[Federal Register Volume 88, Number 143 (Thursday, July 27, 2023)]
[Notices]
[Pages 48475-48476]
[FR Doc No: 2023-15923]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-2608]

Cellular, Tissue, and Gene Therapies Advisory Committee; Notice
of Meeting; Establishment of a Public Docket; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of a public docket; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming
public advisory committee meeting of the Cellular, Tissue, and Gene
Therapies Advisory Committee. The general function of the committee is
to provide advice and recommendations to FDA on regulatory issues. On
September 27, 2023, the committee will discuss and make recommendations
on biologics license application (BLA) 125782 from BrainStorm
Therapeutics, Inc. for debamestrocel (autologous bone marrow-derived
mesenchymal stromal cells induced to secrete neurotrophic factors). The
applicant has requested an indication for the treatment of amyotrophic
lateral sclerosis (ALS). The meeting will be open to the public. FDA is
establishing a docket for public comment on this document.

DATES: The meeting will be held on September 27, 2023, from 10 a.m. to
6 p.m. Eastern Time.

ADDRESSES: All meeting participants will be heard, viewed, captioned,
and recorded for this advisory committee meeting via an online
teleconferencing and/or video conferencing platform. Answers to
commonly asked questions about FDA advisory committee meetings may be
accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
    The online web conference meeting will be available at the
following link on the day of the meeting: https://youtube.com/live/c-2-33ipSbk.
    FDA is establishing a docket for public comment on this meeting.
The docket number is FDA-2023-N-2608. The docket will close on
September 26, 2023. Please note that late, untimely filed comments will
not be considered. The https://www.regulations.gov electronic filing
system will accept comments until 11:59 p.m. Eastern Time at the end of
September 26, 2023. Comments received by mail/hand delivery/courier
(for written/paper submissions) will be considered timely if they are
received on or before that date.
    Comments received on or before September 20, 2023, will be provided
to the committee. Comments received after that date will be taken into
consideration by FDA. In the event that the meeting is cancelled, FDA
will continue to evaluate any relevant applications or information, and
consider any comments submitted to the docket, as appropriate.
    You may submit comments as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''

    Instructions: All submissions received must include the Docket No.
FDA-2023-N-2608 for ``Cellular, Tissue, and Gene Therapies Advisory
Committee; Notice of Meeting; Establishment of a Public Docket; Request
for Comments.'' 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.'' FDA 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 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 the information as ``confidential.'' Any
information marked as ``confidential'' will not be disclosed except in
accordance with 21 CFR 10.20 and other applicable disclosure law. For
more information about FDA's posting of comments to public dockets, see
80 FR 56469, September 18, 2015, or access the information at: https://www.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: Marie DeGregorio or Cicely Reese,
Center for Biologics Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 1246, Silver
Spring, MD 20993-0002, email: [email protected],<PHONE_NUMBER>, or
FDA Advisory Committee Information Line, 1-800-741-8138<PHONE_NUMBER>
in the Washington, DC area). A notice in the Federal Register about
last-minute modifications that impact a previously announced advisory
committee meeting cannot always be published quickly enough to provide
timely notice. Therefore, you should always check FDA's website at
https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to
the appropriate advisory committee meeting link, or call the advisory
committee information line to learn about possible modifications before
the meeting.

SUPPLEMENTARY INFORMATION:
    Agenda: The meeting presentations will be heard, viewed, captioned,
and recorded through an online teleconferencing and/or video
conferencing platform. On September 27, 2023, the committee will
discuss and make recommendations on BLA 125782 from BrainStorm
Therapeutics, Inc. for debamestrocel (autologous bone marrow-derived
mesenchymal stromal cells induced to secrete neurotrophic factors). The
applicant has requested an indication for the treatment of ALS.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its website prior to the meeting, the
background material will be made publicly available on FDA's website at
the time of the advisory committee meeting. Background material and the
link to the online teleconference and/or video conference meeting will
be available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting
link. The meeting will include slide presentations with audio and video
components to allow the presentation of materials in a manner that most
closely resembles an in-person advisory committee meeting.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
All electronic and written submissions submitted to the Docket (see
ADDRESSES) on or before September 20, 2023, will be provided to the
committee. Oral presentations from the public will be scheduled between
approximately 1:40 p.m. and 2:40 p.m. Eastern Time on September 27,
2023. Those individuals interested in making formal oral presentations
should notify the contact person and submit a brief statement of the
general nature of the evidence or arguments they wish to present, the
names and addresses of proposed participants, and an indication of the
approximate time requested to make their presentation on or before 12
p.m. Eastern Time on September 12, 2023. Time allotted for each
presentation may be limited. If the number of registrants requesting to
speak is greater than can be reasonably accommodated during the
scheduled open public hearing session, FDA may conduct a lottery to
determine the speakers for the scheduled open public hearing session.
The contact person will notify interested persons regarding their
request to speak by 6 p.m. Eastern Time on September 14, 2023.
    For press inquiries, please contact the Office of Media Affairs at
[email protected] or<PHONE_NUMBER>.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
disabilities. If you require accommodations due to a disability, please
contact Marie DeGregorio or Cicely Reece at [email protected] (see
FOR FURTHER INFORMATION CONTACT) at least 7 days in advance of the
meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our website at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. 1001 et seq.). This meeting notice also serves
as notice that, pursuant to 21 CFR 10.19, the requirements in 21 CFR
14.22(b), (f), and (g) relating to the location of advisory committee
meetings are hereby waived to allow for this meeting to take place
using an online meeting platform. This waiver is in the interest of
allowing greater transparency and opportunities for public
participation, in addition to convenience for advisory committee
members, speakers, and guest speakers. No participant will be
prejudiced by this waiver, and that the ends of justice will be served
by allowing for this modification to FDA's advisory committee meeting
procedures.

    Dated: July 24, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-15923 Filed 7-26-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 76, Number 41 (Wednesday, March 2, 2011)]
[Rules and Regulations]
[Pages 11324-11327]
[FR Doc No: 2011-4160]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2011-0149; Directorate Identifier 2011-CE-001-AD;
Amendment 39-16616; AD 2011-05-07]
RIN 2120-AA64

Airworthiness Directives; Allied Ag Cat Productions, Inc. Models
G-164, G-164A, G-164B, G-164B With 73'' Wing Gap, G-164B-15T, G-164B-
34T, G-164B-20T, G-164C, G-164D, and G-164D With 73'' Wing Gap
Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule; request for comments.

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

SUMMARY: We are superseding an existing airworthiness directive (AD)
for the products listed above. That AD currently requires repetitively
inspecting the interior and the exterior of the main tubular spar of
the rudder assembly for corrosion, taking necessary corrective action
if corrosion is found, and applying corrosion protection. This AD
retains the requirements of the previous AD and changes the compliance
time for certain products listed above. This AD was prompted by our
determination that the compliance time specified for Models G-164, G-
164A, and G-164B airplanes does not adequately address the unsafe
condition. We are issuing this AD to detect and correct corrosion in
the rudder main tubular spar, which could result in failure of the
rudder main spar tube. This failure could lead to loss of directional
control.

DATES: This AD is effective March 17, 2011.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in this AD as of December 19,
2008 (73 FR 67372, November 14, 2008).
    We must receive any comments on this AD by April 18, 2011.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://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 Allied Ag
Cat Productions, Inc., 301 West Walnut Street, P.O. Box 482, Walnut
Ridge, Arkansas 72479; telephone:<PHONE_NUMBER>. You may review copies
of the referenced service information at the FAA, Small Airplane
Directorate, 901 Locust St., Kansas City, Missouri 64016. For
information on the availability of this material at the FAA, call (816)
329-4148.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Management Facility
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
the Docket Office (phone:<PHONE_NUMBER>) is in the ADDRESSES section.
Comments will be available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Andrew McAnaul, Aerospace Engineer,
ASW-150 (c/o MIDO-43), 10100 Reunion Place, Suite 650, San Antonio,
Texas 78216; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; e-mail:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    On October 23, 2008, we issued AD 2008-22-21, Amendment 39-15718
(73 FR 67372, November 14, 2008), for all Allied Ag Cat Productions,
Inc. Models G-164, G-164A, G-164B, G-164B with 73'' wing gap, G-164B-
15T, G-164B-34T, G-164B-20T, G-164C, G-164D, and G-164D with 73'' wing
gap airplanes.
    That AD supersedes AD 78-08-09, Amendment 39-3191 (43 FR 16699,
April 20, 1978), and requires repetitively inspecting the interior and
the exterior of the main tubular spar of the rudder assembly for
corrosion, taking necessary corrective action if corrosion is found,
and applying corrosion protection. That AD resulted from failure of the
rudder main tubular spar on a Model G164B airplane not previously
affected by AD 78-08-09.
    AD 78-08-09 required a one-time inspection of the interior of the
rudder main tubular spar for corrosion and 300-hour repetitive
inspections of the exterior of the rudder main tubular spar for
corrosion.

