[Federal Register Volume 83, Number 245 (Friday, December 21, 2018)]
[Notices]
[Pages 65652-65653]
[FR Doc No: 2018-27641]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP18-487-000]

Notice of Schedule for Environmental Review of the Natural Gas
Pipeline Company of America, LLC, Sabine Pass Compression Project

    On May 18, 2018, Natural Gas Pipeline Company of America, LLC
(Natural) filed an application in Docket No. CP18-487-000 requesting a
Certificate of Public Convenience and Necessity pursuant to Section
7(c) of the Natural Gas Act to construct and operate certain natural
gas pipeline facilities. The proposed project is known as the Sabine
Pass Compression Project (Project) and involves the construction and
operation of facilities in Cameron Parish, Louisiana. The Project would
enable Natural to transport an additional 400,000 dekatherms per day of
natural gas for delivery to Sabine Pass Liquefaction, LLC's (Sabine
Pass) liquefaction export facility located in Cameron Parish.
    On May 31, 2018, the Federal Energy Regulatory Commission
(Commission or FERC) issued its Notice of Application for the Project.
Among other things, that notice alerted agencies issuing federal
authorizations of the requirement to complete all necessary reviews and
to

reach a final decision on a request for a federal authorization within
90 days of the date of issuance of the Commission staff's Environmental
Assessment (EA) for the Project. This instant notice identifies the
FERC staff's planned schedule for the completion of the EA for the
Project.

Schedule for Environmental Review

Issuance of EA--(March 8, 2019)
90-day Federal Authorization Decision Deadline--(June 6, 2019)

    If a schedule change becomes necessary, additional notice will be
provided so that the relevant agencies are kept informed of the
Project's progress.

Project Description

    Natural proposes to construct and operate the following facilities:
A new 22,490 horsepower Compressor Station No. 348 (CS 348) adjacent to
the Sabine Pass Terminal, a new tie-in facility connecting CS 348 to
the existing Louisiana Line Nos. 1 and 2, a 36-inch tap on the existing
Natural Lateral, and minor modifications at Natural's existing X-L8E
South Valve to allow for remote operation of Natural's existing valve.

Background

    On July 3, 2018, the Commission issued a Notice of Intent to
Prepare an Environmental Assessment for the Proposed Sabine Pass
Compression Project and Request for Comments on Environmental Issues
(NOI). The NOI was sent to affected landowners; federal, state, and
local governmental representatives and agencies; elected officials;
environmental and public interest groups; Native American tribes; other
interested parties; and local libraries and newspapers. We received
comment letters from the Department of Wildlife and Fisheries of the
State of Louisiana and the National Marine Fisheries Service's Habitat
Conservation Division. All substantive comments will be addressed in
the EA.

Additional Information

    In order to receive notification of the issuance of the EA and to
keep track of all formal issuances and submittals in specific dockets,
the Commission offers a free service called eSubscription. This can
reduce the amount of time you spend researching proceedings by
automatically providing you with notification of these filings,
document summaries, and direct links to the documents. Go to
www.ferc.gov/docs-filing/esubscription.asp.
    Additional information about the Project is available from the
Commission's Office of External Affairs at (866) 208-FERC or on the
FERC website (www.ferc.gov). Using the ``eLibrary'' link, select
``General Search'' from the eLibrary menu, enter the selected date
range and ``Docket Number'' excluding the last three digits (i.e.,
CP18-487), and follow the instructions. For assistance with access to
eLibrary, the helpline can be reached at<PHONE_NUMBER>, TTY (202) 502-
8659, or at<EMAIL_ADDRESS>The eLibrary link on the FERC
website also provides access to the texts of formal documents issued by
the Commission, such as orders, notices, and rule makings.

    Dated: December 14, 2018.
Kimberly D. Bose,
 Secretary.
[FR Doc. 2018-27641 Filed 12-20-18; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 84, Number 178 (Friday, September 13, 2019)]
[Notices]
[Pages 48349-48350]
[FR Doc No: 2019-19825]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

    Take notice that the Commission received the following electric
corporate filings:

    Docket Numbers: EC19-136-000.
    Applicants: Consolidated Edison Company of New York, Inc.
    Description: Application for Authorization Under Section 203 of the
Federal Power Act of Consolidated Edison Company of New York, Inc.
    Filed Date: 9/6/19.
    Accession Number: 20190906-5142.
    Comments Due: 5 p.m. ET 9/27/19.

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER10-1521-005; ER10-1520-005; ER10-1522-004.
    Applicants: Occidental Power Marketing, L.P., Occidental Power
Services, Inc., Occidental Chemical Corporation.
    Description: Notice of Non-Material Change in Status of the
Occidental MBRA Entities.
    Filed Date: 9/9/19.
    Accession Number: 20190909-5026.
    Comments Due: 5 p.m. ET 9/30/19.

    Docket Numbers: ER19-1837-001.
    Applicants: California Independent System Operator Corporation.
    Description: Compliance filing: 2019-09-06 Compliance Filing re
ER19-1837 Tariff Clarifications Amendment to be effective 8/12/2019.
    Filed Date: 9/6/19.
    Accession Number: 20190906-5103.
    Comments Due: 5 p.m. ET 9/27/19.

    Docket Numbers: ER19-2105-001.
    Applicants: Appalachian Power Company, PJM Interconnection, L.L.C.
    Description: Tariff Amendment: PJM TOs submit response to the
Commission's 8/8/2019 Deficiency Letter to be effective 8/10/2019.
    Filed Date: 9/6/19.
    Accession Number: 20190906-5128.
    Comments Due: 5 p.m. ET 9/27/19.

    Docket Numbers: ER19-2457-001.
    Applicants: Midcontinent Independent System Operator, Inc.

    Description: Tariff Amendment: 2019-09-09_SA 3333 ITC-DTE Electric
Substitute GIA (J793) to be effective 7/11/2019.
    Filed Date: 9/9/19.
    Accession Number: 20190909-5027.
    Comments Due: 5 p.m. ET 9/30/19.

    Docket Numbers: ER19-2767-000.
    Applicants: Massachusetts Electric Company.
    Description: Sec.  205(d) Rate Filing: 2019 Rate Update Filing for
Massachusetts Electric Borderline Sales Agreement to be effective 11/1/
2017.
    Filed Date: 9/6/19.
    Accession Number: 20190906-5125.
    Comments Due: 5 p.m. ET 9/27/19.

    Docket Numbers: ER19-2768-000.
    Applicants: Portland General Electric Company.
    Description: Sec.  205(d) Rate Filing: Att K Revision Filing to be
effective 1/1/2020.
    Filed Date: 9/6/19.
    Accession Number: 20190906-5127.
    Comments Due: 5 p.m. ET 9/27/19.

    Docket Numbers: ER19-2769-000.
    Applicants: Potomac Electric Power Company.
    Description: Application to Recover Abandoned Plant Costs of
Potomac Electric Power Company.
    Filed Date: 9/6/19.
    Accession Number: 20190906-5143.
    Comments Due: 5 p.m. ET 9/27/19.

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

    Dated: September 9, 2019.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2019-19825 Filed 9-12-19; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 226 (Wednesday, November 23, 2016)]
[Notices]
[Pages 84597-84598]
[FR Doc No: 2016-28122]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-0558]

Contract Manufacturing Arrangements for Drugs: Quality
Agreements; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a guidance for industry entitled ``Contract
Manufacturing Arrangements for Drugs: Quality Agreements.'' This
guidance describes FDA's current thinking on defining, establishing,
and documenting manufacturing activities of the parties involved in
contract drug manufacturing subject to current good manufacturing
practice (CGMP) requirements. In particular, we describe how parties
involved in contract drug manufacturing can use quality agreements to
delineate their manufacturing activities to ensure compliance with
CGMP.

DATES: Submit either electronic or written comments on Agency guidances
at any time.

ADDRESSES: 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): 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-2013-D-0558 for ``Contract Manufacturing Arrangements for Drugs:
Quality Agreements.'' Received comments will be placed in the docket
and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov/ or at the 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 https://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 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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Bldg., 4th Floor, Silver Spring, MD 20993-0002; the Office of
Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002; or
the Policy and Regulations Staff, HFV-6, Center for Veterinary
Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville,
MD 20855. Send one self-addressed adhesive label to assist that office
in processing your requests. See the SUPPLEMENTARY INFORMATION section
for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Paula Katz, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 4330, Silver Spring, MD 20993-0002,<PHONE_NUMBER>; Stephen
Ripley, Center for Biologics Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver
Spring, MD 20993-0002,<PHONE_NUMBER>; or Jonathan Bray, Center for
Veterinary Medicine (HFV-232), Food and Drug Administration, 7519
Standish Pl., Rm. 130, Rockville, MD 20855,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``Contract Manufacturing Arrangements for Drugs: Quality
Agreements.'' This guidance describes FDA's current thinking on
defining, establishing, and documenting manufacturing activities of the
parties involved in contract drug manufacturing subject to CGMP
requirements. Owners and contract facilities can draw on quality
management principles to carry out the complicated process of contract
drug manufacturing by defining, establishing, and documenting their
activities for ensuring compliance with CGMP and to ensure the quality,
safety, and effectiveness of drugs.

    This guidance replaces the draft guidance of the same name that
published in the Federal Register of May 28, 2013 (78 FR 31943). We
have carefully reviewed and considered the comments that were received
on the draft guidance and have made changes for clarification. In
particular, our revisions clarified the scope and applicability of the
guidance and key terms used in the guidance.
    Regarding scope and applicability, we have clarified that the
guidance is limited to commercial manufacturing activities. Although
the principles articulated may be useful in approaching quality
agreements for other kinds of activities, such as clinical research,
development, or distribution, these are outside the scope of this
particular document.
    Many comments concerned the terms ``owner'' and ``contract
facility.'' Although some comments recommended that this guidance adopt
the terms ``contract giver'' and ``contract acceptor,'' these terms do
not align with our goal of showing how the parties to a contract
manufacturing arrangement can work together to define, establish, and
document agreements that delineate manufacturing activities and ensure
compliance with CGMP.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on Contract Manufacturing Arrangements for
Drugs: Quality Agreements. 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.

II. The Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520) and
have been approved under OMB control number 0910-0139.

III. Electronic Access

    Persons with access to the Internet may obtain the document at
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm, or https://www.regulations.gov/.

    Dated: November 17, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-28122 Filed 11-22-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 79, Number 211 (Friday, October 31, 2014)]
[Notices]
[Page 64842]
[FR Doc No: 2014-25876]

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SECURITIES AND EXCHANGE COMMISSION

Proposed Collection; Comment Request

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

Extension: Rule 12d2-2 and Form 25;
    SEC File No. 270-86, OMB Control No. 3235-0080.

