[Federal Register Volume 78, Number 185 (Tuesday, September 24, 2013)]
[Notices]
[Pages 58598-58599]
[FR Doc No: 2013-23224]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Agency Information Collection Activities: Requests for Comments;
Clearance of Renewed Approval of Information Collection: Extended
Operations (ETOPS) of Multi-Engine Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice and request for comments.

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SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FAA
invites public comments about our intention to request the Office of

Management and Budget (OMB) approval to renew an information
collection. A final rule published on January 16, 2007 (72 FR 1807)
codified previous practices that permitted certificated air carriers to
operate two-engine airplanes over long-range routes. The FAA uses this
information collection to ensure that aircraft for long range flights
are equipped to minimize diversions, to preclude and prevent diversions
in remote areas, and to ensure that all personnel are trained to
minimize any adverse impacts of a diversion.

DATES: Written comments should be submitted by November 25, 2013.

FOR FURTHER INFORMATION CONTACT: Kathy DePaepe at<PHONE_NUMBER>, or by
email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    OMB Control Number: 2120-0718
    Title: Extended Operations (ETOPS) of Multi-Engine Airplanes
    Form Numbers: There are no FAA forms associated with this
collection.
    Type of Review: Renewal of an information collection.
    Background: The final rule codified the previous practices that
permitted certificated air carriers to operate two-engine airplanes
over these long-range routes and extended the procedures for extended
operations to all passenger-carrying operations on routes beyond 180
minutes from an alternate airport. This option is voluntary for
operators and manufacturers. The FAA uses this information collection
to ensure that aircraft for long range flights are equipped to minimize
diversions, to preclude and prevent diversions in remote areas, and to
ensure that all personnel are trained to minimize any adverse impacts
of a diversion.
    Respondents: 18 operators and manufacturers.
    Frequency: Information is collected on occasion.
    Estimated Average Burden per Response: 7 hours.
    Estimated Total Annual Burden: 253,384 hours.
    Send comments to the FAA at the following address: Ms. Kathy
DePaepe, Room 126B, Federal Aviation Administration, AES-200, 6500 S.
MacArthur Blvd., Oklahoma City, OK 73169.
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including (a) Whether the proposed
collection of information is necessary for FAA's performance; (b) the
accuracy of the estimated burden; (c) ways for FAA to enhance the
quality, utility and clarity of the information collection; and (d)
ways that the burden could be minimized without reducing the quality of
the collected information. The agency will summarize and/or include
your comments in the request for OMB's clearance of this information
collection.

    Issued in Washington, DC on September 18, 2013.
Albert R. Spence,
FAA Assistant Information Collection Clearance Officer, IT Enterprises
Business Services Division, AES-200.
[FR Doc. 2013-23224 Filed 9-23-13; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: September 28, 2005 (Volume 70, Number 187)]
[Notices]
[Page 56675-56676]
[DOCID:fr28se05-112]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. EC05-136-000, et al.]

EBG Holdings, LLC and EBG Custodial Company, LLC; Electric Rate
and Corporate Filings

September 16, 2005.
    The following filings have been made with the Commission. The
filings are listed in ascending order within each docket
classification.

1. EBG Holdings, LLC and EBG Custodial Company LLC

[Docket No. EC05-136-000]

    On September 9, 2005, EBG Holdings, LLC (EBG) filed an application
pursuant to section 203 of the Federal Power Act requesting
authorization for a change in ownership structure involving future
EBG's upstream owners to allow a portion of their EBG membership
interests to be held by a single Delaware limited liability company,
currently denoted as EBG Custodial Company LLC, that will elect to be
treated as a ``C corporation'' for U.S. Federal tax purposes (Custodial
Company). EBG states that the membership interests or units of the
Custodial Company will in turn be owned by various yet-to-be-identified
foreign financial institutions, banks, institutional investors,
investment companies or related entities that are not primarily engaged
in energy-related business activities in the U.S., which desire to hold
their interests in EBG indirectly through the Custodial Company because
of the tax consequences associated with that structure.
    Comment Date: 5 p.m. Eastern Time on September 30, 2005.

2. Michigan Electric Transmission Co., LLC and Wolverine Power Supply
Cooperative, Inc.

[Docket Nos. EC05-137-000 and ER05-1472-000]

    Take notice that on September 12, 2005, Michigan Electric
Transmission Company, LLC (METC) and Wolverine Power Supply
Cooperative, Inc., (Wolverine) submitted an application under sections
203 and 205 of the Federal Power Act, 16 U.S.C. 824b and 824d and parts
33 and 35 of the Commission's regulations, 18 CFR parts 33 and 35, for
approval to transfer undivided ownership interests in certain of
Wolverine's transmission facilities to METC and certain related
easements, and for approval or acceptance of a new Redwood
Interconnection Facilities Agreement to reflect the transfer of
facilities.
    Comment Date: 5 p.m. Eastern Time on October 3, 2005.

3. Ontelaunee Power Operating Company, LLC

[Docket No. EG05-100-000]

    Take notice that on September 9, 2005, Ontelaunee Power Operating
Company, LLC (Applicant) filed with the Commission an application for
determination of exempt wholesale generator status pursuant to part 365
of the Commission's regulations.

    Applicant states that it is a Delaware limited liability company,
proposes to own and operate an approximately 584 megawatt natural gas-
fired electric generating facility located in Ontelaunee, Pennsylvania.
Applicant further states that copies of the application were served
upon the United States Securities and Exchange Commission and
Pennsylvania Public Utility Commission.
    Comment Date: 5 p.m. Eastern Time on September 30, 2005.

4. Carolina Power & Light Company and Florida Power Corporation

[Docket Nos. EL05-77-000, ER97-2846-005, and ER99-2311-006]

    Take notice that on September 6, 2005, Progress Energy, Inc. on
behalf of its public utility affiliates, Carolina Power & Light
Company, and Florida Power Corporation tendered for filing additional
information requested by the Commission in its August 5, 2005 letter.
    Comment Date: 5 p.m. Eastern Time on September 27, 2005.

Standard Paragraph

    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date.
Anyone filing a motion to intervene or protest must serve a copy of
that document on the Applicant and all the parties in this proceeding.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible online at http://www.ferc.gov, using the

``eLibrary'' link and is available for 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 e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.

Magalie R. Salas,
Secretary.
 [FR Doc. E5-5236 Filed 9-27-05; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 85, Number 15 (Thursday, January 23, 2020)]
[Notices]
[Pages 3910-3911]
[FR Doc No: 2020-01109]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OGC-2020-0020; FRL-10004-65-OGC]

Proposed Information Collection Request; Comment Request; Renewal
of Existing Information Collection Request for Confidential Business
Information Substantiation

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency (EPA) is planning to
submit an information collection request (ICR), ``Renewal of Existing
Information Collection Request for Confidential Business Information
Substantiation'' (EPA ICR No. 1665.14, OMB Control No. 2020-003) to the
Office of Management and Budget (OMB) for review and approval in
accordance with the Paperwork Reduction Act. Before doing so, EPA is
soliciting public comments on specific aspects of the proposed
information collection as described below. This is a proposed extension
of the ICR, which is currently approved through May 31, 2020. An Agency
may not conduct or sponsor, and a person is not required to respond to,
a collection of information unless it displays a currently valid OMB
control number.

DATES: Comments must be submitted on or before March 23, 2020.

ADDRESSES: Submit your comments, referencing Docket ID No. EPA-HQ-OGC-
2020-0020, online using www.regulations.gov (our preferred method), by
email to<EMAIL_ADDRESS>or by mail to: EPA Docket Center,
Environmental Protection Agency, Mail Code 28221T, 1200 Pennsylvania
Ave. NW, Washington, DC 20460.
    EPA's policy is that all comments received will be included in the
public docket without change including any personal information
provided, unless the comment includes profanity, threats, information
claimed to be confidential business information (CBI) or other
information whose disclosure is restricted by statute.

