UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON D.C., 20460

MEMORANDUM	Date:  May 24, 2006

SUBJECT:	Environmental Fate and Ecological Risk Assessment Chapter (DP Barcode D307382) in Support of Phase IV of the Reregistration Eligibility Decision on Rotenone (PC Code 071003)

FROM:	R. David Jones, Ph.D., Senior Agronomist

		Thomas Steeger, Ph.D., Senior Biologist

		Environmental Risk Branch IV

Environmental Fate and Effects Division (7507C)

		Office of Pesticide Programs

THROUGH:	Elizabeth Behl, Branch Chief

		Environmental Risk Branch IV

		Environmental Fate and Effects Division (7507C)

		Office of Pesticide Programs

TO:		Katherine Hall, Chemical Review Manager

		Tom Myers, Risk Manager

		Special Review and Reregistration Divison (7508C)

Office of Pesticide Programs

The Environmental Fate and Effects Division (EFED) has completed the draft environmental fate and ecological risk assessment chapter (DP Barcode D307382) in support of Phase IV of the reregistration eligibility decision on rotenone (PC Code 071003).  The chapter has been revised to reflect comments received during the public comment phase (Phase III) of reregistration.  Conclusions regarding the environmental fate, ecological effects and ecological risks associated with the current uses of rotenone can be found in the executive summary of the attached document.  Although agricultural/commercial uses of rotenone will no longer be supported, the science chapter discusses these uses along with the piscicidal use. EFED recommends that application of rotenone directly to water only be made through close adherence to established standard operating procedures intended to limit the extent to which rotenone can move outside of treatment areas.

As indicated during Phase I (DP Barcode D307390), the risk assessment of terrestrial uses (agricultural, commercial and residential) relied on conservative assumptions regarding the application rate and frequency since labels were not specific.  These assumptions were based on recommendations provided through personal communication with the Special Review and Reregistration Division (SRRD).  Although conservative assumptions were made regarding application rates and frequencies, the assessment explores the extent to which application rates would have to be modified to get below acute and chronic risk levels of concern.

Data Gaps

Table A1 identifies the status of environmental fate and transport study requirements and Table A2 identifies the status of ecological effect study requirements.    SEQ CHAPTER \h \r 1 No data were available to quantify the following fate characteristics of rotenone: photodegradation on soil (Guideline §161-3), aerobic soil metabolism (Guideline §162-1), and anaerobic soil metabolism (Guideline §162-3).  The lack of soil metabolism data is the most critical given the potential for this process to greatly affect the persistence of rotenone following application to crops.  Another source of uncertainty is the lack of a terrestrial field dissipation study (Guideline §164-1).

Most of the ecological effect data gaps result from uncertainties surrounding potential ecological risks associated with the agricultural/commercial and residential uses of rotenone in terrestrial environments.  However, there are ecological effect data gaps associated with the use of rotenone as a piscidide.  Acute (Guideline §72-3) and chronic toxicity (Guideline §72-4) data are not available for estuarine/marine fish or invertebrates.  Additionally, there are no data to evaluate the toxicity of rotenone to aquatic (Guideline §123-2) or terrestrial plants (Guideline §123-1).  These data are important in assessing direct risks to Federally listed threatened and endangered plant species and the potential for indirect effects to a wide variety of Federally listed threatened and endangered animals.

Labeling Recommendations

	According to the Label Review Manual, the following label statements are recommended:

  SEQ CHAPTER \h \r 1 Non-Target Organism Statements

  SEQ CHAPTER \h \r 1 The following statement is required because the pesticide is intended for outdoor use and contains an active ingredient which has a mammalian acute oral LD50 ≤100 mg/kg:

"This pesticide is toxic to mammals."

	The following statement is required because the pesticide is intended for outdoor use and contains an active ingredient with a fish acute LC50 and an aquatic invertebrate EC50 ≤1 ppm:

"This pesticide is toxic to fish, aquatic invertebrates, oysters and shrimp.”