    Notice is hereby given that pursuant to the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') is soliciting comments on the collections
of information summarized below. The Commission plans to submit these
existing collections of information to the Office of Management and
Budget for extension and approval for Rule 12d2-2 (17 CFR 240.12d2-2)
and Form 25 (17 CFR 249.25) Removal and Notification of Removal from
Listing and/or Registration.
    On February 12, 1935, the Commission adopted Rule 12d2-2,\1\ and
Form 25 under the Securities Exchange Act of 1934 (15 U.S.C. 78b et
seq.) (``Act''), to establish the conditions and procedures under which
a security may be delisted from an exchange and withdrawn from
registration under Section 12(b) of the Act.\2\ The Commission adopted
amendments to Rule 12d2-2 and Form 25 in 2005.\3\ Under the amended
Rule 12d2-2, all issuers and national securities exchanges seeking to
delist and deregister a security in accordance with the rules of an
exchange must file the adopted version of Form 25 with the Commission.
The Commission also adopted amendments to Rule 19d-1 under the Act to
require exchanges to file the adopted version of Form 25 as notice to
the Commission under Section 19(d) of the Act. Finally, the Commission
adopted amendments to exempt standardized options and security futures
products from Section 12(d) of the Act. These amendments are intended
to simplify the paperwork and procedure associated with a delisting and
to unify general rules and procedures relating to the delisting
process.
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    \1\ See Securities Exchange Act Release No. 98 (February 12,
1935).
    \2\ See Securities Exchange Act Release No. 7011 (February 5,
1963), 28 FR 1506 (February 16, 1963).
    \3\ See Securities Exchange Act Release No. 52029 (July 14,
2005), 70 FR 42456 (July 22, 2005).
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    The Form 25 is useful because it informs the Commission that a
security previously traded on an exchange is no longer traded. In
addition, the Form 25 enables the Commission to verify that the
delisting and/or deregistration has occurred in accordance with the
rules of the exchange. Further, the Form 25 helps to focus the
attention of delisting issuers to make sure that they abide by the
proper procedural and notice requirements associated with a delisting
and/or a deregistration. Without Rule 12d2-2 and the Form 25, as
applicable, the Commission would be unable to fulfill its statutory
responsibilities.
    There are 18 national securities exchanges that could possibly be
respondents complying with the requirements of the Rule and Form 25.\4\
The burden of complying with Rule 12d2-2 and Form 25 is not evenly
distributed among the exchanges, however, since there are many more
securities listed on the New York Stock Exchange, the NASDAQ Stock
Market, and NYSEMKT than on the other exchanges. However, for purposes
of this filing, the Commission staff has assumed that the number of
responses is evenly divided among the exchanges. Since approximately
690 responses under Rule 12d2-2 and Form 25 for the purpose of
delisting and/or deregistration of equity securities are received
annually by the Commission from the national securities exchanges, the
resultant aggregate annual reporting hour burden would be, assuming on
average one hour per response, 690 annual burden hours for all
exchanges (18 exchanges x an average of 38.3 responses per exchange x 1
hour per response). In addition, since approximately 100 responses are
received by the Commission annually from issuers wishing to remove
their securities from listing and registration on exchanges, the
Commission staff estimates that the aggregate annual reporting hour
burden on issuers would be, assuming on average one reporting hour per
response, 100 annual burden hours for all issuers (100 issuers x 1
response per issuer x 1 hour per response). Accordingly, the total
annual hour burden for all respondents to comply with Rule 12d2-2 is
790 hours (690 hours for exchanges + 100 hours for issuers). The
related internal labor costs associated with these burden hours are
$42,797.50 total ($36,397.50 for exchanges ($52.75 per response x 690
responses) and $6,400 for issuers ($64 per response x 100 responses)).
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    \4\ The staff notes that a few of these 18 registered national
securities exchanges only have rules to permit the listing of
standardized options, which are exempt from Rule 12d2-2 under the
Act. Nevertheless, we have counted national securities exchanges
that can only list options as potential respondents because these
exchanges could potentially adopt new rules, subject to Commission
approval under Section 19(b) of the Act, to list and trade equity
and other securities that have to comply with Rule 12d2-2 under the
Act. Notice registrants that are registered as national securities
exchanges solely for the purposes of trading securities futures
products have not been counted since, as noted above, securities
futures products are exempt from complying with Rule 12d-2-2 under
the Act and therefore do not have to file Form 25.
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    Written comments are invited on: (a) Whether the proposed
collection of information is necessary for the proper performance of
the functions of the Commission, including whether the information
shall have practical utility; (b) the accuracy of the Commission's
estimates of the burden of the proposed collection of information; (c)
ways to enhance the quality, utility, and clarity of the information
collected; and (d) ways to minimize the burden of the collection of
information on respondents, including through the use of automated
collection techniques or other forms of information technology.
Consideration will be given to comments and suggestions submitted in
writing within 60 days of this publication.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information under the PRA unless it
displays a currently valid OMB control number.
    Please direct your written comments to: Thomas Bayer, Director/
Chief Information Officer, Securities and Exchange Commission, c/o Remi
Pavlik-Simon, 100 F Street NE., Washington, DC 20549, or send an email
to<EMAIL_ADDRESS>
    Dated: October 27, 2014.
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2014-25876 Filed 10-30-14; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 76, Number 133 (Tuesday, July 12, 2011)]
[Rules and Regulations]
[Pages 40808-40811]
[FR Doc No: 2011-17393]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2011-0507]
RIN 1625-AA00

Safety Zones; Fireworks Within the Sector Boston Captain of the
Port Zone

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing temporary safety zones within
the Sector Boston Captain of the Port (COTP) Zone for various fireworks
displays. These safety zones are necessary to provide for the safety of
life on navigable waters during these fireworks events. Entering into,
transiting through, mooring or anchoring within these zones is
prohibited unless authorized by the COTP or the designated on-scene
representative.

DATES: This rule is effective in the CFR on July 12, 2011 through 11:59
p.m. September 9, 2011. This rule is effective with actual notice for
purposes of enforcement beginning at 8:30 p.m. June 27, 2011.

ADDRESSES: Documents indicated in this preamble as being available in
the docket are part of docket USCG-2011-0507 and are available online
by going to http://www.regulations.gov, inserting USCG-2011-0507 in the
``Keyword'' box, and then clicking ``Search.'' They are also available
for inspection or copying at the Docket Management Facility (M-30),
U.S. Department of Transportation, West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590, between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary rule, call or e-mail MST1 David Labadie of the Waterways
Management Division, U.S. Coast Guard Sector Boston; telephone 617-223-
3010, e-mail<EMAIL_ADDRESS>If you have questions on viewing
material related to the docket, call Renee V. Wright, Program Manager,
Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Regulatory Information

    The Coast Guard is issuing this temporary final rule without prior
notice and opportunity to comment pursuant to authority under section
4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule. The safety zones listed in this rule are
associated with annual fireworks events. The Coast Guard intends to
make these safety zones permanent regulations and has submitted a NPRM
for submission to the Federal Register requesting public

comments. A delay in publication and the lengthy comment period
associated with the process of rulemaking in the Federal Register does
not allow time to publish a NPRM followed by a final rule as these
events would occur before the rulemaking process was complete. The
sponsors are unable to reschedule these events due to other activities
being held in conjunction with the fireworks displays and the Fourth of
July holiday. Many community members have made holiday plans based on
these fireworks events, and changing the date would cause numerous
cancelations and hurt small businesses. Rescheduling would not be a
viable option because most event venues, entertainers and venders have
fully booked summer schedules making rescheduling nearly impossible.
    Due to the dangers posed by the pyrotechnics used in these
fireworks displays, the safety zones are necessary to provide for the
safety of event participants, spectator craft, and other vessels
transiting the event areas. For the safety concerns noted, it is in the
public interest to have these regulations in effect during the events.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. Any delay in the effective date of
this rule would expose spectators, vessels and other property to the
hazards associated with pyrotechnics used in the fireworks displays.

Basis and Purpose

    The legal basis for the temporary rule is 33 U.S.C. 1226, 1231, 46
U.S.C. Chapter 701, 3306, 3703; 50 U.S.C. 191, 195; Public Law 107-295,
116 Stat. 2064; and Department of Homeland Security Delegation No.
0170.1, which collectively authorize the Coast Guard to define safety
zones.
    The safety zones are being issued to establish temporary regulated
areas within the Sector Boston Captain of the Port (COTP) Zone for
various fireworks displays.

Discussion of Rule

    This temporary rule is necessary to ensure the safety of
spectators, vessels and other property from the hazards associated with
fireworks displays. The COTP Boston has determined that fireworks
displays in close proximity to watercraft and waterfront structures
pose a significant risk to public safety and property. Such hazards
include obstructions to the waterway that may cause marine casualties
and the explosive danger of fireworks and debris falling into the water
that may cause death or serious bodily harm. Establishing safety zones
around the locations of these fireworks events will help ensure the
safety of spectators, vessels and other property and help minimize the
associated risks.
    The Coast Guard has implemented safety zones for past events and
has not received public comments or concerns regarding the impact to
waterway traffic from these events.

Regulatory Analyses

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

Executive Order 12866 and Executive Order 13563

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, as
supplemented by Executive Order 13563, and does not require an
assessment of potential costs and benefits under section 6(a)(3) of
that Order. The Office of Management and Budget has not reviewed it
under that Order.
    The Coast Guard determined that this rule is not a significant
regulatory action for the following reasons: The safety zones will be
of limited duration, are located in waterways that have no deep draft
commercial traffic and are designed to avoid, to the extent possible,
fishing and recreational boating traffic routes.

Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered whether this rule would have a significant economic impact
on a substantial number of small entities. The term ``small entities''
comprises small businesses, not-for-profit organizations that are
independently owned and operated and are not dominant in their fields,
and governmental jurisdictions with populations of less than 50,000.
    The Coast Guard certifies under 5 U.S.C. 605(b) that this rule
would not have a significant economic impact on a substantial number of
small entities.
    This rule will affect the following entities, some of which may be
small entities: the safety zones during the enforcement periods stated
for each event in the List of Subjects.
    These safety zones will not have a significant economic impact on a
substantial number of small entities because of the minimal amount of
time in which the safety zones will be enforced and vessels will be
able to transit around the safety zones. Before the effective periods,
we will issue maritime advisories widely available to users of the
waterway.

Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we offer to assist small
entities in understanding the rule so that they can better evaluate its
effects on them and participate in the rulemaking process. If the rule
would affect your small business, organization, or governmental
jurisdiction and you have questions concerning its provisions or
options for compliance, please contact MST1 David Labadie at the
telephone number or e-mail address indicated under the FOR FURTHER
INFORMATION CONTACT section of this notice.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

Collection of Information

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

Federalism

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

Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or

more in any one year. Though this rule will not result in such
expenditure, we do discuss the effects of this rule elsewhere in this
preamble.

Taking of Private Property

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

Civil Justice Reform

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

Protection of Children

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

Indian Tribal Governments

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

Energy Effects

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

Technical Standards

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

Environment

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

List of Subjects in 33 CFR Part 165

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

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

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

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

    Authority: 33 U.S.C. 1226, 1231; 46 U.S.C. Chapter 701, 3306,
3703; 50 U.S.C. 191, 195; 33 CFR 1.05-1(g), 6.04-1, 6.04-6, and
160.5; Public Law 107-295, 116 Stat. 2064; Department of Homeland
Security Delegation No. 0170.1.

0
2. Add Sec.  165.T01-0507 to read as follows:

Sec.  165.T01-0507  Safety Zones; Fireworks within the Sector Boston
Captain of the Port Zone.

    (a) General. Temporary safety zones are established for the
fireworks display as follows:
    (1) Surfside Fireworks, Salisbury Beach, MA.
    (i) Location. All waters of the Atlantic Ocean near Salisbury
Beach, MA from surface to bottom, within a 350-yard radius of the
fireworks barge located at position 42[deg]50.6' N, 070[deg]48.4' W
(NAD 83).
    (ii) Enforcement Period. This safety zone will be enforced every
Saturday evening from 9:30 p.m. through 10:30 p.m. during the effective
period. This safety zone will also be enforced from 9:30 p.m. through
10:30 p.m. on Sunday July 3, 2011.
    (2) Weymouth Fireworks, Weymouth, MA.
    (i) Location. All waters of Weymouth Fore River, within a 350-yard
radius of the fireworks launch site located at position 42[deg]15.5' N,
070[deg]56.1' W (NAD 83).
    (ii) Enforcement Period. This safety zone will be enforced from 9
p.m. to 11 p.m. on July 3, 2011. In the case this event is rescheduled
due to inclement weather, this safety zone will be enforced from 9 p.m.
to 11 p.m. on July 9, 2011.
    (3) Lynn 4th of July Fireworks, Lynn, MA.
    (i) Location. All waters of Nahant Bay, within a 350-yard radius of
the fireworks barge located at position 42[deg]27.62' N, 070[deg]55.58'
W (NAD 83).
    (ii) Enforcement Period. This safety zone will be enforced from 9
p.m. to 11 p.m. on July 3, 2011. In the case this event is rescheduled
due to inclement weather, this safety zone will be enforced from 9 p.m.
to 11 p.m. on July 5, 2011.
    (4) Marblehead 4th of July Fireworks, Marblehead, MA.
    (i) Location. All waters of Marblehead Harbor within a 350-yard
radius of the fireworks launch site located at position 42[deg]30.34'
N, 070[deg]50.13' W (NAD 83).
    (ii) Enforcement Period. This safety zone will be enforced from
8:30 p.m. to 10 p.m. on July 4, 2011. In the case this event is
rescheduled due to inclement weather, this safety zone will be enforced
from 8:30 p.m. to 10 p.m. on July 5, 2011.
    (5) Beverly Farms 4th of July Celebration Fireworks, Beverly, MA.
    (i) Location. All waters of Manchester Bay within a 350-yard radius
of the fireworks launch site near West Beach located at position
42[deg]33.84' N, 070[deg]48.5' W (NAD 83).
    (ii) Enforcement Period. This safety zone will be enforced from 9
p.m. to 11 p.m. on July 3, 2011. In the case this event is rescheduled
due to inclement weather, this safety zone will be enforced from 9 p.m.
to 11 p.m. on July 5, 2011.
    (6) Boston Pops Fireworks Spectacular, Boston, MA.

