[Federal Register Volume 83, Number 109 (Wednesday, June 6, 2018)]
[Notices]
[Pages 26327-26329]
[FR Doc No: 2018-12115]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-83357; File No. SR-NYSEAMER-2018-24]

Self-Regulatory Organizations; NYSE American LLC; Notice of
Filing and Immediate Effectiveness of Proposed Rule Change To Amend
Rule 7.37E and Rule 7.45E With Respect to NYSE National's Reopening of
Trading and Reactivating Connection to the Securities Information
Processors

May 31, 2018.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (the ``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby
given that on May 18, 2018, NYSE American LLC (the ``Exchange'' or
``NYSE American'') 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 self-regulatory
organization. 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\ 15 U.S.C 78a.
    \3\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of the
Substance of the Proposed Rule Change

    The Exchange proposes to: (1) Amend Rule 7.37E to amend in Exchange
rules the Exchange's use of data feeds from NYSE National, Inc. (``NYSE
National'') for order handling and execution, order routing, and
regulatory compliance; and (2) amend Rule 7.45E to reflect that
Archipelago Securities LLC (``Arca Securities'') would function as a
routing broker for the Exchange's affiliate, NYSE National. The
proposed rule change is available on the Exchange's website at
www.nyse.com, at the principal office of the Exchange, and at the
Commission's Public Reference Room.

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 parts of such statements.

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

1. Purpose
    The Exchange proposes to update and amend the table in Rule 7.37E
that sets forth on a market-by-market basis the specific network
processor and proprietary data feeds that the Exchange utilizes for the
handling, execution and routing of orders, and for performing the
regulatory compliance checks related to each of those functions. NYSE
National intends to reopen trading and reactivate its connections to
the securities information processors (``SIPs''). To reflect that, the
Exchange proposes to revise Rule 7.37E to specify which data feeds the
Exchange would use for NYSE National. Rule 7.37E currently provides
that NYSE National uses the SIP data feeds as the primary source and
does not have a secondary source. The Exchange proposes to use the
direct data feeds for NYSE National and would use the SIP data feeds as
a secondary source.
    Additionally, the Exchange proposes to amend Rule 7.45E to reflect
that Arca Securities would function as a routing broker for the
Exchange's affiliate, NYSE National. Specifically, the Exchange
proposes to amend Rule 7.45E(c)(1) and (2) to reference NYSE National
as an affiliate of the Exchange for the purposes of the inbound routing
function performed by Arca Securities. The proposed rule change would
provide more clarity and transparency to all the functions that Arca
Securities performs on behalf of the Exchange and its affiliates, which
now includes NYSE National. The Exchange is not proposing any
substantive change to the rule.
2. Statutory Basis
    The proposed rule change is consistent with Section 6(b) of the
Securities Exchange Act of 1934 (the ``Act''),\4\ in general, and
furthers the objectives of Section 6(b)(5),\5\ in particular, because
it is designed to prevent fraudulent and manipulative acts and
practices, to promote just and equitable principles of trade, to foster
cooperation and coordination with persons engaged in facilitating
transactions in securities, 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. The Exchange
believes its proposal to update the table in Rule 7.37E will ensure
that the rule correctly identifies on a market-by-market basis all of
the specific network processor and proprietary data feeds that the
Exchange utilizes for the handling, execution and routing of orders,
and for performing the regulatory compliance checks to each of those
functions. The proposed rule change also removes impediments to and
perfects the mechanism of a free and open market and protects investors
and the public interest because it provides additional specificity,
clarity and transparency. The Exchange believes its proposal to amend
Rule 7.45E removes impediments to and perfects the mechanism of a free
and open market and protects investors and the public interest because
the proposed rule change would enhance the clarity and transparency in
Exchange Rules surrounding the inbound routing function performed by
Arca Securities for the Exchange's affiliate, NYSE National.
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    \4\ 15 U.S.C. 78f(B).
    \5\ 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 that is not necessary or appropriate
in furtherance of the purposes of the Act. The proposed change is not
designed to address any competitive issue but rather would provide the
public and investors with information about which data feeds the
Exchange uses for execution and routing decisions, and provide clarity
in Exchange rules that Arca Securities would perform the inbound
routing function on behalf on the Exchange's affiliate, NYSE National.

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

    No written comments were solicited or received with respect to the
proposed rule change.

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

    Because the proposed rule change does not (i) significantly affect
the protection of investors or the public interest; (ii) impose any
significant burden on competition; and (iii) become operative for 30
days from the date on which it was filed, or such shorter time as the
Commission may designate, it has become effective pursuant to Section
19(b)(3)(A) of the Act \6\ and Rule 19b-4(f)(6) thereunder.\7\
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    \6\ 15 U.S.C. 78s(b)(3)(A).
    \7\ 17 CFR 240.19b-4(f)(6). As required under Rule 19b-
4(f)(6)(iii), the Exchange provided the Commission with written
ntoice of its intent to file the proposed rule change, along with a
brief description and the 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.
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    A proposed rule change filed pursuant to Rule 19b-4(f)(6) under the
Act \8\ normally does not become operative for 30 days after the date
of its filing. However, Rule 19b-4(f)(6)(iii) \9\ 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 asked the Commission to waive the 30-day operative delay so that
the proposed rule change may become operative upon filing. The Exchange
states that waiver of the operative delay would be consistent with the
protection of investors and the public interest because it will allow
the Exchange to immediately provide enhanced

transparency in Exchange rules regarding which data feeds the Exchange
will use for NYSE National and clarify in the Exchange's rules that
Arca Securities will perform the inbound routing function for NYSE
National. The Commission believes that waiving the 30-day operative
delay is consistent with the protection of investors and the public
interest. Therefore, the Commission hereby waives the operative delay
and designates the proposal as operative upon filing.\10\
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    \8\ 17 CFR 240.19b-4(f)(6).
    \9\ 17 CFR 240.19b-4(f)(6)(iii).
    \10\ For purposes only of waiving the 30-day operative delay,
the Commission has also 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 the proposed rule
change, the Commission summarily may temporarily suspend 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. If the Commission
takes such action, the Commission shall institute proceedings to
determine whether the proposed rule should be approved or disapproved.

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 email to [email protected]. Please include
File Number SR-NYSEAMER-2018-24 on the subject line.

Paper Comments

     Send paper comments in triplicate to Secretary, Securities
and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
All submissions should refer to File Number SR-NYSEAMER-2018-24. This
file number should be included on the subject line if email 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 website (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 website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549 on official business days between the hours of 10:00 a.m. and
3:00 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. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-NYSEAMER-2018-24, and should be
submitted on or before June 27, 2018.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\11\
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    \11\17 CFR 200.30-3(a)(12).
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Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2018-12115 Filed 6-5-18; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: October 14, 2010 (Volume 75, Number 198)]
[Rules and Regulations]
[Page 63085-63086]
[DOCID:fr14oc10-16]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 529

[Docket No. FDA-2010-N-0002]

Certain Other Dosage Form New Animal Drugs; Progesterone
Intravaginal Inserts

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect approval of a supplemental new animal drug
application (NADA) filed by Pharmacia & Upjohn Co., a Division of
Pfizer, Inc. The supplemental NADA provides for use of progesterone
intravaginal inserts and dinoprost tromethamine by injection for
synchronization of estrus in lactating dairy cows.

DATES: This rule is effective October 14, 2010.

FOR FURTHER INFORMATION CONTACT: Suzanne J. Sechen, Center for
Veterinary Medicine (HFV-126), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855,<PHONE_NUMBER>, e-mail:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Pharmacia & Upjohn Co., a Division of
Pfizer, Inc., 235 East 42d St., New York, NY 10017 filed a supplement
to NADA 141-200 that provides for use of EAZI-BREED CIDR Progesterone
Intravaginal Inserts and dinoprost tromethamine by injection for
synchronization of estrus in lactating dairy cows. The NADA is approved
as of July 22, 2010, and the regulations are amended in 21 CFR 529.1940
to reflect the approval.
    In accordance with the freedom of information provisions of 21 CFR
part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and
effectiveness data and information submitted to support approval of
this application may be seen in the Division of Dockets Management
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.
    Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), this supplemental approval
qualifies for 3 years of marketing exclusivity beginning on the date of
approval.
    The agency has determined under 21 CFR 25.33 that this action is of
a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
    This rule does not meet the definition of ``rule'' in 5 U.S.C.
804(3)(A) because it is a rule of ``particular applicability.''
Therefore, it is not subject to the congressional review requirements
in 5 U.S.C. 801-808.