FOR FURTHER INFORMATION CONTACT: Christopher T. Creech, National FOIA
Office, (2310A), Environmental Protection Agency, 1200 Pennsylvania
Ave. NW, Washington, DC 20460; telephone number:<PHONE_NUMBER>; email
address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Supporting documents which explain in detail
the information that the EPA will be collecting are available in the
public

docket for this ICR. The docket can be viewed online at
www.regulations.gov or in person at the EPA Docket Center, WJC West,
Room 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone
number for the Docket Center is<PHONE_NUMBER>. For additional
information about EPA's public docket, visit http://www.epa.gov/dockets.
    Pursuant to section 3506(c)(2)(A) of the PRA, EPA is soliciting
comments and information to enable it to: (i) Evaluate 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 in completing CBI
determinations; (ii) evaluate 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) enhance the
quality, utility, and clarity of the information to be collected; and
(iv) minimize the burden of the collection of information on those who
are to respond, including through 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. EPA will consider the comments received and
amend the ICR as appropriate. The final ICR package will then be
submitted to OMB for review and approval. At that time, EPA will issue
another Federal Register notice to announce the submission of the ICR
to OMB and the opportunity to submit additional comments to OMB.
    Abstract: The U.S. Environmental Protection Agency (EPA)
established the requirements set forth in 40 CFR, part 2, subpart B,
``Confidentiality of Business Information.'' The requirements govern
business confidentiality claims. The requirements include the handling
by the Agency of business information which is or may be entitled to
confidential treatment, requiring business submitters to substantiate
CBI claims, determining whether such information is entitled to
confidential treatment for reasons of business confidentiality, and
responding to Freedom of Information Act (FOIA) requests pursuant to 5
U.S.C. 552 for information claimed as CBI.
    Form Numbers: None.
    Respondents/affected entities: Respondents include any business
submitting information to EPA that it claims as CBI. EPA receives such
information from both the manufacturing (SIC codes 20-39) and non-
manufacturing sectors (no SIC codes identified).
    Respondent's obligation to respond: Voluntary and mandatory.
    Estimated number of respondents: 198 (total).
    Frequency of response: 1 response per respondent annually.
    Total estimated burden: 752.4 hours (per year). Burden is defined
at 5 CFR 1320.03(b).
    Total estimated cost: $169,290 (per year), includes $0 annualized
capital or operation & maintenance costs.
    Changes in Estimates: The revised requests for substantiation will
decrease the estimated burden hours for each response, although it
increases the total estimated respondent burden compared with the ICR
currently approved by OMB. The decrease is 2 hours for each business
response; the increase is based on an expected higher response rate
under the new form, producing an increase from 488 hours to 752.4 hours
total. These changes are due to the removal of a question that required
a company to describe, with specificity, the ``substantial competitive
harm'' that would occur as a direct result of disclosing the
information. EPA modified its substantiation questions as a result of
the U.S. Supreme Court's decision in Food Marketing Institute v. Argus
Leader Media (Argus), 139 S. Ct. 2356 (2019), which evaluated the
definition of ``confidential'' as used in Exemption 4 of the Freedom of
Information Act (FOIA). 5 U.S.C. 552(b)(4). In the Argus decision, the
Court held that at least where ``[1] commercial or financial
information is both customarily and actually treated as private by its
owner and [2] provided to the government under an assurance of privacy,
the information is `confidential' within the meaning of Exemption 4.''
Argus, 139 S. Ct. at 2366. EPA has reduced burdens to business
submitters by removing the requirement to explain with specificity
whatever ``substantial competitive harm'' a submitter claims would
ensue from release of each CBI claim. The evaluation of ``substantial
competitive harm'' had required businesses to analyze and describe the
potential impacts of release. EPA has replaced that question with
modified questions that require a factual description of the
submitter's handling and treatment of the CBI-claimed information, as
well as a description of any assurances provided by EPA at the time of
submission. This replacement will reduce the burden on companies since
evaluation and analysis of ``substantial competitive harm'' is no
longer required. Further, EPA reframed preexisting questions to solicit
``yes'' or ``no'' responses, which further reduces burdens on
submitters. These modifications will result in greater clarity to
business submitters and improved responses as the Agency completes its
confidentiality determinations. The Agency anticipates that this lower
burden on each response will increase the response rate from 21% in the
prior analysis to 66% in the present analysis. EPA has already
experienced an increase in response rate as a result of the Supreme
Court's decision and expects this change to continue under the new
form. EPA also made other adjustments in its analysis including
adjustments in the hourly costs for both the Agency and responding
companies as well as removing a category of burden that was not
relevant to EPA's information request.

    Dated: January 15, 2020.
Timothy R. Epp,
Associate General Counsel.
[FR Doc. 2020-01109 Filed 1-22-20; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 87, Number 169 (Thursday, September 1, 2022)]
[Notices]
[Page 53742]
[FR Doc No: 2022-18948]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Numbers: RP22-1148-000.
    Applicants: Texas Eastern Transmission, LP.
    Description: Sec.  4(d) Rate Filing: Negotiated Rates--Morg Stanley
to UGI 8972268 eff 8-25-22 to be effective 10/1/2022.
    Filed Date: 8/25/22.
    Accession Number: 20220825-5091.
    Comment Date: 5 p.m. ET 9/6/22.

    Docket Numbers: RP22-1149-000.
    Applicants: Southern LNG Company, L.L.C.
    Description: Sec.  4(d) Rate Filing: Prepayment to be effective 9/
26/2022.
    Filed Date: 8/26/22.
    Accession Number: 20220826-5012.
    Comment Date: 5 p.m. ET 9/7/22.

    Docket Numbers: RP22-1151-000.
    Applicants: Carolina Gas Transmission, LLC.
    Description: Compliance filing: CGT--2022 Penalty Revenue Crediting
Report to be effective N/A.
    Filed Date: 8/26/22.
    Accession Number: 20220826-5045.
    Comment Date: 5 p.m. ET 9/7/22.

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

    Dated: August 26, 2022.
Kimberly D. Bose,
Secretary.
[FR Doc. 2022-18948 Filed 8-31-22; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 88, Number 230 (Friday, December 1, 2023)]
[Notices]
[Pages 84021-84023]
[FR Doc No: 2023-26500]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-99031; File No. SR-NYSEARCA-2023-58]

Self-Regulatory Organizations; NYSE Arca, Inc.; Order Instituting
Proceedings To Determine Whether To Approve or Disapprove a Proposed
Rule Change To List and Trade Shares of the Hashdex Bitcoin Futures ETF
Under NYSE Arca Rule 8.500-E (Trust Units)

November 28, 2023.
    On September 22, 2023, NYSE Arca, Inc. (``NYSE Arca'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\ a
proposed rule change to list and trade shares (``Shares'') of the
Hashdex Bitcoin Futures ETF (``Fund'') under NYSE Arca Rule 8.500-E
(Trust Units). The proposed rule change was published for comment in
the Federal Register on October 3, 2023.\3\
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 98564 (Sept. 27,
2023), 88 FR 68188 (``Notice''). Comments on the proposed rule
change are available at: https://www.sec.gov/comments/sr-nysearca-2023-58/srnysearca202358.htm.
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    On November 15, 2023, pursuant to section 19(b)(2) of the Act,\4\
the Commission designated a longer period within which to approve the
proposed rule change, disapprove the proposed rule change, or institute
proceedings to determine whether to disapprove the proposed rule
change.\5\ This order institutes proceedings under section 19(b)(2)(B)
of the Act \6\ to determine whether to approve or disapprove the
proposed rule change.
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    \4\ 15 U.S.C. 78s(b)(2).
    \5\ See Securities Exchange Act Release No. 98947, 88 FR 81171
(Nov. 21, 2023). The Commission designated January 1, 2024, as the
date by which the Commission shall approve or disapprove, or
institute proceedings to determine whether to disapprove, the
proposed rule change.
    \6\ 15 U.S.C. 78s(b)(2)(B).
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I. Summary of the Proposal