  SEQ CHAPTER \h \r 1

Table A1. Environmental Fate and Transport Data Requirements for Rotenone

Guideline #	Data Requirement	MRID / ACC #

		Study Classification	Are Data Adequate for Risk Assessment

161-1	835.2120	Hydrolysis	00141409 	Supplemental	YES

161-2	835.2240	Photodegradation in Water	00141410 	Unacceptable	NO

161-3	835.2410	Photodegradation on Soil	Required

161-4	835.2370	Photodegradation in Air	Not required

162-1	835.4100	Aerobic Soil Metabolism	Required

162-2	835.4200	Anaerobic Soil Metabolism	Required - For rice use

162-3	835.4400	Anaerobic  Aquatic Metabolism	00141273 	Unacceptable

	NO

162-4	835.4300	Aerobic Aquatic Metabolism	00141274 	Unacceptable	NO

163-1	835.1240

835.1230	Leaching-Adsorption/Desorption	00157850 	Acceptable	YES

163-2	835.1410	Laboratory Volatility	Not required

163-3	835.8100	Field Volatility	Not required

164-1	835.6100	Terrestrial Field Dissipation	Required

164-2	835.6200	Aquatic Field Dissipation	42217701

00167851	Supplemental	YES

164-3	835.6300	Forestry Dissipation	No data submitted

165-4	850.1730	Accumulation in Fish	00146183

00143252

ACC# 258460

ACC# 261714 	Acceptable

Acceptable

Supplemental	 YES

165-5	None	Acummulation-Aqautic, Non-Target	40307403

40307405	Acceptable

Acceptable	YES

166-1	835.71	Small Scale Prospective Groundwater	Not required

166-2	None	Small Scale Retrospective Ground Water	No data submitted

166-3	None	Large Scale Retrospective Ground Water	No data submitted

Table A2.  Ecological Effects Data Requirements for Rotenone.

Guideline # and Data Requirement	Species 	Test Materiala

(% a.i.)	MRID/ACC#	Study Classification	Are Data Adequate for Risk Assessment?

Avian and Mammalian Studies:

71-1, Acute

Avian Oral, Quail/Duck	Mallard Duck		32.38	00143250	Supplemental	YES

	Ring-necked Pheasant		32.38	00143250	Supplemental	YES

71-2, Acute Avian Diet, Quail/Duck		Japanese Quail	34.5	248788 Supplemental	YES

	Mallard Duck	34.5	248788	Supplemental	YES

	Ring-necked Pheasant	34.5	248788	Acceptable	YES

71-4, Avian Reproduction, Quail/Duck

No Data Submitted

	81-1, Acute Mammalian Oral LD50	Rat	TGAI	00145496	Acceptable 	YES

83-1, Chronic Tox Rodent	Rat	TGAI	00141408	Acceptable 	YES

Freshwater Fish Studies:

72-1(a), Acute Freshwater Fish Toxicity, Bluegill	Bluegill Sunfish	2.5 - 98.64

	00061296

00089909

00090288

00090366

00090425

00121874

00121877

00121880

00121881

00121883

00121885

43975101

44382902

00090365

00121888

40063301	Acceptable

Acceptable

Acceptable

Acceptable

Acceptable

Acceptable

Acceptable

Acceptable

Acceptable

Acceptable

Acceptable

Acceptable

Acceptable

Supplemental

Supplemental

Supplemental	YES

72-1(c), Acute Freshwater Fish Toxicity, Rainbow Trout

	Rainbow Trout	5 - 98.64	00089905

00089906

00089907

00089908

00090367

00090420

00090421

00121873

00121875

00121876

00121882

00121884

00121886

43975102

44382901

00089904	Acceptable

Acceptable

Acceptable

Acceptable

Acceptable

Acceptable

Acceptable

Acceptable

Acceptable

Acceptable

Acceptable

Acceptable

Acceptable

Acceptable

Acceptable

Supplemental	YES

72-4(a), Early Life-Stage Fish	Rainbow Trout	96.47	40063302	Supplemental YES

72-5 Life Cycle Fish

No Data Submitted 	waived

Freshwater Invertebrate Studies:

