[Federal Register: December 6, 2007 (Volume 72, Number 234)]
[Notices]
[Page 68955-68956]
[DOCID:fr06de07-128]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[U.S. DOT Docket Number NHTSA-2007-0034]

Reports, Forms, and Recordkeeping Requirements

AGENCY: National Highway Traffic Safety Administration (NHTSA),
Department of Transportation.

ACTION: Request for public comment on proposed collection of
information.

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SUMMARY: Before a Federal agency can collect certain information from
the public, it must receive approval from the Office of Management and
Budget (OMB). Under procedures established by the Paperwork Reduction
Act of 1995, before seeking OMB approval, Federal agencies must solicit
public comment on proposed collections of information, including
extensions and reinstatement of previously approved collections. This
document describes one collection of information for which NHTSA
intends to seek OMB approval.

DATES: Comments must be received on or before February 4, 2008.

ADDRESSES: You may submit comments [identified by DOT Docket No. NHTSA-
2007-0034] by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov.
 Follow the online instructions for submitting

comments.
     Mail: Docket Management Facility: U.S. Department of
Transportation, 1200 New Jersey Avenue, SE., West Building Ground
Floor, Room W12-140, Washington, DC 20590-0001.
     Hand Delivery or Courier: West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue, SE., between 9 a.m. and 5 p.m. ET,
Monday through Friday, except Federal holidays. Telephone: 1-800-647-
5527.
     Fax:<PHONE_NUMBER>.
    Instructions: All submissions must include the agency name and
docket number for this proposed collection of information. Note that
all comments received will be posted without change to http://www.regulations.gov
, including any personal information provided.

Please see the Privacy Act heading below.
    Privacy Act: Anyone is able to search the electronic form of all
comments received into any of our dockets by the name of the individual
submitting the comment (or signing the comment, if submitted on behalf
of an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (65 FR 19477-78) or you may visit http://DocketInfo.dot.gov
.

    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov. or the street

address listed above. Follow the online instructions for accessing the
dockets.

FOR FURTHER INFORMATION CONTACT: Complete copies of each request for
collection of information may be obtained at no charge from Markus
Price, NHTSA, 1200 New Jersey Avenue, SE., W43-472 NVS-121, Washington,
DC 20590.
    Mr. Markus Price's telephone number is<PHONE_NUMBER>. Please
identify the relevant collection of information by referring to its OMB
Control Number.

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995,
before an agency submits a proposed collection of information to OMB
for approval, it must first publish a document in the Federal Register
providing a 60-day comment period and otherwise consult with members of
the public and affected agencies concerning each proposed collection of
information. The OMB has promulgated regulations describing what must
be included in such a document. Under OMB's regulation (at 5 CFR
1320.8(d), an agency must ask for public comment on the following:
    (i) Whether the proposed collection of information is necessary for
the proper performance of the functions of the agency, including
whether the information will have practical utility;
    (ii) the accuracy of the agency's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used;
    (iii) how to enhance the quality, utility, and clarity of the
information to be collected;
    (iv) how to minimize the burden of the collection of information on
those who are to respond, including the use of appropriate automated,
electronic, mechanical, or other technological collection techniques or
other forms of information technology, e.g. permitting electronic
submission of responses.
    In compliance with these requirements, NHTSA asks for public
comments on the following proposed collections of information:
    Title: 49 CFR 571.125, Warning Devices.
    OMB Control Number: 2127-0505.
    Affected Public: Business or other for profit organizations.
    Form Number: This collection of information uses no standard forms.

    Abstract: 49 U.S.C. 3011, 30112, and 30117 (Appendix 1) of the
National Traffic and Motor Vehicle Safety Act of 1996, authorizes the
issuance of Federal Motor Vehicle Safety Standards (FMVSS). The
Secretary is authorized to issue, amend, and revoke such rules and
regulations as she/he deems necessary. Using this authority, the agency
issued FMVSS no.125, ``Warning Devices'' (Appendix 2), which applies to
devices, without self contained energy sources, that are designed to be
carried mandatory in buses and trucks that have a gross vehicle weight
rating (GVWR) greater than 10,000 pounds and voluntarily in other
vehicles. These devices are used to warn approaching traffic of the
presence of a stopped vehicle, except for devices designed to be
permanently affixed to the vehicles.
    Estimated Annual Burden: 1.
    Number of Respondents: 3.
    Comments are invited on: whether the proposed collection of
information is necessary for the proper performance of the functions of
the Department, including whether the information will have practical
utility; the accuracy of the Department's estimate of the burden of the
proposed information collection; ways to enhance the quality, utility
and clarity of the information to be collected; and ways to minimize
the burden of the collection of information on respondents, including
the use of automated collection techniques or other forms of
information technology.

    Issued on November 30, 2007.
Stephen R. Kratzke,
Associate Administrator for Rulemaking.
[FR Doc. E7-23690 Filed 12-5-07; 8:45 am]

BILLING CODE 4910-59-P


[Federal Register Volume 83, Number 105 (Thursday, May 31, 2018)]
[Notices]
[Pages 25013-25014]
[FR Doc No: 2018-11642]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-1636]

Assessment of Pressor Effects of Drugs; Draft 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 draft guidance for industry entitled ``Assessment
of Pressor Effects of Drugs.'' This guidance is intended to advise
sponsors on the premarketing assessment of a drug's effect on blood
pressure. Elevated blood pressure is known to increase the risk of
stroke, heart attack, and death. The effect of a drug on blood pressure
may therefore be an important consideration in benefit-risk assessment.

DATES: Submit either electronic or written comments on the draft
guidance by July 30, 2018 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

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

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2018-D-1636] for ``Assessment of Pressor Effects of Drugs; Draft
Guidance for Industry; Availability.'' Received comments will be placed
in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Norman Stockbridge, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New

Hampshire Ave., Bldg. 22, Rm. 4166, Silver Spring, MD 20903, 301-796-
2240.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Assessment of Pressor Effects of Drugs.'' Elevated blood
pressure is known to increase the risk of stroke, heart attack, and
death. The effect of a drug on blood pressure may therefore be an
important consideration in benefit-risk assessment. This guidance is
intended to advise sponsors on the premarketing assessment of a drug's
effect on blood pressure.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on assessment of
pressor effects of drugs. 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. This guidance is not subject to Executive
Order 12866.

II. Electronic Access

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

    Dated: May 24, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-11642 Filed 5-30-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: August 13, 2009 (Volume 74, Number 155)]
[Notices]
[Page 40862-40864]
[DOCID:fr13au09-94]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-60456; File No. SR-Phlx-2009-63]

 Self-Regulatory Organizations; NASDAQ OMX PHLX, Inc.; Notice of
Filing and Immediate Effectiveness of a Proposed Rule Change Relating
to Extension of Sponsored Access Pilot Program