List of Subjects in 21 CFR Part 529

    Animal drugs.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under the
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR part 529 is
amended as follows:

PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 529 continues to read as
follows:

    Authority: 21 U.S.C. 360b.

0
2. In Sec.  529.1940, revise paragraphs (d)(2) and (e)(1) and remove
the last sentence in paragraph (e)(2)(iii) to read as follows:

Sec.  529.1940  Progesterone intravaginal inserts.

* * * * *
    (d) * * *
    (2) Cows. This product is approved with the concurrent use of
dinoprost solution when used for indications listed in paragraphs
(e)(1)(ii)(A) and (e)(1)(ii)(B) of this section. See Sec.  522.690(c)
of this chapter.
    (e) * * *
    (1) Cows--(i) Amount. Administer one intravaginal insert per animal
for 7 days. When used for indications listed in paragraph (e)(1)(ii)(A)
of this section, administer 25 milligrams (mg) dinoprost (5 milliliters
(mL) of 5 mg/mL solution as in Sec.  522.690(a) of this chapter) as a
single intramuscular injection 1 day prior to insert removal (Day 6).
When used for indications listed in paragraph (e)(1)(ii)(B) of this
section, administer 25 mg dinoprost as a single intramuscular injection
on the day of insert removal (Day 7).
    (ii) Indications for use--(A) For synchronization of estrus in
suckled beef cows and replacement beef and dairy heifers; for
advancement of first postpartum estrus in suckled beef cows; and for
advancement of first pubertal estrus in replacement beef heifers.
    (B) For synchronization of estrus in lactating dairy cows.
    (C) For synchronization of the return to estrus in lactating dairy
cows

inseminated at the immediately preceding estrus.
    (iii) Limitations. Do not use in beef or dairy heifers of
insufficient size or age for breeding or in animals with abnormal,
immature, or infected genital tracts. Do not use in beef cows that are
fewer than 20 days postpartum. Do not use an insert more than once. To
prevent the potential transmission of venereal and bloodborne diseases,
the inserts should be disposed after a single use. Administration of
vaginal inserts for periods greater than 7 days may result in reduced
fertility. Dinoprost solution provided by No. 000009 in Sec.
510.600(c) of this chapter.
* * * * *

    Dated: October 8, 2010.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 2010-25893 Filed 10-13-10; 8:45 am]
BILLING CODE 4160-01-P


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

General Comment:Dear Mr. Zeller:

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

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

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

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

>> I agree with this request to extend the time needed to comment and provide information on the subject of e-cigarettes and the FDA's proposal. By allowing more time I think it would allow all consumers and parties of the e-cigarette community to voice their thoughts on the matter. Six months is not enough time when the FDA has had a few years.


[Federal Register Volume 86, Number 205 (Wednesday, October 27, 2021)]
[Notices]
[Page 59372]
[FR Doc No: 2021-23417]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 9074-053]

Warrensburg Hydropower Limited Partnership; Notice of Intent To
File License Application, Filing of Pre-Application Document, and
Approving Use of the Traditional Licensing Process

    a. Type of Application: Notice of Intent to File License
Application and Request to Use the Traditional Licensing Process.
    b. Project No.: 9074-053.
    c. Date Filed: September 3, 2021.
    d. Submitted by: Warrensburg Hydropower Limited Partnership
(Warrensburg Hydro).
    e. Name of Project: Warrensburg Hydroelectric Project.
    f. Location: Located on the Schroon River in the town of
Warrensburg, Warren County, New York. The project does not occupy any
federal land.
    g. Filed Pursuant to: 18 CFR 5.3 of the Commission's regulations.
    h. Potential Applicant Contact: Mr. Erik Bergman, Manager,
Warrensburg Hydropower Limited Partnership, 33 Hudson Falls Road, South
Glens, NY 12803, Phone:<PHONE_NUMBER>, Email:
[email protected].
    i. FERC Contact: John Stokely, Phone:<PHONE_NUMBER>, Email:
[email protected].
    j. Warrensburg Hydro filed its request to use the Traditional
Licensing Process on September 3, 2021. Warrensburg Hydro provided
public notice of its request on September 15, 2021. In a letter dated
October 21, 2021, the Director of the Division of Hydropower Licensing
approved Warrensburg Hydro's request to use the Traditional Licensing
Process.
    k. With this notice, we are initiating informal consultation with
the U.S. Fish and Wildlife Service and/or NOAA Fisheries under section
7 of the Endangered Species Act and the joint agency regulations
thereunder at 50 CFR, Part 402; and NOAA Fisheries under section 305(b)
of the Magnuson-Stevens Fishery Conservation and Management Act and
implementing regulations at 50 CFR 600.920. We are also initiating
consultation with the New York State Historic Preservation Officer, as
required by section 106, National Historic Preservation Act, and the
implementing regulations of the Advisory Council on Historic
Preservation at 36 CFR 800.2.
    l. With this notice, we are designating Warrensburg Hydro as the
Commission's non-federal representative for carrying out informal
consultation pursuant to section 7 of the Endangered Species Act and
section 305(b) of the Magnuson-Stevens Fishery Conservation and
Management Act; and consultation pursuant to section 106 of the
National Historic Preservation Act.
    m. Warrensburg Hydro filed a Pre-Application Document (PAD;
including a proposed process plan and schedule) with the Commission,
pursuant to 18 CFR 5.6 of the Commission's regulations.
    n. A copy of the PAD may be viewed on the Commission's website
(http://www.ferc.gov), using the ``eLibrary'' link. Enter the docket
number, excluding the last three digits in the docket number field, to
access the document. For assistance, contact FERC Online Support at
[email protected],<PHONE_NUMBER> (toll free), or (202) 502-
8659 (TTY).
    o. The applicant states its unequivocal intent to submit an
application for a new license for Project No. 9074. Pursuant to 18 CFR
16.8, 16.9, and 16.10 each application for a new license and any
competing license applications must be filed with the Commission at
least 24 months prior to the expiration of the existing license. All
applications for license for this project must be filed by December 31,
2024.
    p. Register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filing and issuances
related to this or other pending projects. For assistance, contact FERC
Online Support.

    Dated: October 21, 2021.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2021-23417 Filed 10-26-21; 8:45 am]
BILLING CODE 6717-01-P


Pyrethrins and PBO Combination Label Table

This label table incorporates all of the required label changes from the
pyrethrins and PBO REDs.

Description

Pyrethrins and PBO Required Labeling Language

Placement on Label

All Products

Ingredient statements for piperonyl butoxide	--Delete any reference to
“technical” in the ingredient statement.  (i.e. Some labels refer to
PBO technical as the active ingredient.)

-- Do not include a ratio of PBO components or percent of other related
compounds in the footnote.

Following is an example of an acceptable expression of the PBO
ingredient statement:

Piperonyl butoxide*
………………………………………………100%

*(butyl carbityl)(6-propylpiperonyl) ether and related compounds

	Ingredient Statement

End-Use Products Intended for Occupational Use (WPS and non-WPS)

And Wide Area Mosquito Adulticide Applications

[Note: For products with both occupational and consumer homeowner uses,
the more restrictive language from these labeling tables must be used.]

Handler PPE Requirements for Wettable Powders Formulations1 packaged in
water soluble packaging

[Note: Wettable Powders must be packaged in water soluble bags to be
eligible for reregistration.]

Note:  If the use of handheld foggers in enclosed areas is not permitted
or not feasible for the end-use product, the statement requiring
respirators for those uses may be omitted.

	“Personal Protective Equipment (PPE)”

“Mixers, loaders, applicators, and other handlers must wear:

- long-sleeve shirt,

- long pants, and

- shoes and socks.”