Actions Since AD was Issued

    Since we issued AD 2008-22-21, we determined the compliance time of
the initial inspection for Models G-164, G-164A, and G-164B airplanes
(airplanes previously affected by AD 78-08-09) allows the interior of
the rudder main tubular spar to remain unchecked for corrosion for up
to an additional 5 years beyond the effective date of AD 2008-22-21.
This compliance time does not adequately address the unsafe condition.
    We are issuing this AD to detect and correct corrosion in the
rudder main tubular spar, which could result in failure of the rudder
main spar tube. This failure could lead to loss of directional control.

FAA's Determination

    We are issuing this AD because we evaluated all the relevant
information and determined the unsafe condition described previously is
likely to exist or develop in other products of the same type design.

AD Requirements

    This AD requires repetitively inspecting the interior and the
exterior of the main tubular spar of the rudder assembly for corrosion,
taking necessary corrective action if corrosion is found, and applying
corrosion protection.

FAA's Justification and 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
failure of the rudder main tubular spar could lead to loss of
directional control. Therefore, we find that notice and opportunity for
prior public comment are impracticable and 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 we did not provide you with notice and an opportunity to
provide your comments before it becomes effective. However, we invite
you to send any written data, views, or arguments about this AD. Send
your comments to an address listed under the ADDRESSES section. Include
Docket Number FAA-2011-0149 and Directorate Identifier 2011-CE-001-AD
at the beginning of your comments. We specifically invite comments on
the overall regulatory, economic, environmental, and energy aspects of
this AD. We will consider all comments received by the closing date and
may amend this AD because of those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this AD.

Costs of Compliance

    We estimate that this AD affects 2,700 airplanes of U.S. registry.
    We estimate the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per    Cost on U.S.
              Action                        Labor cost               Parts cost          product      operators
----------------------------------------------------------------------------------------------------------------
Drill access hole and visual        4 work-hours X $85 per      Not applicable......         $340      $918,000
 inspection [retained actions from   hour = $340.
 existing AD].
----------------------------------------------------------------------------------------------------------------

     We have no way of determining the cost of repairs, parts
replacement, or the number of airplanes that may require repair or
parts replacement based on the result of the proposed inspections.

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.

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 part 39 of the Federal Aviation
Regulations (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 removing Airworthiness Directive (AD)
2008-22-21, Amendment 39-15718 (73 FR 67372, November 14, 2008) and
adding the following new AD:

2011-05-07 Allied Ag Cat Productions, Inc.: Amendment 39-16616;
Docket No. FAA-2011-0149; Directorate Identifier 2011-CE-001-AD.

Effective Date

    (a) This AD is effective March 17, 2011.

Affected ADs

    (b) This AD supersedes AD 2008-22-21, Amendment 39-15718.

Applicability

    (c) This AD applies to the following Allied Ag Cat Productions,
Inc. model airplanes, all serial numbers, that are certificated in
any category:

                                                     Models
----------------------------------------------------------------------------------------------------------------

----------------------------------------------------------------------------------------------------------------
G-164................................  G-164A.................  G-164B.................  G-164B with 73'' wing
                                                                                gap.
G-164B-15T...........................  G-164B-20T.............  G-164B-34T.............  G-164C.
G-164D...............................  G-164D with 73'' wing
                                        gap.
----------------------------------------------------------------------------------------------------------------

Subject

    (d) Joint Aircraft System Component (JASC)/Air Transport
Association (ATA) of America Code 55, Stabilizers.

Unsafe Condition

    (e) This AD was prompted by reports of the rudder main tubular
spar failing and our determination that the previous compliance
times specified for Models G-164, G-164A, and G-164B airplanes do
not adequately address the unsafe condition. We are issuing this AD
to detect and correct corrosion in the rudder main tubular spar,
which could result in failure of the rudder main spar tube. This
failure could lead to loss of directional control.

Compliance

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

------------------------------------------------------------------------
           Actions                 Compliance            Procedures
------------------------------------------------------------------------
(1) Drill an access hole and  Initially inspect     Following Steps 1
 do a visual inspection        within the next 30    through 3 of
 using a borescope of the      days after March      Grumman American
 lower end internal cavity     17, 2011 (the         Aviation
 of the rudder main spar       effective date of     Corporation Ag-Cat
 tube for corrosion and do a   this AD), unless      Service Bulletin
 visual inspection of the      already done within   No. 61, dated June
 exterior of the rudder main   the previous 60       6, 1977.
 spar tube for corrosion.      months.
                               Repetitively
                               inspect thereafter
                               at intervals not to
                               exceed 60 months
                               from the last
                               inspection.
(2) If corrosion is found     Before further        As specified in
 during any inspection         flight after any      Steps 5 and 6 of
 required in paragraph         inspection in which   Grumman American
 (f)(1) of this AD, repair     corrosion is found.   Aviation
 in accordance with Chapter                          Corporation Ag-Cat
 4 of FAA Advisory Circular                          Service Bulletin
 43.13-1B, Chg 1, dated                              No. 61, dated June
 September 27, 2001, or                              6, 1977, and
 replace the damaged part(s).                        following Chapter 4
                                                     of FAA Advisory
                                                     Circular 43.13-1B,
                                                     Chg 1, dated
                                                     September 27, 2001,
                                                     which can be found
                                                     at http://rgl.faa.gov/.
(3) After each inspection,    Before further        As specified in Step
 repair, or replacement        flight after each     4 of Grumman
 required in this AD,          inspection required   American Aviation
 corrosion protect the spar    in paragraph (f)(1)   Corporation Ag-Cat
 tube internal cavity by       of this AD and        Service Bulletin
 filling with warm, raw        after each repair     No. 61, dated June
 linseed oil, Paralketone,     or replacement        6, 1977.
 or CRC3 (LPS Heavy Duty       required in
 Rust Inhibitor Type 3), or    paragraph (f)(2) of
 suitable equivalent           this AD.
 protector for alloy steel,
 and allow to drain. Seal
 access hole with Scotch
 caulking compound, a
 suitable silicone based
 sealant, or equivalent.
(4) Verify rigging check of   Before further        Following Ag-Cat
 the rudder.                   flight after each     Maintenance Manual
                               inspection required   pages 6-14 through
                               in paragraph (f)(1)   6-16, copyright
                               of this AD and        1978; or Ag-Cat G-
                               after each repair     164D Maintenance
                               or replacement        Manual pages 6-24
                               required in           and 6-29, copyright
                               paragraph (f)(2) of   1995, as
                               this AD.              applicable.

(5) Only install a rudder     As of 30 days after   Not applicable.
 that has been inspected as    March 17, 2011 (the
 specified in paragraph        effective date of
 (f)(1) of this AD, is found   this AD).
 free of corrosion, has had
 the corrosion protection
 applied, and has been
 sealed as specified in
 paragraph (f)(3) of this AD.
------------------------------------------------------------------------

Alternative Methods of Compliance (AMOCs)

    (g)(1) The Manager, Fort Worth Airplane Certification Office,
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 ACO, send it to the
attention of the person identified in the Related Information
section of this AD.
    (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.

Related Information

    (h) For more information about this AD, contact Andrew McAnaul,
Aerospace Engineer, ASW-150 (c/o MIDO-43), 10100 Reunion Place,
Suite 650, San Antonio, Texas 78216; phone:<PHONE_NUMBER>; fax:
(210) 308-3370; e-mail<EMAIL_ADDRESS>
Material Incorporated by Reference

    (i) You must use Grumman American Aviation Corporation Ag-Cat
Service Bulletin No. 61, dated June 6, 1977; Ag-Cat Maintenance
Manual pages 6-14 through 6-16, copyright 1978; and Ag-Cat G-164D
Maintenance Manual pages 6-24 and 6-29, copyright 1995, to do the
actions required by this AD, unless the AD specifies otherwise.
    (1) The Director of the Federal Register previously approved the
incorporation by reference of Grumman American Aviation Corporation
Ag-Cat Service Bulletin No. 61, dated June 6, 1977; Ag-Cat
Maintenance Manual pages 6-14 through 6-16, copyright 1978; and Ag-
Cat G-164D Maintenance Manual pages 6-24 and 6-29, copyright 1995,
on December 19, 2008 (73 FR 67372, November 14, 2008).
    (2) For service information identified in this AD, contact
Allied Ag Cat Productions, Inc., 301 West Walnut Street, P.O. Box
482, Walnut Ridge, Arkansas 72479; telephone:<PHONE_NUMBER>.
    (3) You may review copies of the service information at the FAA,
Small Airplane Directorate, 901 Locust St., Kansas City, Missouri
64016. For information on the availability of this material at the
FAA, call<PHONE_NUMBER>.
    (4) You may also review copies of the service information that
is incorporated by reference at the National Archives and Records
Administration (NARA). For information on the availability of this
material at an NARA facility, call<PHONE_NUMBER>, or go to http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

    Issued in Kansas City, Missouri, on February 17, 2011.
Earl Lawrence,
Manager, Small Airplane Directorate, Aircraft Certification Service.
[FR Doc. 2011-4160 Filed 3-1-11; 8:45 am]
BILLING CODE 4910-13-P


UNITED STATES OF AMERICA

DEPARTMENT OF TRANSPORTATION

OFFICE OF THE SECRETARY

WASHINGTON, DC

Issued by the Department of Transportation on April 21, 2006

NOTICE OF ACTION TAKEN –

DOCKET OST-2001-10385

________________________________________________________________________
_____________________________________________

This serves as notice to the public of the action described below, taken
by the Department official indicated (no additional confirming order
will be issued in this matter).