    (i) Location. All waters of the Charles River within a 350-yard
radius of the fireworks barges located in the vicinity of position
42[deg]21.47' N, 071[deg]05.00' W (NAD 83).
    (ii) Enforcement Period. This safety zone will be enforced from 9
p.m. to 11 p.m. on July 4, 2011. In the case this event is rescheduled
due to inclement weather, this safety zone will be enforced from 9 p.m.
to 11 p.m. on July 5, 2011.
    (7) Town of Nahant Fireworks, Nahant, MA.
    (i) Location. All waters of Nahant Harbor within a 350-yard radius
of the fireworks launch site on Bailey's Hill Park located at position
42[deg]25.1' N, 070[deg]55.8' W (NAD 83).
    (ii) Enforcement Period. This safety zone will be enforced from 9
p.m. to 11 p.m. on July 4, 2011. In the case this event is rescheduled
due to inclement weather, this safety zone will be enforced from 9 p.m.
to 11 p.m. on July 5, 2011.
    (8) City of Salem Fireworks, Salem, MA.
    (i) Location. All waters of Salem Harbor, within a 350-yard radius
of the fireworks launch site located on Derby Wharf at position
42[deg]31.15' N, 070[deg]53.13' W (NAD 83).
    (ii) Enforcement Period. This safety zone will be enforced from 9
p.m. to 10 p.m. on July 4, 2011. In the case this event is rescheduled
due to inclement weather, this safety zone will be enforced from 9 p.m.
to 10 p.m. on July 5, 2011.
    (9) Plymouth 4th of July Celebration Fireworks, Plymouth, MA.
    (i) Location. All waters of Plymouth Harbor within a 350-yard
radius of the fireworks launch site located at position 42[deg]57.3' N,
070[deg]38.3' W (NAD 83).
    (ii) Enforcement Period. This safety zone will be enforced from 9
p.m. to 10 p.m. on July 4, 2011. In the case this event is rescheduled
due to inclement weather, this safety zone will be enforced from 9 p.m.
to 10 p.m. on July 5, 2011.
    (10) Beverly Homecoming Fireworks.
    (i) Location. All waters of Beverly Harbor within a 350-yard radius
of the fireworks barge located at position 42[deg]32.62' N,
070[deg]52.15' W (NAD 83).
    (ii) Enforcement Period. This safety zone will be enforced from 9
p.m. to 11 p.m. on August 7, 2011.
    (11) Hingham 4th of July Fireworks.
    (i) Location. All waters within a 350-yard radius of the beach on
Button Island located at position 42[deg]15.07' N, 070[deg]53.03' W
(NAD 83).
    (ii) Enforcement Period. This safety zone will be enforced from
9:30 p.m. to 10:30 p.m. on July 2, 2011. In the case this event is
rescheduled due to inclement weather, this safety zone will be enforced
from 9:30 p.m. to 10:30 p.m. on July 9, 2011.
    (12) Gloucester July 4th Celebration Fireworks.
    (i) Location. All waters of Gloucester Harbor, Stage Fort Park,
within a 350-yard radius of the fireworks launch site on the beach
located at position 42[deg]36.3' N, 070[deg]40.5' W (NAD 83).
    (ii) Enforcement Period. This safety zone will be enforced from 8
p.m. to 11 p.m. on July 3, 2011.
    (13) Gloucester Schooner Festival Fireworks.
    (i) Location. All waters of Gloucester Harbor within a 350-yard
radius of the launch site on the beach located at position 42[deg]36.3'
N, 070[deg]40.5' W (NAD 83).
    (ii) Enforcement Period. This safety zone will be enforced from 7
p.m. to 11 p.m. on September 3, 2011. In the case this event is
rescheduled due to inclement weather, this safety zone will be enforced
from 7 p.m. to 11 p.m. on September 5, 2011.
    (b) Regulations. (1) In accordance with the general regulations in
Sec.  165.23 of this part, entering into, transiting through, mooring
or anchoring within these regulated areas is prohibited unless
authorized by the Captain of the Port (COTP) Boston, or the designated
on-scene representative.
    (2) The ``on-scene representative'' is any Coast Guard
commissioned, warrant, or petty officer who has been designated by the
COTP Boston to act on his behalf. The on-scene representative will be
aboard either a Coast Guard or Coast Guard Auxiliary vessel.
    (3) Vessel operators desiring to enter or operate within the
regulated areas shall contact the COTP or the designated on-scene
representative via VHF channel 16 or<PHONE_NUMBER> (Sector Boston
command center) to obtain permission to do so.
    (4) Vessel operators given permission to enter or operate in the
regulated areas must comply with all directions given to them by the
Captain of the Port or the designated on-scene representative.
    (c) Effective Period. This rule is effective in the CFR on July 12,
2011 through 11:59 p.m. September 9, 2011. This rule is effective with
actual notice for purposes of enforcement beginning at 8:30 p.m., June
27, 2011.

    Dated: June 27, 2011.
N.E. Knapp,
Commander, U.S. Coast Guard, Acting Captain of the Port Sector Boston.
[FR Doc. 2011-17393 Filed 7-11-11; 8:45 am]
BILLING CODE 9110-04-P


Endangered Terrestrial Plants Inhabiting Areas Adjacent to Treatment Site: Emergence RQ = Total Loading to Adjacent Area or EEC/ Seedling Emergence EC05 or NOAEC Drift RQ = Drift EEC/ Vegetative Vigor EC05 or NOAEC Endangered Terrestrial Plants Inhabiting Semiaquatic Areas Near Treatment Site: Emergence RQ = Total Loading to Semiaquatic Area or EEC/ Seedling Emergence EC05 or NOAEC Drift RQ = Drift EEC/ Vegetative Vigor EC05 or NOAEC D 2 To calculate EECs for terrestrial plants inhabiting in areas adjacent to treatment sites Un incorporated Ground Application ( Non granular): Sheet Runoff = Application Rate ( lb ai/ A) x Runoff Value Drift = Application Rate ( lb ai/ A) x 0.01 Total Loading = EEC = Sheet Runoff + Drift Incorporated Ground Application with Drift ( Non granular): Sheet Runoff = [ Application Rate ( lb ai/ A)/ Incorporation Depth ( inch)] x Runoff Value Drift = Application Rate ( lb ai/ A) x 0.01 Total Loading = EEC = Sheet Runoff + Drift Un incorporated Ground Application ( Granular): Sheet Runoff = EEC = Application Rate ( lb ai/ A) x Runoff Value Incorporated Ground Application without Drift ( Granular): Sheet Runoff = EEC = [ Application Rate ( lb ai/ A)/ Incorportion Depth ( inch)] x Runoff Value Aerial/ Airblast/ Spray Chemigation Applications: Sheet Runoff = Application Rate ( lb ai/ A) x Runoff Value x Application Efficiency of 0.6 Drift = Application Rate ( lb ai/ A) x 0.05 Total Loading = EEC = Sheet Runoff + Drift Runoff Value = 0.01, 0.02, or 0.05 when the solubility of the chemical is < 10 ppm, 10 100 ppm, or > 100 ppm, respectively Incorporation Depth: Use the minimum incorporation depth reported on the label. D 3 Table ( D 1). Seedling Emergence Study based on most sensitive endpoint dryweight ( most sensitive species are highlighted in RED)

Plant EC05 ( lbs. ai/ acre) EC 25 ( lbs. ai/ acre) EC50 ( lbs. ai/ acre)

Glycine max ( dicot) 0.8448 1.848 3.256 Beta vulgaris ( dicot) 0.000001848 0.00352 0.6688 Brassica naous ( dicot) 2.112 3.784 5.632 Ipomes hederacea ( dicot) NA NA NA Abutilon theophrasti ( dicot) 0.0088 0.1584 1.232 Xanthium strumarium ( dicot) 0.1056 1.056 5.368 Zea mays ( monocot) 1.584 3.256 5.368 Triticum arvense ( monocot) 0.01408 0.44 4.752 Avena fatua ( monocot) 0.02904 0.1144 0.2992 Cyperus rotundus ( monocot) 0.04048 0.3344 1.408 Post Emergence based on the most sensitive endpoint dry weight ( most sensitive species are highlighted)

Plant EC05 ( lbs ai/ acre) EC25 EC50 ( lbs ai/ acre Glycine max ( dicot) 0.00000176 3872 12320000000 Beta vulgaris ( dicot) 0.000000132 5.46E+ 2 2.64E+ 09 Brassica naous ( dicot) 0.00003256 123200 5.544E+ 11 Ipomes hederacea ( dicot) NA NA NA Abutilon theophrasti ( dicot) 0.01936 0.6072 6.6 Xanthium strumarium ( dicot) 1.144 2.728 5.016 Zea mays ( monocot) 0.3784 1.056 2.024 Triticum avense ( monocot) 0.3168 0.8184 1.584 Avena fatua ( monocot) 0.3344 0.8008 1.496 Cyperus rotundus ( monocot) 0.2992 1.32 3.696 E 1 APPENDIX E. SUMMARY OF ECOTOXICITY DATA Ecological Effects Data Requirements for Napropamide Guideline # Data Requirement Is Data Requirement Satisfied? MRID #' s Study Classification 71 1 Avian Oral LD50 yes MRID 79548 and 79555 core 71 2 Avian Dietary LC50 yes 435067 01 core 49497 supplemental 25893 core 39775 and 49497 invalid 258393 and 113820 core 416102 03 core 25894 supplemental 125894 and 113819 core Accession 093519 supplemental Accession supplemental 093519 Stauffer Chem. Comp. core 71 4 Avian Reproduction yes 420813 01 420277 01 core 72 1 Freshwater Fish LC50 yes 39772 Invalid 39772 Invalid 39773 and 118002 Invalid 416102 04 Core 093519 Acc. No. Core E 2 093519 Acc. No. Invalid 093519 Acc. No. Invalid 093519 Acc. No. Core 093519 Acc. No. Core Stauffer Chemical Core 115313 Core 115313 and 25895 Supplemental Invalid 093519 Acc. No. Invalid 093519 Acc. No. Invalid 39771 and 49496 Supplemental 39771 and 49496 Supplemental 72686 Supplemental 72 2 Freshwater Invertebrate Acute LC50 yes 88064 and 57805 core 416102 05 core 72 3( a) Estuarine/ Marine Fish LC50 yes 416102 06 core 72 3( b) Estuarine/ Marine Mollusk EC50 yes 416671 01 core 65360 invalid 72 3( c) Estuarine/ Marine Shrimp EC50 yes 416102 07 core Acc. No 229228 Invalid Acc. No 229228 Invalid 72 4( a) Freshwater Fish Early Life Stage no Not submitted Not submitted 72 4( b) Aquatic Invertebrate Life Cycle no Not submitted Not submitted 72 5 Freshwater Fish Full Life Cycle no Not submitted Not submitted 123 1( a) Seedling Emergence yes 416102 09 core 123 1( b) Vegetative Vigor yes 416102 09 core 123 2 Aquatic Plant Growth partially 416102 10 core E 3 144 1 Honey Bee Acute Contact LD50 yes Not submitted Not submitted 141 2 Honey Bee Residue on Foliage not required NA NA E 4 ECOLOGICAL EFFECTS CHARACTERIZATION Toxicity to Terrestrial Animals Avian Acute Oral Toxicity Since the LD 50 values are > 2000 mg/ kg ( Table 1), Napropamide is classified as practically nontoxic to upland game bird species on an acute oral basis.

Table 1. Acute oral toxicity of Napropamide to Avian Species.

Species % ai LD 50 ( mg/ kg) Toxicity Category MRID or Acc. No. Study Classification Mallard Duck ( Anas platyrhynchos) 94.6 4640 Practically non toxic 79548 and 79555 Core 1Core ( study satisfies guideline). Supplemental ( study is scientifically sound, but does not satisfy guideline)

Avian Subacute Dietary Toxicity Since the LC 50 values are > 5000 ppm ( Table 2), Napropamide is classified as practically nontoxic to avian species on a subacute dietary basis.

Table 2. Subacute dietary toxicity of Napropamide to Northern Bobwhite Quail and Mallard Ducks.