August 7, 2009.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on July 29, 2009, NASDAQ OMX PHLX, Inc. (``Phlx'' or ``Exchange'')
filed with the Securities and Exchange Commission (``Commission'') the
proposed rule change as described in Items I and II below, which Items
have been prepared by the Exchange. The Commission is publishing this
notice to solicit comments on the proposed rule change from interested
persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to renew its sponsored access rule for a
pilot period ending on October 29, 2009. The program expires on July
29, 2009.\3\ The text of the proposed rule change is available on the
Exchange's Web site at http://www.nasdaqtrader.com/
micro.aspx?id=PHLXRulefilings, at the principal office of the Exchange,
and at the Commission's Public Reference Room.
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    \3\ See Securities Exchange Release No. 59362 (February 5,
2009), 74 FR 6931 (February 11, 2009) (SR-Phlx-2009-10).
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II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the self-regulatory organization
included statements concerning the purpose of, and basis for, the
proposed rule change and discussed any comments it received on the
proposed rule change. The text of those statements may be examined at
the places specified in Item IV below. The Exchange has prepared
summaries, set forth in sections A, B, and C below, of the most
significant aspects of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The purpose of the proposed rule change is to attract additional
business by renewing its sponsored access rule, which is similar to
that of other exchanges. During the previous pilot program, no member
organizations availed themselves of the program, but the Exchange seeks
to make another attempt to institute the program, for a pilot period
expiring October 29, 2009. The Exchange will evaluate whether to
continue the sponsored access program or not.
    A Sponsored Participant is a non-member of the Exchange, such as an
institutional investor, that gains access to the Exchange and trades
under a Sponsoring Member's execution and clearing identity pursuant to
a sponsorship arrangement between such non-member and a member
organization. Specifically, the Exchange proposes to permit Sponsored
Participants to be sponsored by Sponsoring Member Organizations, and
thereby access the Exchange, subject to certain requirements. These
requirements are intended to confirm that the Sponsored Participant is
required to and had procedures in place to comply with Exchange rules,
and that the Sponsoring Member Organization takes responsibility for
the Sponsored Participant's activity on the Exchange.
    First, the Sponsored Participant and its Sponsoring Member
Organization must have entered into and maintained an Access Agreement
with the Exchange. The Sponsoring Member Organization must designate
the Sponsored Participant by name in an addendum to the Access
Agreement.
    Second, there must be a Sponsored Participant Agreement between the
Sponsoring Member Organization and the Sponsored Participant that
contains the following sponsorship provisions, enumerated in full in
Rule 1094(b)(ii):
    (i) The orders of the Sponsored Participant are binding in all
respects on the Sponsoring Member Organization;
    (ii) The Sponsoring Member Organization is responsible for the
actions of the Sponsored Participant;
    (iii) In addition to the Sponsoring Member Organization being
required to comply with the Exchange Certificate of Incorporation, By-
laws, Rules and procedures of the Exchange, the Sponsored Participant
shall do so as if such Sponsored Participant were an Exchange member
organization;
    (iv) The Sponsored Participant shall maintain, keep current and
provide to the Sponsoring Member Organization a list of individuals
authorized to obtain access to the Exchange on behalf of the Sponsored
Participant;
    (v) The Sponsored Participant shall familiarize its authorized
individuals with all of the Sponsored Participant's obligations under
this Rule and will assure that they receive appropriate training prior
to any use or access to the Exchange;
    (vi) The Sponsored Participant may not permit anyone other than
authorized individuals to use or obtain access to the Exchange; \4\
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    \4\ If the Exchange determines that an authorized individual has
caused a Member Organization to violate the Exchange's Rules, the
Exchange could direct the Member Organization to suspend or withdraw
the person's status as an authorized individual.

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    (vii) The Sponsored Participant shall take reasonable security
precautions to prevent unauthorized use or access to the Exchange,
including unauthorized entry of information into the Exchange, and
agrees that it is responsible for any and all orders, trades and other
messages and instructions entered, transmitted or received under
identifiers, passwords and security codes of authorized individuals,
and for the trading and other consequences thereof;
    (viii) The Sponsored Participant acknowledges its responsibility to
establish adequate procedures and controls that permit it to
effectively monitor its employees', agents' and Participants' use and
access to the Exchange for compliance with the terms of this agreement;
    (ix) The Sponsored Participant shall pay when due all amounts, if
any, payable to Sponsoring Member Organization, the Exchange, or any
other third parties that arise from the Sponsored Participant's access
to and use of the Exchange. Such amounts include, but are not limited
to applicable exchange and regulatory fees.
    Third, the Sponsoring Member Organization must provide the Exchange
with a Sponsored Participant Addendum to its Access Agreement
acknowledging its responsibility for the orders, executions and actions
of its Sponsored Participant at issue.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act \5\ in general, and furthers the objectives of Section
6(b)(5) of the Act \6\ in particular, in that it is designed to promote
just and equitable principles of trade, to remove impediments to and
perfect the mechanism of a free and open market and a national market
system, and, in general to protect investors and the public interest by
helping market participants seeking access to a marketplace.
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    \5\ 15 U.S.C. 78f(b).
    \6\ 15 U.S.C. 78f(b)(5).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    No written comments were either solicited or received.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Because the foregoing rule change does not: (1) Significantly
affect the protection of investors or the public interest; (2) impose
any significant burden on competition; and (3) become operative for 30
days after the date of this filing, or such shorter time as the
Commission may designate, it has become effective pursuant to Section
19(b)(3)(A) of the Act \7\ and Rule 19b-4(f)(6) thereunder.\8\
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    \7\ 15 U.S.C. 78s(b)(3)(A).
    \8\ 17 CFR 240.19b-4(f)(6).
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    A proposed rule change filed under 19b-4(f)(6) normally may not
become operative prior to 30 days after the date of filing.\9\ However,
Rule 19b-4(f)(6)(iii) \10\ permits the Commission to designate a
shorter time if such action is consistent with the protection of
investors and the public interest. The Exchange has requested that the
Commission waive the 30-day operative delay so that the proposal may
become operative upon filing. The Commission believes that waiving the
30-day operative delay is consistent with the protection of investors
and the public interest because such waiver would allow the pilot
program to continue uninterrupted. The Commission notes that the
proposal is substantially similar to the rules of other national
securities exchanges.\11\ Accordingly, the Commission hereby grants the
Exchange's request and designates the proposal operative upon
filing.\12\
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    \9\ 17 CFR 240.19b-4(f)(6)(iii). In addition, Rule 19b-
4(f)(6)(iii) requires that a self-regulatory organization submit to
the Commission written notice of its intent to file the proposed
rule change, along with a brief description and text of the proposed
rule change, at least five business days prior to the date of filing
of the proposed rule change, or such shorter time as designated by
the Commission. The Exchange has satisfied the five-day pre-filing
notice requirement.
    \10\ Id.
    \11\ See, e.g., International Securities Exchange, LLC Rule 706
and NYSE Arca, Inc. Rule 7.29.
    \12\ For the purposes only of waiving the 30-day operative
delay, the Commission has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
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    At any time within 60 days of the filing of such proposed rule
change the Commission may summarily abrogate such rule change if it
appears to the Commission that such action is necessary or appropriate
in the public interest, for the protection of investors or otherwise in
furtherance of the purposes of the Act.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-Phlx-2009-63 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-Phlx-2009-63. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/
sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for inspection and
copying in the Commission's Public Reference Room, on official business
days between the hours of 10 a.m. and 3 p.m. Copies of the filing also
will be available for inspection and copying at the principal office of
the Exchange. All comments received will be posted without change; the
Commission does not edit personal identifying information from
submissions. You should submit only information that you wish to make
available publicly. All submissions should refer to File Number SR-
Phlx-2009-63 and should be submitted on or before September 3, 2009.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\13\
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    \13\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Deputy Secretary.
[FR Doc. E9-19407 Filed 8-12-09; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 82, Number 12 (Thursday, January 19, 2017)]
[Notices]
[Page 6602]
[FR Doc No: 2017-01095]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4285-DR; Docket ID FEMA-2016-0001]

North Carolina; Amendment No. 16 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the State of North Carolina (FEMA-4285-DR), dated October 10, 2016,
and related determinations.