72-2(a), Acute Freshwater Invertebrate Toxicity	Daphnia magna	TGAI 40063303	Supplemental

Supplemental	YES

72-4(b), Life

Cycle Aquatic Invertebrate	Daphnia magna	TGAI	40063303	Supplemental

(pending study upgrade to acceptable)b	YES

Estuarine/Marine Fish Studies:

72-3, Acute Estuarine/Marine Tox Fish LC50

No data submitted	NO

72-4, Chronic Estuarine/Marine Tox Fish NOAEC

No data submitted	NO

72-7(a), Simulated or actual field testing-- aquatic organism

	Not Required

72-7(b), Actual field-aquatic organism

	Not Required

Estuarine/Marine Aquatic Invertebrates:

72-3(b), Acute Estuarine/Marine Mollusk

No data submitted	NO

72-3(c), Acute Estuarine/Marine Shrimp

No data submitted	NO

72-4, Chronic Estuarine/Marine Shrimp

No data submitted	NO

Terrestrial and Aquatic Plants:

122-1, Seedling Emergence and Vegetative Vigor

No Data Submitted	NO

122-2, Aquatic Plant Growth (Tier I)

No Data Submitted	NO

123-1, Seed Germ,  Seedling Emergence, Vegetative Vigor

(Tier II)

No Data Submitted	NO

123-2 Aquatic Plant Growth (Tier II)

No Data Submitted	NO

Terrestrial Insect Testing:

141-2, Honey Bee Residue on Foliage

				No Data Submitted

						NO

144-1, Honey Bee Acute Contact	Honey Bee	> 95	05001991	Acceptable	YES

a TGAI = technical grade active ingredient; TEP = typical end-use product; ND = not determined, because purity was not reported or original study was unavailable.

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 Study was classified as supplemental pending upgrade to acceptable.  The upgrade was denied, but for piscicidal uses EPA did not require a repeat of the study due to the preponderance of data available.

 PAGE

 PAGE   1


[Federal Register Volume 87, Number 125 (Thursday, June 30, 2022)]
[Notices]
[Pages 39091-39092]
[FR Doc No: 2022-13986]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-R10-OW-2022-0418; FRL-9860-02-R10]

Proposed Determination To Prohibit and Restrict the Use of
Certain Waters Within Defined Areas as Disposal Sites; Pebble Deposit
Area, Southwest Alaska; Extension of Comment Period

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of extension of public comment period and public hearing
comment period.

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

SUMMARY: The Environmental Protection Agency (EPA) is extending the
public comment period for its 2022 Proposed Determination to Prohibit
and Restrict the Use of Certain Waters Within Defined Areas as Disposal
Sites; Pebble Deposit Area, Southwest Alaska issued pursuant to Section
404(c) of the Clean Water Act (CWA). Notice of availability and notice
of public hearing were published in the Federal Register on May 26,
2022. The notice provided that the public comment period would remain
open through July 5, 2022. The public comment period for the 2022
Proposed Determination and the post hearing comment period are hereby
extended through September 6, 2022.

DATES: The comment period for the 2022 Proposed Determination published
May 26, 2022 (87 FR 32021) is extended. Written comments on the 2022
Proposed Determination must be received on or before September 6, 2022.