Species % AI 8 Day LC 50 ( ppm) 1 Toxicity Category MRID or Acc. No. Author/ Year Study Classification Bobwhite quail ( Colinus virginianus) 94.9 > 2250 Practically non toxic 435067 01 Core Bobwhite quail ( Colinus virginianus) 97.8 > 5600 Practically non toxic 49497 Supplemental Bobwhite quail ( Colinus virginianus) 87 > 5620 Practically non toxic 25893 Core Bobwhite quail ( Colinus virginianus) 97.8 > 56000 Practically non toxic 39775 and 49497 Invalid Bobwhite quail ( Colinus virginianus 97.8 > 5620 Practically non toxic 258393 and 113820 Core Mallard duck ( Anas platyrhynchos) 95.2 > 5620 Practically non toxic 416102 03 Core Mallard duck ( Anas platyrhynchos) 97.8 > 10,000 Practically non toxic 25894 Supplemental 1 Mallard duck ( Anas platyrhynchos) 97.8 > 3000 Practically non toxic 25894 and 113819 Core Bobwhite quail ( Colinus virginianus 50 > 32000 Practically non toxic 79548 Supplemental Bobwhite quail ( Colinus virginianus 97.8 > 56000 Practically non toxic 79555 Supplemental Mallard duck ( Anas platyrhynchos) 97.8 > 7200 Practically non toxic Stauffer Chem. Comp. Core E 5 E 6 Avian Chronic Species/ Study Type % ai Test Type Toxicity NOAEC ( mg/ kg) Affected Endpoints MRID No. Classification Bobwhite quail ( Colinus virginianus) 95.2 Reproduction 3000 NA 1 420813 01 Core Mallard duck ( Anas platyrhynchos) 95.2 Reproduction 10002 Reduced Body Weight2 420277 01 Core 1 No endpoints were significantly effected. The NOAEC occurred at the highest concentration tested. Therefore, this NOEAC will not be used to calculate an RQ. 2 The effect demonstrated on body weight was deemed not related to the toxicant effects of napropamide. This is because the effects was only demonstrated in the 3000 ppm males during the last two weeks of the study. The differences observed were slight, and appeared to be related to a slightly lighter initial body weight of the males in this group. Furthermore, there were no significant differences in mean body weight change between the control group and the 3000 ppm treatment group at any time during the course of the study. Therefore, EFED conclusion is that a LOAEC was not established in the study. Therefore, this NOEAC will not be used to calculate an RQ.

Mammal, acute and chronic Based on the available data ( Table 3), Napropamide is practically non toxic to small mammals on an acute oral basis with an LD 50 of rat.

Table 3. Mammalian toxicity data for rats exposed to Napropamide.

Species/ Study Type % ai Toxicity Value Affected Endpoints MRID No. or Acc. # Classification Rat acute oral Tech. > 5000 mg/ kg ( LD50) Mortality MRID 40362902 Core Multi generation Reproduction and Fertility Study Tech. 100 ppm ( LOEL) 30 ppm ( NOAEL) Decreased body weight MRID 92125069 Core Toxicity to Freshwater Aquatic Animals Freshwater Fish, Acute Since the TGAI LC 50 for freshwater fish ranges from 29 to 6.4 ppm, the TGAI of Napropamide is categorized as moderately to slightly toxic to freshwater fish on an acute basis ( Table 4). E 7 Table 4. Acute Toxicity of Napropamide to Freshwater Fish.

Species % AI 96 hour LC50 ( ppm) Toxicity Category MRID, Acc. No., or Reference Study Classification Bluegill Sunfish ( Lepomis macrohirus) 98.5 29 Slightly Toxic 39772 MRID Invalid Bluegill Sunfish ( Lepomis macrohirus) 50 13.3 Slightly Toxic 39772 MRID Invalid Bluegill Sunfish ( Lepomis macrohirus) 97.8 12.6 ( 144 hr.) Slightly Toxic 39773 and 118002 MRID Invalid Bluegill Sunfish ( Lepomis macrohirus) 98.5 12 Slightly Toxic 416102 04 MRID Core Bluegill Sunfish ( Lepomis macrohirus) 95.2 18 Slightly Toxic 093519 Acc. No. Core Bluegill Sunfish ( Lepomis macrohirus) 50 ( R 7465 Devrinol Technical) 13.5 Slightly Toxic 093519 Acc. No. Invalid Bluegill Sunfish ( Lepomis macrohirus) 97.5 30 Slightly Toxic 093519 Acc. No. Invalid Bluegill Sunfish ( Lepomis macrohirus) 97.8 18 ( 24hr) Slightly Toxic 093519 Acc. No. Core Bluegill Sunfish ( Lepomis macrohirus) 97.8 12.2 ( 144 hr LC50) Slightly Toxic 093519 Acc. No. Core Rainbow trout ( Salmo gairdneri) 97.8 9.4 Moderately Toxic Stauffer Chemical Core Rainbow trout ( Salmo gairdneri) 97.8 6.4 Moderately Toxic 115313 MRID Core Rainbow trout ( Salmo gairdneri) Tech. 13.4 Slightly Toxic 115313 and 25895 MRID Supplemental Rainbow trout ( Salmo gairdneri) 50 ( R 7465 Devrinol Technical) 10.7 Slightly Toxic 093519 Acc. No. Invalid Rainbow trout ( Salmo gairdneri) 97.8 16.6 Slightly Toxic 093519 Acc. No. Invalid Table 4. Acute Toxicity of Napropamide to Freshwater Fish.

Species % AI 96 hour LC50 ( ppm) Toxicity Category MRID, Acc. No., or Reference Study Classification E 8 Rainbow trout ( Salmo gairdneri) 97.8 18.1 Slightly Toxic 39771 and 49496 MRIDs Supplemental Rainbow trout ( Salmo gairdneri) 50 10.1 Slightly Toxic 39771 and 49496 MRIDs Supplemental Rainbow trout ( Salmo gairdneri) Tech. 9.3 Moderately Toxic 72686 MRID Supplemental Freshwater Invertebrates, Acute A freshwater aquatic invertebrate toxicity test using the TGAI is required to establish the toxicity of Napropamide is slightly to aquatic invertebrates. The preferred test species is Daphnia magna. Results indicate that Napropamide is slightly toxic to freshwater invertebrates ( Table 5).

Table 5. Freshwater Invertebrate Acute Toxicity for Napropamide Species % AI 48 hour EC50 ( ppm) Toxicity Category MRID or Acc. No. Author/ Year Study Classification Water flea ( Daphnia magna) 94.6 14.3 Slightly MRID 88064 and 57805 Core Water flea ( Daphnia magna) Tech. 24.7 Slightly MRID 416102 05 Core Toxicity to Estuarine and Marine Aquatic Animals Estuarine and Marine Fish, Acute Acute toxicity testing with estuarine/ marine fish using the TGAI is required for Napropamide because the use may be associated with estaurine or marine habitats. The preferred test species is sheepshead minnow. The LC 50 value indicates that Napropamide is slightly toxic on an acute basis to estuarine/ marine fish ( Table 6).

Table 6. Acute Toxicity of Napropamide to Estuarine/ Marine Fish.

Species % AI 96 hour LC 50 ( ppm) Toxicity Category MRID or Acc. No. Author/ Year Study Classification Sheepshead minnow 95.2 14 Slightly Toxic MRID 416102 06 Core E 9 Estuarine and Marine Invertebrates, Acute Acute toxicity testing with estuarine/ marine invertebrate using the TGAI is required for Napropamide because the use site may be associated with estaurine or marine habitat. The preferred test species are mysid shrimp and eastern oyster. The EC 50 value for Napropamide indicates that the TGAI is moderately toxic on an acute basis to estuarine/ marine eastern oyster ( Table 9). The LC 50 value for Napropamide indicates that the TGAI is practically non toxic to moderately toxic on an acute basis to the mysid shrimp.

Table 7. Acute Toxicity of Napropamide to Estuarine/ Marine Invertebrates.

Species % AI 96 hour EC50 ( ppm) Toxicity Category MRID or Acc. No. Author/ Year Study Classification Eastern Oyster Tech. 1.4 Moderately Toxic MRID 416671 01 Core Mysidopis bahia Tech. 4.2 Moderately Toxic MRID 416102 07 Core Easter Oyster larvae 97.4 Not Obtained NA 65360 Invalid Pink Shrimp 97.4 18 Slightly Toxic 65360 Invalid Fiddler Crab 97.4 > 100 Practically non toxic 65360 Invalid Toxicity to Non Target Plants Terrestrial Plants Tier II phytotoxicity tests measured the response of plants to Napropamide, relative to a control, and five or more test concentrations. Results from the Tier II toxicity testing on the technical/ TEP material are reported in Table 10. E 10 Table 8. Terrestrial Non Target Plant Toxicity Data ( Tier II) for Napropamide.

Type of Test Most sensitive species EC 25 ( lb ai/ A) EC05 ( lb ai/ a) Parameter MRID No. Author/ Year Study Classification Seedling Germination NC1 NC NC NC 416102 09 Invalid Seedling Emergence Avena fatua ( Monocot species) 0.1144 0.029 Dry weight 416102 09 Core Seedling Emergence Beta vulgaris ( Dicot) 0.00352 0.000001848 Dryweight 416102 09 Core Vegetative Avena fatua ( Monocot) 0.8008 0.3344 Dry weight 416102 09 Core Vegetative Beta vulgaris ( Dicot) 546 0.000000132 Dry weight 416102 09 Core Toxicity to Aquatic Plants Aquatic plant testing is required for Napropamide because aerial application and outdoor non residential aquatic use will expose non target aquatic plants to Napropamide. EFED only has aquatic plant toxicity data for Selenastrum capricornutum, however, data were not submitted for the following algal and aquatic plants species: Lemna gibba, Skeletonema costatum, Anabaena flos aquae, and a freshwater diatom, usually Navicula pelliculosa). Therefore, EFED cannot fully assess potential adverse effects to aquatic plants and algae.