Application of  Continental Airlines, Inc.  filed  07/21/05  to:

XX Renew exemption pursuant to 49 U.S.C. §40109 to provide the
following service:

Scheduled foreign air transportation of persons, property and mail
between New York/Newark and Malaga and Palma de Mallorca, Spain, via
Madrid, and its authority to integrate this authority with
Continental’s other exemption and certificate authority.  Continental
requests that the Department renew this authority for an indefinite
period.  Continental states that it plans to continue using this
authority in connection with its code share with Air Europa.

Applicant rep: Bruce Keiner<PHONE_NUMBER>  DOT Analyst:  Michael D.
Bodman<PHONE_NUMBER>

D I S P O S I T I O N

XX  Granted, in part (See conditions below).

XX  Balance dismissed (i.e., for route integration and for indefinite
renewal, see remarks below)

The above action was effective when taken:  April 21, 2006,  through
April 21, 2008.

Action taken by:   Paul L. Gretch, Director

		    Office of International Aviation

XX  The authority granted is consistent with the aviation agreement
between the United States and Spain.

Except to the extent exempted or waived, this authority is subject to
the terms, conditions, and limitations indicated:

XX  Holder’s certificates of public convenience and necessity

XX  Standard exemption conditions (attached)

XX  Statement of Authorization approving Continental/Air Europa
code-share operations dated November 6, 2001, and conditions therein.

________________________________________________________________________
_____________

Remarks:  Consistent with our standard practice for applications of this
type, we will grant Continental’s exemption for a period of two years
and dismiss its request for longer-term authority.  The carrier’s
request for route integration authority has been superseded by Order
2006-1-1, where the Department awarded the carrier a blanket route
integration certificate.

Continental’s exemption expired on September 26, 2005 but has been
kept in force pursuant to the provisions of the Administrative Procedure
Act, 5 U.S.C. 558(c), as implemented by 14 CFR Part 377, pending action
on Continental’s timely-filed renewal application that is the subject
of this notice.

_________________________________

On the basis of data officially noticeable under Rule 24(g) of the
Department's regulations, we found the applicant qualified to provide
the services authorized.

Under authority assigned by the Department in its regulations, 14 CFR
Part 385, we found that (1) our action was consistent with Department
policy; (2) grant of the exemption authority was consistent with the
public interest; and (3) grant of the authority would not constitute a
major regulatory action under the Energy Policy and Conservation Act of
1975.  To the extent not granted, we denied all requests in the
referenced Docket.  We may amend, modify, or revoke the authority
granted in this Notice at any time without hearing at our discretion.

Persons entitled to petition the Department for review of the action set
forth in this Notice under the Department’s regulations, 14 CFR
§385.30, may file their petitions within seven (7) days after the date
of issuance of this Notice.  This action was effective when taken, and
the filing of a petition for review will not alter such effectiveness.

An electronic version of this document is available on the World Wide
Web at:

http://dms.dot.gov//reports/reports_aviation.asp

APPENDIX

U.S. Carrier

Standard Exemption Conditions

In the conduct of the operations authorized, the U.S. carrier
applicant(s) shall:

(1)  Hold at all times effective operating authority from the government
of each country served;

(2)  Comply with applicable requirements concerning oversales contained
in 14 CFR 250 (for scheduled operations, if authorized);

(3)  Comply with the requirements for reporting data contained in 14 CFR
241;

(4)  Comply with requirements for minimum insurance coverage, and for
certifying that coverage to the Department, contained in 14 CFR 205;

(5)  Except as specifically exempted or otherwise provided for in a
Department Order, comply with the requirements of 14 CFR 203, concerning
waiver of Warsaw Convention liability limits and defenses;

(6)  Comply with all applicable requirements of the Federal Aviation
Administration and with all applicable U.S. Government requirements
concerning security, including, but not limited to, 49 CFR Part 1544.
To assure compliance with all applicable U.S. Government requirements
concerning security, the holder shall, before commencing any new service
(including charter flights) to or from a foreign airport, contact its
International Principal Security Inspector (IPSI) to advise the IPSI of
its plans and to find out whether the Transportation Security
Administration has determined that security is adequate to allow such
airport(s) to be served; and

(7)  Comply with such other reasonable terms, conditions, and
limitations required by the public interest as may be prescribed by the
Department of Transportation, with all applicable orders and regulations
of other U.S. agencies and courts, and with all applicable laws of the
United States.

The authority granted shall be effective only during the period when the
holder is in compliance with the conditions imposed above.

 PAGE

 PAGE   3


[Federal Register Volume 85, Number 241 (Tuesday, December 15, 2020)]
[Notices]
[Pages 81199-81200]
[FR Doc No: 2020-27539]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2020-0570; FRL-10016-95]

Broflanilide; Receipt of Application for Emergency Exemption,
Solicitation of Public Comment

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: EPA has received a specific exemption request from the
Washington State Department of Agriculture to use the pesticide
broflanilide (CAS No. 1207727-04-5) to treat an amount of spring wheat
seed sufficient to plant up to 206,000 acres to control wireworms. The
applicant proposes the use of a new chemical which has not been
registered by EPA.

DATES: Comments must be received on or before December 30, 2020.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2020-0570, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online

instructions for submitting comments. Do not submit electronically any
information you consider to be Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
    Due to the public health concerns related to COVID-19, the EPA
Docket Center (EPA/DC) and Reading Room is closed to visitors with
limited exceptions. The staff continues to provide remote customer
service via email, phone, and webform. For the latest status
information on EPA/DC services and docket access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Marietta Echeverria, Registration
Division (7505P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; main telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In accordance with the regulations at 40 CFR
166.24(a)(1), EPA is soliciting public comment before making the
decision whether or not to grant the exemption.

I. General Information

A. Does this action apply to me?

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

B. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through
www.regulations.gov or email. 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 preparing and submitting
your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.
    3. Environmental justice. EPA seeks to achieve environmental
justice, the fair treatment and meaningful involvement of any group,
including minority and/or low-income populations, in the development,
implementation, and enforcement of environmental laws, regulations, and
policies. To help address potential environmental justice issues, the
Agency seeks information on any groups or segments of the population
who, as a result of their location, cultural practices, or other
factors, may have atypical or disproportionately high and adverse human
health impacts or environmental effects from exposure to the
pesticide(s) discussed in this document, compared to the general
population.

II. What Action is the Agency Taking?

    Under section 18 of the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) (7 U.S.C. 136p), at the discretion of the EPA
Administrator, a Federal or State agency may be exempted from any
provision of FIFRA if the EPA Administrator determines that emergency
conditions exist which require the exemption. The Washington State
Department of Agriculture (WSDA) has requested the EPA Administrator to
issue a specific exemption for the use of broflanilide (CAS No.
1207727-04-5) as a seed treatment on spring wheat to control wireworms.
Information in accordance with 40 CFR part 166 was submitted as part of
this request.
    As part of this request, the applicant stated that the currently
registered products do not provide adequate control of wireworms, which
are having a devastating and severe impact upon wheat fields and
growers, especially in the dryland wheat growing counties of eastern
Washington. Approximately 1,029 lbs. of the active ingredient
broflanilide would be needed for this emergency exemption program.
Additional information regarding the critical need for the emergency
and the proposed use pattern can be found in the section 18 emergency
exemption application request at http://www.regulations.gov, under the
docket number EPA-HQ-OPP-2020-0570.
    This notice does not constitute a decision by EPA on the
application itself. The regulations governing FIFRA section 18
emergency exemptions require publication of a notice of receipt of an
application for an emergency exemption if it proposes the use of a new
chemical which has not been registered by EPA. Broflanilide is not
currently registered.
    This notice provides an opportunity for public comment on this
application. The Agency will review and consider all comments received
during the comment period in determining whether to issue the specific
exemption requested by WSDA.