DATES: Effective December 23, 2016.

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

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the State of North Carolina is hereby amended to include the
following area among those areas determined to have been adversely
affected by the event declared a major disaster by the President in his
declaration of October 10, 2016.

    Warren County for Public Assistance, including direct federal
assistance.

The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households In
Presidentially Declared Disaster Areas; 97.049, Presidentially
Declared Disaster Assistance--Disaster Housing Operations for
Individuals and Households; 97.050, Presidentially Declared Disaster
Assistance to Individuals and Households--Other Needs; 97.036,
Disaster Grants--Public Assistance (Presidentially Declared
Disasters); 97.039, Hazard Mitigation Grant.

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2017-01095 Filed 1-18-17; 8:45 am]
 BILLING CODE 9111-23-P


United States
Environmental Protection Agency
   Office of Chemical Safety
   and Pollution Prevention
   (7101)
EPA 712-C-009
January 2012

Ecological Effects
Test Guidelines

OCSPP 850.4300:

Terrestrial Plants
Field Study

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  NOTICE
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--------------------------------------------------------------------------------
  This guideline is one of a series of test guidelines established by the United States Environmental Protection Agency's Office of Chemical Safety and Pollution Prevention (OCSPP) for use in testing pesticides and chemical substances to develop data for submission to the Agency under the Toxic Substances Control Act (TSCA) (15 U.S.C. 2601, et seq.), the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) (7 U.S.C. 136, et seq.), and section 408 of the Federal Food, Drug and Cosmetic (FFDCA) (21 U.S.C. 346a).  Prior to April 22, 2010, OCSPP was known as the Office of Prevention, Pesticides and Toxic Substances (OPPTS).  To distinguish these guidelines from guidelines issued by other organizations, the numbering convention adopted in 1994 specifically included OPPTS as part of the guideline's number.  Any test guidelines developed after April 22, 2010 will use the new acronym (OCSPP) in their title.
--------------------------------------------------------------------------------

--------------------------------------------------------------------------------
  	The OCSPP harmonized test guidelines serve as a compendium of accepted scientific methodologies and protocols that are intended to provide data to inform regulatory decisions under TSCA, FIFRA, and/or FFDCA.  This document provides guidance for conducting the test, and is also used by EPA, the public, and the companies that are subject to data submission requirements under TSCA, FIFRA, and/or the FFDCA.  As a guidance document, these guidelines are not binding on either EPA or any outside parties, and the EPA may depart from the guidelines where circumstances warrant and without prior notice.  At places in this guidance, the Agency uses the word "should."  In this guidance, the use of "should" with regard to an action means that the action is recommended rather than mandatory.  The procedures contained in this guideline are strongly recommended for generating the data that are the subject of the guideline, but EPA recognizes that departures may be appropriate in specific situations. You may propose alternatives to the recommendations described in these guidelines, and the Agency will assess them for appropriateness on a case-by-case basis
--------------------------------------------------------------------------------
  	For additional information about these test guidelines and to access these guidelines electronically, please go to http://www.epa.gov/ocspp and select "Test Methods & Guidelines" on the left side navigation menu.  You may also access the guidelines in http://www.regulations.gov grouped by Series under Docket ID #s: EPA-HQ-OPPT-2009-0150 through EPA-HQ-OPPT-2009-0159, and EPA-HQ-OPPT-2009-0576.
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OCSPP 850.4300: Terrestrial plants field study.
(a) Scope--
      (1) Applicability.  This guideline is intended to be used to help develop data to submit to EPA under the Toxic Substances Control Act (TSCA) (15 U.S.C. 2601, et seq.), the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) (7 U.S.C. 136, et seq.), and the Federal Food, Drug, and Cosmetic Act (FFDCA) (21 U.S.C. 346a).
      (2) Background.  The source materials used in developing this harmonized OCSPP test guideline include OPP 121-1 Target Area Phytotoxicity Testing and OPP 124-1 Terrestrial Field Testing (Pesticide Assessment Guidelines Subdivision J--Hazard Evaluation: Nontarget Plants); the Non-Target Plants: Target Area Testing Standard Evaluation Procedure; the Non-Target Plants: Terrestrial Field Testing Tier 3 Standard Evaluation Procedure; and ASTM E 1963-02, Standard Guide for Conducting Terrestrial Plant Toxicity Tests. This guideline incorporates what was formerly Public Drafts OCSPP 850.4025 Target area phytotoxicity and OCSPP 850.4300 Terrestrial plants field study (April, 1996).
      (3) General.  This guideline describes general procedures for performing plant toxicity tests under field conditions, whether target area or off-target area.  Thus, for pesticide testing guidance there are no longer separate guidelines for target and non-target area tests.  This guideline should be used in conjunction with OCSPP 850.4000, which provides general information and overall guidance for the nontarget plants test guidelines.
(b) Purpose.  This guideline describes factors to be considered in the design and conduct of field studies for effects of chemical substances and mixtures on terrestrial plants.  Effects considered may include mortality, and sublethal toxic effects such as decreased biomass or other morphological changes, changes in population or community parameters, and lowered productivity such as fewer flowers, pods, fruits or seeds or viability of seeds.  The purpose of the field study is either to provide quantification of the risk that may occur to terrestrial plants, plant populations or plant communities or refute the assumption that risks will occur under conditions of actual use of the test substance (primary consideration for pesticides) or occur under the pattern of production, use, disposal, or accidental release of industrial chemicals in the terrestrial environment.
(c) Definitions.  The definitions in the OCSPP 850.4000 guideline apply to this guideline.  In addition, the definitions in this paragraph apply:
	Community is defined as an assemblage of populations of different species.
	Population is defined as a group of individuals of the same species.
(d) General considerations--
      (1) General test guidance.  In contrast to laboratory tests, which are generally amenable to a high degree of standardization, field study protocols are more flexible reflecting the case-by-case nature of issues and decisions a given field study is designed to address.  Additionally standardization of field studies is made difficult by the variability in the factors that are considered in the design such as chemical mode of action, plant population and community dynamics, and additionally for pesticides differences in use pattern, crop type, and method of application.  This guideline provides a general outline of factors to consider in the conduct of field studies; specific protocols should be developed and submitted to the Agency for review.  Despite the variability among field studies, several key elements common to most field studies can be identified.  This guideline was prepared to identify and discuss these elements as they pertain to terrestrial upland and riparian plants, and to provide a better understanding of the purpose of field studies.  There are two types of field studies, screening and definitive.  The type of field study conducted (screening or definitive) depends on the available data on the test chemical or substance in question and the terrestrial plant population and community dynamics such as species composition, frequency, percent (%) cover and other indices that describe the use and/or study area.  The general guidance in the OCSPP 850.4000 guideline applies to this guideline, except as specifically noted herein.
      (2) Summary of test.  The test substance may be applied in a variety of ways; the selected method should support the specific study objective.  Application methods range from a single application, at a single dose or at a wide range of anticipated test substance doses (or concentrations), as may be found in the environment to multiple applications at a single dose or over a wide range of anticipated test substance levels.  The test is performed under natural conditions and in the environment in which the test substance would be either applied and/or disperses to under normal use practices for pesticides or would occur under the pattern of production, use, disposal, or accidental release for industrial chemicals.  Specific objectives and associated qualitative and quantitative decision statements establishing measurement endpoints and their accuracy and precision should be provided as part of the study plan.  Development of data quality objectives for generating environmental effects data for decision making include: development of decision rules, specifying limits on decision errors, and optimizing design (see the OCSPP 850.4000 guideline and paragraph (i)(11) of this guideline).  Specific protocols should be developed and submitted to the Agency for review prior to conduct of the study.
      (3) Environmental chemistry methods.  Procedures and validity elements for independent laboratory validation of environmental chemistry methods used to generate data associated with this study can be found in 850.6100.  Elements of the original addendum as referenced in 40 CFR 158.660 for this purpose are now contained in 850.6100. These procedures, if followed, would result in data that would generally be of scientific merit for the purposes described in 40 CFR 158.660.
      (4) Screening field study.  If the available effects data is limited to laboratory toxicity data on a limited number of species, a screening field study may be appropriate to determine if hazards or risks extrapolated to populations and communities from the laboratory data are occurring in the field and, if so, to what species before conducting a definitive field study.  The objective of the screening field study is to determine whether impacts to plant populations are occurring and to which species.  "Pass-fail" methods are used to determine whether impacts occur.  Effects considered include measurements of survival, biomass, density, frequency or other appropriate indicators.
      (5) Definitive field study.  If a screening study indicates impacts are occurring, or if other available data suggest or document that deleterious effects have occurred or are extremely likely, the study design should be quantitative, evaluating the magnitude of the impacts in a definitive study.  A quantitative field study focuses on the species affected in the screening phase.  For some test substances or chemicals it may be appropriate to proceed directly to a definitive study without the screening phase.  Careful consideration should to be given to the likelihood of impacts occurring in order to determine which approach to use.  At the quantitative level (definitive study), the objectives should include estimating the magnitude of the effects caused by the application, the existence and extent of reproductive effects, and the influence of chemical use on the survival and ecological function of species of concern.
      (6) Endangered species.  Studies should not be conducted in critical habitats or areas where endangered or threatened species could be exposed.
(e) Test standards.  Environmental and exposure conditions under which a field test is conducted should resemble the conditions likely to be encountered under actual production, use, disposal or fate of the test substance.
      (1) Test substance.  For industrial chemicals, the substance to be tested should be technical grade unless the test is designed to test a specific formulation, mixture, or end-use product.  For pesticides the substance to be tested is usually the typical end-use product (TEP).  In addition, if an adjuvant is recommended for use on a TEP label, the adjuvant is added with the TEP at the label rate to constitute the test substance.  If the pesticide product is applied in a tank mixture, dosages of each active ingredient (a.i.) should be reported with identification and formulation for each product in the tank mix.  The OCSPP 850.4000 guideline lists the type information that should be known about the test substance before testing.
      (2) Test duration.  Due to the highly variable nature of objectives for field studies, no single test duration can be established for the screening or definitive field studies.  Investigators are encouraged to consult with the Agency to reach agreement on acceptable study duration prior to conduct of the field study.  Several seasons or one or more years may be appropriate where one of the objectives of the definitive field study includes evaluating lowered productivity due to effects on seed viability or evaluating alteration in community integrity.  Seasonal and annual variation in plant species, population and community attributes should be considered when selecting the study duration.  The field study duration should be selected to meet the stated study objectives.
      (3) Study species.  The number and type of species investigated should be based on the specific objectives of the field study.  The scope and scale can vary from investigation of effects to a specific crop species to one or more plant communities which are comprised of a wide-range of species.  For a community the test may investigate a selected cross-section of the nontarget plant population.