Table 9. Nontarget Aquatic Plant Toxicity ( Tier II) for Napropamide Species % AI EC50/ EC05 ( ppm) MRID No. Author/ Year Study Classification Selenastrum capricornumtum 45 3.4 416102 10 Core F 1 APPENDIX F. ENDANGERED SPECIES Table F 1: Number of endangered plant and mammal species by state for each crop group Crop Group Stat e # of endangered plants # of endangered mammals Nuts AL 17 4 AZ 11 8 AR 1 1 CA 165 21 FL 20 7 GA 14 2 ID 0 3 KS 2 2 KY 2 2 LA 1 2 MD 0 1 MS 2 1 MO 5 2 NE 1 0 NV 7 0 NM 8 5 NC 9 4 OH 0 1 OK 2 3 OR 8 1 SC 18 3 TN 9 4 TX 19 3 UT 4 1 VA 3 2 WA 3 4 Berries Berries ( cont) AL 16 4 AZ 7 4 AR 2 3 CA 169 21 CO 4 2 CT 2 2 DE 2 2 FL 39 8 GA 15 4 ID 3 3 IL 6 1 IN 0 2 IA 4 1 KS 2 2 KY 3 2 LA 1 1 ME 3 2 MD 6 3 MA 3 2 MI 6 2 MN 4 1 MS 1 1 MO 6 2 MT 2 2 NE 1 0 NV 7 0 NH 2 1 NJ 5 2 NM 6 1 NY 6 2 NC 25 6 OH 4 1 OK 1 3 OR 9 1 PA 2 2 RI 2 2 SC 17 3 SD 1 0 TN 12 4 TX 13 3 UT 14 2 VT 2 1 VA 11 6 WA 4 4 WV 5 4 WI 6 1 Brassica AL 4 2 AZ 3 2 AR 2 2 CA 155 21 CO 4 2 CT 2 2 DE 1 1 FL 27 5 GA 4 1 HI 134 2 IL 4 1 IN 1 2 IA 4 1 KS 0 1 KY 3 2 LA 1 1 ME 3 2 MD 5 3 MA 2 2 MI 5 2 MN 3 1 MS 0 1 MO 4 2 MT 1 2 Crop Group Stat e # of endangered plants # of endangered mammals F 2 NE 1 0 NH 1 1 NJ 5 2 NM 4 1 NY 6 2 NC 21 6 OH 4 1 OK 0 1 OR 7 1 PA 2 2 RI 1 1 SC 10 3 TN 6 2 Crop Group Stat e # of endangered plants # of endangered mammals Brassica ( cont) TX 8 3 VT 2 1 VA 5 3 WA 2 3 WV 1 1 WI 6 0 Citrus AL 3 1 AZ 4 3 CA 155 20 CT 0 1 FL 42 6 HI 134 2 MD 2 2 MA 1 1 MI 2 0 NJ 2 1 NY 0 2 NC 0 2 OH 0 1 OR 7 0 PA 1 2 TX 3 2 VA 0 1 WA 2 3 Stone Fruits AL 16 4 AZ 11 8 AR 4 3 CA 165 21 CO 6 2 CT 2 2 DE 1 2 FL 23 3 GA 12 2 ID 3 3 IL 4 2 IN 0 2 IA 3 1 KS 2 2 KY 4 2 LA 1 2 ME 0 1 MD 5 3 MA 3 1 MI 6 1 MN 0 1 MS 1 1 MO 7 2 MT 2 2 NV 7 0 NH 1 1 NJ 5 2 NM 10 2 NY 6 2 NC 22 5 OH 4 1 OK 2 3 OR 10 1 PA 2 2 RI 1 2 SC 18 1 SD 1 0 TN 15 4 TX 13 3 UT 18 2 VT 1 0 VA 11 5 WA 6 4 Crop Group Stat e # of endangered plants # of endangered mammals F 3 WV 4 2 WI 4 0 Pome Fruits AL 17 4 AZ 15 8 AR 1 3 CA 176 22 CO 7 2 CT 2 2 DE 2 1 FL 10 4 GA 14 2 ID 3 3 IL 6 2 IN 1 2 IA 5 1 KS 2 2 KY 9 3 LA 1 1 ME 1 2 MD 5 3 MA 3 1 MI 7 2 MN 4 1 MS 1 1 MO 7 2 MT 2 2 NE 1 0 NV 8 0 NH 2 1 NJ 5 2 NM 13 2 NY 6 2 NC 22 5 OH 4 1 OK 1 3 OR 13 1 PA 2 2 RI 2 2 SC 17 1 SD 1 0 TN 19 4 TX 10 2 SC 17 1 SD 1 0 TN 19 4 TX 10 2 UT 23 2 VT 2 1 VA 12 6 WA 6 4 WV 5 5 WI 6 1 WY 0 3 Crop Group Stat e # of endangered plants # of endangered mammals Fruiting Vegetables AL 13 4 AZ 8 6 AR 2 3 CA 168 21 CO 6 2 CT 2 2 DE 2 2 FL 39 7 GA 11 2 HI 134 2 ID 2 3 IL 6 2 IN 1 2 IA 5 1 KS 2 1 KY 7 2 LA 2 1 ME 3 2 MD 6 3 MA 3 2 MI 6 2 MN 2 1 MS 0 1 MO 6 2 MT 1 2 NE 1 1 NV 7 0 NH 2 1 NJ 5 2 NM 11 5 NY 6 2 NC 24 5 OH 4 1 OK 1 3 OR 7 1 PA 2 2 RI 2 2 SC 15 3 SD 1 0 TN 13 4 F 4 TX 10 3 UT 11 2 VT 2 1 VA 9 6 WA 4 4 WV 3 1 WI 6 1 Tropical Fruits AL 2 2 AZ 3 2 CA 159 21 FL 20 5 GA 1 1 HI 134 2 LA 1 1 MS 0 1 NC 0 1 OR 3 1 SC 0 1 TX 7 3 VA 0 1 WA 0 2 Misc. Crops AL 6 3 AR 1 0 CA 63 9 CT 1 1 FL 8 4 GA 5 3 HI 134 2 IN 1 2 KS 2 0 KY 10 3 LA 0 1 ME 1 1 MD 2 3 MA 1 1 MI 3 0 MS 1 1 MO 3 2 NJ 4 2 NY 2 2 NC 27 6 OH 1 1 OR 1 0 PA 2 2 SC 14 1 TN 15 4 TX 0 1 VA 7 6 WA 0 2 WV 1 1 WI 3 0 Oil Seed Crops CA 103 17 IN 1 1 MT 1 2 OR 4 0 WA 0 3 WI 2 0 Trees/ Ornamentals AL 16 4 AZ 13 8 AR 1 3 CA 174 22 CO 8 2 CT 2 2 DE 2 2 FL 49 8 GA 16 4 HI 134 2 ID 1 4 IL 8 2 IN 2 2 IA 6 1 KS 2 2 KY 5 3 LA 1 1 ME 3 2 MD 5 3 MA 3 2 MI 7 2 MN 4 1 MS 1 1 MO 7 2 MT 2 2 NE 2 1 NH 2 1 NJ 5 2 NM 12 1 NY 6 2 NC 26 6 OH 4 1 OK 1 3 OR 11 1 PA 2 2 RI 2 2 SC 18 3 SD 1 1 TN 16 4 TX 11 3 UT 20 2 VT 2 1 VA 12 6 WA 6 4 WV 5 3 WI 6 1 WY 2 4 Nuts ( almond, pistachio, pecan, filbert, walnut) F 5 Berries/ small fruit ( blackberry, boysenberry, loganberry, raspberry, blueberry, strawberry, cranberry, currant, grape) Brassica and leafy vegetables ( broccoli, brussels sprouts, cabbage, cauliflower, asparagus) Citrus ( grapefruit, lemon, nectarine, orange, tangerine, tangelo) Stone fruit ( apricot, cherry, peach, plum, prune) Pome fruit ( apple, pear) Fruiting vegetables ( eggplant, pepper, tomato) Tropical fruit ( fig, kiwi fruit, persimmon, avacado, pomegranate) Additional crops ( artichoke, rhubarb, tobacco, sweet potato) Oil seed crops ( mint, olive) Trees/ ornamentals ( conifer, shade tree, ornamental tree, ground cover, herbaceous plants, woody shrubs, vines, lawns, turf, potting soil) F 6 Table F 2. List of endangered plant species potentially at risk from napropamide use SPECIES NAME STATE ( S) ACHYRANTHES MUTICA ( NCN) HI ADOBE SUNBURST, SAN JOAQUIN CA A'E ( ZANTHOXYLUM DIPETALUM VAR. TOMENTOSUM) HI A'E ( ZANTHOXYLUM HIENSE) HI AGAVE, AZ AZ ' AIEA ( NOTHOCESTRUM BREVIFLORUM) HI ' AIEA ( NOTHOCESTRUM PELTATUM) HI ' AKOKO ( EUPHORBIA HAELEELEANA) HI ALANI ( MELICOPE HAUPUENSIS) HI ALANI ( MELICOPE KNUDSENII) HI ALANI ( MELICOPE PALLIDA) HI ALANI ( MELICOPE QUADRANGULARIS) HI ALANI ( MELICOPE ZAHLBRUCKNERI) HI ALLOCARYA, CALISTOGA CA ALOPECURUS, SONOMA CA ALSINIDENDRON VISCOSUM ( NCN) HI AMARANTH, SEABEACH NY, NC AMBROSIA, SAN DIEGO CA AMBROSIA, SOUTH TX TX Amole, Camatta Canyon CA AMOLE, PURPLE CA AMPHIANTHUS, LITTLE AL, GA, SC ' ANUNU ( SICYOS ALBA) HI ARROWHEAD, BUNCHED NC, SC ASPLENIUM FRAGILE VAR. INSULARE ( NCN) HI ASTER, DECURRENT FALSE IL, MO ASTER, DEL MAR SAND CA ASTER, FL GOLDEN FL ASTER, RUTH'S GOLDEN TN AUPAKA ( ISODENDRION HOSAKAE) HI AUPAKA ( ISODENDRION LAURIFOLIUM) HI AUPAKA ( ISODENDRION LONGIFOLIUM) HI AVENS, SPREADING NC, TN ' AWIWI ( CENTAURIUM SEBAEOIDES) HI ' AWIWI ( HEDYOTIS COOKIANA) HI AYENIA, TX TX BACCHARIS, ENCINITAS CA BARBARA'S BUTTONS, MOHR'S AL, GA BARBERRY, ISLAND CA BARBERRY, NEVIN'S CA BEAKED RUSH, KNIESKERN'S NJ BEARGRASS, BRITTON'S FL BEAR POPPY, DWARF UT F 7 BEDSTRAW, EL DORADO CA BEDSTRAW, ISLAND CA BELLFLOWER, BROOKSVILLE FL BIRCH, VA ROUND LEAF VA BIRD'S BEAK, PALMATE BRACTED CA BIRD'S BEAK, PENNELL'S CA BIRD'S BEAK, SALT MARSH CA BIRD'S BEAK, SOFT CA BIRDS IN A NEST, WHITE FL BITTERCRESS, SMALL ANTHERED NC, VA BLADDERPOD, KODACHROME UT BLADDERPOD, LYRATE AL BLADDERPOD, MO AR, MO BLADDERPOD, SAN BERNARDINO MOUNTAINS CA BLADDERPOD, SPRING CREEK TN BLADDERPOD, WHITE TX BLADDERPOD, ZAPATA TX BLAZING STAR, ASH MEADOWS NV BLAZING STAR, HELLER'S NC BLAZING STAR, SCRUB FL BLUECURLS, HIDDEN LAKE CA BLUEGRASS, HIAN HI BLUEGRASS, MANN'S ( POA MANNII) HI BLUEGRASS, NAPA CA BLUEGRASS, SAN BERNARDINO CA BLUE STAR, KEARNEY'S AZ BLUET, ROAN MOUNTAIN NC, TN BONAMIA MENZIESII ( NCN) HI BONAMIA, FL FL BRODIAEA, CHINESE CAMP CA BRODIAEA, THREAD LEAVED CA BROOM, SAN CLEMENTE ISLAND CA BUCKWHEAT, CUSHENBURY CA BUCKWHEAT, IONE ( IRISH HILL) CA BUCKWHEAT, SCRUB FL BUCKWHEAT, SOUTHERN MOUNTAIN WILD CA BULRUSH, NORTHEASTERN (= BARBED BRISTLE) MD, MA, PA, VT, VA, WV BUSH CLOVER, PRAIRIE IL, IA, MN, WI BUSH MALLOW, SAN CLEMENTE ISLAND CA BUSHMALLOW, SANTA CRUZ ISLAND CA BUTTERCUP, AUTUMN UT BUTTERFLY PLANT, CO CO BUTTERWEED, LAYNE'S CA BUTTERWORT, GODFREY'S FL BUTTON CELERY, SAN DIEGO CA CACTUS, AZ HEDGEHOG AZ CACTUS, BAKERSFIELD CA CACTUS, BLACK LACE TX F 8 CACTUS, BRADY PINCUSHION AZ CACTUS, COCHISE PINCUSHION AZ CACTUS, KNOWLTON CO, NM CACTUS, KUENZLER HEDGEHOG NM CACTUS, LEE PINCUSHION NM CACTUS, MESA VERDE CO, NM CACTUS, NICHOL'S TURK'S HEAD AZ CACTUS, PEEBLES NAVAJO AZ CACTUS, PIMA PINEAPPLE AZ CACTUS, SAN RAFAEL UT CACTUS, SILER PINCUSHION AZ, UT CACTUS, SNEED PINCUSHION NM, TX CACTUS, STAR TX CACTUS, TOBUSCH FISHHOOK TX CACTUS, UINTA BASIN HOOKLESS CO, UT CACTUS, WINKLER UT CACTUS, WRIGHT FISHHOOK UT CAMPION, FRINGED FL, GA CATCHFLY, SPALDING'S ID. MT, OR, WA CEANOTHUS, COYOTE CA CEANOTHUS, PINE HILL CA CEANOTHUS, VAIL LAKE CA CENTAURY, SPRING LOVING CA, NV CHAFFSEED, AMERICAN FL, NJ, NC, SC CHAMAESYCE HALEMANUI HI CHECKER MALLOW, KECK'S CA CHECKER