“In addition to the above PPE, applicators using a high pressure
handwand in an enclosed area must wear   SEQ CHAPTER \h \r 1 at least a
NIOSH-approved respirator with:

-- a dust/mist filter with MSHA/NIOSH approval number prefix TC-21C or

-- any N, R, P, or HE filter.”

“In addition to the above PPE, applicators using hand held foggers in
an enclosed area must wear a half-face, full-face, or hood-style
NIOSH-approved respirator with:

  SEQ CHAPTER \h \r 1 -- a dust/mist filtering cartridge (MSHA/NIOSH
approval number prefix TC-21C), or

-- a canister approved for pesticides (MSHA/NIOSH approval number prefix
TC-14G), or

-- a cartridge or canister with any N,R,P or HE filter.”

“See engineering controls for additional requirements.”

Instruction to Registrant:

Drop the “N” type prefilter from the respirator statement, if the
pesticide product contains, or is used with, oil.

	Precautionary Statements: Hazards to Humans and Domestic Animals

Handler PPE Requirements for Liquid Formulations1

[including: liquid concentrates,  total release foggers,
microencapsulated concentrates, foams, aerosols, gels, pastes, and
pressurized liquids]

Note:  If the use of handheld foggers in enclosed areas is not permitted
or not feasible for the end-use product, the statement requiring
respirators for those uses may be omitted.

	“Personal Protective Equipment (PPE)”

“Mixers, loaders, applicators, and other handlers must wear the
following:

- long-sleeve shirt,

- long pants,

- shoes and socks.”

“In addition to the above PPE, applicators using a high pressure
handwand in an enclosed area must wear   SEQ CHAPTER \h \r 1 at least a
NIOSH-approved respirator with:

-- a dust/mist filter with MSHA/NIOSH approval number prefix TC-21C or

-- any N, R, P, or HE filter.”

“In addition to the above PPE, applicators using hand held foggers in
an enclosed area must wear a half-face, full-face, or hood-style
NIOSH-approved respirator with:

  SEQ CHAPTER \h \r 1 -- a dust/mist filtering cartridge (MSHA/NIOSH
approval number prefix TC-21C), or

-- a canister approved for pesticides (MSHA/NIOSH approval number prefix
TC-14G), or

-- a cartridge or canister with any N,R,P or HE filter.”

“See engineering controls for additional requirements.”

Instruction to Registrant:

Drop the “N” type filter from the respirator statement, if the
pesticide product contains, or is used with, oil.

	Precautionary Statements: Hazards to Humans and Domestic Animals

Handler PPE Requirements for Dusts

	“Personal Protective Equipment (PPE)”

“Loaders, applicators, and other handlers must wear the following:

- long-sleeve shirt,

- long pants,

- shoes and socks.”	Precautionary Statements: Hazards to Humans and
Domestic Animals

User Safety Requirements	“Follow manufacturer's instructions for
cleaning/maintaining PPE.  If no such instructions for washables exist,
use detergent and hot water.  Keep and wash PPE separately from other
laundry.”

“Discard clothing and other absorbent material that have been drenched
or heavily contaminated with the product’s concentrate.  Do not reuse
them.”

	Precautionary Statements: Hazards to Humans and Domestic Animals
immediately following the PPE requirements

Engineering Controls: Wettable Powders packaged in Water-Soluble Bags

[Note: Wettable Powders must be packaged in water soluble packages to be
eligible for reregistration.]

	 “Engineering Controls:”

“  SEQ CHAPTER \h \r 1 Water-soluble packets when used correctly
qualify as a closed mixing/loading system under the Worker Protection
Standard for Agricultural Pesticides [40 CFR 170.240(d)(4)].  Mixers and
loaders using water-soluble packets must :

-- wear the personal protective equipment required in the PPE section of
this labeling for mixers and loaders, and

-- be provided and must have immediately available for use in an
emergency, such as a broken package, spill, or equipment breakdown a
half-face, full-face, or hood-style NIOSH-approved respirator with:

  SEQ CHAPTER \h \r 1 -- a dust/mist filtering cartridge (MSHA/NIOSH
approval number prefix TC-21C), or

-- a canister approved for pesticides (MSHA/NIOSH approval number prefix
TC-14G), or

-- a cartridge or canister with any N,R,P or HE filter.”

“Pilots must use an enclosed cockpit that meets the requirements
listed in the Worker Protection Standard (WPS) for agricultural
pesticides [40 CFR 170.240(d)(6)].”

“Human flagging is prohibited.  Flagging to support aerial application
is limited to use of the Global Positioning System (GPS) or mechanical
flaggers.”

Instructions to Registrant:

Drop the “N” type prefilter from the respirator statement, if the
pesticide product contains, or is used with, oil.

	Precautionary Statements: Hazards to Humans and Domestic Animals
(Immediately following PPE and User Safety Requirements.)

Engineering Controls for all liquid formulations.

Note if aerial application is not permitted or not feasible for the
end-use product, the engineering control statements referring to pilots
or human flaggers may be omitted.

	“Engineering Controls:”

“Pilots must use an enclosed cockpit that meets the requirements
listed in the Worker Protection Standard (WPS) for agricultural
pesticides [40 CFR 170.240(d)(6)].”

“Human flagging is prohibited.  Flagging to support aerial application
is limited to use of the Global Positioning System (GPS) or mechanical
flaggers.”	Precautionary Statements: Hazards to Humans and Domestic
Animals   (Immediately following PPE and User Safety Requirements.)

Environmental

Hazards Statements for products labeled for outdoor uses other than as a
wide area mosquito adulticide:

(PR Notice 2005-1 recommends separating labels intended for wide area
mosquito adulticide applications.)	“ENVIRONMENTAL HAZARDS”

“This product is toxic to aquatic organisms, including fish and
invertebrates.  Drift and runoff may be hazardous to aquatic organisms
in water adjacent to treated areas.  This product may contaminate water
through runoff.  This product has a potential for runoff for several
weeks after application.  Poorly draining soils and soils with shallow
water tables are more prone to produce runoff that contains this
product.”

“This product is highly toxic to bees exposed to direct treatment on
blooming crops or weeds.  Do not apply this product or allow it to drift
to blooming crops or weeds while bees are actively visiting the
treatment area.”

“Do not apply directly to water, to areas where surface water is
present or to intertidal areas below the mean high water mark.  Do not
contaminate water when disposing of equipment wash-waters or rinsate.”

  	Precautionary Statements under Environmental Hazards

Environmental

Hazards Statements for products labeled solely for  use as a wide area
mosquito adulticide:

(PR Notice 2005-1 recommends separating labels intended for wide area
mosquito adulticide  applications.)	“ENVIRONMENTAL HAZARDS”

“This pesticide is toxic to aquatic organisms, including fish and
invertebrates.  Runoff from treated areas or deposition of spray
droplets into a body of water may be hazardous to fish and aquatic
invertebrates.”

“This product is highly toxic to bees exposed to direct treatment on
blooming crops or weeds.  Do not apply this product or allow it to drift
to blooming crops or weeds while bees are actively visiting the
treatment area.”

“Before making the first application in a season, it is advisable to
consult with the state or tribal agency with primary responsibility for
pesticide regulation to determine if other regulatory requirements
exist.”

“Do not apply over bodies of water (lakes, rivers, permanent streams,
natural ponds, commercial fish ponds, swamps, marshes or estuaries),
except when necessary to target areas where adult mosquitoes are
present, and weather conditions will facilitate movement of applied
material away from the water in order to minimize incidental deposition
into the water body.  Do not contaminate bodies of water when disposing
of equipment rinsate or washwaters.”	Precautionary Statements under
Environmental Hazards

Environmental

Hazards Statements for products labeled as a wide area mosquito
adulticide  AND is labeled for other outdoor uses as well:

(PR Notice 2005-1 recommends separating labels intended for wide area
mosquito adulticide applications.)	“ENVIRONMENTAL HAZARDS for
TERRESTRIAL APPLICATIONS”

“This product is toxic to aquatic organisms, including fish and
invertebrates. Drift and runoff may be hazardous to aquatic organisms in
water adjacent to treated areas.  This product may contaminate water
through runoff.  This product has a potential for runoff for several
weeks after application.  Poorly draining soils and soils with shallow
water tables are more prone to produce runoff that contains this
product.”