    As described in more detail in the Notice,\7\ the Exchange proposes
to list and trade the Shares of the Fund, a series of the Tidal
Commodities Trust I (``Trust''), under NYSE Arca Rule 8.500-E, which
governs the listing and trading of Trust Units on the Exchange.\8\
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    \7\ See Notice, supra note 3.
    \8\ The Exchange states that the Commission previously approved
the listing and trading of the Shares pursuant to NYSE Arca Rule
8.200-E, Commentary .02, which governs the listing and trading of
Trust Issued Receipts on the Exchange, as shares of the Teucrium
Bitcoin Futures Fund. See Securities Exchange Act Release No. 34-
94620 (Apr. 6, 2022), 87 FR 21676 (Apr. 12, 2022) (SR-NYSEArca-2021-
53) (Order Approving a Proposed Rule Change, as Modified by
Amendment No. 2, To List and Trade Shares of the Teucrium Bitcoin
Futures Fund) (the ``Approval Order''). See also Securities Exchange
Act Release No. 92573 (Aug. 5, 2021), 86 FR 44062 (Aug. 11, 2021)
(SR-NYSEArca-2021-53) (Notice of Filing of a Proposed Rule Change To
List and Trade Shares of Teucrium Bitcoin Futures Fund Under NYSE
Arca Rule 8.200-E) and Partial Amendment No. 2, available at https://www.sec.gov/comments/sr-nysearca-2021-53/srnysearca202153-20118884-271701.pdf. According to the Exchange, the name of the Teucrium
Bitcoin Futures Fund was subsequently changed to the Hashdex Bitcoin
Futures ETF. See Notice, 88 FR at 68188. The Exchange states that
the representations set forth in the Notice supersede and replace
the representations in the Exchange's prior rule filing relating to
the Teucrium Bitcoin Futures Fund and Partial Amendment No. 2
thereto. See id. at 68188 n.4.
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    The investment objective of the Fund is to have the daily changes
in the net asset value (``NAV'') of the Shares reflect the daily
changes in the price of a specified benchmark (``Benchmark'').\9\ The
Benchmark will be calculated using the Nasdaq Bitcoin Reference Price--
Settlement (``NQBTCS''), which tracks the price of bitcoin.\10\ The
Fund will seek to achieve its investment objective by investing in
bitcoin futures contracts \11\ as well as in physical bitcoin to the
extent allowed by the Fund's investment restrictions on spot
bitcoin.\12\ The Fund will use the CME's Exchange for Physical
(``EFP'') transactions to acquire and dispose of spot bitcoin.\13\ The
Fund will be subject to investment restrictions on spot bitcoin which
are currently set at 100% of the 30-day Average Daily Traded Volume on
the core bitcoin platforms of the NQBTCS that are subject to regulatory
and reporting rules in the United States, including companies that are
publicly traded in the United States.\14\ The administrator of the Fund
will calculate the NAV of the Fund once each trading day, as of the
earlier of the close of the New York Stock Exchange or 4:00 p.m.
Eastern Standard Time.\15\ To determine the value of bitcoin futures
contracts, the Fund's administrator will use the bitcoin futures
contract settlement price on the exchange on which the contract is
traded, except that the fair value of bitcoin futures contracts may be
used when bitcoin futures contracts close at their price fluctuation
limit for the day. The value of spot bitcoin held by the Fund would be
determined by the Sponsor and by Hashdex Asset Management Ltd.
(``Digital Asset Adviser'') in good faith based on a methodology that
is entirely derived from the settlement prices of bitcoin futures
contracts on the CME and that considers all available facts and all
available information on the valuation date.\16\ When the Fund sells or
redeems its Shares, it will do so in cash transactions with authorized
participants in blocks of 12,500 Shares.\17\
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    \9\ See Notice, 88 FR at 68189. The Fund is managed and
controlled by Toroso Investments LLC (``Sponsor''). See id. at
68188.
    \10\ See id. at 68189.
    \11\ It is unclear from the filing whether the Fund is limited
to investing in bitcoin futures contracts traded on the Chicago
Mercantile Exchange, Inc. (``CME'').
    \12\ See id. at 68190. The Fund will hold a mix of spot bitcoin,
bitcoin futures contracts, and cash and cash equivalents, subject to
certain investment restrictions. See id. at 68197.
    \13\ See id. at 68197. According to the Exchange, EFP
transactions are a type of private agreement between two parties to
trade a futures position for the underlying asset. In an EFP
transaction, two parties exchange equivalent but offsetting
positions in a bitcoin futures contract and the underlying physical
bitcoin. In the context of the Fund, these transactions will be used
to purchase and sell spot bitcoin by delivering or receiving the
equivalent futures position. See id. at 68204.
    \14\ See id. at 68203. According to the Exchange, as of the date
of the filing, Coinbase Inc. was the only bitcoin platform to
satisfy this criterion. See id. at 68203 n.78.
    \15\ See id. at 68206. The Fund's NAV will include any
unrealized profit or loss on open bitcoin futures contacts and any
other credit or debit accruing to the Fund but unpaid or not
received by the Fund. See id.
    \16\ See id. at 68199. This ``futures-based spot price''
methodology is sensitive to both the tenor of a bitcoin futures
contract and the final settlement price for such contract. The
calculation produces a set of weighting factors, with each factor
indicating the contribution of the corresponding bitcoin futures
contract to the estimated current spot price of bitcoin. The
estimated spot price is the component of the result corresponding to
a tenor of zero days. The Sponsor and Digital Asset Advisor will not
use data from bitcoin trading platforms or directly from spot
bitcoin trading activity in determining the value of spot bitcoin
held by the Fund. See id. at 68206.
    \17\ See id. at 68204, 68206.
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II. Proceedings To Determine Whether To Approve or Disapprove SR-
NYSEARCA-2023-58 and Grounds for Disapproval Under Consideration

    The Commission is instituting proceedings pursuant to section
19(b)(2)(B) of the Act \18\ to determine whether the proposed rule
change should be approved or disapproved. Institution of proceedings is
appropriate at this time in view of the legal and policy issues raised
by the proposed rule change, as discussed below. Institution of
proceedings does not indicate that the Commission has reached any
conclusions with respect to any of the issues involved. Rather, as
described below, the Commission seeks and encourages interested persons
to provide comments on the proposed rule change.
---------------------------------------------------------------------------

    \18\ 15 U.S.C. 78s(b)(2)(B).

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

    Pursuant to section 19(b)(2)(B) of the Act,\19\ the Commission is
providing notice of the grounds for disapproval under consideration.
The Commission is instituting proceedings to allow for additional
analysis of the proposed rule change's consistency with section 6(b)(5)
of the Act, which requires, among other things, that the rules of a
national securities exchange be ``designed to prevent fraudulent and
manipulative acts and practices'' and ``to protect investors and the
public interest.'' \20\
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    \19\ Id.
    \20\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The Commission asks that commenters address the sufficiency of the
Exchange's statements in support of the proposal, which are set forth
in the Notice, in addition to any other comments they may wish to
submit about the proposed rule change. In particular, the Commission
seeks comment on the following questions and asks commenters to submit
data where appropriate to support their views:
    1. What are commenters' views on whether the proposed Fund and
Shares would be susceptible to manipulation? What are commenters' views
generally on whether the Exchange's proposal is designed to prevent
fraudulent and manipulative acts and practices? What are commenters'
views generally with respect to the liquidity and transparency of the
bitcoin markets and the bitcoin markets' susceptibility to
manipulation?
    2. Based on data and analysis provided and the academic research
cited by the Exchange,\21\ what are commenters views on whether the
CME, on which CME bitcoin futures trade and through which the Fund
intends to engage in EFP transactions to purchase or sell spot bitcoin,
represents a regulated market of significant size related to spot
bitcoin? \22\ What are commenters' views on whether there is a
reasonable likelihood that a person attempting to manipulate the Shares
would also have to trade on the CME to manipulate the Shares? \23\ Do
commenters agree with the Exchange that trading in the Shares would not
be the predominant influence on prices in the CME bitcoin futures
market? \24\
---------------------------------------------------------------------------

    \21\ See Notice, 88 FR at 68198-99, 68201 n.74, 68202-03.
    \22\ See id. at 68197.
    \23\ See id.
    \24\ See id.
---------------------------------------------------------------------------

    3. The Exchange states that the Fund intends to adopt ``an
innovative approach to mitigate the risks of fraud and manipulation
that are unique to the Fund'' by ``structur[ing] the operation of the
Fund such that the regulated market of significant size in relation to
the Fund is the [CME] because it is the same market on which the Fund
trades its non-cash assets.'' \25\ The Exchange further states that the
Fund has novel features that underscore its significant
interrelationship with the CME, including that the Fund (i) utilizes
futures-based pricing for spot bitcoin such that the NAV calculation
for the spot bitcoin holdings of the Fund will be derived from the CME
bitcoin futures curve; (ii) is subject to investment restrictions on
spot bitcoin; (iii) will use CME EFP transactions to acquire and
dispose of spot bitcoin ``instead of transactions on unregulated spot
exchanges''; and (iv) will utilize only cash creations and
redemptions.\26\ Based on the structure and operation of the Fund and
the Fund's investments as described in the filing, what are commenters'
views on whether the CME represents a regulated market of significant
size related to spot bitcoin? \27\
---------------------------------------------------------------------------

    \25\ See id. at 68196.
    \26\ See id. at 68197.
    \27\ See id. at 68197.
---------------------------------------------------------------------------

    4. The Fund will only use CME EFP transactions to acquire and
dispose of spot bitcoin.\28\ The Exchange states that ``trading
activity in EFP transactions is sporadic'' but that, ``[n]onetheless,
the Sponsor believes that a large number of liquidity providers are
ready to execute this type of transaction and can provide enough
liquidity to support the [Fund's] demand.'' \29\ Do commenters agree?
Why or why not?
---------------------------------------------------------------------------

