(a)(3) of that Order or under section
1 of Executive Order 13563. The Office of Management and Budget has not
reviewed it under that Order. It is not ``significant'' under the
regulatory policies and procedures of the Department of Homeland
Security (DHS).
    The Coast Guard bases this finding on the fact that the safety
zones will be in place for a limited period of time and vessel traffic
will be able to transit around the safety zones. Maritime traffic may
also request permission to transit through the zones from the COTP,
Puget Sound or Designated Representative.

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 will affect the following entities, some of which
may be small entities; the owners and operators of vessels intending to
operate in the waters covered by the safety zone while it is in effect.
The rule will not have a significant economic impact on a substantial
number of small entities because the safety zone will be in place for a
limited period of time and maritime traffic will still be able to
transit around the safety zone. Maritime traffic may also request
permission to transit though the zones from the COTP, Puget Sound or
Designated Representative.

Assistance for Small Entities

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

Collection of Information

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

Federalism

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

Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) 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 effect 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, as supplemented by
Executive Order 13563, Improving Regulation and Regulatory Review, and
is not likely to have a significant adverse effect on the supply,
distribution, or use of energy. The Administrator of the Office of
Information and Regulatory Affairs has not designated it as a
significant energy action. Therefore, it does not require a Statement
of Energy Effects under Executive Order 13211.

Technical Standards

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

Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded
this action is one of a category of actions which do not individually
or cumulatively have a significant effect on the human environment.
This rule is categorically excluded, under figure 2-1, paragraph
(34)(g), of the Instruction. This rule involves the establishment of 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.

    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. 1231; 46 U.S.C. Chapter 701, 3306, 3703;
50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, 160.5; Pub. L.
107-295, 116 Stat. 2064; Department of Homeland Security Delegation
No. 0170.1.

0
2. Add Sec.  165.T13-200 to read as follows:

Sec.  165.T13-200  Safety Zone; Department of Defense Exercise, Hood
Canal, Washington.

    (a) Location. The following area is a safety zone: All waters
encompassed within 1000 yards of any vessel that is involved in the
Department of Defense exercise while such vessel is transiting Hood
Canal, WA between Foul Weather Bluff and the entrance to Dabob Bay.
Vessels involved will be various sizes, including 25, 33, and 64 feet
in length and can be identified as being gray in color with an orange
United States Coast Guard stripe on the vessels' hull.
    (b) Regulations. In accordance with the general regulations in 33
CFR part 165, subpart C, no person may enter or remain in the safety
zone created in this rule unless authorized by the Captain of the Port
or his Designated Representative. See 33 CFR part 165, subpart C, for
additional information and requirements. Vessel operators wishing to
enter the zone during the enforcement period must request permission
for entry by contacting the on-scene patrol commander on VHF channel 13
or 16, or the Sector Puget Sound Joint Harbor Operations Center at
(206) 217-6001.
    (c) Enforcement Period. This rule is effective on November 21, 2011
from 6 a.m. to 11:59 p.m., unless canceled sooner by the Captain of the
Port.

    Dated: October 27, 2011.
S.J. Ferguson,
Captain, U.S. Coast Guard, Captain of the Port, Puget Sound.
[FR Doc. 2011-29408 Filed 11-14-11; 8:45 am]
BILLING CODE 9110-04-P