“This product is highly toxic to bees exposed to direct treatment on
blooming crops or weeds.  Do not apply this product or allow it to drift
to blooming crops or weeds while bees are actively visiting the
treatment area.”

“Except as specified in the directions for use, do not apply directly
to water, to areas where surface water is present or to intertidal areas
below the mean high water mark.  Do not contaminate water when disposing
of equipment wash-waters or rinsate.”

“ENVIRONMENTAL HAZARDS for WIDE AREA MOSQUITO ADULTICIDE
APPLICATIONS”

 “This pesticide is toxic to aquatic organisms, including fish and
invertebrates.  Runoff from treated areas or deposition of spray
droplets into a body of water may be hazardous to fish and aquatic
invertebrates.”

“When applying as a wide area mosquito adulticide, before making the
first application in a season, it is advisable to consult with the state
or tribal agency with primary responsibility for pesticide regulation to
determine if other regulatory requirements exist.”

“This product is highly toxic to bees exposed to direct treatment on
blooming crops or weeds.  Do not apply when bees are visiting the
treatment area, except when applications are made to prevent or control
a threat to public and/or animal health determined by a state, tribal,
or local health or vector control agency on the bases of documented
evidence of disease causing agents in vector mosquitoes or the
occurrence of mosquito-borne disease in animal or human populations, or
if specifically approved by the state or tribe during a natural disaster
recovery effort.”

“When applying as a wide area mosquito adulticide, do not apply over
bodies of water (lakes, rivers, permanent streams, natural ponds,
commercial fish ponds, swamps, marshes or estuaries), except when
necessary to target areas where adult mosquitoes are present, and
weather conditions will facilitate movement of applied material away
from the water in order to minimize incidental deposition into the water
body.  	Precautionary Statements under Environmental Hazards

Environmental Hazards for Products labeled only for Indoor Use 	No
environmental hazard statement is required for products labeled for
indoor use only.

For indoor products packaged in containers equal to or greater than 5
gallons or 50 lbs add the following statement:

“Do not discharge effluent containing this product into lakes,
streams, ponds, estuaries, oceans, or other waters unless in accordance
with the requirements of a National Pollution Discharge Elimination
System (NPDES) permit and the permitting authority has been notified in
writing prior to discharge.  Do not discharge effluent containing this
product to sewer systems without previously notifying the local sewage
treatment plant authority.  For guidance contact your State Water Board
or Regional Office of the EPA."	Precautionary Statements under
Environmental Hazards

Environmental hazard statements on Liquid Concentrate consumer outdoor
products (e.g., liquids mixed with water by the user for a tank sprayer
or hose-end attachment)	“This pesticide is toxic to aquatic organisms,
including fish and invertebrates.  To protect the environment, do not
allow pesticide to enter or run off into storm drains, drainage ditches,
gutters or surface waters.  Applying this product in calm weather when
rain is not predicted for the next 24 hours will help to ensure that
wind or rain does not blow or wash pesticide off the treatment area.
Rinsing application equipment over the treated area will help avoid run
off to water bodies or drainage systems.”

“This product is highly toxic to bees exposed to direct treatment on
blooming crops or weeds.  Do not apply this product or allow it to drift
to blooming crops or weeds while bees are actively visiting the
treatment area.”

	Environmental Hazard Statement

Environmental hazard statements on Dusts consumer outdoor products
(e.g., for garden or ornamental)	“This pesticide is toxic to aquatic
organisms, including fish and invertebrates.  To protect the
environment, do not allow pesticide to enter or run off into storm
drains, drainage ditches, gutters or surface waters.  Applying this
product in calm weather when rain is not predicted for the next 24 hours
will help to ensure that wind or rain does not blow or wash pesticide
off the treatment area.”

“This product is highly toxic to bees exposed to direct treatment on
blooming crops or weeds.  Do not apply this product or allow it to drift
to blooming crops or weeds while bees are actively visiting the
treatment area.”

	Environmental Hazard Statement

Environmental hazard statements on Ready-to-Use  consumer outdoor
products (except aerosols and foggers)	“This pesticide is toxic to
aquatic organisms, including fish and invertebrates.  To protect the
environment, do not allow pesticide to enter or run off into storm
drains, drainage ditches, gutters or surface waters.  Applying this
product in calm weather when rain is not predicted for the next 24 hours
will help to ensure that wind or rain does not blow or wash pesticide
off the treatment area.”

“This product is highly toxic to bees exposed to direct treatment on
blooming crops or weeds.  Do not apply this product or allow it to drift
to blooming crops or weeds while bees are actively visiting the
treatment area.”

	Environmental Hazard Statement

Environmental Hazard Statements for Ready to Use aerosol and fogger
consumer outdoor products	“This pesticide is toxic to aquatic
organisms, including fish and invertebrates.  Do not apply directly to
or near water.  Drift and run-off may be hazardous to fish in water
adjacent to treated areas.  Do not contaminate water when disposing of
equipment, washwater, or rinsate.  See Directions for Use for additional
precautions and requirements.”

“This product is highly toxic to bees exposed to direct treatment on
blooming crops or weeds.  Do not apply this product or allow it to drift
to blooming crops or weeds while bees are actively visiting the
treatment area.”

	Environmental Hazard Statement

Restricted-Entry Interval

for products with WPS uses 	“Do not enter or allow worker entry into
treated areas during the restricted entry interval (REI) of 12 hours.”

	Directions for Use, Agricultural Use Requirements Box

Early Entry Personal Protective Equipment for  products with WPS uses
“PPE required for early entry to treated areas that is permitted under
the Worker Protection Standard and that involves contact with anything
that has been treated, such as soil or water, is:

- coveralls,

- shoes plus socks, and

- chemical-resistant gloves made of any waterproof material.”
Directions for Use, Agricultural Use Requirements Box

Entry Restrictions

for products with non-WPS uses on the label

Note:  This excludes products labeled for use when people are permitted
to be present (e.g. wide-area mosquito adulticide applications, metered
release devices, and pet applications)

	  SEQ CHAPTER \h \r 1 Entry Restriction for products applied as a
surface spray (does not apply to products applied directly to domestic
animals):

“Do not enter or allow others to enter until sprays have dried.”

Entry Restriction for products applied dry:

“Do not enter or allow others to enter until dusts have settled.”

Entry Restriction for products applied as a space spray or as a fog:

“Do not enter or allow others to enter until vapors, mists, and
aerosols have dispersed, and the treated area has been thoroughly
ventilated.”

Total release foggers labeled for indoor use must contain the following
entry restriction:

“Wait two (2) hours after application, then open windows, vents and
doors for two hours.  In an odor is still detected additional
ventilation is required.”

Note to Registrant:  If there is information that justified a change in
the duration after application (2 hours), submit the information to the
Agency.

	  SEQ CHAPTER \h \r 1 If no WPS uses on the product label, place the
appropriate statement in the Directions for Use Under General
Precautions and Restrictions.  If the product also contains WPS uses,
then create a Non-Agricultural Use Requirements box as directed in PR
Notice 93-7 and place the appropriate statement inside that box.

Entry Restrictions for products labeled  solely for use when people are
present (e.g. wide-area mosquito adulticide applications, metered
release devices, and applications to pets)	Note to Registrants:  No
entry restrictions are required.  See below under Use Restrictions for
further requirements.

	Entry Restrictions for products labeled for use when people are present
(e.g. wide-area mosquito adulticide applications, metered release
devices, and  applications to pets) and for use on other sites as a
directed or space spray.	  SEQ CHAPTER \h \r 1 Products labeled for use
as a directed spray (does not apply to products applied directly to
domestic animals):

“Except when (insert application method or site that allows people to
be present), do not enter or allow others to enter until sprays have
dried.”

Products labeled for use as a space spray:

“Except when (insert application method or site that allows people to
be present), do not enter or allow others to enter until vapors, mists,
and aerosols have dispersed, and the treated area has been thoroughly
ventilated.”