    \28\ See, e.g., id. at 68204-06.
    \29\ See id. at 68205.
---------------------------------------------------------------------------

    5. The value of spot bitcoin held by the Fund would be determined
using a futures-based spot price methodology that is derived from the
settlement prices of bitcoin futures contracts on the CME.\30\ The
Exchange presents data \31\ that it states ``strongly suggests that
[futures-based spot pricing] is a suitable choice for the NAV
calculation.'' \32\ The Exchange states that futures-based spot pricing
``could create some level of uncertainty due to the potential
divergences between the [futures-based spot price] and the spot prices
observed in unregulated markets'' but that authorized participants
``will always be in a position to hedge their exposure using
exclusively the [CME bitcoin futures market], which will make them more
likely to provide liquidity to the Fund thus making its market price
converge to its NAV.'' \33\ Do commenters agree with the Exchange? Why
or why not?
---------------------------------------------------------------------------

    \30\ See id. at 68199.
    \31\ See id. at 68199-201.
    \32\ See id. at 68201.
    \33\ See id. at 68201.
---------------------------------------------------------------------------

    6. Some sponsors of proposed spot bitcoin exchange-traded products
have provided data regarding the correlation between certain bitcoin
spot markets and the CME bitcoin futures market.\34\ What are
commenters' views on the correlation between the bitcoin spot market
and the CME bitcoin futures market? What are commenters' views on the
extent to which that correlation provides evidence that the CME bitcoin
futures market is ``significant'' related to spot bitcoin? What are
commenters' views on the Sponsor's own statistical analysis of the
relationship between prices in certain unregulated bitcoin markets and
prices of CME bitcoin futures contracts? \35\
---------------------------------------------------------------------------

    \34\ See, e.g., Notice of Filing of Amendment No. 3 to, and
Order Instituting Proceedings to Determine Whether to Approve or
Disapprove, a Proposed Rule Change to List and Trade Shares of the
ARK 21Shares Bitcoin ETF under BZX Rule 14.11(e)(4), Commodity-Based
Trust Shares, Securities Exchange Act Release No. 98112 (Aug. 11,
2023), 88 FR 55743 (Aug. 16, 2023) (including data from sponsor
21Shares US LLC that purports to show correlations of returns across
the two-year period from January 20, 2021, to February 1, 2023, of
no less than 92% among certain spot bitcoin platforms and between
the CME bitcoin futures market and such spot bitcoin platforms on an
hourly basis, and no less than 78% on a minutely basis).
    \35\ See id. at 68202.
---------------------------------------------------------------------------

III. Procedure: Request for Written Comments

    The Commission requests that interested persons provide written
submissions of their views, data, and arguments with respect to the
issues identified above, as well as any other concerns they may have
with the proposal. In particular, the Commission invites the written
views of interested persons concerning whether the proposal is
consistent with section 6(b)(5) or any other provision of the Act, and
the rules and regulations thereunder. Although there do not appear to
be any issues relevant to approval or disapproval that would be
facilitated by an oral presentation of views, data, and arguments, the
Commission will consider, pursuant to Rule 19b-4, any request for an
opportunity to make an oral presentation.\36\
---------------------------------------------------------------------------

    \36\ Section 19(b)(2) of the Act, as amended by the Securities
Acts Amendments of 1975, Public Law 94-29 (June 4, 1975), grants the
Commission flexibility to determine what type of proceeding--either
oral or notice and opportunity for written comments--is appropriate
for consideration of a particular proposal by a self-regulatory
organization. See Securities Acts Amendments of 1975, Senate Comm.
on Banking, Housing & Urban Affairs, S. Rep. No. 75, 94th Cong., 1st
Sess. 30 (1975).

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

    Interested persons are invited to submit written data, views, and
arguments regarding whether the proposed rule change should be approved
or disapproved by December 22, 2023. Any person who wishes to file a
rebuttal to any other person's submission must file that rebuttal by
January 5, 2024.
    Comments may be submitted by any of the following methods:

Electronic Comments

     Use the Commission's internet comment form (https://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
file number SR-NYSEARCA-2023-58 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-NYSEARCA-2023-58. 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 (https://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
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. Do not
include personal identifiable information in submissions; you should
submit only information that you wish to make available publicly. We
may redact in part or withhold entirely from publication submitted
material that is obscene or subject to copyright protection. All
submissions should refer to file number SR-NYSEARCA-2023-58 and should
be submitted on or before December 22, 2023. Rebuttal comments should
be submitted by January 5, 2024.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\37\
---------------------------------------------------------------------------

    \37\ 17 CFR 200.30-3(a)(57).
---------------------------------------------------------------------------

Sherry R. Haywood,
Assistant Secretary.
[FR Doc. 2023-26500 Filed 11-30-23; 8:45 am]
BILLING CODE 8011-01-P


PESTICIDE REGISTRATION ( PR) NOTICE 2005  1 NOTICE TO MANUFACTURERS, PRODUCERS, FORMULATORS AND REGISTRANTS OF PESTICIDE PRODUCTS ATTENTION: Persons Responsible for Federal Registration and Reregistration of Pesticide Products SUBJECT: Labeling Statements on Products Used for Adult Mosquito Control This Notice presents the Agency's guidance on appropriate label language for pesticide products intended for wide area application to control adult mosquitoes. EPA undertakes initiatives such as this in order to improve and clarify pesticide product labeling. The specific label statements and label organization principles recommended in this Notice are intended to improve existing labels by clarifying language conveying environmental hazards posed by these products, as well as specific use directions and instructions to the applicators. The Agency believes that adoption of these recommendations will help both pesticide users and pesticide enforcement officials to improve effective mosquito control and protection of public health, while ensuring that use of these products will not pose unreasonable risks to the environment. The Agency believes the incremental cost of label modifications is outweighed by the benefits to public health protection by having appropriate label statements that help ensure the proper and effective use of these products for mosquito control.

I. BACKGROUND In recent years state pesticide regulators and vector control agencies have raised a variety of concerns about the labeling of pesticides used for adult mosquito control. For example, in 1999 the State FIFRA Issues Research and Evaluation Group ( SFIREG) submitted an issue paper to the Agency raising two specific concerns about such labeling. ( SFIREG is a committee of the Association of American Pesticide Control Officials, and its public meetings serve as a forum for state regulators to discuss issues concerning the Federal Insecticide, Fungicide and Rodenticide Act ( FIFRA) with Agency officials and other interested parties). The SFIREG paper noted that the statement " do not apply directly to water" which appears on many outdoor use pesticide products, if broadly interpreted, would severely restrict the application of mosquito adulticides, especially in Page 2 floodwater situations, such as those encountered in the aftermath of hurricane Floyd in September 1999. SFIREG also noted that the standard label language intended to protect bees, which prohibits pesticide applications "... to blooming crops or weeds if bees are visiting the treatment area", could be seen as making virtually any daylight application of mosquito adulticides a violation of the label, even during an urgent threat to public health. Since state agencies enforce pesticide use regulations under cooperative agreements with EPA, and since FIFRA section 12( a)( 2)( G) makes it an unlawful act " to use any registered pesticide in a manner inconsistent with its labeling", the interpretation of label requirements is a critical issue for EPA headquarters and regional offices, state pesticide regulatory agencies, and users.

In February 2001, the increasing impact of West Nile Virus on vector control and regulatory agencies led EPA's Region II office to sponsor an Inter Regional Mosquito Control Conference for EPA and state agency representatives. Although labeling was one of many subjects discussed at the conference, participants felt this was an area that should be addressed. It was agreed that a group representing EPA's Office of Pesticide Programs ( OPP), Office of Enforcement and Compliance Assurance ( OECA), EPA Regional offices and state lead agency volunteers would develop initial, informal proposals for improving mosquito control product labels, with the focus on adulticides only. The EPA State workgroup developed a paper which included seven recommendations. It also raised the question of overriding bee protection use directions in a public health emergency, but did not make a recommendation on that issue.

In April 2003, the initial recommendations were discussed at a public meeting of the Pesticide Program Dialogue Committee ( PPDC). The PPDC is chartered under the Federal Advisory Committee Act to advise EPA on pesticide issues. Its members represent a broad spectrum of interests, including the pesticide industry, grower groups, public health agencies, academic researchers, public interest and advocacy organizations. In general, PPDC agreed that improved labeling for this class of products should be pursued, and that the initial set of recommendations were generally appropriate, but needed further development. PPDC recommended that EPA develop the initial recommendations into more formal Agency positions.