      (4) Administration of test substance--
      (i) Test substance application.
                  (A) The choice of method for test substance application is dependent upon the properties of the test substance, expected exposure pathways for plants in the environment from purposeful application, when the test substance is a pesticide, or expected exposure pathways based on the pattern of production, use, disposal, or accidental release, when the test substance is an industrial chemical, and the anticipated range and distribution of test substance quantities likely to be found in the environment.
                  (B) For pesticides, consideration should also be given to proposed or registered application rates and application methods.  Where the study objective is to directly measure effects or "lack of effects" from labeled use, the method of application used and the frequency of application should be consistent with the label.  Equipment used may influence potential exposure of nontarget species.  The diversity of types of application equipment that, depending on the particular use pattern involved, could influence exposure.  The various types of equipment normally used for the particular pesticide application should be evaluated to estimate the potential influence of equipment used on exposure.  In some instances, preliminary tests may be required to estimate which method and equipment poses the highest exposure.  The use of small site field equipment that may mimic the application equipment may be useful.
            (ii) Treatment levels.
                  (A) For a screening field study, where the objective is to determine whether impacts occur or not (i.e., "pass-fail"), a single treatment level plus a control may be appropriate.  For a pesticide screening field study, where the study objective is to directly measure effects from labeled use, the treatment level should be applied at a minimum at the maximum use rate and frequency specified on the label.
                  (B) For a definitive field study, where the objective is to evaluate the magnitude of effects across a range of environmental concentrations, multiple treatment levels plus a control would be appropriate.  The range of treatment levels selected should bracket the range of environmental concentrations for which conclusions are to be drawn.  The number of treatment levels selected when fitting a response-relationship should be sufficient to meet the level of precision desired and allow determination of the goodness-of-fit.  Consult a statistician for assistance in determining the number of treatment levels.  For a pesticide definitive field study where the study objective is to directly measure effects from labeled use, one of the treatment levels should at a minimum include the maximum use rate and frequency specified on the label.
            (iii) Application timing.  When the test substance, particularly a herbicide, plant regulator, desiccant, or defoliant, is applied to any desirable nontarget plants within or adjacent to the target area, the stage of growth or development of the plants at application should be observed and recorded.  Field studies should not be done during the period of seasonal senescence of the foliage in which the leaves die back in the late summer.  For serial applications, record the times of application (or application interval) for each product or tank mix involved in the serial application.
      (5) Test conditions.  The test conditions for conducting a field test should resemble the conditions likely to be encountered under actual use, disposal, or accidental spill of an industrial test substance or under actual application conditions for a pesticide.  While each field study is unique, some elements may be common among many field studies.
            (i) Review of pertinent literature.  A well-designed protocol should include a restatement of the concerns to be addressed to ensure that there is an adequate understanding of the Agency's position.  Literature and other available information that may bear upon the problem should be reviewed and pertinent information summarized in the protocol.  It is possible that the literature may contain a valid answer to the questions raised by the Agency.  At a minimum, the literature may orient the investigator to address the concerns in a particular way.
            (ii) Site characteristics.  All protocols should contain a description of the characteristics to be used, or that were used, in selecting sites within a given area.  If sites were selected a description of the study sites should also in the protocol.
            (iii) Methods.  All protocols should contain a description of the methods to be used in conducting the study.  The protocol should provide the reasons why particular methods are being used, including, at least qualitatively, the meaning that different results might have based on choice of methods.
            (iv) Timing.  Consideration should be given to the season(s) over which the study is conducted.  For certain species (ferns, shrubs, trees, etc.) tests should not be performed at a time or season where the timing of the study outdoors (August and September) is during a period of senescence of the foliage in which the leaves die back in late summer.  This dieback may contribute to the lessening of the test substance's effect on the terrestrial plant test species.  If effects to a crop species are under consideration, plants should be grown under crop/cultivar agronomic or horticultural practices.  For pesticides, the test substance is to be applied over a period of time or season according to label instructions.
      (6) Sampling and experimental design.
            (i) While examples of acceptable experimental designs are given, it is beyond the purpose of this guideline to cover the fundamentals of this topic.  References in paragraphs (i)(2) through (i)(7), and (i)(11) of this guideline provide resources for guidance regarding sampling and experimental design, especially for measuring effects on plants in natural habitats.
            (ii) A well-designed protocol will contain an experimental design that will indicate how the results are to be assessed quantitatively and a section on how results will be interpreted.
                  (A) As part of the description of the experimental design for hypothesis testing approaches, the magnitude of the difference the study is designed to detect between treated and untreated plots and the power (ability) of the design to detect this difference should be discussed.  Coefficient of variation estimates from screening studies, literature, or laboratory tests that closely approximates reality can be used to design the study and determine the number of replicates.
                  (B) As part of the description of the experimental design for response-relationship field studies, the environmental range for which the predictions are to address, the treatment spacing, and approach for assessing fit should be discussed.
      (7) Geographic area selection.
            (i) Studies should be performed in representative biogeographic areas where the test substance will occur under conditions of actual use of the test substance (primary consideration for pesticides) or occur under the pattern of production, use, disposal, or accidental release of industrial chemicals.  To keep the number of geographic areas at a manageable level while still accomplishing the purpose of the field study, area selection should emphasize situations likely to present the greatest risk taking into account the diversity and variability in ecosystems involved.
            (ii) A careful review of the species and habitats in the geographical areas involved should be performed to aid in identifying the areas of highest concern.  A sound understanding of the biology of the species that are found in association with the areas is essential.  Identifying these areas is likely to include a literature review and consultation with experts familiar with the areas and species of concern.  The study area selected should be appropriate for the species of concern.  If exposure and fate (e.g., degradation, transformation) parameters vary geographically, study area selection should also focus on those areas with factors which maximize residues available for exposure.  In some circumstances preliminary monitoring of candidate areas may be appropriate to determine which ones should be selected for detailed study.
      (8) Study site selection.