MALLOW, KENWOOD MARSH CA CHECKER MALLOW, NELSON'S OR, WA CHECKER MALLOW, PEDATE CA CHECKER MALLOW, WENATCHEE MOUNTAINS WA CLADONIA, FL PERFORATE FL CLARKIA, PISMO CA CLARKIA, PRESIDIO CA CLARKIA, SPRINGVILLE CA CLARKIA, VINE HILL CA CLIFFROSE, AZ AZ CLOVER, MONTEREY CA CLOVER, RUNNING BUFFALO IN, KY, MO, OH, WV CLOVER, SHOWY INDIAN CA CONEFLOWER, SMOOTH NC, SC, VA CONEFLOWER, TN PURPLE TN COYOTE THISTLE, LOCH LOMOND CA CROWN BEARD, BIG LEAVED CA CROWNSCALE, SAN JACINTO VALLEY CA CYANEA UNDULATA ( NCN) HI CYCLADENIA, JONES AZ, UT CYPRESS, GOWEN CA CYPRESS, SANTA CRUZ CA F 9 DAISY, LAKESIDE IL, OH DAISY, MAGUIRE UT DAISY, PARISH'S CA DAISY, WILLAMETTE OR DAWN FLOWER, TX PRAIRIE (= TX BITTERWEED TX DELISSEA RHYTODISPERMA ( NCN) HI DIELLIA ERECTA ( NCN) HI DIELLIA PALLIDA ( NCN) HI DOCK, CHIRICAHUA AZ, NM DOGWEED, ASHY TX DROPWORT, CANBY'S GA, MD, NC, SC DUBAUTIA LATIFOLIA HI DUBAUTIA PAUCIFLORULA HI DUDLEYA, CONEJO CA DUDLEYA, MARCESCENT CA DUDLEYA, SANTA CLARA VALLEY CA DUDLEYA, SANTA CRUZ ISLAND CA DUDLEYA, SANTA MONICA MOUNTAINS CA DUDLEYA, VERITY'S CA DWARF FLAX, MARIN CA EVENING PRIMROSE, ANTIOCH DUNES CA EVENING PRIMROSE, EUREKA VALLEY CA EVENING PRIMROSE, SAN BENITO CA FERN, AL STREAK SORUS AL FERN, AMERICAN HART'S TONGUE AL, MI, NY, TN FERN, PENDANT KIHI ( ADENOPHORUS PERIENS) HI FIDDLENECK, LARGE FLOWERED CA FLANNELBUSH, MEXICAN CA FLANNELBUSH, PINE HILL CA FLEABANE, ZUNI AZ, NM FOUR O'CLOCK, MACFARLANE'S ID, OR FRINGE TREE, PYGMY FL FRINGEPOD, SANTA CRUZ ISLAND CA FRITILLARY, GENTNER'S OR GEOCARPON MINIMUM AR, LA,, MO GERARDIA, SANDPLAIN CT, MD, MA, NY, RI GILIA, HOFFMANN'S SLENDER FLOWERED CA GILIA, MONTEREY CA GOLDEN SUNBURST, HARTWEG'S CA GOLDENROD, BLUE RIDGE NC GOLDENROD, BLUE RIDGE TN GOLDENROD, HOUGHTON'S MI GOLDENROD, SHORT'S KY GOLDENROD, WHITE HAIRED KY GOLDFIELDS, BURKE'S CA GOLDFIELDS, CONTRA COSTA CA GOOSEBERRY, MICCOSUKEE ( FL) FL GOUANIA MEYENII ( NCN) HI F 10 GOURD, OKEECHOBEE FL GRASS, CA ORCUTT CA GRASS, COLUSA CA GRASS, EUREKA DUNE CA GRASS, HAIRY ORCUTT CA GRASS, SACRAMENTO ORCUTT CA GRASS, SAN JOAQUIN VALLEY ORCUTT CA GRASS, SLENDER ORCUTT CA GRASS, SOLANO CA GRASS, TN YELLOW EYED AL, GA, TN GROUND PLUM, GUTHRIE'S TN GROUNDSEL, SAN FRANCISCO PEAKS AZ GUMPLANT, ASH MEADOWS CA, NV HAHA ( CYANEA ASARIFOLIA) HI HAHA ( CYANEA COPELANDII SSP. COPELANDII) HI HAHA ( CYANEA HAMATIFLORA SSP. CARLSONII) HI HAHA ( CYANEA PLATYPHYLLA) HI HAHA ( CYANEA RECTA) HI HAHA ( CYANEA REMYI) HI HAHA ( CYANEA SHIPMANII) HI HAHA ( CYANEA STICTOPHYLLA) HI HA'IWALE ( CYRTANDRA GIFFARDII) HI HA'IWALE ( CYRTANDRA LIMAHULIENSIS) HI HALA PEPE ( PLEOMELE HIENSIS) HI HAPLOSTACHYS HAPLOSTACHYA ( NCN) HI HAREBELLS, AVON PARK FL HARPERELLA AL, AR, MD, NC, SC, WV HAU KAUHIWI ( HIBISCADELPHUS WOODI) HI HAU KUAHIWI ( HIBISCADELPHUS DISTANS) HI HEARTLEAF, DWARF FLOWERED NC, SC HEATHER, MOUNTAIN GOLDEN NC HEAU ( EXOCARPOS LUTEOLUS) HI HEDYOTIS ST. JOHNII ( NCN) HI HESPEROMANNIA LYDGATEI ( NCN) HI HIBISCUS, CLAY'S HI HILO ISCHAEMUM ( ISCHAEMUM BYRONE) HI HOLEI ( OCHROSIA KILAUEAENSIS) HI HOWELLIA, WATER ID, MT, WA HYPERICUM, HIGHLANDS SCRUB FL ILIAU ( WILKESIA HOBDYI) HI IPOMOPSIS, HOLY GHOST NM IRIS, DWARF LAKE MI, WI IRISETTE, WHITE NC, SC IVESIA, ASH MEADOWS CA IVESIA, ASH MEADOWS NV JACQUEMONTIA, BEACH FL JEWELFLOWER, CA CA JEWELFLOWER, TIBURON CA F 11 JOINT VETCH, SENSITIVE MD, NJ, NC, VA KAMAKAHALA ( LABORDIA LYDGATEI) HI KAMAKAHALA ( LABORDIA TINIFOLIA VAR. WAHIAWAEN HI KAUILA ( COLUBRINA OPPOSITIFOLIA) HI KAULU ( PTERALYXIA KAUAIENSIS) HI KIO'ELE ( HEDYOTIS CORIACEA) HI KIPONAPONA ( PHYLLOSTEGIA RACEMOSA) HI KOKI'O ( KOKIA DRYNARIOIDES) HI KOKI'O ( KOKIA KAUAIENSIS) HI KOKI'O KE'OKE'O ( HIBISCUS WAIMEAE SSP. HANNER HI KOLEA ( MYRSINE LINEARIFOLIA) HI KO'OLOA'ULA ( ABUTILON MENZIESII) HI KUAWAWAENOHU ( ALSINIDENDRON LYCHNOIDES) HI LADIES' TRESSES, CANELO HILLS AZ LADIES' TRESSES, NAVASOTA TX LADIES' TRESSES, UTE CO, NV, UT LARKSPUR, BAKER'S CA LARKSPUR, SAN CLEMENTE ISLAND CA LARKSPUR, YELLOW CA LAU'EHU ( PANICUM NIIHAUENSE) HI LAUKAHI KUAHIWI ( PLANTAGO HAWAIENSIS) HI LAUKAHI KUAHIWI ( PLANTAGO PRINCEPS) HI LAULIHILIHI ( SCHIEDEA STELLARIOIDES) HI LAYIA, BEACH CA LEAD PLANT, CRENULATE FL LEATHER FLOWER, AL AL LEATHER FLOWER, MOREFIELD'S AL LESSINGIA, SAN FRANCISCO CA LICHEN, ROCK GNOME NC, TN LILY, MN TROUT MN LILY, PITKIN MARSH CA LILY, WESTERN CA, OR LIPOCHAETA VENOSA ( NCN) HI LIVEFOREVER, LAGUNA BEACH CA LIVEFOREVER, SANTA BARBARA ISLAND CA LOBELIA NIIHAUENSIS ( NCN) HI LOCOWEED, FASSETT'S WI LOMATIUM, BRADSHAW'S OR LOMATIUM, COOK'S OR LOOSESTRIFE, ROUGH LEAVED NC, SC LOULU ( PRITCHARDIA AFFINIS) HI LOULU ( PRITCHARDIA NAPALIENSIS) HI LOULU ( PRITCHARDIA SCHATTAUERI) HI LOULU ( PRITCHARDIA VISCOSA) HI LOUSEWORT, FURBISH ME LUPINE, CLOVER CA F 12 LUPINE, KINCAID'S OR, WA LUPINE, NIPOMO MESA CA LUPINE, SCRUB FL LYSIMACHIA FILIFOLIA ( NCN) HI MAHOE ( ALECTRYON MACROCOCCUS) HI MAKOU ( PEUCEDANUM SANDWICENSE) HI MALACOTHRIX, ISLAND CA MALACOTHRIX, SANTA CRUZ ISLAND CA MALLOW, KERN CA MALLOW, PETER'S MOUNTAIN VA MANIOC, WALKER'S TX MANZANITA, DEL MAR CA MANZANITA, IONE CA MANZANITA, MORRO CA MANZANITA, PALLID CA MANZANITA, SAN BRUNO MOUNTAIN CA MANZANITA, SANTA ROSA ISLAND CA MA'O HAU HELE ( HIBISCUS BRACKENRIDGEI) HI MA'OLI'OLI ( SCHIEDEA APOKREMNOS) HI MAPELE ( CYRTANDRA CYANEOIDES) HI MARISCUS FAURIEI ( NCN) HI MARISCUS PENNATIFORMIS ( NCN) HI MEADOWFOAM, BUTTE COUNTY CA MEADOWFOAM, LARGE FLOWERED WOOLY OR MEADOWFOAM, SEBASTOPOL CA MEADOWRUE, COOLEY'S FL, NC MEHAMEHAME ( FLUEGGEA NEOWAWRAEA) HI MILKPEA, SMALL'S FL MILK VETCH, APPLEGATE'S OR MILK VETCH, ASH MEADOWS NV MILK VETCH, BRAUNTON'S CA MILK VETCH, CLARA HUNT'S CA MILK VETCH, COACHELLA VALLEY CA MILK VETCH, COASTAL DUNES CA MILK VETCH, CUSHENBURY CA MILK VETCH, DESERET UT MILK VETCH, FISH SLOUGH CA MILK VETCH, HELIOTROPE UT MILK VETCH, HOLMGREN AZ, UT MILK VETCH, JESUP'S NH, VT MILK VETCH, LANE MOUNTAIN CA MILK VETCH, MANCOS CO, NM MILK VETCH, PIERSON'S CA MILK VETCH, SENTRY AZ MILK VETCH, SHIVWITS UT MILK VETCH, TRIPLE RIBBED CA MILK VETCH, VENTURA MARSH CA MILKWEED, MEAD'S IL, IA, KS, MO F 13 MILKWEED, WELSH'S AZ. UT MINT, GARRETT'S FL MINT, LAKELA'S FL MINT, LONGSPURRED FL MINT, OTAY MESA CA MINT, SAN DIEGO MESA CA MINT, SCRUB FL MONARDELLA, WILLOWY CA MONKEY FLOWER, MI MI MONKSHOOD, NORTHERN WILD IA, NY, OH, WI MORNING GLORY, STEBBINS CA MOUNTAINBALM, INDIAN KNOB CA MOUNTAIN MAHOGANY, CATALINA ISLAND CA MUNROIDENDRON RACEMOSUM ( NCN) HI MUSTARD, CARTER'S FL MUSTARD, SLENDER PETALED CA NANI WAI'ALE'ALE ( VIOLA KAUAENSIS VAR. WAHIAW HI NAVARRETIA, FEW FLOWERED CA NAVARRETIA, MANY FLOWERED CA NAVARRETIA, SPREADING CA NEHE ( LIPOCHAETA FAURIEI) HI NEHE ( LIPOCHAETA MICRANTHA) HI NEHE ( LIPOCHAETA WAIMEAENSIS) HI NERAUDIA OVATA ( NCN) HI NERAUDIA SERICEA ( NCN) HI NITERWORT, AMARGOSA CA NITERWORT, AMARGOSA NV NOHOANU ( GERANIUM MULTIFLORUM) HI ' OHA ( DELISSEA RIVULARIS) HI ' OHA ( DELISSEA UNDULATA) HI ' OHA WAI ( CLERMONTIA DREPANOMORPHA) HI ' OHA WAI ( CLERMONTIA LINDSEYANA) HI ' OHA WAI ( CLERMONTIA PELEANA) HI ' OHA WAI ( CLERMONTIA PYRULARIA) HI ' OHAI ( SESBANIA TOMENTOSA) HI ' OLULU ( BRIGHAMIA INSIGNIS) HI ONION, MUNZ'S CA ORCHID, EASTERN PRAIRIE FRINGED IL, IA, ME, MI, OH, OK, VA, WI OWL'S CLOVER, FLESHY CA OXYTHECA, CUSHENBURY CA PAINTBRUSH, ASH GREY INDIAN CA PAINTBRUSH, GOLDEN WA PAINTBRUSH, SAN CLEMENTE ISLAND INDIAN CA PAINTBRUSH, SOFT LEAVED CA PAINTBRUSH, TIBURON CA PAWPAW, BEAUTIFUL FL PAWPAW, FOUR PETAL FL F 14 PAWPAW, RUGEL'S FL PENNY CRESS, KNEELAND PRAIRIE CA PENNYROYAL, TODSEN'S NM PENSTEMON, BLOWOUT NE PENTACHAETA, LYON'S CA PENTACHAETA, WHITE RAYED CA PEPPER GRASS, KODACHROME UT PEPPERGRASS, SLICK SPOT ID PHACELIA, CLAY UT PHACELIA, ISLAND