    Authority: 7 U.S.C. 136 et seq.

    Dated: November 23, 2020.
Marietta Echeverria,
Acting Director, Registration Division, Office of Pesticide Programs.
[FR Doc. 2020-27539 Filed 12-14-20; 8:45 am]
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[Federal Register Volume 76, Number 72 (Thursday, April 14, 2011)]
[Notices]
[Page 20970]
[FR Doc No: 2011-9067]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 739-022-VA]

Appalachian Power Company; Notice of Availability of
Environmental Assessment

    In accordance with the National Environmental Policy Act of 1969
and the Federal Energy Regulatory Commission (Commission) regulations,
18 CFR Part 380 (Order No. 486, 52 FR 47879), the Office of Energy
Projects has reviewed the application for a new license for the Claytor
Hydroelectric Project, located on the New River in Pulaski County,
Virginia, and prepared a final environmental assessment (EA). In the
final EA, Commission staff analyzes the potential environmental effects
of licensing the project and conclude that issuing a license for the
project, with appropriate environmental measures, would not constitute
a major Federal action significantly affecting the quality of the human
environment.
    A copy of the final EA is on file with the Commission and is
available for public inspection. The final EA may also be viewed on the
Commission's Web site at http://www.ferc.gov using the ``eLibrary''
link. Enter the docket number excluding the last three digits in the
docket number field to access the document. For assistance, contact
FERC Online Support at<EMAIL_ADDRESS>or toll-free at 1-
866-208-3676, or for TTY,<PHONE_NUMBER>.
    For further information, contact Emily Carter at<PHONE_NUMBER>.

    Dated: April 8, 2011.
Kimberly D. Bose,
Secretary.
[FR Doc. 2011-9067 Filed 4-13-11; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 199 (Friday, October 14, 2016)]
[Notices]
[Pages 71105-71106]
[FR Doc No: 2016-24805]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-2483]

Software as a Medical Device: Clinical Evaluation; International
Medical Device Regulators Forum; Draft Guidance for Industry;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance entitled ``Software as a Medical
Device (SaMD): Clinical Evaluation.'' The draft guidance was prepared
under the auspices of the International Medical Device Regulators Forum
(IMDRF), formerly the Global Harmonization Task Force. The draft
guidance pertains to the conduct of clinical evaluation of Software as
a Medical Device (SaMD) and focuses on the general principles of
clinical evaluation, which includes establishing the scientific
validity, clinical performance, and analytical validity for a SaMD. The
draft guidance is intended to provide globally harmonized principles of
when and what type of clinical evaluation is appropriate based on the
risk of the SaMD. This draft guidance is not final nor is it in effect
at this time.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115 (g)(5)), to ensure that the Agency considers your comment on
this draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by December 13, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2016-D-2483 for ``Software as a Medical Device (SaMD): Clinical
Evaluation.'' Received comments will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at http://www.regulations.gov or at the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
    An electronic copy of the guidance document is available for
download from the Internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the draft guidance document entitled
``Software as a Medical Device (SaMD): Clinical Evaluation'' to the
Office of the Center Director, Guidance and Policy Development, Center
for Devices and Radiological Health, Food and Drug

Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist
that office in processing your requests.

FOR FURTHER INFORMATION CONTACT: Regarding the draft guidance: Bakul
Patel, Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5458, Silver
Spring, MD 20993-0002,<PHONE_NUMBER>.
    Regarding the IMDRF: Melissa A. Torres, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5432, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In recent years, many important initiatives have been undertaken by
regulatory authorities and industry associations to promote
international harmonization of regulatory requirements. One of the
goals of global harmonization is to identify and then reduce
differences in regulatory policies among regulatory agencies. IMDRF
seeks to advance international harmonization or convergence of medical
device regulation.
    IMDRF was organized to provide an opportunity for global
harmonization initiatives to be developed with input from both
regulatory and industry representatives. The current members of the
Management Committee of the IMDRF are regulatory officials from
Australia (Therapeutic Goods Administration), Brazil (National Health
Surveillance Agency), Canada (Health Canada), China (China Food and
Drug Administration), European Union (European Commission Directorate-
General for Internal Market, Industry, Entrepreneurship and Small and
Medium-sized Enterprises), Japan (Pharmaceuticals and Medical Devices
Agency and the Ministry of Health, Labour and Welfare), Russia
(Ministry of Healthcare), and the United States (U.S. FDA). The World
Health Organization and the Asia-Pacific Economic Cooperation Life
Sciences Innovation Forum Regulatory Harmonization Steering Committee
are Official Observers. The Asian Harmonization Working Party and the
Pan American Health Organization are IMDRF Affiliate Organizations.
    In September 2016, the IMDRF Management Committee endorsed the
draft guidance entitled ``Software as a Medical Device (SaMD): Clinical
Evaluation'' and agreed that the guidance should be made available for
public comment. The IMDRF SaMD Working Group (WG) includes
representatives from the IMDRF members, as well as members from the
Medical Device Regulatory Authorities and Regional Harmonization
Initiatives from around the world. The draft guidance is the product of
the IMDRF SaMD WG. Comments about this draft will be considered by FDA
and the IMDRF SaMD WG.
    We welcome comments on all aspects of the draft guidance as well as
the following specific issues:
    1. Does the document address the intention captured in the
introduction/scope or vice versa?
    2. Does the document appropriately translate and apply current
clinical vocabulary for SaMD?
    3. Are there other types of SaMD beyond those intended for non-
diagnostic, diagnostic and therapeutic purposes that should be
highlighted/considered in the document?
    4. Does the document adequately address the relevant clinical
evaluation methods and processes for SaMD to generate clinical
evidence?
    5. Are there other appropriate methods for generating clinical
evaluation evidence that are relevant for SaMD beyond those described
in the document?
    6. Are the recommendations identified in section 7.2 related to the
``importance of clinical evidence and expectations'' appropriate as
outlined for the different SaMD categories?
    7. Are the recommendations identified in section 7.3 related to the
``importance of independent review'' appropriate as outlined for the
different SaMD categories?
    8. Given the uniqueness of SaMD and the proposed framework--is
there any impact on currently regulated devices or any possible adverse
consequences?
    The draft guidance and the IMDRF comment page are available at
http://www.imdrf.org/consultations/consultations.asp#current.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``Software as
a Medical Device (SaMD): Clinical Evaluation.'' It does not establish
any rights for any person and is not binding on FDA or the public. You
can use an alternative approach if it satisfies the requirements of the
applicable statutes and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do
so by downloading an electronic copy from the Internet. A search
capability for all Center for Devices and Radiological Health guidance
documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at http://www.regulations.gov. Persons
unable to download an electronic copy of ``Software as a Medical Device
(SaMD): Clinical Evaluation'' may send an email request to<EMAIL_ADDRESS>to receive an electronic copy of the document.
Please use the document number 16039 to identify the guidance you are
requesting.

    Dated: October 6, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-24805 Filed 10-13-16; 8:45 am]
BILLING CODE 4164-01-P


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES PC Code: 035506 DP Barcode: D275651 Date: 10/ 14/ 01 MEMORANDUM: Drinking Water Assessment for Linuron on Carrots in California.

TO: Carol Christensen Reregistration actions Branch II Health Effects Division (7509C)

FROM: Ibrahim Abdel Saheb/ Agronomist Environmental Risk Branch II Environmental Fate and Effects Division (7507C)

PEER REVIEW: Jim Carleton/ Chemist Environmental Risk Branch II Environmental Fate and Effects Division (7507C)

THRU: Tom Bailey, Branch Chief Environmental Risk Branch II Environmental Fate and Effects Division (7507C)

Conclusions:

The 3( 3, 4 dichlorophenyl) 1 methoxy 1 methylurea (Linuron) use on carrots in Griffin Label (EPA Reg. No. 1812 320) is represented by this memorandum.

Linuron is a herbicide used to control germinating and newly emerging grasses and broad leafed weeds. It is applied to agricultural crops, ornamental bulbs, and poplar trees for use in shelterbelts in the mid west. 2 Formulations include water dispersable granules, wettable powders, flowable concentrates, and emulsifiable concentrates/ liquid suspensions.

Linuron usually is applied after a crop has been planted but before weeds emerge, using ground or aerial equipment. In some crops, such as carrots and celery, linuron is applied to newly emerging plants as an over top spray. In asparagus, linuron is applied between cuttings of newly emerging spears for weed control during harvest.