This notice is the result of Agency deliberations and public input, and represents the Agency's formal recommendations. The recommendations consist of some specific statements that should generally appear on labels for this class of products, some model statements that registrants may adapt to the specific characteristics of their products, and some principles on organizing elements of the label.

II. PRODUCTS POTENTIALLY AFFECTED BY THIS NOTICE Since current labels for adult mosquito control products show a great deal of variation, the relevance of the recommendations in this Notice will vary from product to product. Registrants are encouraged to review and, as appropriate, apply to amend their product labels for insecticides registered for wide area adult mosquito control to include the additional or revised use directions Page 3 and other statements, and take related actions as described in this Notice. These recommendations apply to products labeled for wide area application by ground or aerial equipment, as Ultra Low Volume ( ULV) sprays or fogs, and not to home and garden use products which may list mosquitoes on the label, or to coarse non ULV sprays intended for residual treatment of vegetation or other surfaces. Control of mosquito larvae is a wholly different use pattern from adult mosquito control, and thus, products registered as mosquito larvicides are not included in the scope of this Notice.

III. DISCUSSION OF ISSUES AND RECOMMENDATIONS This section presents seven labeling issues the Agency wishes to address, followed by a statement of a specific improvement that the Agency believes appropriate to deal with each issue. The label improvements recommended in this Notice are not identical to the seven initial recommendations presented to the PPDC in April 2003. In some cases, the initial recommendation was stated as a general principle, which has now been developed into specific language. The Agency's own assessment led to merging some of the initial recommendations and adding new ones.

The general purpose of these recommendations is to improve consistency in the labeling of this group of products. Differences in use directions and hazard statements are appropriate for different active ingredients, formulations or application methods. However, since products were registered and labels approved individually over many years, variations have occurred in the level of detail for use directions and approaches to precautionary language, especially those related to hazards to aquatic organisms. The Agency has identified seven aspects of labeling discussed below for which consistency rather than differences among labels for this class of product would generally better serve the needs of users, regulators and the public.

Most publicly supported mosquito or vector control programs use an Integrated Pest Management ( IPM) approach to mosquito control which includes public education, control of mosquito larvae through habitat modification and the use of registered larvicides, breeding site elimination and bite prevention advice for the public, as well as wide area spraying or fogging when necessary to control adult populations. EPA supports IPM approaches in its public outreach materials and believes that the use of mosquito adulticides should be consistent with IPM principles, including the use of mosquito population surveillance data in determining treatment schedules. Similarly, mosquito control program guidance developed by the federal Centers for Disease Control and Prevention ( CDC) and interim recommendations developed by the Association of State and Territorial Health Officials ( ASTHO) also advocate the use of an array of control strategies with adulticide applications as one available component.

Wide area adult mosquito control employs different techniques from those used to control most other insect pests. Mosquito adulticides are typically applied as Ultra Low Volume ( ULV) sprays or fogs in which small amounts of pesticide, typically a few ounces per acre, are dispersed over a relatively wide area in the form of extremely fine droplets. Optimum control is achieved by Page 4 the dispersion of the ULV spray over a wide area in order to make direct contact with mosquitoes in flight. In other words, the primary area being treated by a ULV spray is the air where flying mosquitoes are present, rather than a specific, defined area of infestation on the ground. Since mosquitoes are often found in close proximity to and over bodies of water, effective targeting of ULV sprays may require application of the pesticide over or near a body of water in order to disperse the pesticide to a downwind area where mosquitoes are present. Given the tendency of a ULV spray to stay airborne and be carried by wind, deposition of pesticide droplets to a body of water may occur on some occasions, even though this is incidental to the intended application. A body of water is never the intended target site of application for a mosquito adulticide. These pesticides are applied over, as opposed to directly to, water.

All currently registered pesticides for adult mosquito control pose some degree of risk to aquatic organisms, and the synthetic pyrethroids, such as permethrin, sumithrin and resmethrin, are considered very toxic to aquatic organisms. All of the commonly used adulticides carry label precautions to warn of potential adverse effects to aquatic life. To avoid such adverse effects, an applicator treating areas near water must calculate many factors in order to avoid depositing spray material into a body of water. Weather conditions including wind speed and direction are important, but other factors that determine how far a spray will carry include the size of the spray droplets, the height above ground at which spray is applied, nozzle orientation, the flow rate, and the speed of the delivery vehicle. Some of these factors are addressed by label directions, but as noted above, with varying degrees of specificity among different products. The recommendations given below are intended to improve the clarity of certain use directions and precautions, and bring about more consistency among labels for this group of products. The Agency believes that adopting these recommendations will assist users in making effective mosquito control applications with minimal risks to the environment. Clear and consistent labels also assist regulators and the public in recognizing appropriate application practices.

Issue 1. Adult mosquito control applications should be limited to trained personnel.

Adult mosquito control often includes treatment of residential areas and publically controlled lands, and typically involves special ground or aerial equipment for applying Ultra Low Volume ( ULV) sprays or fogs. Correct use of the equipment and application techniques require adequate training. The state and local agencies responsible for vector control programs are also accountable to the public for ensuring safe and effective applications. Given the complex application methods and the potential of the adulticide chemicals to cause adverse effects to the aquatic environment if misapplied, there is broad agreement among interested parties that proper training and supervision of applicators are essential to avoid adverse effects and ensure a safe and effective mosquito abatement program. However, there is not complete agreement on how best to accomplish this goal. For example, state laws can limit the use of pesticides for wide area mosquito control to persons trained in a specified manner, and some states do have such requirements. However, not all states limit use in this manner. Since pesticide use regulation is geared to enforcing label provisions, there is a strong interest among regulators in using the label to help Page 5 ensure use by appropriately trained and supervised applicators.

One way to ensure use or supervision by trained applicators is to classify a product for restricted use. Products classified by EPA for restricted use under section 3( d) of FIFRA are labeled as such, and may only be applied by or under the direct supervision of a certified applicator. Each state has an EPA approved certification and training ( C & T) program for the purpose of allowing trained applicators to use restricted pesticides. Resmethrin, sumithrin, permethrin, malathion and naled are among the pesticides most often used for adult mosquito control programs. Products using the active ingredient resmethrin are classified by the Agency as restricted use products ( RUPs), and some states restrict other mosquito control products through state regulations. However, at this time, most of the pesticides used in adult mosquito control are not classified for restricted use. As noted above, some states do require health or vector control agency personnel or their contractors to be certified even though RUP products are not used. However, other states require a lower level of training or none at all for mosquito control applicators, unless RUPs are being applied.

Independent of EPA's authority to classify a product for restricted use pursuant to FIFRA section 3( d), it is also possible to limit use to appropriate personnel through enforceable use instructions, provided that the label language identifies a clearly defined group of potential applicators. It would not be effective, however, to use a phrase that is ambiguous or subject to broad interpretation, such as " pest control professionals". Since there is considerable variation among state programs for both the regulation of vector control applicators and the certification categories that cover training for mosquito control, the Agency has not been able to identify a universally appropriate training requirement to include on product labels. However, the Agency believes that limiting the use of mosquito adulticides to appropriately trained and supervised persons should be part of the label of any such product which is not already classified for restricted use. In the recommendation below the term " direct supervision" is similar in meaning to the FIFRA definition of " under the direct supervision of a certified applicator" ( FIFRA section 2 ( e)( 4)), that is, the applicator must act under the instruction and control of an appropriately authorized person, but such person does not have to be physically present at the time and place the pesticide is applied. It is the Agency's position that the following statement should appear on the label of non restricted use products labeled for wide area adult mosquito control:

Recommendation 1. " For use only 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."

Issue 2. Some products combine adult mosquito control and other uses on the same label, generating uncertainty about which directions and precautions are applicable to which uses. Page 6 The Agency believes that adult mosquito control products should be labeled solely for adult mosquito control, or for mosquitoes and other pests such as blackflies or midges which are treated in essentially the same manner. Different uses involve different use directions and precautionary statements, which can be confusing when they appear on a single label. For example, among products currently labeled for agricultural uses in addition to mosquito control, the " Environmental Hazards" section of the label usually includes this statement: " For terrestrial uses, do not apply directly to water or to areas where surface water is present or to intertidal areas below the mean high water mark." In this context, EPA employs " terrestrial uses" as a collective term for conventional agricultural and non agricultural outdoor uses, but the term is not meant to include certain other general use patterns including adult mosquito control, direct aquatic applications ( e. g., mosquito larvicides, aquatic weed control, etc.), greenhouse applications, indoor uses, or aerial forestry applications. The statement has become virtually standard on outdoor use pesticides. Thus, on some labels, the qualifying phrase " For terrestrial uses" introduces an environmental hazard section of the label that is intended to distinguish these other uses from mosquito adulticide treatments. However, the overall effect is that when the language quoted above appears on a label of a product intended for multiple uses, it may not be clear to users that it does not apply to adult mosquito control. To avoid confusion over what language is meant to apply to adult mosquito control, products should be labeled solely for that use. If a label does include non mosquito control use directions, it is essential to distinguish portions of the label applicable to different uses.