            (i) Within a geographic area, study sites should be selected from those considered to be typical application sites for pesticides, or a typical exposure site which occurs under the pattern of production, use, disposal, or accidental release of industrial chemicals, but at the same time, study sites should contain the widest possible diversity and density of plant species for the geographic area.
            (ii) To maximize the hazard, the sites selected should have associated species that would be at highest risk, as well as a good diversity of species to serve as indicators for other species not present at that specific location.  The choice of study sites that are as similar as possible in terms of abundance, diversity, and associated habitat will facilitate an analysis of the results.
            (iii) Identifying potential study sites may call for consultation with experts familiar with the areas where studies are proposed, and preliminary sampling.  Field surveys of a number of sites may be used to identify which sites contain species likely to be at highest risk.  Preliminary surveys may also be used to determine which sites have adequate numbers of the high risk species as well as a good diversity of other species.
            (iv) If crop species are the selected study species, then the selection of the site should be representative of major production sites for that particular crop.  In such situations, diversity and density of non-crop plant species may not be necessary to answer the questions posed by the study.
      (9) Control sites.  Controls sites should be selected to be as comparable with treated study sites in species, diversity, biomass, and selected study variables.  The control sites should also be located as close as possible to selected treated study sites but at enough of a distance and juxtaposition that cross-contamination from application or treatment will not occur.
      (10) Size of study sites.  Study sites should be large enough to provide adequate sample. The size is dependent on the methods used, the sensitivity needed, and the density and diversity of species.  Consideration should be given to the distance between study sites.  Sites should be separated adequately to ensure independence.
      (11) Number of sites.
            (i) The number of sites (or replicates) to include in the study may be estimated in many ways, but the number should be sufficient to detect the size of difference with a given level of power identified as part of the data quality objectives or estimate the parameter(s) of interest with the level of desired confidence identified as part of the data quality objectives.  The methodology and rationale for selecting the number of sites should be clearly outlined and described in the study plan.  Paragraph (i)(11) of this guideline provides guidance on estimating number of replicates for a number of statistical methods.  Recommend consulting a statistician when estimating the number of replicates which should be used.
            (ii) Under some circumstances, particularly if endangered species could be exposed from the proposed use, additional replication may be desirable because under these conditions, a high degree of confidence that effects are negligible is likely to be desired.  (Under no circumstances should field studies on chemicals be conducted in areas where endangered species could be exposed unless approval is provided by the FWS authority for that particular listed species.)
            (iii) It is important to define the critical or threshold level for an effect, and to be sure that the methods used are sensitive enough to detect the effect size of concern.  Whatever parameters are used, defining the criteria level for an effect is extremely important, and when designing studies this issue should be considered carefully.
            (iv) Careful consideration should be given to the controls having sufficient number of replicate sites so that a statistical analysis can provide meaningful insight regarding the study objective.
(f) Interpretation of results.  Because of the substantial diversity in the types of problems to be assessed and the variety of available investigative methods, the key to understanding and interpreting a field study lies in the development of a sound protocol.  A sound protocol should contain a description of the study sites, or the characteristics to be used in selecting sites within a given area, and the methods to be used in conducting the study.  However, a well designed protocol will go beyond this descriptive approach in three ways.
      (1) First, a well-designed protocol should contain a restatement of the concerns to be addressed to ensure that there is an adequate understanding of the Agency's position.  The investigator should review the literature and other available information that may bear upon the problem.  It is possible that the literature may contain a valid answer to the questions raised by the Agency.  Far more likely, the literature may orient the investigator to address the concerns in a particular way.  By using the available literature on both the chemical and the particular species of concern, the investigators may be able to narrow the study while still providing sufficient information for evaluation.  However, in narrowing the focus of the study (e.g., to a single species or a single geographic area) it may limit the adequacy of the study for evaluating effects to other species, or for other use patterns that may result in exposure to different species or geographic areas.
      (2) Second, a well designed protocol will provide the reasons why particular methods are being used, including, at least qualitatively, the meaning that different results might have. For example, a protocol may include collection of residues in plant tissues, but it also should include a statement of purpose and meaning for such collection.  Residues may be used to confirm exposure to nontarget plants by spray drift or runoff, or that a particular chemical was likely to be the cause of any observed effects. Interpretation of data is facilitated substantially by a statement of what results were intended by using a particular technique.
      (3) Third, a well designed protocol will contain an experimental design that will indicate how the results can be assessed quantitatively.  The experimental design has been discussed in previous sections of this guideline, but there are two facets that relate closely to the interpretation of results: the difference that can be detected between treated and untreated plots and the power (ability) of the design to detect this difference.  An experimental design with number of replicates based on an estimated coefficient of variation that closely approximates reality will allow the study to detect a stated concern level.  The actual difference between treated and control units is measured during the field study, but the design can form an initial basis for interpretation when combined with the available information on the species of concern. As a result, the well-designed protocol should include a section on interpretation.
      (4) The Agency would like to be able to obtain a standardized result from a field study so that the result could be applied in a very consistent manner.  As discussed in previous sections of this guideline, the different effects and species of concern will vary and specific study protocols should be developed to address these factors.  Although most of the various techniques have some degree of standardization, the field study may combine the individual techniques in a wide variety of ways to address specific concerns.  A standardized result might be attainable for the individual techniques, although that result would still have to be applied differently for various species, depending on their biology and ecological characteristics.  However, determining a result for the whole field study that would unequivocally lead to a statement of the degree of risk, while obviously desirable, is not currently practical.
(g) Test validity elements.  In the case of field studies, validity elements will vary with the purpose and design of the study, and should be developed in cooperation with the Agency prior to the implementation of the study.  Generally, studies would be considered to be unacceptable if one or more of the conditions in Table 1 occurred.  This list should not be misconstrued as limiting the reason(s) that a test could be found unacceptable.
	Table 1. -- Some test validity elements for the terrestrial plants field study
--------------------------------------------------------------------------------
1.  The population of test plants and/or replicates was of an insufficient size to characterize or detect effects with an acceptable degree of certainty.