ADDRESSES:
    I. How to Obtain a Copy of the Proposed Determination: The proposed
determination is available primarily via the internet on the EPA Region
10 Bristol Bay site at www.epa.gov/bristolbay.
    II. How to Submit Comments to the Docket at www.regulations.gov:
    Submit your comments, identified by Docket ID No. EPA-R10-OW-2022-
0418, by one of the following methods:
    Federal eRulemaking Portal (recommended method of comment
submission): Follow the online instructions at http://www.regulations.gov for submitting comments.
    Email: [email protected]. Include the docket number EPA-R10-OW-
2022-0418 in the subject line of the message.
    Mail and Hand Delivery/Courier: Send your original comments and
three copies to: Water Docket, Environmental Protection Agency, Mail
Code 2822T, 1200 Pennsylvania Avenue NW, Washington, DC 20460,
Attention: Docket ID No. EPA-R10-OW-2022-0418.
    Hand Delivery/Courier: Deliver your comments to EPA Docket Center,
EPA West, Room 3334, 1301 Constitution Avenue NW, Washington, DC 20460,
Attention: Docket ID No. EPA-R10-OW-2022-0418. Such deliveries are
accepted only during the Docket's normal hours of operation, 8:30 a.m.
to 4:30 p.m. ET, Monday through Friday (excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The telephone number for the Water Docket is (202) 566-
2426.
    Instructions: EPA's policy is that all comments received will be
included in the public docket without change and will be made available
online at http://www.regulations.gov, including any personal
information provided, unless the comment includes information claimed
to be Confidential Business Information (CBI) or other information
disclosure of which is restricted by statute. Do not submit information
that you consider to be CBI or otherwise protected information through
http://www.regulations.gov or email. The http://www.regulations.gov
website is an ``anonymous access'' system, which means EPA will not
know your identity or contact information unless you provide it in the
body of your comment. If you send an email comment directly to EPA
without going through http://www.regulations.gov, your email address
will be captured automatically and included as part of the comment that
is placed in the public docket and made publicly available on the
internet. Multimedia submissions (audio, video, etc.) must be
accompanied by a written comment. The written comment is considered the
official comment and should include discussion of all points you wish
to make. EPA will generally not consider comments or comment contents
located outside of the primary submission (i.e., on the web, cloud, or
other file sharing system). For additional submission methods, the full
EPA public comment policy, information about CBI or multimedia
submissions, and general guidance on making effective comments, please
visit https://www.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: For information on the public comment
period, contact the Water Docket; telephone:<PHONE_NUMBER> or email:
[email protected]. For information concerning the proposed
determination, contact Erin Seyfried; telephone<PHONE_NUMBER> or
email: [email protected]. For more information about EPA's efforts
in Bristol Bay, copies of the Section 404(c) proposed determination,
see http://www.epa.gov/bristolbay.

SUPPLEMENTARY INFORMATION: EPA Region 10 has received several
communications regarding an extension of the comment period, including
requests to extend the comment period by 60 days and 120 days. EPA
Region 10 also received requests not to extend the public comment
period. EPA Region 10 has considered each of these requests and finds
that good cause exists pursuant to 40 CFR 231.8 to extend the public
comment period through September 6, 2022 to provide sufficient time for
all parties to meaningfully comment on the 2022 Proposed Determination
and supporting documents.

Casey Sixkiller,
Regional Administrator, Region 10.
[FR Doc. 2022-13986 Filed 6-29-22; 8:45 am]
BILLING CODE 6560-50-P


RE: One more modeling question. and updates to Minnesota's Lead Emissions

Sheffer, Melissa (MPCA)

to:

Andy Chang

04/01/2010 11:45 AM

Cc:

"Neuschler, Catherine (MPCA)"

From:	"Sheffer, Melissa (MPCA)"<EMAIL_ADDRESS>

	To:	Andy Chang/R5/USEPA/US@EPA

	Cc:	"Neuschler, Catherine (MPCA)"<EMAIL_ADDRESS>

Hey Andy,

It’s been pretty warm this week up here as well!  We hit 76 yesterday and will probably see that again today.  Then hopefully we’ll see some needed rain this weekend.

I can answer your questions to the first piece of information that you need.  For GRC, modeling was based on projected actual emissions.  Re-entrainment of dust was factored into the modeling analysis by modeling with volume sources for truck traffic-related re-entrainment of dust.

Hopefully this answers your questions.  Let me know if you need additional information.  Thanks!