Recommendation 2. Products labeled for wide area adult mosquito control should not bear container labeling for uses unrelated to adult mosquito control. The standard terrestrial use water hazard statement should not appear on product containers labeled solely for mosquito control. If a container label includes non mosquito control use directions, those directions and associated precautions should be clearly distinguished from those applicable to mosquito control. The terrestrial use statements on a mixed use label should be followed by the statement " See separate directions and precautions for mosquito control applications."

Issue 3. Label statements intended to protect bodies of water and aquatic life should be harmonized, as well as improved to assist effective mosquito control applications.

The precautionary label language intended to manage risks to aquatic life varies considerably from product to product. For example, some permethrin based mosquito control products direct the user not to apply the product within 100 feet of lakes or streams. This restriction or " buffer zone" was put on many permethrin labels out of concern for aquatic toxicity that might result due to runoff from agricultural sites, not as a result of an assessment of risks associated with the significantly lower concentrations of the active ingredient involved in ULV mosquito control applications. Resmethrin product labels state " Avoid direct application over lakes, ponds and streams" ( emphasis added), but the same labels state that vegetation " around stagnant pools, marshy areas, ponds and shorelines may be treated" and there is no buffer zone requirement. Products based on other active ingredients, including malathion and sumithrin, have label warnings about hazards to aquatic organisms, but neither buffer zones nor the prohibition of " over water" Page 7 applications appear on these labels. Naled labels explicitly do allow application over water in order to treat adult mosquitoes, blackflies or houseflies.

For different active ingredients, differing environmental hazard statements may be warranted, based on the level of risks posed. Generally, however, the Agency believes that a consistent approach to the environmental hazard label statements for this class of products is a practical benefit to both users and enforcement agencies and should be achieved where permissible under FIFRA. The language recommended in this notice will help to resolve inconsistencies among labels, although departures from this language may prove necessary on a case by case basis. For example, the Agency may not approve an application for an amended label based on these recommendations, if analysis indicates that the amended label would lead to increased risks to aquatic organisms compared to the previous label for that product.

The recommended language will also help to achieve the objective of effective mosquito control. From a vector control point of view, applications sometimes do need to be made over or near bodies of water in order to reach areas where mosquitoes are present, and limitations such as buffer zones or " over water" prohibitions can impede effective control. For example, an " over water" prohibition may sometimes interfere unnecessarily with the timely treatment of infested areas adjacent to water if an area happens to be downwind of a water body. In such cases, the pesticide needs to be applied over the water in order to target mosquitoes in the air above and adjacent to the water. Similarly, a 100 foot buffer zone may require leaving potentially infested areas untreated if they happen to be within 100 feet of a water body. In mosquito control, ULV sprays or fogs are intended to remain in the air for an extended time, unlike typical agricultural applications where the droplets are intended to fall immediately. Thus, mitigating risks to water bodies during mosquito control applications is best accomplished by controlling for such factors as droplet size, wind direction and speed, application rate and the height and speed of release, rather than an absolute prohibition on application over water or a buffer zone requirement. Under the language in today's recommendation, mosquito adulticides can be applied over water bodies when such application is necessary to target mosquitoes in the air above and near water, and where the weather conditions will facilitate movement of the pesticide away from the water body to the target area, such that any incidental deposition into the water body is minimized. Factors such as droplet size, application rate, and height and speed of release will be addressed in other provisions of the label.

The Agency believes that the purpose of environmental hazard statements for these pesticides, in general terms, is to enable the user to recognize and minimize risks in the context of carrying out an effective public health pest control program, consistent with the risks posed by the product's use. Protecting public health from mosquito borne diseases with the pesticides now available often involves some degree of ecological risk. The Agency concludes, however, that the public interest would generally be better served in terms of health protection if ULV mosquito control pesticides can be applied in a manner consistent with commonly accepted vector control practices, rather than under widely varying limits that now appear on some products. It also follows that environmental hazard statements need to be as clear as possible in order to identify the Page 8 potential risks that applicators are expected to avoid. When necessary, according to our regulations and based on the results of studies conducted by the applicant/ registrant, the Agency will retain the general statement that these products are toxic to aquatic organisms, but believes that it is also useful to add less abstract language, such as " toxic to fish, crustaceans, and oysters," if the Agency has information showing that to be the case. These are intended to be general statements about types of organisms and not refer to specific species, such as rainbow trout or bluegill, which may have been tested under laboratory conditions in order to determine toxicity levels. Proper application, including mitigation measures for mosquitocides and similar applications noted above, i. e., droplet size, wind direction and speed, application rate and height and speed of release, can reduce and/ or avoid potential toxic effects. Warnings about types of organisms should be consistent for products based on a particular active ingredient, and the Agency will identify the appropriate general types of organisms for registrants to include at the time labels are amended.

Based on all of these considerations, the Agency recommends the model environmental hazard statement embodied in recommendation # 3 for mosquito adulticides. ( Note that the parts of this statement concerning bee protection and consultation with state agencies are the subject of additional recommendations in this Notice, and are represented here with a placeholder in brackets).

Recommendation 3. " This pesticide is [ toxic/ extremely toxic] to aquatic organisms, including [ insert general types of organisms]. Runoff from treated areas or deposition of spray droplets into a body of water may be hazardous to [ insert general types of organisms]. [ If appropriate, insert any additional wildlife hazard statements]. [ Bee precaution can be inserted here or as a third paragraph of this section of the label]. [ Insert consultation with state/ tribal agency statement].

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 ."

Issue 4. Users should consult with the State or Tribal lead agency for pesticide regulation to determine if permits or other regulatory requirements exist.

State and Tribal agencies often have specific information about sensitive areas in terms of species habitats, drinking water sources and other factors, and may require specific protective measures through permits or other regulations. Obligations imposed on applicators by a State or Tribal regulation do not depend on whether there is any notice of them on a pesticide label, nor can a pesticide label create a new role for a state ( or federal) agency if they do not already have one under existing laws and regulations. The Agency does not believe it is appropriate for the label to create an obligation for applicators to consult state/ tribal pesticide agencies, but it is reasonable that Page 9 applicators be advised of the possibility of additional requirements, since this promotes compliance with measures to protect the environment.

Current labels are inconsistent in referring the user to state authorities. Some labels are silent on the matter, others mention " applicable state and federal regulations", and others instruct the user to consult the State's Fish and Wildlife Agency. Some labels do instruct users to consult the State or Tribal agency responsible for pesticide regulation, which the Agency believes is the better approach. States differ widely in terms of agency roles in protecting environmental and wildlife resources, so no single term like " Fish and Wildlife Agency" is universally appropriate. The Agency concludes that the most reliable source of information on whether there are additional requirements for mosquito control is the lead agency for pesticide regulation. Although the pesticide agency is often not the permitting authority, they will generally know if such regulations exist in their state or tribe, and who administers them. The Agency concludes that the following statement is appropriate for all wide area mosquito control product labels.

Recommendation 4. " 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."

Issue 5. Labels need to specify the appropriate spectrum of ULV spray/ fog droplet sizes, and indicate that droplet size must be determined according to directions from the equipment manufacturer or vendor, pesticide registrant or a facility using laser based measurement methods.

Effective use of mosquito adulticides depends on proper application rates delivered in the appropriate droplet spectrum. Current labels vary greatly in the level of detail instructing the user on what droplet size spectrum to use and how to achieve a particular droplet size spectrum. While some labels simply specify a droplet size spectrum, others appear to make the user responsible for selecting the appropriate droplet size. Because droplet size is a critical parameter in defining efficacy and risk to non target organisms, the Agency believes that droplet size affording good efficacy and low risk should be specified on product labels and applicators should regularly evaluate the performance of their equipment. The appropriate range of droplet sizes may vary somewhat from one formulation to another, so registrants should propose the acceptable droplet size range for their individual products. Many methods are available for evaluating equipment performance, including methods described in state sponsored training sessions, published by mosquito control organizations, and in a few cases, by pesticide registrants as part of labeling. The Agency believes that equipment used for mosquito control must be evaluated at least once a year using sound methods supported by states, professional organizations or registrants. Also, since ground based and aerial application equipment and conditions are different, the Agency believes application directions would be more clear if requirements for ground and aerial applications were identified in separate paragraphs with appropriate headers.