2.  The controls were contaminated with the test substance or there was insufficient sampling or study conditions to document that controls were not contaminated.

--------------------------------------------------------------------------------
3.  Control plants were not maintained under the same test conditions as the test substance plants.

(h) Reporting--
      (1) Background information.  Background information to be supplied in the report consists at a minimum of those background information items listed in paragraph (j)(1) of the OCSPP 850.4000 guideline.  Due to the variability among tests and test objectives, this list should not be considered comprehensive.
      (2) Test substance.
            (i) Identification of the test substance (name, state or form, source), its purity (for pesticides, the identity (common name, IUPAC and CAS names, CAS number) and concentration of active ingredient(s)), and known physical and chemical properties that are pertinent to the test.
		(ii) Storage conditions of the test substance.
            (iii) Methods of preparation of test substance for application onto foliage, the maximum label rate, and the actual application rate (lb a.i./A) with the finished spray volume per acre.
            (iv) If residue analysis is performed on foliage, describe the stability of the test substance under storage conditions.
		(v) Data on storage of the plant material, if applicable.
      (3) Site of the test.
            (i) Site description of the terrestrial field testing study such as a grassland, forested area, fallow field, tilled field, etc.
            (ii) Location of the test sites that represent the general regional areas of potential usage such as Northeastern temperate deciduous; Southeastern temperate deciduous; Northern grassland (cool prairie); Southern grassland (warm prairie); Northwestern (and Alaskan) conifer forest and high desert; Southwestern chaparral Mediterranean and low desert; and Hawaiian and Caribbean semitropical and tropical regions.
		(iii) Physiographic conditions including:
                  (A) The edaphic conditions and characterization including soil type and texture, approximate pH and temperature, Kd and Kow values.
                  (B) Where the presence of a fragipan or shallow bedrock may lead to restricted leaching or soil waterflow, the depth of that restriction.
                  (C) The degree and direction of slope and its orientation to the row direction if the slope will lead to excessive runoff.
			(D) Map or diagram showing location of treated plants and controls.
            (iv) Climatological data during the test: records of applicable conditions for the type of site, i.e., temperature, thermoperiod, rainfall or watering regime, light regime including intensity and quality, photoperiod, relative humidity, wind speed, etc.
            (v) Substrate characteristics of the sites: name/designation of soil type and its physical and chemical properties, including pH and percent organic matter.
      (4) Species at test site.
            (i) For investigation of a crop species the information in paragraphs (h)(4)(1)(A) through (h)(4)(1)(H) of this guideline should be reported.
                  (A) Scientific and common name, plant family and variety including species/variety and cultivar if appropriate.
			(B) Test date of germination rating and germination percentage.
                  (C) History of the seed: Source, name of supplier, seed year or growing season collected, batch or lot number, seed treatment(s), and storage conditions.
			(D) Seed size class.
			(E) Description of handling and processing of seeds before use in test.
			(F) Planting dates.
			(G) Stage of development, height and condition of plants that are treated.
			(H) Population density of seeds or plants.
            (ii) For nontarget plant species the study design objectives and protocols will impact the scale (i.e., all species, cross-section, selected species) of reporting of the information on nontarget species.
                  (A) Number and type of species investigated and the scale of identification (e.g., a single species of concern, all species of a community or a selected cross-section).
			(B) Scientific and common name, plant family and variety.
			(C) Stage of development and condition of plants at test initiation.
      (5) Study conditions and experimental design.  Description of the study conditions and experimental design used in the screening or definitive tests, and any preliminary testing.
            (i) A statement of the concerns to be addressed and the type and frequency of monitoring of vegetation measures (e.g., diversity, abundance, biomass, emergence) addressing these concerns.
            (ii) The field study design: size of field sites, number of control sites, the number of experimental treatment levels and the number of experimental sites (replicates) for each treatment, the lay-out and distance of field sites to each other and to control sites.
		(iii) Methods used for treatment randomization.
            (iv) Method of test substance application: exposure route (e.g., irrigation, soil incorporation, surface soil, or foliar exposure), application or delivery methods (including equipment type and design (nozzles, orifices, pressures, flow rates, volumes, etc.)) and method for calibrating the application equipment), information about any solvent used to dissolve and apply the test substance.
		(v) Number of applications and dates applied.
		(vi) Study duration.
            (vii) Methods and frequency of climatological monitoring performed during the screening or definitive study for air temperature, thermoperiod, humidity, rainfall and watering regime, light intensity, and wind speed.
		(viii) The photoperiod and light quality.
            (ix) Methods and frequency of monitoring of other ancillary nontreatment related factors that may influence the measures of effect at the study site should be reported.  For example, if a crop species is studied or if a crop is treated concurrent to the investigation of nontarget plant effects, cultural practices during the tests such as cultivation, pest control, irrigation practices; and any nutrient amendments.  Any infestations of disease or insects should be monitored and reported for the study sites.
            (x) For the screening and definitive studies, all analytical procedures should be described.  The accuracy of the method, method detection limit, and limit of quantification should be given.  Provide the ILV report.
      (6) Results.
            (i) Environmental monitoring data results (air temperature, humidity and light intensity, rainfall) in tabular form (provide raw data for measurements not made on a continuous basis), and descriptive statistics (mean, standard deviation, minimum, maximum).
      	(ii) Tabulation of the results of study-specific vegetative measures (e.g., emergence, height, dry weight, yield of seeds or fruit, germination rate of second generation, phytotoxicity rating, diversity, abundance) by field site and treatment (provide the raw data), and summary statistics.  If phytotoxicity rating measures are made a description of the rating system should be included.
      	(iii) Description (i.e., method of determination) of and tabular summary of any secondary vegetative measures.
      	(iv) Statement of the data objectives for specific direct and secondary vegetative measures (i.e., the critical or threshold level for an effect, precision of a point estimate).
      	(v) Description of the statistical method(s), software package(s) used, the basis for the choice of the method(s), statements of the reasons why particular methods are being used, including, at least qualitatively, the meaning that different results might have.
      	(vi) Results of the statistical analysis including graphical and tabular summaries, and results of goodness-of-fit tests or minimum significant differences detectable, as appropriate.
(i) References.  The references in this paragraph should be consulted for additional background material on this test guideline.
	(1) American Society for Testing and Materials.  2002.  ASTM E 1963-02.  Standard guide for conducting terrestrial plant toxicity tests. In Annual Book of ASTM Standards, Vol. 11.06, ASTM, West Conshohocken, PA.  Current edition approved December 10, 2002.
	(2) Cooperrider, A. Y., R. J. Boyd and H. R. Stuart, eds.  1986.  Inventory and monitoring of wildlife habitat.  U.S. Department of Interior, Bureau of Land Management Service Center, Denver, CO. sviii, 858 pp.
	(3) Little, T.M. and F.J. Hills.  1978.  Agricultural Experimentation - Design and Analysis. Wiley, NY.
	(4) Pfleeger, T., 1991.  Impact of Airborne Pesticides on Natural Plant Communities. In EPA Publ. EPA/600/9-91/041, Plant Tier Testing: A Workshop to Evaluate Nontarget Plant Testing in Subdivision J Pesticide Guidelines, Nov. 29-Dec. 1, 1990, ERL, Corvallis, OR. pp. 108-123.
	(5) Phillips, E.A., 1959. Methods of Vegetation Study. NY: Holt, Rhinehart, and Winston.
	(6) Ratsch, H. and J.S. Fletcher.  1991.  Plant Reproduction and/or Life Cycle Testing. In EPA Publ. EPA/600/9-91/041, Plant Tier Testing: A Workshop to Evaluate Nontarget Plant Testing in Subdivision J Pesticide Guidelines, Nov. 29-Dec. 1, 1990, ERL, Corvallis, OR. pp. 80-89.
	(7) Truelove, B., ed., 1977.  Research Methods in Weed Science. Southern Weed Science Society, Auburn Printing, Auburn, AL.
	(8) U.S. Environmental Protection Agency, 1982.  Pesticide Assessment Guidelines, Subdivision J -- Hazard Evaluation: Non-target plants.  Office of Pesticides Programs, EPA 540/9-82-020, Washington, DC.
	(9) U.S. Environmental Protection Agency, 1986.  Hazard Evaluation Division Standard Evaluation Procedure, Non-target Plants: Terrestrial Field Testing Tier 3.  Office of Pesticides Programs, Washington, D.C.  EPA 540/9-86-135, June 1986.
	(10) U.S. Environmental Protection Agency, 1986.  Hazard Evaluation Division Standard Evaluation Procedure, Non-target Plants: Target Area Testing.  Office of Pesticides Programs, Washington, D.C.  EPA 540/9-86-130, June 1986.
	(11) U.S. Environmental Protection Agency, 2000.  Guidance for the Data Quality Objectives Process (QA/G-4), EPA/600/R-96/055, Office of Research and Development.