The Tier II screening models PRZM 1 and EXAMS 2 with the Index Reservoir and Percent Crop Area adjustment (IR PCA PRZM/ EXAMS) were used to determine estimated surface water concentrations of linuron. The Screening Concentration in Groundwater (SCI GROW 3 ) model was used to estimate groundwater concentrations for linuron. Modeling results are shown in Table 1.

Table 1. Estimated environmental concentrations in surface and groundwater for linuron use on carrots.

model EECs (µg/ L) use( s) modeled PCA Surface water/ peak (90 th percentile annual daily max.) 31.3 two applications on carrots @ 1.0 lb ai/ acre, ground application Defaul t PCA (0.87)

Surface water/ 90 t h percentile annual mean) 12.5 Surface water/ 36 year overall mean 7.31 Groundwater/ peak and long term average 0.54 The IR PCA PRZM/ EXAMS modeling results indicate that linuron has the potential to contaminate surface waters by spray drift, and runoff in areas with large amounts of annual rainfall. Modeling results are higher than those from existing surface water monitoring data for linuron targeted to the pesticide use area. 3 The recommended groundwater drinking water EECs is 5.0 ppb (from the USEPA Pesticide in Groundwater Database). The modeling result is lower than historical data from the USEPA (data > 10 years old). The maximum observed concentration was 5.0 ppb. Recent NAWQA data which includes drinking water wells show no concentration > 0.029 ppb. This recommendation is based on the fact that there are no obvious changes in the use pattern presented in the June 7, 2001 Linuron SMART meeting.

Usage map for linuron 4 is attached.

Environmental Fate and Transport Assessment Although the environmental fate data base for parent linuron is essentially complete, two environmental fate data requirements (leaching/ adsorption/ desorption and terrestrial field dissipation studies) are not fulfilled. The environmental fate assessment for linuron is incomplete and tentative because information on the persistence, mobility and dissipation pathways of several degradates of linuron is not available.

Parent linuron appears to be moderately persistent and relatively immobile. Increased mobility may occur under specific environmental conditions such as in coarse textured soils and soils with low levels of organic matter. Linuron dissipates principally by biotic processes such as microbial degradation. In surface soils with adequate organic matter, the combined processes of adsorption and microbial degradation would limit linuron's potential to migrate to ground water. Linuron could runoff to surface water bodies. In that case, it would degrade fairly rapidly to three primary metabolites (desmethoxy linuron, desmethyl linuron, norlinuron, and 3,4 DCA, none of each is >10% of the applied radioactivity in the aerobic soil metabolism study). However, information on the persistence and mobility of these degradates is not currently available.

Linuron exhibits some of the properties and characteristics of chemicals that have been detected in ground water, and linuron itself has been detected in ground water in four states (Georgia, Missouri, Virginia and Wisconsin). Linuron is moderately persistent with an aerobic soil metabolism half life ranging from 57 to 100 days. Because linuron is sufficiently persistent and may be mobile under certain environmental conditions, it has the potential to impact ground water quality.

Linuron can be applied aerially or by ground spray and therefore could contaminate surface waters through spray drift. It has the potential to be somewhat persistent in surface 4 waters, particularly those with low microbiological activity and long hydrological residence times. Linuron degraded with a halflife of less than 3 weeks in nonsterile anaerobic silt loam and sand soil: water (1: 1) systems. It may be less persistent in water and sediment under anaerobic conditions than under aerobic conditions. Its bioconcentration potential is relatively low.

Linuron is not currently regulated under the Safe Drinking Water Act, and water supply systems are not required to sample and analyze for it. No Maximum Contaminant Level (MCL) or drinking water health advisories have been established for linuron. The primary treatment processes employed by most water systems may not always be completely effective in removing linuron. As a result, the Agency does have some moderate concerns regarding potential risks of linuron to surface water source supply systems.

Surface Water Monitoring The EFED has limited monitoring data on the concentrations of linuron in surface water at the present time.

The USGS National Water Quality Assessment Program, San Joaquin  Tulare Basins analyzed surface water samples from a fixed site on the San Joaquin River near Vernalis, CA. Grab water samples were collected biweekly for one year (1993). Maximum linuron concentration was 0.29 ppb 5 , even though the San Joaquin Valley is a major production region for carrots in California 6 .

In another study, the US Geological Survey (USGS) National Water Quality Assessment Program (NAWQA) collected 5196 surface water samples from 40 agricultural stream sites through the nation during the period from 1992 1998. One to two samples were collected at each site each month during periods when pesticide transport in the streams was expected to be low. At most sites, the sampling frequency was increased to 1 to 3 samples per week during periods when elevated levels of pesticides were expected in the streams. Linuron was detected in 2.70% of the samples (detection limit = 0.01 ppb) with a linuron maximum concentration of 1.4 ppb 7 .

The frequency of sampling and the length of sampling period of both of the USGS studies were not sufficient to represent the temporal and spatial requirements for use in making regulatory determinations concerning drinking water. 5 Modeling Tier II surface water modeling was done using the Index Reservoir (IR) and Percent Crop Area (PCA) modifications to PRZM and EXAMS.

The index reservoir represents a potentially vulnerable drinking water source based on the geometry of an actual reservoir and its watershed in a specific area (Illinois), using regional screening specific cropping patterns, weather, soils, and other factors.

The PCA is a generic watershed based adjustment factor which represent the portion of a watershed planted to a crop or crops and will be applied to pesticide concentrations estimated for the surface water component of the drinking water exposure assessment using PRZM/ EXAMS with the index reservoir scenario.

The IR PCA PRZM/ EXAMS model use and fate input parameters for linuron in surface water are shown in Table 2. The IR PCA PRZM/ EXAMS model input and output files for linuron are shown in Appendix I.

Table 2: IR PC PRZM/ EXAMS input parameters for linuron use on carrots in California.

Input variable Input value & calculations Source/ Quality of data Crop name carrots label EPA Reg. No. 1812 320).

application rate (lb ai/ acre) 2 label EPA Reg. No. 1812 320).

Interval between appl. (d) 14 label EPA Reg. No. 1812 320).

Application efficiency 0.99 IR PCA Guidance 8 Spray drift fraction 0.064 IR PCA Guidance Application method ground label (EPA Reg. No. 1812 362).

DWRATE (day 1 ) 0.005 MRID# 41625401; Input parameters guidance 9 ; single value X 3.

DSRATE (day 1 ) 0.005 MRID# 41625401; Input parameters guidance; single value X 3 Kd (mL/ g) 2.7 (sandy loam) MRID# 00148443; Input parameters guidance. Soil Kd for best match of soil in model was used.

Henry (atm. m 3 /mole) 6.07X10 8 (calculated) RED, 1994. 6 KBACW (h 1 ) 0.0003 No aerobic aquatic data is available, the aerobic soil met. degradation rate was multiplied by 0 .5. MRID# 41625401. Input parameters guidance.

KBACS (h 1 ) 0.0002 Anaerobic aquatic half life (21 days) was multiplied by 3. MRID# 40142501. Input parameters guidance .

KDP (h 1 ) 0.0006 MRID# 40103601; Input parameters guidance.

KBH, KNH, KAH (h 1 ) (stable) MRID# 40916201; Input parameters guidance.

KPS (mL/ g) 2.7 MRID# 00148443; Input parameters guidance.

MWT (g/ mole) 249.1 RED, 1994.

Solubility @ 25 0 C (ppm) 81 RED, 1994.

Vapor pressure (torr) 1.5X10 5 The MERCK Index 10 .

Assumptions and Uncertainties 11,12 Index Reservoir The results from the index reservoir represent potential drinking water exposure from a specific area (Illinois) with specific cropping patterns, weather, soils, and other factors. Use of the index reservoir for areas with different climates, crops, pesticides used, sources of water (e. g. rivers instead of reservoirs, etc), and hydrogeology creates uncertainties. In general, because the index reservoir represents a fairly vulnerable watershed, the exposure estimated with the index reservoir will likely be higher than the actual exposure for most drinking water sources. However, the index reservoir is not a worst case scenario, communities that derive their drinking water from smaller bodies of water with minimal outflow, or with more runoff prone soils would likely get higher drinking water exposure than estimated using the index reservoir. Areas with a more humid climate that use a similar reservoir and cropping patterns may also get more pesticides in their drinking water than predicted using this scenario.

A single steady flow has been used to represent the flow through the reservoir. Discharge from the reservoir also removes chemical so this assumption will underestimate removal from the reservoir during wet periods and overestimates removal during dry periods. This assumption can underestimate or overestimate the concentration in the pond depending upon the annual precipitation pattern at the site. 7 The index reservoir scenario uses the characteristics of a single soil to represent the soil in the basin. In fact, soils can vary substantially across even small areas, and this variation is not reflected in these simulations.