The Agency believes the most reliable approach for calibrating application equipment to Page 10 produce specified size spectra is for the applicator to follow equipment manufacturer directions for droplet size or to rely on directions from a facility using laser based measurement methods ( i. e. laser diffraction, phase doppler or imaging). The Agency acknowledges that many applicators prefer to have flexibility in choosing droplet size spectra appropriate for their specific treatment areas. The recommended language below provides an upper bound requirement for droplet size, allowing applicators to use finer sprays when necessary. Identifying an allowable range of droplet spectra also allows the Agency to estimate downwind airborne concentrations and deposition levels of adulticide sprays for risk assessment purposes. The following language is recommended as a model for droplet size calibration instructions on adulticide labels.

Recommendation 5. " Ground based application: Spray equipment must be adjusted so that the volume median diameter is less than [ X = value to be provided by registrant] microns ( Dv 0.5 < X um) and that 90% of the spray is contained in droplets smaller than [ Y = value to be provided by registrant] microns ( Dv 0.9 < Y um). Directions from the equipment manufacturer or vendor, pesticide registrant or a test facility using a 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.

" Aerial Application: Spray equipment must be adjusted so that the volume median diameter produced is less than [ A = value to be provided by registrant] microns ( Dv 0.5 < A um) and that 90% of the spray is contained in droplets smaller than [ B = value to be provided by registrant] microns ( Dv 0.9 < B um). 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."

Issue 6. Precautionary language to protect bees should have a provision to allow mosquito control applications that might otherwise be prohibited in order to respond to immediate threats to public health.

Applications for adult mosquito control are generally made in the evenings, at night, or in the early hours of the morning   the periods when most mosquito species are active. These are the periods of the day when bees are not active, so mosquito control applications usually do not pose a serious threat to bees, nor do they conflict with bee precautionary language which prohibits applications "... to blooming crops or weeds if bees are visiting the treatment area." In some circumstances, however, public health protection may require daylight treatments which could include areas being visited by bees. For example, the widespread flooding caused by Hurricane Floyd in 1999 caused a mosquito and fly population explosion that threatened public health and Page 11 required extremely large area applications by military aircraft. These applications were made in daylight for safety reasons. There are also some mosquito species that do feed during the day and can be vectors for West Nile Virus and other diseases. If those species are numerous at a time when human or animal disease cases have occurred in the region, daylight applications may be appropriate in spite of increased risk to bees.

The Agency believes that provision should be made to allow public health considerations to override a strict interpretation of bee precaution label language, and that the determination to make this unusual type of application needs to be linked to specific evidence of a health threat. The Agency recognizes, however, that it is not possible or appropriate to try to define a specific threat level on a pesticide label. In its guidance for West Nile Virus programs, CDC points out that many local variables affect the seriousness of a health threat, and no specific, quantified thresholds for number or types of cases or similar factors would be appropriate for all situations. The Agency also does not believe the label should try to limit the authority to evaluate threats to a particular state or local agency, since these have widely variable technical capabilities and legal authorities across the country. Linking any extraordinary applications to specific evidence of a disease threat helps to assure pesticide regulators and the public that the applications are warranted. The following language should be added to the last sentence of the bee precaution statement on the labels of mosquito adulticide products.

Recommendation 6. "... [ do not apply to blooming crops or weeds 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 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."

Issue 7. Mosquito adulticide labels should include specific statements on timing and frequency of applications.

The Agency's labeling regulations at 40 CFR 156.10 ( i)( 2)( vii) state that directions for use shall include "[ T] he frequency and timing of applications necessary to obtain effective results without causing unreasonable adverse effects on the environment." With very few exceptions, however, mosquito adulticide labels direct the user to " repeat as necessary" and do not specify an interval between treatments, or any limitation on the number of treatments to the same site, and this poses several problems. " Repeat as needed" clearly does not meet the intent of the regulation by indicating to users or enforcement agencies what is an acceptable, efficacious, and safe application frequency, and it may lead to overuse and increased risks. It also impedes the Agency's ability to conduct risk assessments for the pesticides involved, since there is no clear starting point for estimating use and exposure. For risk assessment purposes the Agency would ideally like to know the maximum number of applications in a year, since some endpoints of concern may have cumulative or chronic effects. A specific limit on applications provides a baseline for assessment, Page 12 rather than relying on assumptions about what may be " typical" and " worst case" use scenarios.

The Agency recognizes that many vector control agencies utilize Integrated Pest Management ( IPM) principles and mosquito population surveillance data in determining treatment schedules. The Agency also recognizes that there may be limited health effects data available to support specific interval and frequency limitations for some products, since comprehensive reassessments of some of the mosquito control pesticides have yet to be completed. Nevertheless, registrants have data on the toxicity, environmental fate and efficacy of their products, and should be able to propose reasonable interval and frequency limits appropriate to their individual products.

Although interval and frequency limits are appropriate for the adulticide labels, mosquito control is primarily a public health concern, and the Agency does not believe that the label should prevent applications needed for effective control unless there is specific evidence that finite limitations are appropriate for a particular product or active ingredient. For that reason, the Agency is recommending a model for timing and frequency statements that includes the same provisions for additional treatments to address threats to public health as contained in recommendation # 6 for the bee precaution. Thus, the following language should be included in the directions for use section of the label.

Recommendation 7. " Do not re treat a site more than once in [ X hours/ days]; no more than [ Y] applications should be made to a site in any [ Z weeks/ months] or [ one year]. 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."

IV. IMPLEMENTATION A. Application for New Registration EPA expects that beginning on the effective date of this Notice each applicant for registration of new products labeled for adult mosquito control will adopt the recommended labeling statements and principles in this Notice, to the extent appropriate for the product.

B. Application for Amendment EPA requests that registrants of existing products covered by this Notice submit an application for amended registration. An acceptable application for amendment includes the following items:

! a completed EPA application form 8570 1; Page 13 ! three copies of the draft label ( highlighting the changes made on one label);

! a description on the application, such as, " Amended consistent with the guidance set out in PR Notice 2005 1."

All such submissions must pertain only to this PR Notice. Additional unrelated amendments and/ or changes to the product must be submitted as a separate action or the submission will be considered unacceptable and will not be reviewed. The Agency will attempt to process correctly submitted applications in a timely manner.

The Pesticide Registration Improvement Act of 2003 ( PRIA) established a new registration service fee system for applications for registration, amended registration, and associated tolerance actions. Under this system, registration service fees are charged for covered applications received by the Agency on or after March 23, 2004. However, applications for EPA initiated amendments are not subject to a fee. Therefore, an application to amend a registration submitted solely in response to this Notice will be classified as an " EPA initiated amendment" and will not be subject to a registration service fee provided that the only changes being proposed to the labeling for the registered product are those described in this Notice.

Registrants should send applications for amendment to the following addresses:

U. S. Postal Service Deliveries:

The following official mailing address should be used for all correspondence or data submissions sent to OPP by mail:

Document Processing Desk ( AMEND) Office of Pesticide Programs ( 7504C) U. S. Environmental Protection Agency Ariel Rios Building 1200 Pennsylvania Avenue, NW Washington, DC 20460 Hand Carried/ Courier Deliveries:

The following address should be used for all correspondence or data submissions that are hand carried or sent by courier service Monday through Friday, from 8: 00 AM to 4: 30 PM, excluding Federal holidays:

Document Processing Desk ( AMEND) Office of Pesticide Programs ( 7504C) Page 14 U. S. Environmental Protection Agency Room 266A, Crystal Mall 2 1801 S. Bell Street Arlington, Virginia 22202 V. SCOPE OF POLICY This Notice describes certain requirements set forth by FIFRA and its regulations and provides general guidance to EPA and affected parties. While the requirements in FIFRA and its regulations are binding on EPA and other affected parties, this Notice is intended to provide guidance to EPA, applicants, registrants and the public. As guidance, this policy is not binding on either EPA or any outside parties, and EPA may depart from the guidance where circumstances warrant and without prior notice. Registrants and applicants may propose alternatives to the recommendations in this Notice, and the EPA will assess them on a case by case basis. If a product does not meet the requirements of FIFRA section 2( q) or the regulations at 40 C. F. R. Part 156, the Agency may find the product to be misbranded and may take appropriate enforcement and/ or regulatory action.