[Federal Register Volume 86, Number 150 (Monday, August 9, 2021)]
[Notices]
[Page 43537]
[FR Doc No: 2021-16924]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. NJ21-12-000]

Oncor Electric Delivery Company LLC; Notice of Filing

    Take notice that on August 3, 2021, Oncor Electric Delivery Company
LLC submitted its tariff filing: Oncor TFO Tariff Rate Changes, to be
effective 3/26/2021.
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docketed proceedings should be delivered to Health and Human Services,
12225 Wilkins Avenue, Rockville, Maryland 20852.
    Comment Date: 5:00 p.m. Eastern Time on August 24, 2021.

    Dated: August 3, 2021.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2021-16924 Filed 8-6-21; 8:45 am]
BILLING CODE 6717-01-P


public notification), and part C of this subchapter (relating to PSD of
air quality and visibility protection).''
    The State has demonstrated it has the authority and rules in place
through its certifications (contained within this docket) to provide a
process of consultation with general purpose local governments,
designated organizations of elected officials of local governments and
any Federal Land Manager having authority over federal land to which
the SIP applies, consistent with the requirements of CAA section 121.
Furthermore, EPA previously addressed the requirements of CAA section
127 for the South Dakota SIP and determined public notification
requirements are appropriate (45 FR 58528, Sept. 4, 1980).
    As discussed above, the State has a SIP-approved PSD program that
incorporates by reference the federal program at 40 CFR 52.21. EPA has
further evaluated South Dakota's SIP approved PSD program in this
proposed action under element (C) and determined the State has
satisfied the requirements of element 110(a)(2)(C), as noted above.
Therefore, the State has also satisfied the requirements of element
110(a)(2)(J).
    Finally, with regard to the applicable requirements for visibility
protection, EPA recognizes states are subject to visibility and
regional haze program requirements under part C of the Act. In the
event of the establishment of a new NAAQS, however, the visibility and
regional haze program requirements under part C do not change. Thus, we
find that there are no applicable visibility requirements under section
110(a)(2)(J) when a new NAAQS becomes effective.
    Based on the above analysis, we propose to approve the South Dakota
SIP as meeting the requirements of CAA section 110(a)(2)(J) for the
1997 and 2006 PM2.5, 2008 Pb, 2008 ozone, and 2010
NO2 NAAQS.
    11. Air quality and modeling/data: Section 110(a)(2)(K) requires
each SIP provide for: (i) The performance of such air quality modeling
as the Administrator may prescribe for the purpose of predicting the
effect on ambient air quality of any emissions of any air pollutant for
which the Administrator has established a NAAQS, and (ii) the
submission, upon request, of data related to such air quality modeling
to the Administrator.
    South Dakota's PSD program incorporates by reference the federal
program at 40 CFR 52.21, including the provision at 40 CFR 52.21(l)(1)
requiring that estimates of ambient air concentrations be based on
applicable air quality models specified in Appendix W of 40 CFR part
51, and the provision at 40 CFR 52.21(l)(2) requiring that modification
or substitution of a model specified in Appendix W must be approved by
the Administrator.
    Additionally, SDLC section 34A-1-1, 34A-1-10, and 1-40-31 provide
the Department with the authority to advise, consult, and cooperate
with EPA and provide EPA with public records, such as air quality
modeling. As a result, the SIP provides for such air quality modeling
as the Administrator has prescribed. Therefore, we propose to approve
the South Dakota SIP as meeting the CAA section 110(a)(2)(K) for the
1997 and 2006 PM2.5, 2008 Pb, 2008 ozone, and 2010
NO2 NAAQS.
    12. Permitting fees: Section 110(a)(2)(L) requires SIPs to: Require
the owner or operator of each major stationary source to pay to the
permitting authority, as a condition of any permit required under this
act, a fee sufficient to cover; (i) the reasonable costs of reviewing
and acting upon any application for such a permit; and (ii) if the
owner or operator receives a permit for such source, the reasonable
costs of implementing and enforcing the terms and conditions of any
such permit (not including any court costs or other costs associated
with any enforcement action), until such fee requirement is superseded
with respect to such sources by the Administrator's approval of a fee
program under title V.
    The funding sources used for the PSD permit reviews conducted by
South Dakota derive from EPA grant and matching State general
funds.\39\ There are no nonattainment areas in the State. In light of
the State's experience that funding from grants and general funds has
been sufficient to operate a successful PSD program, it is reasonable
that the PSD permit applicants are not charged any permit-specific
fees.
---------------------------------------------------------------------------

    \39\ See Email from Brian Gustafson ``Question Regarding
Permitting Fees for SD iSIP Action'' July 24, 2014, available within
docket.
---------------------------------------------------------------------------

    We also note that all the State SIPs we are proposing to approve in
this action

cite the regulation that provides for collection of permitting fees
under the State's EPA-approved title V permit program (ARSD 74:37:01),
which we approved and became effective February 28, 1996 (61 FR 2720,
Jan. 29, 1996).
    Therefore, based on the State's experience in relying on the grant
and general funds for PSD permits, and the use of title V fees to
implement and enforce PSD permits once they are incorporated into title
V permits, we propose to approve the submissions as supplemented by the
State for the 1997 and 2006 p.m.2.5, 2008 Pb, 2008 ozone,
and 2010 NO2 NAAQS.
    13. Consultation/participation by affected local entities: Section
110(a)(2)(M) requires states to provide for consultation and
participation in SIP development by local political subdivisions
affected by the SIP.
    The statutory provisions cited in South Dakota's SIP submittals
(contained within this docket) meet the requirements of CAA section
110(a)(2)(M), so we propose to approve South Dakota's SIP as meeting
these requirements for the 1997 and 2006 PM2.5, 2008 Pb,
2008 ozone, and 2010 NO2 NAAQS.