Note to Registrant:  An example is as follows:  Except when applying in
a metered release system, do not enter or allow others to enter until
sprays have dried.

	If no WPS uses on the product label, place the appropriate statement in
the Directions for Use Under General Precautions and Restrictions.  If
the product also contains WPS uses, then create a Non-Agricultural Use
Requirements box as directed in PR Notice 93-7 and place the appropriate
statement inside that box.

General Application Restrictions for products with WPS or non-WPS uses
on the label

Note:  This excludes products that contain any directions for uses when
people are permitted to be present in the treated area (e.g. . wide-area
mosquito adulticide applications, metered release devices, and
applications to pets)

	“Do not apply this product in a way that will contact workers or
other persons, either directly or through drift.”

“Only protected handlers may be in the area during application.”

	Place in the Direction for Use.

General Application Restrictions for products with WPS and non-WPS uses
on the label AND contain directions for uses when people are permitted
to be present in the treated area (e.g. . wide-area mosquito adulticide
applications, metered release devices, and applications to pets)

	“Except when” (insert application method or site that allows people
to be present) “do not apply this product in a way that will contact
workers or other persons, either directly or through drift.”

“Except when” (insert application method or site that allows people
to be present) “only protected handlers may be in the area during
application.”

	Place in the Direction for Use.

General Application Restrictions for products labeled for use solely
when people are permitted to be present in the treated area (e.g.
wide-area mosquito adulticide applications, metered-release devices, and
applications to pets)	Note to Registrants:  No entry restrictions are
required.  See below under Use Restrictions for further requirements.
Place in the Direction for Use.

Other Application Restrictions

  SEQ CHAPTER \h \r 1 	Note to Registrants:  Delete any reference to
tolerance exemptions on labels.

In addition add the following restrictions depending on the registered
product uses and formulation:

All formulations labeled or intended for outdoor residential uses:

“Do not make applications during rain.”

Wettable powder formulations:

“Do not apply this product as a dust.”

“Do not apply in forestry areas.”

Dust formulations:

“Aerial applications are prohibited.”

“Applications with power duster equipment are prohibited.”

“Only apply as a spot treatment to areas no greater than 3 feet by 3
feet per room.”

Products labeled for use as a  space spray excluding metered release
devices:

“Do not remain in treated area.  Exit area immediately and remain
outside the treated area until aerosols, vapors, and/or mists have
dispersed.”

Products labeled for spray applications to plants:

“Do not wet plants to point of runoff or drip.”

Products labeled for spray applications to articles:

“Do not wet articles to point of runoff or drip.”

“Do not use treated article until spray has dried.”

Products labeled for applications to clothing articles:

“Dry clean treated clothes before wearing.”

Products labeled for dip applications to empty containers:

“Do not use treated article before it is dry.”

Products labeled for crack and crevice, surface or space spray, fogging
or dust applications indoors excluding metered release devices:

“Remove or cover exposed food and drinking water before
application.”

“Remove or cover dishes, utensils, food processing equipment, and food
preparation surfaces, or wash them before use.”

Liquid, Dust, and Ready-To-Use products intended for outdoor residential
use:

“Do not water the treated area to the point of run-off.”

Products labeled for applications to non-residential indoor sites:

“Do not use in aircraft cabins except in compliance with PR Notice
96-3.”

“When used in dairy barns or facilities: Close milk bulk tank lids to
prevent contamination from spray and from dead or falling insects.
Remove or cover milking utensils before application.  Wash teats of
animals before milking.”

Products labeled for use in food handling and processing facilities
excluding metered release devices:

“Do not make space spray applications when facility is in
operation.”

“Prior to space spray applications, cover or remove food.”

“Prior to space spray applications, cover food processing surfaces or
clean after treatment and before use.”

Products labeled for use around or near floor drains. Products labeled
for use in drains or sewers are excluded from this label requirement:
“Do not apply directly into sewers or drains, or to any area like a
gutter where drainage to storm sewers, water bodies, or aquatic habitat
can occur. Do not allow the product to enter any drain during or after
application.”

Products labeled for use in drains or sewers:

“Except when applying to sewers or drains as instructed on this label,
do not apply directly to sewers or drains, or to any area like a gutter
where drainage to sewers, storm drains, water bodies, or aquatic habitat
can occur.”

Residential Outdoor Surface and Space Sprays, except for outdoor fogging
devices:

“All outdoor applications must be limited to spot or crack-and-crevice
treatments only, except for the following permitted uses:

(1) Treatment to soil or vegetation around structures;

(2) Applications to lawns, turf, and other vegetation;

(3) Applications to building foundations, up to a maximum height of 3
feet.

Other than applications to building foundations, all outdoor
applications to impervious surfaces such as sidewalks, driveways,
patios, porches and structural surfaces (such as windows, doors, and
eaves) are limited to spot and crack-and-crevice applications, only.”

	Directions for Use under Use Restrictions

Use-Specific Application Restrictions

(Note: The maximum allowable application rate and maximum allowable
seasonal rate must be listed as pounds or gallons of formulated product
per acre, not just as pounds active ingredient per acre.

All rates must be expressed in terms the applicator can use in order to
arrive at the maximum application rate.  For example, for sprays rates
must specify the duration of spray to a specific area, i.e., spray for X
seconds to a space Y feet by Z feet.)

	Note:  See Appendix A for a complete list of application rates and
restrictions that are eligible for reregistration.

Note to Registrant:  In addition, these label statements should be
deleted from all products registered for food handling and processing
facilities:

“Except in Federally inspected meat and poultry plants, food
processing operations may continue when the product is applied as a
general surface spray/crack and crevice spray with care and in
accordance with the directions and precautions on the label, at a
maximum rate of X pounds of product  per 1000 square feet.”

These rate changes must be updated on all products:

The maximum PBO rate for indoor crack and crevice spray is 0.56 lbs
ai/1000 square feet.

Formulated indoor space spray products eligible for reregistration must
not contain more than 0.05 lbs ai/16 ounce can.

Formulated pet spray products eligible for reregistration must not
contain more than 10 % piperonyl butoxide.

Formulated pet spray products eligible for reregistration must not
contain more than 0.2 % pyrethrins.

The maximum space spray rate for food handling establishments is 0.0033
lbs pyrethrins per 1000 cubic feet.

The maximum space spray rate for residential areas is 0.00033 lbs
pyrethrins per 1000 cubic feet.

The maximum space spray rate for post-harvest applications to fruits,
vegetables and copra is 0.001 lbs pyrethrins per 1000 cubic feet.

The maximum space spray rate for post-harvest application to fruits,
vegetables, and nuts is 0.01 lbs PBO per 1000 cubic feet.	Directions for
Use under Use Restrictions

Application Restrictions for products used in Metered Release Devices
Note to Registrants:  Delete nurseries, day care centers, schools,
hospitals, and nursing homes as registered use sites on all product
labels for this use pattern.

Add the following statements:

“Not for use in Residential areas.”

“Do not use in nurseries or rooms where infants, ill, or aged persons
are confined.”

“Do not place metering device directly over or within 8 feet of
exposed food, dishes, utensils, food processing equipment, and food
handling or preparation.”

“Do not install within 3 feet of air vents.”

 “Carefully follow directions for the dispenser unit when installing
the dispenser and replacing cans or conducting maintenance.”

“The maximum application rate for metered release devices is 0.00046
lb pyrethrin per 1000 cubic feet.”

	Directions for Use under Use Restrictions

Indoor Misting Systems Used in Commercial Barns, Stables, and Animal
Quarters

	“Directions for use in commercial animal premise automatic misting
systems”

“Not for use in outdoor residential misting systems (indoor or
outdoor).”

“Do not apply this product in barns or stables where animals intended
for slaughter or human consumption will be maintained.”

“Do not apply when food, feed, and/or water is present.”

“When using this product, installers and service technicians must
comply with the license, certification, or registration requirements of
the state(s), tribe(s), or local authority(ies) where they are
installed.”

“When applying via a remote activation device, do not apply when
people and pets are present.  If possible, when applying via automatic
timer, set the timing for application when people and pets are unlikely
to be present.”