The index reservoir scenario does not consider tile drainage. Areas that are prone to substantial runoff are often tile drained. Tile drainage contributes additional water and in some cases, additional pesticide loading to the reservoir. This may cause either an increase or decrease in the pesticide concentration in the reservoir. Tile drainage also causes the surface soil to dry out faster. This will reduce runoff of the pesticide into the reservoir. The watershed used as the model for the index reservoir (Shipman City Lake) does not have tile drainage in the cropped areas.

EXAMS is unable to easily model spring and fall turnover. Turnover occurs when the temperature drops in the fall and the thermal stratification of the reservoir is removed. Turnover occurs again in the spring when the reservoir warms up. This results in complete mixing of the chemical through the water column at these times. Because of this inability, the Index Reservoir has been simulated without stratification. There is data to suggest that Shipman City Lake, upon which the Index Reservoir is based, does indeed stratify in the deepest parts of the lake at least in some years. This may result in over or underestimation of the concentration in drinking water depending upon the time of the year and the depth the drinking water intake is drawing from.

Percent Crop Area Correction Factor The PCA is a watershed based modification. Implicit in its application is the assumption that currently used field scale models reflect basin scale processes consistently for all pesticides and uses. In other words, we assume that the field scale processes simulated by the coupled PRZM and EXAMS models are a reasonable approximation of pesticide fate and transport within a watershed that contains a drinking water reservoir. If the models fail to capture pertinent basin scale fate and transport processes consistently for all pesticides and all uses, the application of a factor that reduces the estimated concentrations predicted by modeling could, in some instances, result in inadvertently passing a chemical through the screen that may actually pose a risk. Some preliminary assessments made in the development of the PCA suggest that PRZM/ EXAMS may not be realistically capturing basin scale processes for all pesticides or for all uses. A preliminary survey of water assessments which 8 compared screening model estimates to readily available monitoring data suggest uneven model results. In some instances, the screening model estimates are more than an order of magnitude greater than the highest concentrations reported in available monitoring data; in other instances, the model estimates are less than monitoring concentrations. Because of these concerns, the SAP recommended using the PCA only for "major" crops in the Midwest. For other crops, development of PCA's will depend on the availability of relevant monitoring data that could be used to evaluate the result of the PCA adjustment.

The spatial data used for the PCA came from readily available sources and have a number of inherent limitations:

° The size of the 8 digit HUC [mean = 366,989 ha; range = 6. 7 2,282,081 ha; n = 2,111] may not provide reasonable estimates of actual PCA's for smaller watersheds. The watersheds that drain into drinking water reservoirs are generally smaller than the 8 digit HUC and may be better represented by watersheds defined for drinking water intakes. ° The conversion of the county level data to watershed based percent crop areas assumes the distribution of the crops within a county is uniform and homogeneous throughout the county area. Distance between the treated fields and the water body is not addressed. ° The PCA's were generated using data from the 1992 Census of Agriculture. However, recent changes in the agriculture sector from farm bill legislation may significantly impact the distribution of crops throughout the country. The methods described in this report can rapidly be updated as more current agricultural crops data are obtained. The assumption that yearly changes in cropping patterns will cause minimal impact needs to be evaluated.

The PCA adjustment is only applicable to pesticides applied to agricultural crops. Contributions to surface waters from nonagricultural uses such as urban environments are not wellmodeled Currently, non agricultural uses are not included in the screening model assessments for drinking water.

The PCA does not consider percent crop treated because detailed pesticide usage data are extremely limited at this time. Detailed pesticide usage data are currently available for only a few states. 9 Groundwater Monitoring EFED has limited monitoring data on the concentrations of Linuron in groundwater. Table 3 shows validated monitoring data for linuron that are available for the states of Georgia (GA), Missouri (MO), Virginia (VA), and Wisconsin (WI).

Table 3. Groundwater monitoring data for linuron. Number of wells sampled (number of wells with residues) 13 .

State well results range of conc. (ppb)

GA 70 (67) 1.0  5.0 Mo 269 (38) 0.2  1.9 VA 12 (5) 0.042  3.79 WI 26 (1) 3.00 In addition, the US Geological Survey (USGS) National Water Quality Assessment Program (NAWQA) analyzed pesticide occurrence and concentrations in shallow ground water in agricultural areas (detection limit = 0.01 ppb). Analysis of 924 samples showed linuron in 0.11% of the samples analyzed with a maximum concentration of 0.029 ppb 14 .

A Major component of the sampling design in the NAWQA study was to target specific watersheds and shallow ground water areas that are influenced primarily by a single dominant land use( agricultural or urban) that is important in the particular area. The ground water data were primarily collected from a combination of production and monitoring wells. Ground water sites in the NAWQA study were sampled for pesticides once at each site.

Even though the groundwater monitoring data collected by USGS NAWQA are from sites considered to represent typical use areas, the frequency and duration of sampling were not sufficient to represent an adequate monitoring data set for exclusive use in drinking water exposure determination.

The SCI GROW model was used to estimate potential groundwater concentrations of linuron. 10 Table 4 shows the input parameter values used in SCI GROW modeling.

Table 4. Input parameters for linuron used in the SCI GROW model.

Input variable Input value & calculation s Source/ Quality of data 1 Application rate (lb ai/ acre) 1.0 (EPA Reg. No. 1812 320).

Maximum No. of Applications 2 (EPA Reg. No. 1812 320).

Koc (mL/ g) 208 MRID# 46007015 (median value); Input parameters guidance.

Aerobic Soil metabolism t1/ 2. (day) 49 MRID# 41625401; Input parameters guidance.

Groundwater EECs predicted using the SCI GROW screening model are substantially less than those estimated for surface water using PRZM and EXAMS. SCI GROW estimated concentrations of linuron are also much less than those from monitoring data shown in Table 3. Therefore, for drinking water concentrations from groundwater sources we recommend 5.0 ppb to be used in the drinking water assessment.

REFERENCES 1. Carsel, R. F., J. C. Imhoff, P. R. Hummel, J. M. Cheplick and J. S. Donigian, Jr. 1997. PRZM 3, A Model for Predicting Pesticide and Nitrogen Fate in Crop Root and Unsaturated Soil Zones: Users Manual for Release 3.0; Environmental Research Laboratory, Office of Research and Development, U. S. Environmental Protection Agency, Athens, GA.

2. Burns, L. A. March 1997. Exposure Analysis Modeling System (EXAMSII) Users Guide for Version 2.97.5, Environmental Research Laboratory, Office of Research and Development, U. S. Environmental Protection Agency, Athens, GA.

3. Barrett, M., 1997, Proposal For a Method to Determine Screening Concentration Estimates for Drinking Water Derived from Groundwater Studies, EFED/ OPP. 11 4. U. S GS. 1992. National Water Quality Assessment (NWQA), Pesticides National Synthesis Project, Annual Use: Linuron.

5. U. S GS. 1993. National Water Quality Assessment Program San Joaquin  Tulare Basins Study Unit, [Online]. Available at http:// ca. water. usgs. gov/ sanj_ nawqa/ data_ sw/ ifs. 1993. herb2.

6. The United State Department of Agriculture, Office of Pesticide Management Policy & Pesticide Impact Assessment Program. Crop Profile for Carrots in California, [Online]. A v a i l a b l e a t http:// pestdata. ncsu. edu/ cropprofiles/ Detail. CFM? FactShee ts_ RecordID= 285.

7. USGS. 1998. Pesticides in Surface and Ground Water of the United States: Summary of Results of the National Water Quality Assessment Program, [Online]. Available at http://( NAWQA)= http:// ca. water. usgs. gov/ pnsp/ allsum/# t1.

8. Effland, W., N. Thurman, I. Kennedy, R. D. Jones, J. Breithaupt, J. Lin, J. Carleton, L. Libel. R. Parker, and R. Matzner. 2000. " Guidance for use of the index Reservoir and Percent Crop Area Factor in drinking water exposure assessment s. Office of Pesticide Programs.

9. Guidance for Chemistry and Management Practice Input Parameters For Use in Modeling the Environmental Fate and Transport of Pesticides. Version 2. November 7, 2000. U. S. EPA Office of Pesticide Programs, Environmental Fate and Effects Division.

10. The Merck Index. 1989. An encyclopedia of chemicals, drugs, and biologicals. 11 th ed. Rahway, N. J. p. 533.

11. Carsel, R. F., J. C. Imhoff, P. R. Hummel, J. M. Cheplick and J. S. Donigian, Jr. 1997. PRZM 3, A Model for Predicting Pesticide and Nitrogen Fate in Crop Root and Unsaturated Soil Zones: Users Manual for Release 3.0; Environmental Research Laboratory, Office of Research and Development, U. S. Environmental Protection Agency, Athens, GA.