VI. EFFECTIVE DATES For all products covered by this PR Notice:

° The effective date of this Notice is April 15, 2005. As of that date, EPA will review all applications for new pesticide product registrations, amendments to registered products and reregistration of registered products consistent with the guidance contained herein.

° As of October 1, 2005, EPA will begin to evaluate products released for shipment by registrants and distributors to ensure consistency with the guidance contained herein. Registrants are reminded that they are responsible for informing their distributors when they change their labeling, and for monitoring the labeling of their distributors to assure that they make the necessary changes.

Various states' requirements should be taken into consideration when deciding on the timing of your amendment submission to EPA. Some states may require a review of the modified label by EPA prior to submission to the state for state approval purposes.

VII. FOR FURTHER INFORMATION For information on this Notice contact Jim Roelofs ( Telephone 703 308 2964; e mail roelofs. jim@ epa. gov. ). Page 15 ________________________________

Jim Jones, Director Office of Pesticide Programs


[Federal Register Volume 78, Number 11 (Wednesday, January 16, 2013)]
[Notices]
[Pages 3418-3420]
[FR Doc No: 2013-00560]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2012-0906; FRL-9374-4]

Pesticides; Draft Guidance for Pesticide Registrants on Web-
Distributed Labeling for Pesticide Products

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of availability.

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SUMMARY: The Agency is announcing the availability of and seeking
public comment on a draft Pesticide Registration Notice (PR Notice)
titled ``Web-Distributed Labeling for Pesticide Products.'' PR Notices
are issued by the Office of Pesticide Programs (OPP) to inform
pesticide registrants and other interested persons about important
policies, procedures, and registration related decisions, and serve to
provide guidance to pesticide registrants and OPP personnel. This
particular draft PR Notice provides guidance concerning the process by
which registrants can make legally valid versions of pesticide labeling
available through the Internet. Web-distributed labeling would allow
users to retrieve a streamlined version of the pesticide product
labeling, containing the directions for use and necessary information
related to the user's specific state and intended site of use. Shorter,
relevant labeling could be clearer and easier for the user to
understand, improving compliance with pesticide labeling requirements
and thereby protecting human health and the environment from
unintentional misuse of pesticides. Web-distributed labeling would also
allow for more rapid updates to pesticide labeling, meaning risk
mitigation measures and new uses can reach the user more quickly than
under the current paper-based system.

DATES: Comments must be received on or before April 16, 2013.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2012-0906, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.htm.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Michelle Arling, Field and External
Affairs Division (7506P), Office of Pesticide Programs, Environmental

Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-
0001; telephone number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>;
email address: arling.michelle<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    This action is directed to the public in general, although this
action may be of particular interest to those persons who register and
use pesticide products and to state regulators of pesticide products.
Since other entities may also be interested, the Agency has not
attempted to describe all the specific entities that may be affected by
this action. If you have any questions regarding the information in
this notice, consult the person listed under FOR FURTHER INFORMATION
CONTACT.

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

    1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When submitting comments,
remember to:
    i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period
deadline identified.
    3. Specific Areas for Comment. EPA has identified questions about
the PR Notice on which the Agency would like to receive specific input
from commenters. These questions and topic areas are presented below.
    i. Would an appendix with sample master labeling and web-
distributed labeling rendered output assist in understanding the PR
Notice and how to follow the recommendations in the PR Notice?
    ii. The PR Notice suggests that it ``is targeted towards pesticide
products marketed primarily to applicators for use in the course of
commercial activity.'' Please comment on the scope of coverage. Should
the Agency expand or contract the targeted products? Are there
alternate ways to describe the targeted products?
    iii. Should the Agency consider combining the released for shipment
date and the unique identifier into a single alpha-numeric combination?
If so, why? Please provide suggested definitions for any proposed
alternative.
    iv. Should the released for shipment date and unique identifier
have a standard location on the container or pesticide labeling? If so,
where? If not, why?
    v. Should EPA approve web-distributed labeling for one or some, but
not all, uses listed on a product's labeling? If so, how would users
know that no web-distributed labeling was available for their intended
use?
    vi. Should EPA consider only accepting WDL submissions to the
Agency for review as electronic files?
    vii. Please provide comments on the web-distributed labeling
statements and their recommended location. Should they be located at
the beginning of the directions for use? Should they be a separate
section on the labeling, similar to the Agricultural Use Box that
conveys information about the Worker Protection Standard? Would either
approach make the user more likely to read and comply with the
information?
    viii. Please provide comments on the minimum functionality
discussed in Unit IV. ix. Are the proposed standards reasonable? If
not, please suggest alternative guidelines.
    x. Please provide any other comments on the PR Notice. If you
disagree with or do not understand any aspect of the PR Notice, please
describe the area and an alternative that incorporates your
suggestions.

C. How can I get copies of this document and other related information?

    A copy of the draft PR notice is available in the docket under
docket identification (ID) number EPA-HQ-OPP-2012-0906.

II. What guidance does this PR notice provide?

A. Background

    Since 2007, the Agency has been exploring the feasibility and
advisability of allowing registrants to make legally enforceable
pesticide product labeling available to users via the Internet, an
initiative referred to as ``web-distributed labeling'' (WDL). At the
end of 2010, EPA initiated a ``user acceptance pilot.'' (75 FR 51058,
August 18, 2010; EPA-HQ-OPP-2010-0632) The user acceptance pilot
involved a simulation of a WDL Web site that users could visit and on
which they could provide feedback. The user acceptance pilot did not
involve any changes to existing pesticide labeling on containers or
legally valid electronic versions of pesticide labeling. EPA also
published a Federal Register notice which outlined EPA's positions on
issues related to WDL and sought comment on a number of these issues.
(75 FR 82011, December 29, 2010; EPA-HQ-OPP-2010-0648).
    Based on its review of the comments and other feedback received
from the Federal Register notice and the user acceptance pilot, EPA is
proposing a voluntary approach to WDL that would allow registrants to
distribute pesticide products with labeling that refers the user to the
Web site from which the user may download legally valid, enforceable
labeling. The container would still be accompanied by a physical copy
of the EPA-accepted labeling sufficient for the correct use of the
product, but a user could access the most current version of the state-
and site-specific labeling from a Web site identified on the container
label. Offering WDL while retaining the full labeling on or
accompanying pesticide containers would allow users, registrants, and
EPA to acquire a better understanding of the strengths and limitations
of WDL and possibly serve as a transition to a system which relies more
heavily on the Internet and other technologies to provide users with
legally enforceable labeling. For example, registrants could determine
whether specific types of products would be better suited to WDL and
users could evaluate the relative benefit

of WDL versus the current pesticide product labeling.
    As considered by EPA, WDL would make available via the Internet
site- and state-specific use directions for pesticide products as
downloadable electronic files. To access this labeling, a user would
visit the Web site identified on the pesticide label, enter information
identifying the product, and select the intended state and use site.
The Web site would return a streamlined version of the pesticide
labeling containing the language applicable to all uses of the product,
such as hazard statement and first aid, and the relevant state/site
specific directions for use (e.g., application to cranberries in
Maine). Sufficient labeling for the correct use of the product would
still be available with the pesticide either on the container label or
in accompanying material.

B. Overview of PR Notice

    This PR Notice provides guidance about how EPA intends to implement
WDL under this system. First, the PR Notice defines terms used related
to WDL in this notice. It includes suggested language that registrants
can use on the labeling affixed to or accompanying the pesticide
container to reference the WDL portion of labeling. It recommends
content, function, and security for the Web site associated with a
product's WDL. Finally, the PR Notice suggests a process by which
registrants can request that a product's labeling include WDL and
outlines what information EPA expects to receive.

III. Do PR notices contain binding requirements?

    The PR Notice discussed in this notice is intended to provide
guidance to EPA personnel and decisionmakers and to pesticide
registrants. While the requirements in the statutes and Agency
regulations are binding on EPA and the applicants, this PR Notice is
not binding on either EPA or pesticide registrants, and EPA may depart
from the guidance where circumstances warrant and without prior notice.
Likewise, pesticide registrants may assert that the guidance is not
appropriate generally or not applicable to a specific pesticide or
situation.

List of Subjects

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests.

    Dated: January 3, 2013.
Steven Bradbury,
Director, Office of Pesticide Programs.
[FR Doc. 2013-00560 Filed 1-15-13; 8:45 am]
BILLING CODE 6560-50-P