“Direct nozzles to spray towards the target area and away from areas
where people are typically present.”

“Do not use in an evaporative cooling system.”

“Do not use in misters located within 3 feet of air vents, air
conditioner units, or windows.”

“If used in a system with a reservoir tank for the end use dilution,
the system reservoir tank must be locked.  Securely attach the end use
pesticide label and a dilution statement to the system reservoir tank in
a weather protected area or plastic sleeve.  The dilution statement must
be phrased as follows: this container holds __ parts [product name] to
__ parts water”

“If used in a direct injection system, the pesticide container must be
locked.  Securely attach the end use label to the pesticide container in
a weather protected area or plastic sleeve.”  (These instructions not
applicable to wettable powder products).

 “This product must only be used in systems that have been calibrated
to apply no more than the maximum application rate of” [insert product
application rate].

Note to registrant:  Also express this application rate as pounds or
gallons of end-use product formulation.	Directions for Use under Use
Restrictions

Application Restrictions for products used in Outdoor Metered Release
Devices	Outdoor Metered Release Devices

“Directions for use in outdoor metered release devices:”

“If the device works on an automatic timer, set the timing for
application when people, pets, and/or food are unlikely to be
present.”

“If the device works when a person operates a remote activation
device, then application of this pesticide when people, pets, and food
are/or present is prohibited.”

“Direct nozzle to spray towards the target area and away from areas
where people are typically present.”

“The pesticide container must be locked.”

“Do not install within 3 feet of air vents, air conditioner units, or
windows.”

“Carefully follow directions for the dispenser unit when installing
the dispenser and replacing cans or conducting maintenance.”

	Directions for Use under Use Restrictions

Use-Specific Application Restrictions for all liquid and wettable powder
labels

(Outdoor residential misting system requirement)

(Note: The maximum allowable application rate and maximum allowable
seasonal rate must be listed as pounds or gallons of formulated product
per acre, not just as pounds active ingredient per acre.)

	Outdoor Residential Misting Systems

Products not intended for use in outdoor residential misting systems
must contain the following statement:

“Not for use in outdoor residential misting systems.”

Products intended for use in outdoor residential misting systems must
contain the following statements:

“Directions for use in outdoor residential misting systems:”

“When using this product installers and service technicians must
comply with the license, certification, or registration requirements of
the state(s), tribe(s), or local authority(ies) where they are
installed.”

“If the system works on an automatic timer, set the timing for
application when people, pets, and food are unlikely to be present.”

“If the system works when a person operates a remote activation
device, then application of this pesticide when people, pets, and food
are present is prohibited.”

“Do not use in an evaporative cooling system.”

“Direct nozzles to spray towards the target area and away from
swimming pools, water bodies, or eating and cooking areas.”

“Do not set nozzles to direct mist near outside air condition  systems
or other home air intakes.”

“If used in a system with a reservoir tank for the end use dilution,
the system reservoir tank must be locked.  Securely attach the end use
pesticide label and a dilution statement to the system reservoir tank in
a weather protected area or plastic sleeve.  The dilution statement must
be phrased as follows: this container holds __ parts [product name] to
__ parts water”

“If used in a direct injection system, the pesticide container must be
locked.  Securely attach the end use label to the pesticide container in
a weather protected area or plastic sleeve.”  (These instructions not
applicable to wettable powder products).

“Contact the system manufacture for guidance or assistance to ensure
compliance with the following requirement:”

 “This product must only be used in systems that have been calibrated
to apply no more than the maximum application rate of” [insert product
application rate that is equal to 0.00011 lbs pyrethrins per 1000 cubic
feet per day or 0.00058 lbs piperonyl butoxide per 1000 cubic feet per
day, whichever is lower].

Note to registrant:  Also express this application rate as pounds or
gallons of end-use product formulation.

	Directions for Use under Use Restrictions

Use-Specific Application Restrictions for products labels for

Mosquito Adulticide Application by ground or air.

(Note: The maximum allowable application rate and maximum allowable
seasonal rate must be listed as pounds or gallons of formulated product
per acre, not just as pounds active ingredient per acre.)

	“For use by federal, state, tribal, or local government officials
responsible for public health or vector control, or by persons certified
in the appropriate category or otherwise authorized by the state or
tribal lead pesticide regulatory agency to perform adult mosquito
control applications, or by persons under their direct supervision.”

The maximum application rate for wide area mosquito adulticide
applications is 0.0025 lbs pyrethrin/acre, or 0.025 lbs piperonyl
butoxide/acre, whichever is lower.  When targeting Aedes Taeirorhynchus
and other difficult species applications may be made up to 0.008 lbs
pyrethrin/acre/day, or 0.08 lbs piperonyl butoxide/acre/day, whichever
is lower.

“Do not apply more than 0.2 lbs pyrethrin/acre/year, or 2.0 lbs
piperonyl butoxide/acre/year, whichever is lower, in any treated area
More frequent treatments may be made to prevent or control a threat to
public and/or animal health determined by a state, tribal, or local
health or vector control agency on the basis of documented evidence of
disease causing agents in vector mosquitoes or the occurrence of
mosquito-borne disease in animal or human populations, or if
specifically approved by the state or tribe during a natural disaster
recovery effort.”

WIND SPEED:

“Apply only when wind speed is greater than or equal to 1 mph.”

“Ground-based applications for wide-area mosquito abatement
application:

Spray equipment must be adjusted so that the volume median diameter is
less than 30 microns (Dv 0.5 < 30 μm) and that 90% of the spray is
contained in droplets smaller than 50 microns (Dv 0.9 < 50 μm).
Directions from the equipment manufacturer or vendor, pesticide
registrant or a test facility using a lazer-based measurement instrument
must be used to adjust equipment to produce acceptable droplet size
spectra.  Application equipment must be tested at least annually to
confirm that pressure at the nozzle and nozzle flow rate(s) are properly
calibrated.”

“Aerial applications for wide-area mosquito abatement application:

μm) and that 90% of the spray is contained in droplets smaller than 80
microns (Dv 0.9 < 80 μm).  The effects of flight speed, and for
non-rotary nozzles, nozzle angle on the droplet size spectrum must be
considered.   Directions from the equipment manufacturer or vendor,
pesticide registrant or a test facility using a wind tunnel and
laser-based measurement instrument must be used to adjust equipment to
produce acceptable droplet size spectra.  Application equipment must be
tested at least annually to confirm that pressure at the nozzle and
nozzle flow rate(s) are properly calibrated.”

RELEASE HEIGHT for AERIAL:

“Fixed wing:”

“Apply using a nozzle height of no less than 100 feet above the ground
or canopy.”

“Rotary wing:”

“Apply using a nozzle height of no less than 75 feet above the ground
or canopy.”

	Directions for Use under Use Restrictions

Spray Drift Label Language for all products labeled for outdoor
applications  to agricultural use sites 	“SPRAY DRIFT MANAGEMENT for
AGRICULTURE CROPS”

“Avoiding spray drift at the application site is the responsibility of
the applicator and the grower.  The interactions of many equipment and
weather-related factors determine the potential for spray drift.  The
applicator and the grower are responsible for considering all these
factors when making decisions.”

“Do not apply at wind speeds greater than 10 mph at the application
site.”

“Do not make any type of application into temperature inversions.”

“Apply as a medium or coarser spray (ASABE standard 572).”

“Additional requirements for aerial applications:”

“Do not release spray at a height greater than 10 feet above the
ground or crop canopy.”

“The boom length must not exceed 75% of the wingspan or 90% of the
rotor blade diameter.”

“Aerial applicators must consider flight speed and nozzle orientation
in determining droplet size.”

“When applications are made with a cross-wind, the swath will be
displaced downwind.  The applicator must compensate for this
displacement at the downwind edge of the application area by adjusting
the path of the aircraft upwind.”

“Additional requirements for ground applications:”

“Do not release spray at a height greater than 4 feet above the ground
or crop canopy.”

“Additional requirements for airblast applications:”

“Direct sprays into the canopy.”

“Turn off outward pointing nozzles at row ends and when spraying outer
rows.”