Melissa Sheffer

Research Scientist

Risk Evaluation & Air Modeling Unit

Minnesota Pollution Control Agency (MPCA)

520 Lafayette Rd. N., Saint Paul, MN 55155

Office #:<PHONE_NUMBER>, Email:   HYPERLINK <EMAIL_ADDRESS><EMAIL_ADDRESS>


[Federal Register Volume 85, Number 163 (Friday, August 21, 2020)]
[Notices]
[Pages 51815-51817]
[FR Doc No: 2020-18355]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-89575; File No. SR-ISE-2020-32]

Self-Regulatory Organizations; Nasdaq ISE, LLC; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change To Amend Options 6,
Section 5 (Transfer of Positions)

August 17, 2020.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on August 6, 2020, Nasdaq ISE, LLC (``ISE'' or ``Exchange'') filed
with the Securities and Exchange Commission (the ``Commission'') the
proposed rule change as described in Items I and II below, which Items
have been prepared by the Exchange. The Exchange filed the proposal as
a ``non-controversial'' proposed rule change pursuant to Section
19(b)(3)(A)(iii) of the Act \3\ and Rule 19b-4(f)(6) thereunder.\4\ The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \4\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend Options 6, Section 5, titled
``Transfer of Positions.''
    The text of the proposed rule change is available on the Exchange's
website at https://listingcenter.nasdaq.com/rulebook/ise/rules, at the
principal office of the Exchange, and at the Commission's Public
Reference Room.

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

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

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

1. Purpose
    The Exchange proposes to amend Options 6, Section 5, titled
``Transfer of Positions.'' The proposed rule change is similar to Cboe
Exchange, Inc. (``Cboe'') Rule 6.7.\5\
---------------------------------------------------------------------------

    \5\ See Securities and Exchange Act Release No. 89389 (July 23,
2020), 85 FR 45709 (July 29, 2020) (SR-Cboe-2020-067) (Notice of
Filing and Immediate Effectiveness of a Proposed Rule Change to
Amend Rule 6.7 Concerning Off-Floor Transfers).
---------------------------------------------------------------------------

    Options 6, Section 5 permits market participants to move positions
from one account to another without first exposure of the transaction
on the Exchange, provided certain exceptions are met. Specifically,
Options 6, Section 5(a)(2) \6\ provides that transfers of positions are
permissible if from one account to another account where no change in
ownership is involved (i.e., accounts of the same Person),\7\ provided
the accounts are not in separate aggregation units or otherwise subject
to information barrier or account segregation requirements. These
transfers are subject to, among other things, the requirement to submit
prior written notice of the transfers to the Exchange pursuant to
Options 6, Section 5(d) and the restriction on effecting these
transfers repeatedly or routinely.
---------------------------------------------------------------------------

    \6\ Options 6, Section 5(a) states, ``Permissible Transfers.
Existing positions in options listed on the Exchange of a Member or
non-Member that are to be transferred on, from, or to the books of a
Clearing Member may be transferred off the Exchange if the transfer
involves on or more of the following events:. . (2) the transfer of
positions from one account to another account where no change in
ownership is involved (i.e., accounts of the same Person, provided
the accounts are not in separate aggregation units or otherwise
subject to information barrier or account segregation requirements;.
. .''
    \7\ For purposes of this rule, the term ``Person'' as an
individual, partnership (general or limited), joint stock company,
corporation, limited liability company, trust, or unincorporated
organization, or any governmental entity or agency or political
subdivision thereof. See Options 6, Section 5(a).
---------------------------------------------------------------------------