12. U. S. Environmental Protection Agency. 1984. Chemical Information Fact Sheet Number 28: Linuron. Office of Pesticides and Toxic Substances, Washington, DC, 9 13.

13. U. S. EPA. 1992. Pesticides in Ground Water Database A compilation of Monitoring Studies: 1971  1991. Office of 12 Prevention, Pesticides, and Toxic Substances, EPA 734 12 92 001.

14. U. S GS. 1998. National Water Quality Assessment (NWQA), Pesticides National Synthesis Project [Online] at http:// ca. water. usgs. gov/ pnsp/ allsum/# over.

APPENDIX I IR PCA PRZM/ EXAMS INPUT FILE FOR THE USE OF LINURON ON CARROTS IN CALIFORNIA LINURON Lerdo clay loam, MLRA C 17; Central Valley, CA, Carrots 0.700 0.500 0 17.00 1 1 4 0.21 1.00 1.000 172.8 3 1.00 600.00 1 1 0.20 60.00 80.00 3 91 85 88 0.00 100.00 1 3 0101 21 9 2209 0.10 0.10 0.10 .023 .023 .023 36 100948 231248 311248 1 100949 231249 311249 1 100950 231250 311250 1 100951 231251 311251 1 100952 231252 311252 1 100953 231253 311253 1 100954 231254 311254 1 100955 231255 311255 1 100956 231256 311256 1 100957 231257 311257 1 100958 231258 311258 1 100959 231259 311259 1 100960 231260 311260 1 100961 231261 311261 1 100962 231262 311262 1 100963 231263 311263 1 100964 231264 311264 1 100965 231265 311265 1 100966 231266 311266 1 100967 231267 311267 1 13 100968 231268 311268 1 100969 231269 311269 1 100970 231270 311270 1 100971 231271 311271 1 100972 231272 311272 1 100973 231273 311273 1 100974 231274 311274 1 100975 231275 311275 1 100976 231276 311276 1 100977 231277 311277 1 100978 231278 311278 1 100979 231279 311279 1 100980 231280 311280 1 100981 231281 311281 1 100982 231282 311282 1 100983 231283 311283 1 2 non incorporated applications of 2.0 lbs A. I./ acre (2.24 Kg/ Ha), spry drift 0.99, APPEFF. 0.064 72 1 0 Linuron *** Kd: 2.7 AeSM: T1/ 2= 49 days AnAQ Met: T1/ 2= 21 days *** 101248 0 2 0.00 2.24 0.99 0.064 241248 0 2 0.00 2.24 0.99 0.064 101249 0 2 0.00 2.24 0.99 0.064 241249 0 2 0.00 2.24 0.99 0.064 101250 0 2 0.00 2.24 0.99 0.064 241250 0 2 0.00 2.24 0.99 0.064 101251 0 2 0.00 2.24 0.99 0.064 241251 0 2 0.00 2.24 0.99 0.064 101252 0 2 0.00 2.24 0.99 0.064 241252 0 2 0.00 2.24 0.99 0.064 101253 0 2 0.00 2.24 0.99 0.064 241253 0 2 0.00 2.24 0.99 0.064 101254 0 2 0.00 2.24 0.99 0.064 241254 0 2 0.00 2.24 0.99 0.064 101255 0 2 0.00 2.24 0.99 0.064 241255 0 2 0.00 2.24 0.99 0.064 101256 0 2 0.00 2.24 0.99 0.064 241256 0 2 0.00 2.24 0.99 0.064 101257 0 2 0.00 2.24 0.99 0.064 241257 0 2 0.00 2.24 0.99 0.064 101258 0 2 0.00 2.24 0.99 0.064 241258 0 2 0.00 2.24 0.99 0.064 101259 0 2 0.00 2.24 0.99 0.064 241259 0 2 0.00 2.24 0.99 0.064 101260 0 2 0.00 2.24 0.99 0.064 241260 0 2 0.00 2.24 0.99 0.064 101261 0 2 0.00 2.24 0.99 0.064 241261 0 2 0.00 2.24 0.99 0.064 101262 0 2 0.00 2.24 0.99 0.064 241262 0 2 0.00 2.24 0.99 0.064 101263 0 2 0.00 2.24 0.99 0.064 241263 0 2 0.00 2.24 0.99 0.064 14 101264 0 2 0.00 2.24 0.99 0.064 241264 0 2 0.00 2.24 0.99 0.064 101265 0 2 0.00 2.24 0.99 0.064 241265 0 2 0.00 2.24 0.99 0.064 101266 0 2 0.00 2.24 0.99 0.064 241266 0 2 0.00 2.24 0.99 0.064 101267 0 2 0.00 2.24 0.99 0.064 241267 0 2 0.00 2.24 0.99 0.064 101268 0 2 0.00 2.24 0.99 0.064 241268 0 2 0.00 2.24 0.99 0.064 101269 0 2 0.00 2.24 0.99 0.064 241269 0 2 0.00 2.24 0.99 0.064 101270 0 2 0.00 2.24 0.99 0.064 241270 0 2 0.00 2.24 0.99 0.064 101271 0 2 0.00 2.24 0.99 0.064 241271 0 2 0.00 2.24 0.99 0.064 101272 0 2 0.00 2.24 0.99 0.064 241272 0 2 0.00 2.24 0.99 0.064 101273 0 2 0.00 2.24 0.99 0.064 241273 0 2 0.00 2.24 0.99 0.064 101274 0 2 0.00 2.24 0.99 0.064 241274 0 2 0.00 2.24 0.99 0.064 101275 0 2 0.00 2.24 0.99 0.064 241275 0 2 0.00 2.24 0.99 0.064 101276 0 2 0.00 2.24 0.99 0.064 241276 0 2 0.00 2.24 0.99 0.064 101277 0 2 0.00 2.24 0.99 0.064 241277 0 2 0.00 2.24 0.99 0.064 101278 0 2 0.00 2.24 0.99 0.064 241278 0 2 0.00 2.24 0.99 0.064 101279 0 2 0.00 2.24 0.99 0.064 241279 0 2 0.00 2.24 0.99 0.064 101280 0 2 0.00 2.24 0.99 0.064 241280 0 2 0.00 2.24 0.99 0.064 101281 0 2 0.00 2.24 0.99 0.064 241281 0 2 0.00 2.24 0.99 0.064 101282 0 2 0.00 2.24 0.99 0.064 241282 0 2 0.00 2.24 0.99 0.064 101283 0 2 0.00 2.24 0.99 0.064 241283 0 2 0.00 2.24 0.99 0.064 0. 1 0.0 0.00 0.072 0.5 Lerdo clay loam; Hydrologic Group C 100.00 0 0 0 0 0 0 0 0 0 0.0 0.000 0.00 2 1 18.00 1.600 0.325 0.000 0.000 0.000 0.005 0.005 0.000 1.00 0.325 0.175 0.017 2.700 2 82.00 1.500 0.249 0.000 0.000 0.000 0.005 0.005 0.000 1.0 0.249 0.129 0.002 2.700 0 WATR YEAR 10 PEST YEAR 10 CONC YEAR 10 1 6 15 11

5 DAY RUNF TSER 0 0 1. E0 EFLX TSER 0 0 1. E0 ESLS TSER 0 0 1. E0 RUNF TSER 0 0 1. E0 PRCP TSER 0 0 1. E0 16 IR PCA PRZM/ EXAMS OUTPUT FILE FOR THE USE OF LINURON ON CARROTS IN CALIFORNIA WATER COLUMN DISSOLVED CONCENTRATION (PPB)