CA PHLOX, TX TRAILING TX PHLOX, YREKA CA PHYLLOSTEGIA KNUDSENII ( NCN) HI PHYLLOSTEGIA VELUTINA ( NCN) HI PHYLLOSTEGIA WAIMEAE ( NCN) HI PHYLLOSTEGIA WARSHAUERI ( NCN) HI PHYLLOSTEGIA WAWRANA ( NCN) HI PINK, SWAMP DE, GA, MD, NJ, NC, SC, VA PINKROOT, GENTIAN FL PIPERIA, YADON'S CA PITCHER PLANT, AL CANEBRAKE AL PITCHER PLANT, GREEN AL, GA, NC PITCHER PLANT, MOUNTAIN SWEET NC, SC PLATANTHERA HOLOCHILA ( NCN) HI PLUM, SCRUB FL POA SIPHONOGLOSSA ( NCN) HI PO'E ( PORTULACA SCLEROCARPA) HI POGONIA, SMALL WHORLED CT, DE, GA, IL, ME, MA, MI, NH, NJ, NY, NC, PA, RI, SC, TN, VA POLYGALA, LEWTON'S FL POLYGALA, TINY FL POLYGONUM, SCOTT'S VALLEY CA PONDBERRY AR, GA, MS, MO, NC, SC PONDWEED, LITTLE AGUJA CREEK TX POPCORNFLOWER, ROUGH OR POPOLO ' AIAKEAKUA ( SOLANUM SANDWICENSE) HI POPOLO KU MAI ( SOLANUM INCOMPLETUM) HI POPPY, SACRAMENTO PRICKLY NM POPPY MALLOW, TX TX POTATO BEAN, PRICE'S AL, IL, KY, NC, TN POTENTILLA, HICKMAN'S CA PRAIRIE CLOVER, LEAFY AL, IL, TN PRICKLY APPLE, FRAGRANT FL PRIMROSE, MAGUIRE UT PUSSYPAWS, MARIPOSA CA PU'UKA'A ( CYPERUS TRACHYSANTHOS) HI QUILLWORT, BLACK SPORED GA, SC QUILLWORT, LOUISIANA AL, LA F 15 QUILLWORT, MAT FORMING GA RATTLEWEED, HAIRY GA REED MUSTARD, BARNEBY UT REED MUSTARD, CLAY UT REED MUSTARD, SHRUBBY UT REMYA KAUAIENSIS ( NCN) HI REMYA MONTGOMERYI ( NCN) HI RHODODENDRON, CHAPMAN FL RIDGE CRESS (= PEPPER CRESS), BARNEBY UT ROCK CRESS, HOFFMANN'S CA ROCK CRESS, LARGE (= BRAUN'S) KY, TN ROCK CRESS, MCDONALD'S CA ROCK CRESS, SANTA CRUZ ISLAND CA ROCK CRESS, SHALE BARREN VA, WV ROCK CRESS, SMALL KY ROSEMARY, CUMBERLAND KY, TN ROSEMARY, ETONIA FL ROSEMARY, SHORT LEAVED FL ROSEROOT, LEEDY'S MN, NY RUSH PEA, SLENDER TX RUSH ROSE, ISLAND CA SANDLACE FL SAND VERBENA, LARGE FRUITED TX SANDWORT, BEAR VALLEY CA SANDWORT, CUMBERLAND KY, TN SANDWORT, MARSH CA SCHIEDEA HELLERI ( NCN) HI SCHIEDEA KAUAIENSIS ( NCN) HI SCHIEDEA MEMBRANACEA ( NCN) HI SCHIEDEA NUTTALLII ( NCN) HI SCHIEDEA SPERGULINA VAR. LEIOPODA ( NCN) HI SCHIEDEA SPERGULINA VAR. SPERGULINA ( NCN) HI SEA BLITE, CA CA SEAGRASS, JOHNSON'S FL SEDGE, GOLDEN NC SEDGE, NAVAJO AZ, UT SEDGE, WHITE CA SILENE HIENSIS ( NCN) HI SILENE LANCEOLATA ( NCN) HI SILVERSWORD, KA'U ( ARGYROXIPHIUM KAUENSE) HI SILVERSWORD, MAUNA KEA (' AHINAHINA) HI SKULLCAP, LARGE FLOWERED GA, TN SNAKEROOT FL SNEEZEWEED, VA MO, VA SNOWBELLS, TX TX SPERMOLEPIS HIENSIS ( NCN) HI SPIDERLING, MATHIS TX SPINEFLOWER, BEN LOMOND CA F 16 SPINEFLOWER, HOWELL'S CA SPINEFLOWER, MONTEREY CA SPINEFLOWER, ORCUTT'S CA SPINEFLOWER, ROBUST CA SPINEFLOWER, SCOTTS VALLEY CA SPINEFLOWER, SLENDER HORNED CA SPINEFLOWER, SONOMA CA SPIRAEA, VA GA, KY, NC, TN, VA, WV SPURGE, DELTOID FL SPURGE, GARBER'S FL SPURGE, HOOVER'S CA SPURGE, TELEPHUS FL STENOGYNE ANGUSTIFOLIA ( NCN) HI STENOGYNE CAMPANULATA ( NCN) HI STICKSEED, SHOWY WA STICKYSEED, BAKER'S CA STONECROP, LAKE COUNTY CA SUMAC, MICHAUX'S GA, NC, VA SUNFLOWER, EGGERT'S AL, KY, TN SUNFLOWER, PECOS NM, TX SUNFLOWER, SAN MATEO WOOLLY CA SUNFLOWER, SCHWEINITZ'S NC, SC SUNRAY, ASH MEADOWS NV TARAXACUM, CA CA TARPLANT, GAVIOTA CA TARPLANT, OTAY CA TARPLANT, SANTA CRUZ CA TETRAMOLOPIUM ARENARIUM ( NCN) HI THELYPODY, HOWELL'S SPECTACULAR OR THISTLE, CHORRO CREEK BOG CA THISTLE, FOUNTAIN CA THISTLE, LA GRACIOSA CA THISTLE, PITCHER'S IN, MI, WI THISTLE, SACRAMENTO MOUNTAINS NM THISTLE, SUISUN CA THORNMINT, SAN DIEGO CA THORNMINT, SAN MATEO CA TORREYA, FL FL. GA TOWNSENDIA, LAST CHANCE UT TRILLIUM, PERSISTENT GA, SC TRILLIUM, RELICT AL, GA, SC TUCTORIA, GREEN'S CA UHIUHI ( CAESALPINIA KAVAIENSIS) HI UMBEL, HUACHUCA WATER AZ VERVAIN, CA CA VETCH, HIAN ( VICIA MENZIESII) HI VIGNA O WAHUENSIS ( NCN) HI VIOLA HELENAE ( NCN) HI F 17 WAHINE NOHO KULA ( ISODENDRION PYRIFOLIUM) HI WALLFLOWER, BEN LOMOND CA WALLFLOWER, CONTRA COSTA CA WALLFLOWER, MENZIE'S CA WAREA, WIDE LEAF FL WATERCRESS, GAMBEL'S CA WATER PLANTAIN, KRAL'S AL, GA WATER WILLOW, COOLEY'S FL WAWAE'IOLE ( PHLEGMARIURUS (= HUPERZIA) MANNII) HI WAWAE'IOLE ( PHLEGMARIURUS (= LYCOPODIUM) NUTAN HI WHITLOW WORT, PAPERY FL WILD BUCKWHEAT, CLAY LOVING CO WILD BUCKWHEAT, GYPSUM NM WILD RICE, TX TX WINGS, PIGEON FL WIRE LETTUCE, MALHEUR OR WIREWEED FL WOODLAND STAR, SAN CLEMENTE ISLAND CA WOOLLY STAR, SANTA ANA RIVER CA WOOLLY THREADS, SAN JOAQUIN CA XYLOSMA CRENATUM ( NCN) HI YERBA SANTA, LOMPOC CA ZIZIPHUS, FL FL F 18 Table F 3. List of endangered mammalian species potentially at risk from napropamide use SPECIES NAME STATE( S) BAT, GRAY AL, AR, FL, GA, IL, IN, KS, KY, MO, OK, TN, VA, WV BAT, HIAN HOARY HI BAT, INDIANA AL, AR, CT, FL, GA, IL, IN, IA, KY, MD, MA, MI, MO, NH, NJ, NY, NC, OH, OK, PA, RI, TN, VT, VA, WV BAT, LESSER (= SANBORN'S) LONG NOSED AZ, NM BAT, MEXICAN LONG NOSED NM BAT, OZARK BIG EARED AR, OK BAT, VA BIG EARED GA, KY, NC, VA, WV BEAR, AMERICAN BLACK LA BEAR, GRIZZLY ID, MT, WA, WY BEAR, LA BLACK LA, MS, TX CARIBOU, WOODLAND ID DEER, COLUMBIAN WHITE TAILED OR, WA FERRET, BLACK FOOTED CO, KS, MT, NE, NM, SD, UT, WY FOX, SAN JOAQUIN KIT CA FOX, SAN MIGUEL ISLAND CA FOX, SANTA CATALINA ISLAND CA FOX, SANTA CRUZ ISLAND CA FOX, SANTA ROSA ISLAND CA JAGUAR AZ, NM JAGUARUNDI, Gulf Coast TX Jaguarundi, Sinaloan AZ KANGAROO RAT, FRESNO CA KANGAROO RAT, GIANT CA KANGAROO RAT, MORRO BAY CA KANGAROO RAT, SAN BERNARDINO CA KANGAROO RAT, STEPHENS' CA KANGAROO RAT, TIPTON CA LYNX, CANADA ME MANATEE, WEST INDIAN ( FL) FL, GA MOUNTAIN BEAVER, POINT ARENA CA MOUSE, AL BEACH AL MOUSE, ANASTASIA ISLAND BEACH FL MOUSE, CHOCTAWHATCHEE BEACH FL MOUSE, PACIFIC POCKET CA MOUSE, PERDIDO KEY BEACH AL, FL MOUSE, PREBLE'S MEADOW JUMPING CO MOUSE, SALT MARSH HARVEST CA MOUSE, SOUTHEASTERN BEACH FL OCELOT AZ, TX OTTER, SOUTHERN SEA CA PANTHER, FL FL PRAIRIE DOG, UT UT F 19 PRONGHORN, SONORAN AZ RABBIT, PYGMY WA RABBIT, RIPARIAN BRUSH CA SEAL, GUADALUPE FUR CA SEAL, HIAN MONK HI SHEEP, PENINSULAR BIGHORN CA SHEEP, SIERRA NEVADA BIGHORN CA SHREW, BUENA VISTA CA SQUIRREL, CAROLINA NORTHERN FLYING NC, TN, WV SQUIRREL, DELMARVA PENINSULA FOX DE, MD, PA, VA SQUIRREL, MOUNT GRAHAM RED AZ SQUIRREL, NORTHERN ID GROUND ID SQUIRREL, VA NORTHERN FLYING VA, WV VOLE, AMARGOSA CA VOLE, FL SALT MARSH FL VOLE, HUALAPAI MEXICAN AZ WHALE, NORTHERN RIGHT CT, DE, FL, ME, MD, MA, NJ, NY, NC, RI, SC, VA WOLF, GRAY AZ, ID, MI, MN, MT, NM, WA, WI, WY WOLF, RED NC, SC, TN WOODRAT, RIPARIAN CA F 20 APPENDIX G. EXPLANATION OF LEVEL OF CONCERN ( LOC) AND PROBIT SLOPE Use of the Probit Dose Response Relationship to Provide Information on the Endangered Species Levels of Concern Introduction The document entitled Overview of Ecological Risk Assessment Process in the Office of Pesticide Programs, U. S. Environmental Protection Agency ( USEPA 2004, the Overview Document) discusses methods for providing the U. S. Fish and Wildlife Service ( USFWS) and the National Marine Fisheries Service ( NMFS) with additional information regarding the listed animal species acute levels of concern ( LOCs). This document provides ( 1) the background information on how agreements were reached between the services and USEPA for methods to provide additional LOC information, and ( 2) a discussion of issues concerning those methods and their resolution. Risk Assessors within the Environmental Fate and Effects Division ( EFED) should use the Overview Document as well as the following information as guidance for using the probit dose response relationship as a tool for providing additional information on the listed species LOCs Effective immediately, all screening level risk assessments ( REDS, Section 3' s, Section 18' s, etc.) using risk quotient ( RQ) methods will incorporate this analysis, regardless of whether listed species LOCs are exceeded or not.