    The proposed rule change excepts position transfers effected
pursuant to Options 6, Section(a)(2) from the prior written notice
requirement in paragraph (d) and from repeated, recurring use
restriction in paragraph (g). Position transfers pursuant to Options 6,
Section(a)(2) do not involve a change in ownership. In other words,
such transfers may only occur between the same individual or legal
entity. These types of transfers are merely transfers of positions from
one account to another, both of which accounts are attributable to the
same individual or legal entity, and thus the transferred option
positions will continue to be attributable to the same Person. A market
participant effecting an position transfer pursuant to Options 6,
Section 5(a)(2) is analogous to an individual transferring funds from a
checking account to a savings account, or from an account at one bank
to an account at another bank--the money still belongs to the same
person, who is just holding it in a different account for personal
financial reasons.
    Because there is no change in ownership of positions transferred
pursuant to Options 6, Section 5(a)(2), the Exchange believes it is
appropriate to permit them to occur as routinely and repeatedly as a
market participant would like. These transfers will continue to be
subject to the prohibition on netting set forth in Options 6, Section
5(b), and thus may not result in the closing of any positions. While
the position transfers permitted by Options 6, Section 5 were intended
to accommodate non-routine and non-recurring transfers, the Exchange
believes permitting routine, recurring position transfers that do not
result in a change in ownership or reduction in open interest is
consistent with the purpose of not being used to circumvent the normal
auction purpose. Additionally, given that these transfers may occur on
a regular basis in accordance with a market participants' business
needs and procedures, the Exchange believes prior written notice would
be onerous and would not serve any purpose given the lack of change in
ownership and in open interest. The Exchange believes this will provide
market participants with additional flexibility to structure their
option position accounts as they believe is appropriate and move their
positions between accounts as they deem necessary and appropriate for
their business and trading needs, including for risk management
purposes.
    The proposed rule change also corrects an erroneous cross-reference
in Rule Options 6, Section 5(d)(1), as the method for determining the
transfer price is in paragraph (c) rather than paragraph (e) of Options
6, Section 5.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b)

of the Act,\8\ in general, and furthers the objectives of Section
6(b)(5) of the Act.\9\ Specifically, the Exchange believes the proposed
rule change is consistent with the Section 6(b)(5) \10\ requirements
that the rules of an exchange be designed to prevent fraudulent and
manipulative acts and practices, to promote just and equitable
principles of trade, to foster cooperation and coordination with
persons engaged in regulating, clearing, settling, processing
information with respect to, and facilitating transactions in
securities, to remove impediments to and perfect the mechanism of a
free and open market and a national market system, and, in general, to
protect investors and the public interest. Additionally, the Exchange
believes the proposed rule change is consistent with the Section
6(b)(5) \11\ requirement that the rules of an exchange not be designed
to permit unfair discrimination between customers, issuers, brokers, or
dealers.
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78f(b).
    \9\ 15 U.S.C. 78f(b)(5).
    \10\ Id.
    \11\ Id.
---------------------------------------------------------------------------

    In particular, the Exchange believes the proposed rule change will
remove impediments to and perfect the mechanism of a free and open
market and a national market system, and, in general, to protect
investors and the public interest because it will provide market
participants with a more efficient process to transfer open positions
between their own accounts in accordance with their own business and
trading needs, including to respond to then-current market conditions.
Because these transfers would not result in a change in ownership or a
reduction in open interest, the Exchange believes the proposed rule
change remains consistent with the purpose of Options 6, Section 5,
which was to prohibit use of the transfer procedure in circumvention of
the normal auction process, as the normal auction process involves the
opening or closing of positions through a transaction among multiple
market participants. Market participants may maintain different
accounts for a variety of reasons, such as the structure of their
businesses, the manner in which they trade, their risk management
procedures, and for capital purposes. Given that these transfers may
occur on a regular basis in accordance with a market participants'
business needs and procedures, the Exchange believes prior written
notice would be onerous and would not serve any purpose given the lack
of change in ownership and in open interest. Therefore, the proposed
rule change will benefit investors by permitting market participants to
manage the open positions in their accounts in a manner consistent with
their businesses.
    The Exchange recognizes the numerous benefits of executing options
transactions on an exchange, including price transparency, potential
price improvement, and a clearing guarantee. However, the Exchange
believes it is appropriate to permit position transfers among accounts
of the same individual or legal entity where there is no impact on open
interest to occur off the exchange, as these benefits are inapplicable
to those transfers. These transfers have a narrow scope and are
intended to permit market participants to achieve their own business
needs. These transfers are not intended to be a competitive trading
tool. There is no need for price discovery or improvement, as the
transfer merely moves positions to different accounts for the same
Person and does not open or close any positions. These transfers will
result in no change in ownership. The transactions that resulted in the
open positions to be transferred pursuant to Options 6, Section 5(a)(2)
were already guaranteed by a clearing member of The Options Clearing
Corporation (``OCC''), and the positions may not be closed pursuant to
the transfer and will continue to be subject to OCC rules, as they will
continue to be held in an account with an OCC clearing member.