YEAR PEAK 96 HOUR 21 DAY 60 DAY 90 DAY YEARLY

1948 9.435 9.325 6.422 2.329 1.553 0.404 1949 9.955 9.840 8.497 7.644 7.053 3.680 1950 11.890 11.760 11.330 10.280 9.819 5.169 1951 10.600 10.480 9.986 9.396 8.974 4.647 1952 21.000 20.770 19.830 18.430 17.710 9.137 1953 12.020 11.890 11.640 10.740 9.992 5.283 1954 27.190 26.890 25.790 23.460 21.690 10.420 1955 15.580 15.410 14.710 13.740 12.790 6.510 1956 11.290 11.160 9.362 8.490 7.831 4.669 1957 12.600 12.460 11.880 10.920 10.360 5.678 1958 13.920 13.710 13.000 11.700 10.870 6.840 1959 10.270 10.160 9.697 8.797 8.148 4.086 1960 16.510 16.330 15.640 14.390 13.280 6.984 1961 11.670 11.550 11.020 9.910 9.124 4.476 1962 37.470 37.030 35.920 32.460 29.850 14.070 1963 28.360 28.030 26.690 24.540 22.870 11.350 1964 11.050 10.930 10.430 9.383 8.641 4.259 1965 24.260 20.610 10.820 10.240 9.405 5.963 1966 29.150 28.820 27.450 24.760 23.860 11.930 1967 17.300 17.110 16.320 14.610 13.830 7.722 1968 10.360 10.240 9.774 8.791 8.478 4.829 1969 12.320 12.180 11.610 10.550 10.350 5.865 1970 14.000 13.840 13.180 11.760 10.730 5.920 1971 10.990 10.870 10.400 9.372 8.630 5.431 1972 11.240 11.110 9.625 8.657 7.971 5.639 1973 25.240 24.960 23.810 21.460 20.490 10.300 1974 17.600 17.380 16.470 14.490 13.000 7.568 1975 15.110 14.940 14.230 12.690 11.890 6.320 1976 12.340 12.200 11.650 10.480 10.000 5.397 1977 22.180 21.930 11.240 9.721 9.147 6.433 1978 73.250 72.400 68.960 61.770 56.310 26.430 1979 16.730 16.550 15.790 14.530 13.770 6.910 1980 15.100 14.940 14.580 14.130 13.460 7.027 1981 13.080 12.930 12.390 11.380 11.000 6.157 1982 11.170 11.000 10.320 9.676 9.229 5.630 1983 36.360 35.960 34.270 31.170 28.770 13.920 17 SORTED FOR PLOTTING

PROB PEAK 96 HOUR 21 DAY 60 DAY 90 DAY EARLY

0.027 73.250 72.400 68.960 61.770 56.310 26.430 0.054 37.470 37.030 35.920 32.460 29.850 14.070 0.081 36.360 35.960 34.270 31.170 28.770 13.920 0.108 29.150 28.820 27.450 24.760 23.860 11.930 0.135 28.360 28.030 26.690 24.540 22.870 11.350 0.162 27.190 26.890 25.790 23.460 21.690 10.420 0.189 25.240 24.960 23.810 21.460 20.490 10.300 0.216 24.260 21.930 19.830 18.430 17.710 9.137 0.243 22.180 20.770 16.470 14.610 13.830 7.722 0.270 21.000 20.610 16.320 14.530 13.770 7.568 0.297 17.600 17.380 15.790 14.490 13.460 7.027 0.324 17.300 17.110 15.640 14.390 13.280 6.984 0.351 16.730 16.550 14.710 14.130 13.000 6.910 0.378 16.510 16.330 14.580 13.740 12.790 6.840 0.405 15.580 15.410 14.230 12.690 11.890 6.510 0.432 15.110 14.940 13.180 11.760 11.000 6.433 0.459 15.100 14.940 13.000 11.700 10.870 6.320 0.486 14.000 13.840 12.390 11.380 10.730 6.157 0.514 13.920 13.710 11.880 10.920 10.360 5.963 0.541 13.080 12.930 11.650 10.740 10.350 5.920 0.568 12.600 12.460 11.640 10.550 10.000 5.865 0.595 12.340 12.200 11.610 10.480 9.992 5.678 0.622 12.320 12.180 11.330 10.280 9.819 5.639 0.649 12.020 11.890 11.240 10.240 9.405 5.630 0.676 11.890 11.760 11.020 9.910 9.229 5.431 0.703 11.670 11.550 10.820 9.721 9.147 5.397 0.730 11.290 11.160 10.430 9.676 9.124 5.283 0.757 11.240 11.110 10.400 9.396 8.974 5.169 0.784 11.170 11.000 10.320 9.383 8.641 4.829 0.811 11.050 10.930 9.986 9.372 8.630 4.669 0.838 10.990 10.870 9.774 8.797 8.478 4.647 0.865 10.600 10.480 9.697 8.791 8.148 4.476 0.892 10.360 10.240 9.625 8.657 7.971 4.259 0.919 10.270 10.160 9.362 8.490 7.831 4.086 0.946 9.955 9.840 8.497 7.644 7.053 3.680 0.973 9.435 9.325 6.422 2.329 1.553 0.404 1/ 10 31.313 30.962 29.496 26.683 25.333 12.527 MEAN OF ANNUAL VALUES = 7.307 STANDARD DEVIATION OF ANNUAL VALUES = 4.336 UPPER 90% CONFIDENCE LIMIT ON MEAN = 8.377 18 SCI GROW output file RUN No. 1 FOR linuron INPUT VALUES

APPL (#/ AC) APPL. URATE SOIL SOIL AEROBIC RATE NO. (#/ AC/ YR) KOC METABOLISM (DAYS)

1.000 2 2.000 208.0 49.0 GROUND WATER SCREENING CONCENTRATIONS IN PPB

.544

A= 44.000 B= 207.000 C= 1.643 D= 2.316 RILP= 2.768 F= . 553 G= .280 URATE= 2.000 GWSC= .560119


[Federal Register: April 16, 2008 (Volume 73, Number 74)]
[Notices]
[Page 20620]
[DOCID:fr16ap08-36]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP98-150-010]

Millennium Pipeline Company, L.L.C.; Notice of Application

April 10, 2008.
    Take notice that on March 31, 2008, Millennium Pipeline Company,
L.L.C. (Millennium) One Blue Hill Plaza, Seventh Floor, P.O. Box 1565,
Pearl River, New York 10965 filed, pursuant to section 7(c) of the
Natural Gas Act, an application to amend its certificate issued in
Docket No. CP98-150. Millennium proposes to amend its certificate to:
(1) Authorize the lease and leaseback agreements it has entered into
with the Industrial Development Agencies of the Counties of Orange,
Sullivan, Broome, Chemung, and Delaware, New York, in order to obtain
partial abatement of state property taxes and other tax relief; (2)
extend the term of the regulatory asset Millennium has been authorized
to record from ten to fifteen years to coincide with its executed firm
transportation agreements; and (3) authorize certain amendments to the
lease agreements between Millennium and Columbia Gas Transmission
Corporation. This filing is available for review at the Commission in
the Public Reference Room or may be viewed on the Commission's Web site
at http://www.ferc.gov using the ``eLibrary'' link. Enter the docket
number excluding the last three digits in the docket number field to
access the document. For assistance, please contact FERC Online Support
at<EMAIL_ADDRESS>or toll free at<PHONE_NUMBER>, or for
TTY, contact<PHONE_NUMBER>.
    Any questions regarding this Application should be directed to
Daniel F. Collins or Glenn S. Benson, Fulbright & Jaworski, L.L.P., 801
Pennsylvania Avenue, Washington, DC 20004, at<PHONE_NUMBER> (Daniel)
or<PHONE_NUMBER> (Glenn) or by fax at<PHONE_NUMBER>.
    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 final environmental impact statement (FEIS) or 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 FEIS or EA.
    There are two ways to become involved in the Commission's review of
this project. First, any person wishing to obtain legal status by
becoming a party to the proceedings for this project should, on or
before the below listed comment date, file with the Federal Energy
Regulatory Commission, 888 First Street, NE., Washington, DC 20426, a
motion to intervene in accordance with the requirements of the
Commission's Rules of Practice and Procedure (18 CFR 385.214 or
385.211) and the Regulations under the NGA (18 CFR 157.10). A person
obtaining party status will be placed on the service list maintained by
the Secretary of the Commission and will receive copies of all
documents filed by the applicant and by all other parties. A party must
submit 14 copies of filings made with the Commission and must mail a
copy to the applicant and to every other party in the proceeding. Only
parties to the proceeding can ask for court review of Commission orders
in the proceeding.
    However, a person does not have to intervene in order to have
comments considered. The second way to participate is by filing with
the Secretary of the Commission, as soon as possible, an original and
two copies of comments in support of or in opposition to this project.
The Commission will consider these comments in determining the
appropriate action to be taken, but the filing of a comment alone will
not serve to make the filer a party to the proceeding. The Commission's
rules require that persons filing comments in opposition to the project
provide copies of their protests only to the party or parties directly
involved in the protest.
    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 commenters 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 commenters 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.
    Motions to intervene, protests and comments may be filed
electronically via the Internet in lieu of paper; see, 18 CFR
385.2001(a)(1)(iii) and the instructions on the Commission's Web site
under the ``e-Filing'' link. The Commission strongly encourages
electronic filings.
    Comment Date: May 1, 2008.

Kimberly D. Bose,
Secretary.
[FR Doc. E8-8145 Filed 4-15-08; 8:45 am]

BILLING CODE 6717-01-P