	Directions for Use under General Precautions and Restrictions

Products Primarily Used by Consumers/Homeowners

[Note: For products with both occupational and consumer homeowner uses,
the more restrictive language from these labeling tables must be used.]

Entry Restrictions

for products except those products that contain any directions for uses
when people are permitted to be present in the treated area (e.g. .
applications to pets)

	  SEQ CHAPTER \h \r 1 Entry Restriction for products applied as a spray
except for sprays applied directly to domestic animals:

“Do not allow adults, children, or pets to enter the treated area
until sprays have dried.”

Entry Restriction for products applied dry:

“Do not allow adults, children, or pets to enter the treated area
until dusts have settled.”

Entry Restriction for products applied as a space spray or as a fog:

“Do not allow adults, children, or pets to enter until vapors, mists,
and aerosols have dispersed, and the treated area has been thoroughly
ventilated.”

Total release foggers labeled for indoor use must contain the following
entry restriction:

“Wait two (2) hours after application, then open windows, vents and
doors for two hours.  In an odor is still detected additional
ventilation is required.”

Note to Registrant:  If there is information that justified a change in
the duration after application (2 hours), submit the information to the
Agency.

	  SEQ CHAPTER \h \r 1 Directions for use under General Precautions and
Restrictions

Entry Restrictions for products that only contain directions for uses
when people are permitted to be present (e.g. pet applications)	Note to
Registrants:  No entry restrictions are required.  See below under Use
Restrictions for further requirements.  	Directions for use under
General Precautions and Restrictions

Entry Restrictions for products that contain directions for uses when
people are permitted to be present in the treated area (e.g.
applications to pets) AND for use on other sites as a surface spray.
SEQ CHAPTER \h \r 1 Products labeled for use as a surface spray (does
not apply to products applied directly to domestic animals):

“Except when (insert application method or site that allows people to
be present), do not allow adults, children, or pets to enter until
sprays have dried.”

Note to Registrant an example is as follows:  Except when applying
directly to pets, do not allow adults, children, or pets to enter until
sprays have dried.

	Directions for use under General Precautions and Restrictions

General Application Restrictions for all products except those that
contain any directions for uses when people are permitted to be present
in the treated area (e.g., applications to pets)

	“Do not apply this product in a way that will contact adults,
children, or pets, either directly or through drift.”

“Remove pets, birds, and cover fish aquariums before spraying.”

 	Place in the Direction for Use

General Application Restrictions for products that only contain
directions for uses when people are permitted to be present (e.g. pet
applications)	Note to Registrants:  No entry restrictions are required.
See below under Use Restrictions for further requirements.  	Place in
the Direction for Use

General Application Restrictions for products that contain directions
for uses when people are permitted to be present in the treated area
(e.g. applications to pets) AND for use on other sites as a surface
spray.

“Except when (insert application method or site that allows people to
be present), do not apply this product in a way that will contact
adults, children, or pets, either directly or through drift.”

Note to Registrant an example is as follows:  Except when applying to
pets, do not apply this product in a way that will contact adults,
children, or pets, either directly or through drift.

	Place in the Direction for Use

Environmental hazard statements on Liquid Concentrate consumer outdoor
products (e.g., liquids mixed with water by the user for a tank sprayer
or hose-end attachment)	“This pesticide is toxic to aquatic organisms,
including fish and invertebrates.  To protect the environment, do not
allow pesticide to enter or run off into storm drains, drainage ditches,
gutters or surface waters.  Applying this product in calm weather when
rain is not predicted for the next 24 hours will help to ensure that
wind or rain does not blow or wash pesticide off the treatment area.
Rinsing application equipment over the treated area will help avoid run
off to water bodies or drainage systems.

 “This product is highly toxic to bees exposed to direct treatment on
blooming crops or weeds.  Do not apply this product or allow it to drift
to blooming crops or weeds while bees are actively visiting the
treatment area.”

	Environmental Hazard Statement

Environmental hazard statements on Dusts consumer outdoor products
(e.g., for garden or ornamental)	“This pesticide is toxic to aquatic
organisms, including fish and invertebrates.  To protect the
environment, do not allow pesticide to enter or run off into storm
drains, drainage ditches, gutters or surface waters.  Applying this
product in calm weather when rain is not predicted for the next 24 hours
will help to ensure that wind or rain does not blow or wash pesticide
off the treatment area.”

“This product is highly toxic to bees exposed to direct treatment on
blooming crops or weeds.  Do not apply this product or allow it to drift
to blooming crops or weeds while bees are actively visiting the
treatment area.”

	Environmental Hazard Statement

Environmental hazard statements on Ready-to-Use  consumer outdoor
products (except aerosols and foggers)	“This pesticide is toxic to
aquatic organisms, including fish and invertebrates.  To protect the
environment, do not allow pesticide to enter or run off into storm
drains, drainage ditches, gutters or surface waters.  Applying this
product in calm weather when rain is not predicted for the next 24 hours
will help to ensure that wind or rain does not blow or wash pesticide
off the treatment area.”

“This product is highly toxic to bees exposed to direct treatment on
blooming crops or weeds.  Do not apply this product or allow it to drift
to blooming crops or weeds while bees are actively visiting the
treatment area.”

	Environmental Hazard Statement

Environmental Hazard Statements aerosol and fogger consumer outdoor
products	“This pesticide is toxic to aquatic organisms, including fish
and invertebrates.  Do not apply directly to or near water.  Drift and
run-off may be hazardous to fish in water adjacent to treated areas.  Do
not contaminate water when disposing of equipment, washwater, or
rinsate.  See Directions for Use for additional precautions and
requirements.”

“This product is highly toxic to bees exposed to direct treatment on
blooming crops or weeds.  Do not apply this product or allow it to drift
to blooming crops or weeds while bees are actively visiting the
treatment area.”

	Environmental Hazard Statement

Other Application Restrictions (as applicable)

  SEQ CHAPTER \h \r 1 	Note to Registrants:  Delete any reference to
tolerance exemptions on labels.

In addition add the following restrictions depending on the registered
product uses and formulation:

All formulations labeled or intended for outdoor residential uses:

“Do not make applications during rain.”

Wettable powder formulations:

“Do not apply this product as a dust.”

Dust formulations:

“Aerial applications are prohibited.”

“Only apply as a spot treatment to areas no greater than 3 feet by 3
feet per room.”

Products labeled for use as a  space spray:

“Do not remain in treated area.  Exit area immediately and remain
outside the treated area until aerosols, vapors, and/or mists have
dispersed.”

Products labeled for spray applications to plants:

“Do not wet plants to point of runoff or drip.”

Products labeled for spray applications to articles:

“Do not wet articles to point of runoff or drip.”

“Do not use treated article until spray has dried.”

Products labeled for applications to clothing articles:

“Dry clean treated clothes before wearing.”

Products labeled for dip applications to empty containers:

“Do not use treated article before it is dry.”

Products labeled for crack and crevice, surface or space spray, fogging
or dust applications indoors:

“Remove or cover exposed food and drinking water before
application.”

“Remove or cover dishes, utensils, food processing equipment, and food
preparation surfaces, or wash them before use.”

Liquid, Dust, and Ready-To-Use products intended for outdoor residential
use:

“Do not water the treated area to the point of run-off.”

Products labeled for use around or near floor drains. Products labeled
for use in drains or sewers are excluded from this label requirement:
“Do not apply directly into sewers or drains, or to any area like a
gutter where drainage to storm sewers, water bodies, or aquatic habitat
can occur. Do not allow the product to enter any drain during or after
application.”

Products labeled for use in drains or sewers:

“Except when applying to sewers or drains as instructed on this label,
do not apply directly to sewers or drains, or to any area like a gutter
where drainage to sewers, storm drains, water bodies, or aquatic habitat
can occur.”

Residential Outdoor Surface and Space Sprays, except for outdoor fogging
devices:

“All outdoor applications must be limited to spot or crack-and-crevice
treatments only, except for the following permitted uses:

(1) Treatment to soil or vegetation around structures;

(2) Applications to lawns, turf, and other vegetation;

(3) Applications to building foundations, up to a maximum height of 3
feet.