B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act. The proposed rule change is
not intended to address competitive issues. The Exchange does not
believe that the proposed rule change will impose any burden on
intramarket competition that is not necessary or appropriate in
furtherance of the purposes of the Act because the proposed rule change
will apply to all market participants in the same manner. All market
participants will be able to effect position transfers pursuant to
Options 6, Section 5(a)(2) on a recurring or routine basis without
providing the Exchange with notice of such transfers. The Exchange does
not believe the proposed rule change will impose any burden on
intermarket competition that is not necessary or appropriate in
furtherance of the purposes of the Act, because it relates solely to
the notice required for transfers that may occur today, and the
frequency with which those transfers may occur. These transfers will
continue to not result in a change in ownership or netting, and thus
will have no impact on outstanding option positions.

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

    No written comments were either solicited or received.

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

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A) of the Act \12\ and Rule 19b-
4(f)(6) thereunder.\13\
---------------------------------------------------------------------------

    \12\ 15 U.S.C. 78s(b)(3)(A).
    \13\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change, along
with a brief description and text of the proposed rule change, at
least five business days prior to the date of filing of the proposed
rule change, or such shorter time as designated by the Commission.
The Exchange has satisfied this requirement.
---------------------------------------------------------------------------

    A proposed rule change filed under Rule 19b-4(f)(6) \14\ normally
does not become operative for 30 days after the date of the filing.
However, pursuant to Rule 19b-4(f)(6)(iii),\15\ the Commission may
designate a shorter time if such action is consistent with the
protection of investors and the public interest. The Exchange has asked
the Commission to waive the 30-day operative delay to so that it may
adopt the proposed position transfer rules as soon as possible which,
according to the Exchange, would benefit investors and the general
public because it will provide Participants with the ability to request
a transfer, for limited, non-recurring types of transfers, without the
need for exposing those orders on the Exchange. The proposed rule
change does not present any unique or novel regulatory issues and is
substantively identical to provisions in Cboe Rule 6.7. Accordingly,
the Commission hereby waives the operative delay and designates the
proposal operative upon filing.\16\
---------------------------------------------------------------------------

    \14\ 17 CFR 240.19b-4(f)(6).
    \15\ 17 CFR 240.19b-4(f)(6)(iii).
    \16\ For purposes only of waiving the 30-day operative delay,
the Commission has also considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may

temporarily suspend such rule change if it appears to the Commission
that such action is necessary or appropriate in the public interest,
for the protection of investors, or otherwise in furtherance of the
purposes of the Act. If the Commission takes such action, the
Commission will institute proceedings to determine whether the proposed
rule change should be approved or disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-ISE-2020-32 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-ISE-2020-32. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street, NE, Washington,
DC 20549 on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change; the Commission does not edit
personal identifying information from submissions. You should submit
only information that you wish to make available publicly. All
submissions should refer to File Number SR-ISE-2020-32 and should be
submitted on or before September 11, 2020.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\17\
J. Matthew DeLesDernier,
Assistant Secretary.

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

    \17\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

[FR Doc. 2020-18355 Filed 8-20-20; 8:45 am]
BILLING CODE 8011-01-P


P-18-0382 Sanitized Support Documents Index:
 P-18-0382 Sanitized Determination Document (linked)
 P-18-0382 Sanitized CHEM Report (attached)
 P-18-0382 Sanitized ECO Report (attached)
 P-18-0382 Sanitized ENG Report (attached)
 P-18-0382 Sanitized EXP Report (attached)
 P-18-0382 Sanitized Fate Report (attached)
 P-18-0382 Sanitized HLTH Report_POST-FOCUS FINAL (attached)


[Federal Register Volume 81, Number 46 (Wednesday, March 9, 2016)]
[Notices]
[Pages 12509-12511]
[FR Doc No: 2016-05214]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0511]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Medicated Feed Mill License Application

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA, we) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the collection of information
associated with Medicated Feed Mill License Applications.