VII. What action is EPA taking?

    In this action, EPA is proposing to approve the following
infrastructure elements for the 1997 and 2006 PM2.5, 2008
Pb, 2008 ozone, and 2010 NO2 NAAQS: (A), (B), (C) with
respect to minor NSR and PSD requirements, (D)(i)(II) prongs 3 and 4,
(D)(ii), (E), (F), (G), (H), (J), (K), (L), and (M). EPA is also
proposing to approve revisions to ARSD 74:36:09 submitted on July 29,
2013, which incorporate by reference the requirements of the 2010
PM2.5 Increment Rule. Specifically, we propose to approve
the adoption of the text of 40 CFR 52.21, paragraphs
(b)(14)(i),(ii),(iii), (b)(15)(i),(ii), and paragraph (c) as they
existed on July 1, 2012 by proposing to approve revisions to: ARSD
74:34:09:02 (Prevention of significant deterioration) and 74:36:09:03
(Public participation). EPA is also proposing to approve revisions to
ARSD 74:09 and SDCL 1-40-25.1 submitted on June 11, 2014 to satisfy
requirements of element (E)(ii), state boards. Finally, EPA proposes
approval of D(i)(I) prongs 1 and 2 for the 2006 PM2.5, 2008
Pb, and 2010 NO2 NAAQS. EPA will act separately on
infrastructure element (D)(i)(I), interstate transport for the 2008
ozone NAAQS.

VIII. Statutory and Executive Orders Review

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
federal regulations (42 U.S.C. 7410(k), 40 CFR 52.02(a)). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
proposed action merely approves some state law as meeting federal
requirements and disapproves other state law because it does not meet
federal requirements; this proposed action does not impose additional
requirements beyond those imposed by state law. For that reason, this
proposed action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, Oct. 4, 1993);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, Aug. 10, 1999); is not an
economically significant regulatory action based on health or safety
risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and,
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, Feb. 16, 1994).
    In addition, this rule does not have tribal implications as
specified by Executive Order 13175 (65 FR 67249, Nov. 9, 2000), because
the SIP is not approved to apply in Indian country located in the
state, and EPA notes that it will not impose substantial direct costs
on tribal governments or preempt tribal law.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Carbon monoxide,
Greenhouse gases, Incorporation by reference, Intergovernmental
relations, Lead, Nitrogen dioxide, Ozone, Particulate matter, Reporting
and recordkeeping requirements, Sulfur oxides, Volatile organic
compounds.

    Authority:  42 U.S.C. 7401 et seq.

    Dated: November 19, 2014.
Shaun L. McGrath,
Regional Administrator, Region 8.
[FR Doc. 2014-28301 Filed 11-28-14; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 82, Number 185 (Tuesday, September 26, 2017)]
[Notices]
[Page 44770]
[FR Doc No: 2017-20516]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER17-2510-000]

RE Gaskell West 4 LLC; Supplemental Notice That Initial Market-
Based Rate Filing Includes Request for Blanket Section 204
Authorization

    This is a supplemental notice in the above-referenced proceeding of
RE Gaskell West 4 LLC's application for market-based rate authority,
with an accompanying rate tariff, noting that such application includes
a request for blanket authorization, under 18 CFR part 34, of future
issuances of securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is October 10, 2017.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
5 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for electronic review in the
Commission's Public Reference Room in Washington, DC. There is an
eSubscription link on the Web site that enables subscribers to receive
email notification when a document is added to a subscribed docket(s).
For assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For TTY,
call<PHONE_NUMBER>.

    Dated: September 20, 2017.
Kimberly D. Bose,
Secretary.
[FR Doc. 2017-20516 Filed 9-25-17; 8:45 am]
 BILLING CODE 6717-01-P


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NIOSH Pocket Guide to Chemical Hazards

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E - OSHA Respirator Requirements for Selected Chemicals

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                    Toluene-2,4-diisocyanate

Synonyms & Trade Names

                  TDI; 2,4-TDI; 2,4-Toluene diisocyanate

CAS No.

                  584-84-9

RTECS No.

                  CZ6300000

DOT ID & Guide

                  2078 156

Formula
CH3C6H3(NCO)2

Conversion

                  1 ppm = 7.13 mg/m3

IDLH

                  Ca [2.5 ppm]
See: 584849

Exposure Limits

NIOSH REL
: Ca See Appendix A

OSHA PEL
†: C 0.02 ppm (0.14 mg/m3)

Measurement Methods

                  NIOSH 2535  , 5521  , 5522  , 5525 ;
OSHA 18 , 33 , 42

                  See: NMAM or OSHA Methods

Physical Description

                  Colorless to pale-yellow solid or liquid (above 71°F) with a sharp, pungent odor.

MW:
 174.2

BP:
 484°F
                MLT: 71°F

Sol:
 Insoluble
                VP(77°F): 0.01 mmHg

IP:
 ?

Sp.Gr:
 1.22

Fl.P:
 260°F

UEL:
 9.5%

LEL:
 0.9%

                Class IIIB Combustible Liquid: Fl.P. at or above 200°F.

Incompatibilities & Reactivities

                  Strong oxidizers, water, acids, bases & amines (may cause foam & spatter); alcohols
                  [Note: Reacts slowly with water to form carbon dioxide and polyureas.]

Exposure Routes

                  inhalation, ingestion, skin and/or eye contact

Symptoms

                  irritation eyes, skin, nose, throat; choke, paroxysmal cough; chest pain, retrosternal (occurring behind the sternum) soreness; nausea, vomiting, abdominal pain; bronchitis, bronchospasm, pulmonary edema; dyspnea (breathing difficulty), asthma; conjunctivitis, lacrimation (discharge of tears); dermatitis, skin sensitization; [potential occupational carcinogen]

Target Organs

                  Eyes, skin, respiratory system

Cancer Site
[in animals: pancreas, liver, mammary gland, circulatory sys & skin tumors]

Personal Protection/Sanitation

                  (See protection codes)

                  Skin: Prevent skin contact

                  Eyes: Prevent eye contact

                  Wash skin: When contaminated/Daily

                  Remove: When wet or contaminated

                  Change: Daily

                  Provide: Eyewash, Quick drench

First Aid

                  (See procedures)

                  Eye: Irrigate immediately

                  Skin: Soap wash immediately

                  Breathing: Respiratory support

                  Swallow: Medical attention immediately

Respirator Recommendations

NIOSH

At concentrations above the NIOSH REL, or where there is no REL, at any detectable concentration:
(APF = 10,000) Any self-contained breathing apparatus that has a full facepiece and is operated in a pressure-demand or other positive-pressure mode
(APF = 10,000) Any supplied-air respirator that has a full facepiece and is operated in a pressure-demand or other positive-pressure mode in combination with an auxiliary self-contained positive-pressure breathing apparatus

Escape:
(APF = 50) Any air-purifying, full-facepiece respirator (gas mask) with a chin-style, front- or back-mounted organic vapor canister
Any appropriate escape-type, self-contained breathing apparatus

 Important additional information about respirator selection

                See also: INTRODUCTION
                    See ICSC CARD: 0339
                    See MEDICAL TESTS: 0233

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