Background on Discussion of LOCs with USFWS and NMFS Over the course of negotiations with the USFWS and NMFS, one topic of discussion centered on the risk quotient values established as screening thresholds for consideration of direct toxic effects on listed species ( i. e., the acute listed species LOCs of 0.1 and 0.05 used for terrestrial and aquatic animals, respectively). The Agency provided the Services with the mathematical interpretations of these LOC values, which was documented in the background information supplied to the Services and is included in the Overview Document CD distributed to all employees in EFED. In short, the interpretation of the LOCs was discussed in terms of best estimates of the chance of an individual event ( mortality or immobilization) should exposure at the estimated environmental concentration actually occur for a species with sensitivity to the pesticide on par with the toxicity endpoint selected for RQ calculation.

The mathematics were based on a long held assumption of a probit dose response relationship for acute toxicity endpoints. The listed species LOCs or the fraction ( 0.05 or 0.1) of the dose estimated to produce 50% mortality were used to interpolate from a probit dose response curve to estimate the associated ECx, LDx, or LCx. These values were then used to estimate the chance of an individual event.

Two issues were identified over the course of discussions with the Services in regard to the Agency's presentations of the math and the interpretation of the LOCs. First was the issue that the chance of F 21 individual event was highly dependant upon the assumed shape and slope of the dose response relationship. Second was that the Services were unwilling to present a generic threshold of the chance of an individual event, below which the Services would not have a concern for listed species impacts The services indicated that the baseline conditions of a species and it's biology would dictate species specific concerns for tolerated effects. Further discussion on the confidence of extreme value extrapolations for probit dose response did not achieve an agreement between all parties on what the lower limit of cutoff in reporting extreme events should be for interpretation of listed species acute LOCs. Even consideration of using the most intolerant listed species within taxonomic groups as a screening basis for other more tolerant listed species was not accepted as a viable strategy for establishing generic effects thresholds for listed species.

Consequently, it was accepted by all parties that the Agency would provide in its risk assessments an interpretation of the listed species LOCs in terms of the chance of an individual effect should organisms be exposed to a media concentration or dose corresponding to 1/ 10 or 1/ 20 of the LC 50, LD 50, or EC 50 used as the acute toxicity measurement endpoint for a particular animal taxonomic group. To accomplish this interpretation, the Agency would use ( 1) the slope of the dose response relationship available from the toxicity study used to establish the acute toxicity measurement endpoints for each animal taxonomic group; ( 2) an assumption of a probit dose response relationship; ( 3) a mean estimate of slope consistent with current Agency statistical procedures; and ( 4) a lower limit to the estimate of individual effect chance based on what could be calculated by Excel spreadsheet " Normdist" function.

Issues with the LOC Interpretation Method and Their Resolution Discussion within the Agency has identified three issues with regard to the calculation of the chance of individual event corresponding to the listed species acute LOCs. The largest issue is the extrapolation to extremely low probability events, referring to the very large confidence intervals surrounding such estimates. A secondary issue, but still very important, is the extent to which probit dose response slopes can be calculated for existing studies ( i. e., the fitting of a probit dose response relationship to available data). The third issue is how to proceed when information is unavailable to estimate a slope. The following guidance information will address these issues:

Extrapolation to Extremely Low Probability Events The nature of this issue centers on the fact that slope estimates are accompanied by a corresponding variance in the slope term. This variance in the slope term and to some extent the variance in the median lethal dose estimate, can result in wide variations of effects probabilities at the upper and lower tails of the dose range. While the Agency has agreed to present the effects probability associated with the LOCs based on the mean estimate of slope, it is evident that expression of this single estimate of the corresponding effects probability would suggest that the Agency has inordinately high confidence in this estimate, when in fact there is likely considerable variability in the estimate. Consequently, for the short term, it is recommended that both the estimate of effects probability be calculated for the mean slope estimate and listed species LOC and available information on the 95% confidence interval of the slope estimate be used to calculate an upper and lower estimate of the effects probability. It is important to F 22 note that interpretation of these results is not required under agreement with the Services. The Services have requested that the results be made available in the screening assessment reports. It is recommended that reporting minimally include the following discussion:

" Based on an assumption of a probit dose response relationship with a mean estimated slope of ( enter slope here), the corresponding estimated chance of individual mortality associated with the listed species LOC of ( 0.1 or 0.05) the acute toxic endpoint for ( enter appropriate animal taxonomic group) is ( enter value). It is recognized that extrapolation of very low probability events is associated with considerable uncertainty in the resulting estimates. To explore possible bounds to such estimates, the upper and lower values for the mean slope estimate ( enter the 95 percent confidence interval for the slope) were used to calculate upper and lower estimates of the effects probability associated with the listed species LOC. These values are ( enter the upper and lower estimates)."

For the present time, the Excel spreadsheet tool IECV1.1 will allow for such calculations by entering in the mean slope estimate and the 95 percent confidence bounds of that estimate as the slope parameter for the spreadsheet. It is important to note that the model output can go as low as 10 E 16 in estimating the event probability. This cut off is a limit in the Excel spreadsheet environment and is not to be interpreted as an agreed upon lower bound threshold for concern for individual effects in any given listed species.

EFED will continue to work on establishing subsequent approaches to account for both the variance in the slope and the median lethal dose estimate when establishing this upper and lower estimates of effects estimates associated with the listed species LOCs.

Probit Slopes for Existing Studies Slope information may or may not be estimated for a given study upon which RQs were calculated. When the available data evaluation records ( DERs) or study reports provide the slope information ( i. e., mean slope estimate, p value of estimate, and 95% confidence interval of the estimate) , it should be used as reported once these reported values have been carefully reviewed to ensure their accuracy. However, there are likely to be situations where slope information is not provided in the DERs. For such situations, the raw data from the study must be entered into and analyzed by the EFED current statistical package for acute effects studies. See the EFED Statistical Workgroup for assistance with accessing these software. Probit slope information will be used from these analyses. However, there a re two distinctions that must be made in the reporting of these results for listed species evaluation. First, studies with good probit fit characteristics can be used as reported accompanied with a statement that the probit dose response relationship was statistically appropriate for the data set. Alternatively, if the assumption of a probit dose response was shown to be statistically unsupported, the slope estimates are still used in the listed species LOC interpretation ( remember we have in our policy assumed probit dose response when LOCs were established), but the statistical rejection criteria must be presented along with a statement : F 23 " Although the Agency has assumed a probit dose response relationship in establishing the listed species LOCs, the available data for the toxicity study generating RQs for this taxonomic group do not statistically support a probit dose response relationship ( enter the p value from the statistical package) and so the confidence in estimated event probabilities based on this dose response relationship and the listed species LOC is low."

EFED will continue to work on the development of statistical tools to explore alternative dose response relationships in situations where the assumption of probit dose response relationship is not upheld by available data.

How to Proceed When Information is Unavailable to Estimate a Slope State in the assessment that information is unavailable to estimate a slope from the available toxicity study and the reason why re analysis of raw data is not possible. Then state that a event probability was calculated for the listed species LOC based on a default slope assumption of 4.5 as per original Agency assumptions of typical slope cited in Urban and Cook ( 1986).

References United States Environmental Protection Agency ( USEPA). 2004. Overview of Ecological Risk Assessment Process in the Office of Pesticide Programs, U. S. Environmental Protection Agency. Office of Prevention, Pesticides and Toxic Substances, Office of Pesticide Programs, Washington, DC.

Urban D. J. and N. J. Cook. 1986. Hazard Evaluation Division Standard Evaluation Procedure Ecological Risk Assessment. EPA 540/ 9 85 001. U. S. Environmental Protection Agency, Office of Pesticide Programs, Washington, DC.


[Federal Register Volume 87, Number 163 (Wednesday, August 24, 2022)]
[Notices]
[Pages 51977-51978]
[FR Doc No: 2022-18251]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-10085-01-R4]

Public Water System Supervision Program Revision for the State of
Georgia

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of intended approval.

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SUMMARY: Notice is hereby given that the State of Georgia is revising
its approved Public Water System Supervision Program. Georgia has
adopted drinking water regulations for the Lead and Copper Rule Minor
Revisions, Public Notification Rule, Radionuclides Rule, Arsenic and
Clarifications to Compliance and New Source Contaminants Monitoring
Rule, Stage 2 Disinfectants and Disinfection Byproducts Rule, Long Term
2 Enhanced Surface Water Treatment Rule, Ground Water Rule, Lead and
Copper Rule Short-Term Regulatory Revisions and Clarifications, and
Revised Total Coliform Rule. The Environmental Protection Agency (EPA)
has determined that Georgia's regulations are no less stringent than
these Federal rules and the revisions otherwise meet applicable Safe
Drinking Water Act requirements. Therefore, the EPA intends to approve
these revisions to the State of Georgia's Public Water System
Supervision Program.

DATES: Any interested person may request a public hearing. A request
for a public hearing must be submitted by September 23, 2022, to the
Regional Administrator at the following address: U.S. Environmental
Protection Agency, Region 4, Atlanta Federal Center, 61 Forsyth Street
SW, Atlanta, Georgia 30303. The Regional Administrator may deny
frivolous or insubstantial requests for a hearing. However, if a
substantial request for a public hearing is made by September 23, 2022,
a public hearing will be held. If no timely and appropriate request for
a hearing is received and the Regional Administrator does not elect to
hold a hearing on his own motion, this determination shall become final
on September 23, 2022. Any request for a public hearing shall include
the following information: the name, address, and telephone number of
the individual, organization, or other entity requesting a hearing; a
brief statement of the requesting person's interest in the Regional
Administrator's determination and a brief statement of the information
that the requesting person intends to submit at such hearing; and the
signature of the individual making the request, or, if the request is
made on behalf of an organization or other entity, the signature of a
responsible official of the organization or other entity.

ADDRESSES: Documents relating to this determination are available for
inspection between the hours of 9:00 a.m. and 4:00 p.m., Monday through
Friday (excluding legal holidays), at the following location: Macon
Conference Room, 3rd Floor Tower Building, Atlanta Federal Center, 61
Forsyth Street SW, Atlanta, Georgia 30303. Those intending to view
documents should contact Dale Froneberger, EPA Region 4, by telephone
at<PHONE_NUMBER> at least 24 hours prior to arriving to coordinate
viewing.

FOR FURTHER INFORMATION CONTACT: Dale Froneberger, EPA Region 4, Safe
Drinking Water Branch, by telephone at<PHONE_NUMBER>, or by email at
[email protected].

SUPPLEMENTARY INFORMATION: The State of Georgia has submitted requests
that the EPA approve revisions to the State's Safe Drinking Water Act
Public Water System Supervision Program to include the authority to
implement and enforce the Lead and Copper Rule Minor Revisions, Public
Notification Rule, Radionuclides Rule, Arsenic and Clarifications to
Compliance and New Source Contaminants Monitoring Rule, Stage 2
Disinfectants and Disinfection Byproducts Rule, Long Term 2 Enhanced
Surface Water Treatment Rule, Ground Water Rule, Lead and Copper Rule
Short-Term Regulatory Revisions and Clarifications, and

Revised Total Coliform Rule. For the requests to be approved, the EPA
must find the state regulations codified at Ga. Comp. R. & Regs. r.
391-3-5 to be no less stringent than the Federal rules codified at 40
CFR part 141. The EPA reviewed Georgia's applications using the Federal
statutory provisions (section 1413 of the Safe Drinking Water Act),
federal regulations (at 40 CFR parts 141 and 142), state regulations,
state policies and procedures for implementing the rules, regulatory
crosswalks, and the EPA regulatory guidance to determine whether the
requests for revision are approvable. The EPA determined that the
Georgia regulations are no less stringent than the corresponding
Federal rules and the revisions otherwise meet applicable Safe Drinking
Water Act requirements. Therefore, the EPA intends to approve these
revisions. If the EPA does not receive a timely and appropriate request
for a hearing and the Regional Administrator does not elect to hold a
hearing on his own motion, this approval shall become final on
September 23, 2022.
    Authority: Section 1413 of the Safe Drinking Water Act, as amended
(1996), and 40 CFR part 142.

    Dated: August 18, 2022.
Daniel Blackman,
Regional Administrator.
[FR Doc. 2022-18251 Filed 8-23-22; 8:45 am]
BILLING CODE 6560-50-P