DATES: Submit either electronic or written comments on the collection
of information by May 9, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2009-N-0511 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Medicated Feed Mill License
Application.'' Received comments will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at http://www.regulations.gov or at the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION''. The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Medicated Feed Mill License Application--21 CFR Part 5157--OMB Control
Number 0910-0337--Revision

    Feed manufacturers that seek to manufacture feed using Category II,
Type A medicated articles or manufacture certain liquid and free-choice
feed, using Category I, Type A medicated articles that must follow
proprietary formulas or specifications are required to obtain a
facility license under section 512 of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C. 360b). Our regulations in part
515 (21 CFR part 515) establish the procedures associated with applying
for a facility license. We require that a manufacturer seeking a
facility license submit a completed medicated feed mill license
application using Form FDA 3448 (21 CFR 515.10(b)). We use the
information submitted to establish that the applicant has made the
certifications required by section 512 of the FD&C Act, to register the
mill, and to schedule a pre-approval inspection. We have made minor
editorial revisions to Form FDA 3448, including the addition of a
dedicated field for the submitter's email address in the contact
information section. We estimate that the revisions will not change the
amount of time necessary to complete the form.
    We require the submission of a supplemental medicated feed mill
license application for a change in facility ownership or a change in
facility address (21 CFR 515.11(b)). If a licensed facility is no
longer manufacturing medicated animal feed under 21 CFR 515.23, a
manufacturer may request voluntary revocation of a medicated feed mill
license. An applicant also has the right to file a request for hearing
under 21 CFR 515.30(c) to give reasons why a medicated feed mill
license should not be refused or revoked.
    We estimate the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                    Number of
          21 CFR section and activity               Number of     responses per   Total annual         Average burden per response          Total hours
                                                   respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Medicated Feed Mill License Application Using                20               1              20  0.25 (15 minutes)......................               5
 Form FDA 3448 (515.10(b)).

Supplemental Feed Mill License Application                   40               1              40  0.25 (15 minutes)......................              10
 Using Form FDA 3448 (515.11(b)).
Voluntary Revocation of Medicated Feed Mill                  40               1              40  0.25 (15 minutes)......................              10
 License (515.23).
Filing a Request for a Hearing on Medicated                   1               1               1  4......................................               4
 Feed Mill License (515.30(c)).
                                                --------------------------------------------------------------------------------------------------------
    Total......................................  ..............  ..............  ..............  .......................................              29
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\1\ ``There are no capital costs or operating and maintenance costs associated with this collection of information.

                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                    Number of
          21 CFR section and activity               Number of      records per    Total annual      Average  burden per  recordkeeping      Total hours
                                                  recordkeepers   recordkeeper       records
--------------------------------------------------------------------------------------------------------------------------------------------------------
Maintenance of Records for Approved Labeling                890               1             890  0.03 (2 minutes).......................            26.7
 for Each ``Type B'' and ``Type C'' Feed
 (510.305).
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    These estimates are based on our experience with medicated feed
mill license applications. We estimate that we will receive 20
medicated feed mill license applications, 40 supplemental applications,
40 requests for voluntary revocation, and that these submissions will
take approximately 15 minutes per response, as shown in table 1, rows 1
through 3. We estimate that preparing a request for a hearing under 21
CFR 515.30(c) takes approximately 4 hours, as shown in table 1, row 4.
In table 2, we estimate that 890 licensees will keep the records
required by 21 CFR 510.305 expending a total of 26.7 hours annually.

    Dated: March 2, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-05214 Filed 3-8-16; 8:45 am]
 BILLING CODE 4164-01-P