Other than applications to building foundations, all outdoor
applications to impervious surfaces such as sidewalks, driveways,
patios, porches and structural surfaces (such as windows, doors, and
eaves) are limited to spot and crack-and-crevice applications, only.”

	Directions for Use under Use Restrictions

Residential Use Restriction

(Note: The maximum allowable application rate and maximum allowable
seasonal rate must be listed as pounds or gallons of formulated product
per acre or per square feet or per cubic feet, not just as pounds active
ingredient per unit area.)

	Note:  See Appendix A for a complete list of application rates and
restrictions that are eligible for reregistration.

These rate changes must be updated on all products:

The maximum PBO rate for indoor crack and crevice spray is 0.56 lbs
ai/1000 square feet.

Formulated indoor space spray products eligible for reregistration must
not contain more than 0.05 lbs ai/16 ounce can.

Formulated pet spray products eligible for reregistration must not
contain more than 10 % piperonyl butoxide.

Formulated pet spray products eligible for reregistration must not
contain more than 0.2 % pyrethrins.

The maximum space spray rate for residential areas is 0.00033 lbs
pyrethrins per 1000 cubic feet.

The maximum space spray rate for post-harvest applications to fruits,
vegetables and copra is 0.001 lbs pyrethrins per 1000 cubic feet.

The maximum space spray rate for post-harvest application to fruits,
vegetables, and nuts is 0.01 lbs PBO per 1000 cubic feet.	Directions for
Use under Use Restrictions

Application Restrictions for products used in Outdoor Metered Release
Devices	Outdoor Metered Release Devices

“Directions for use in outdoor metered release devices:”

“If the device works on an automatic timer, set the timing for
application when people, pets, and/or food are unlikely to be
present.”

“If the device works when a person operates a remote activation
device, then application of this pesticide when people, pets, and food
are/or present is prohibited.”

“Direct nozzle to spray towards the target area and away from areas
where people are typically present.”

“The pesticide container must be locked.”

“Do not install within 3 feet of air vents, air conditioner units, or
windows.”

“Carefully follow directions for the dispenser unit when installing
the dispenser and replacing cans or conducting maintenance.”

	Directions for Use under Use Restrictions

Use-Specific Application Restrictions for all liquid and wettable powder
labels

(Outdoor residential misting system requirement)

Note to registrant:  Also express this application rate as pounds or
gallons of end-use product formulation.

	Outdoor Residential Misting Systems

Products not intended for use in outdoor residential misting systems
must contain the following statement:

“Not for use in outdoor residential misting systems.”

Products intended for use in outdoor residential misting systems must
contain the following statements:

“Directions for use in outdoor residential misting systems:”

“When using this product installers and service technicians must
comply with the license, certification, or registration requirements of
the state(s), tribe(s), or local authority(ies) where they are
installed.”

“If the system works on an automatic timer, set the timing for
application when people, pets, and food are unlikely to be present.”

“If the system works when a person operates a remote activation
device, then application of this pesticide when people, pets, and food
are present is prohibited.”

“Do not use in an evaporative cooling system.”

“Direct nozzles to spray towards the target area and away from
swimming pools, water bodies, or eating and cooking areas.”

“Do not set nozzles to direct mist near outside air condition systems
or other home air intakes.”

“If used in a system with a reservoir tank for the end use dilution,
the system reservoir tank must be locked.  Securely attach the end use
pesticide label and a dilution statement to the system reservoir tank in
a weather protected area or plastic sleeve.  The dilution statement must
be phrased as follows: this container holds __ parts [product name] to
__ parts water”

“If used in a direct injection system, the pesticide container must be
locked.  Securely attach the end use label to the pesticide container in
a weather protected area or plastic sleeve.”  (These instructions not
applicable to wettable powder products).

“Contact the system manufacture for guidance or assistance to ensure
compliance with the following  requirement:

 “This product must only be used in systems that have been calibrated
to apply no more than the maximum application rate of” [insert product
application rate that is equal to 0.00011 lbs pyrethrins per 1000 cubic
feet per day, or 0.00058 lbs piperonyl butoxide per 1000 cubic feet per
day, whichever is lower].

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:  Also express this application rate as pounds or gallons of end-use
product formulation.	Directions for Use under Use Restrictions

1   	PPE that is established on the basis of Acute Toxicity of the
end-use product must be compared to the active ingredient PPE in this
document.  In the case of multiple active ingredients, the more
protective PPE must be placed on the product labeling.  For guidance on
which PPE is considered more protective, see PR Notice 93-7.

 PAGE

 PAGE   1


[Federal Register Volume 87, Number 79 (Monday, April 25, 2022)]
[Notices]
[Pages 24351-24352]
[FR Doc No: 2022-08670]

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

SECURITIES AND EXCHANGE COMMISSION

[SEC File No. 270-448, OMB Control No. 3235-0507]

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 19b-5 and Form PILOT

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (``PRA'') (44 U.S.C. 3501 et seq.), the Securities and
Exchange Commission (``SEC'') is soliciting comments on the existing
collection of information provided for in Rule 19b-5 (17 CFR 240.19b-5)
and Form PILOT (17 CFR

249.821) under the Securities Exchange Act of 1934 (``Exchange Act'')
(15 U.S.C. 78a et seq.). The SEC plans to submit this existing
collection of information to the Office of Management and Budget
(``OMB'') for extension and approval.
    Rule 19b-5 provides a temporary exemption from the rule-filing
requirements of Section 19(b) of the Exchange Act (15 U.S.C. 78s(b)) to
self-regulatory organizations (``SROs'') wishing to establish and
operate pilot trading systems. Rule 19b-5 permits an SRO to develop a
pilot trading system and to begin operation of such system shortly
after submitting an initial report on Form PILOT to the SEC. During
operation of any such pilot trading system, the SRO must submit
quarterly reports of the system's operation to the SEC, as well as
timely amendments describing any material changes to the system. Within
two years of operating such pilot trading system under the exemption
afforded by Rule 19b-5, the SRO must submit a rule filing pursuant to
Section 19(b)(2) of the Exchange Act (15 U.S.C. 78s(b)(2)) to obtain
permanent approval of the pilot trading system from the SEC.
    The collection of information is designed to allow the SEC to
maintain an accurate record of all new pilot trading systems operated
by SROs and to determine whether an SRO has properly availed itself of
the exemption afforded by Rule 19b-5, is operating a pilot trading
system in compliance with the Exchange Act, and is carrying out its
statutory oversight obligations under the Exchange Act.
    The respondents to the collection of information are national
securities exchanges and national securities associations.
    There are 24 SROs which could avail themselves of the exemption
under Rule 19b-5 and the use of Form PILOT. The SEC estimates that
approximately one of these SROs each year will file on Form PILOT one
initial report (i.e., 1 report total, for an estimated annual burden of
24 hours total), four quarterly reports (i.e., 4 reports total, for an
estimated annual burden of 12 hours total (3 hours per report)), and
two amendments (i.e., 2 reports total, for an estimated annual burden
of 6 hours total (3 hours per report)). Thus, the estimated annual time
burden resulting from Form PILOT is 42 hours for the estimated sole SRO
respondent. The SEC estimates that the aggregate annual internal cost
of compliance for the sole SRO respondent is approximately $12,880 (42
hours at an average of $306.67 per hour). In addition, the SEC
estimates that the sole SRO respondent will incur, in the aggregate,
printing, supplies, copying, and postage expenses of $2,287 per year
for filing initial reports, $1,142 per year for filing quarterly
reports, and $571 per year for filing notices of material systems
changes, for a total annual cost burden of $4,000.
    Written comments are invited on (a) whether the proposed collection
of information is necessary for the proper performance of the functions
of the SEC, including whether the information shall have practical
utility; (b) the accuracy of the SEC's estimate 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
by June 24, 2022.
    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: David Bottom, Director/
Chief Information Officer, Securities and Exchange Commission, c/o John
Pezzullo, 100 F Street NE, Washington, DC 20549, or send an email to:
[email protected].

    Dated: April 19, 2022.
J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2022-08670 Filed 4-22-22; 8:45 am]
BILLING CODE 8011-01-P