[Federal Register Volume 85, Number 96 (Monday, May 18, 2020)]
[Rules and Regulations]
[Pages 29630-29633]
[FR Doc No: 2020-08964]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2019-0368; FRL-10006-98]

Methyl Mercaptan; Exemption From the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of methyl mercaptan in or on all food
commodities when methyl mercaptan is used as a gopher repellent in
irrigation lines in accordance with label directions and good
agricultural practices. Acqua Concepts, Inc. (d/b/a Ag Water Chemical)
submitted a petition to EPA under the Federal Food, Drug, and Cosmetic
Act (FFDCA), requesting an exemption from the requirement of a
tolerance. This regulation eliminates the

need to establish a maximum permissible level for residues of methyl
mercaptan under FFDCA.

DATES: This regulation is effective May 18, 2020. Objections and
requests for hearings must be received on or before July 17, 2020 and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2019-0368, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Robert McNally, Biopesticides and
Pollution Prevention Division (7511P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; main telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR
part 180 through the Government Publishing Office's e-CFR site at
http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file
an objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2019-0368 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing and must be received by the Hearing Clerk on or before
July 17, 2020. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2019-0368, 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 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.html. Additional
instructions on commenting or visiting the docket, along with more
information about dockets generally, is available at http://www.epa.gov/dockets.

II. Background

    In the Federal Register of August 2, 2019 (84 FR 37818) (FRL-9996-
78), EPA issued a notice pursuant to FFDCA section 408(d)(3), 21 U.S.C.
346a(d)(3), announcing the filing of a pesticide tolerance exemption
petition (PP 8F8713) by Acqua Concepts, Inc. (d/b/a Ag Water Chemical),
2665 S. Chestnut, Fresno, CA 93725. The petition requested that 40 CFR
part 180 be amended by establishing an exemption from the requirement
of a tolerance for residues of the gopher repellent methyl mercaptan in
or on all food commodities that use irrigation lines treated with
methyl mercaptan. That notice referenced a summary of the petition
prepared by the petitioner Acqua Concepts, Inc. (d/b/a Ag Water
Chemical) and available in the docket via http://www.regulations.gov.
There were no comments received in response to the notice of filing.

III. Final Rule

A. EPA's Safety Determination

    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement of a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the exemption is ``safe.'' Section 408(c)(2)(A)(ii) of FFDCA defines
``safe'' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.'' This includes exposure through
drinking water and in residential settings but does not include
occupational exposure. Pursuant to FFDCA section 408(c)(2)(B), in
establishing or maintaining in effect an exemption from the requirement
of a tolerance, EPA must take into account the factors set forth in
FFDCA section 408(b)(2)(C) and (D), which require EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance or tolerance exemption and
to ``ensure that there is a reasonable certainty that no harm will
result to infants and children from aggregate exposure to the pesticide
chemical residue . . . .'' Additionally, FFDCA section 408(b)(2)(D)
requires that EPA consider ``available information concerning the
cumulative effects of [a particular pesticide's] . . . residues and
other substances that have a common mechanism of toxicity.''
    EPA evaluated the available toxicology and exposure data on methyl
mercaptan and considered their validity, completeness, and reliability,
as well as the relationship of this information to human risk. EPA also
considered available information concerning the variability of the
sensitivities of major identifiable

subgroups of consumers, including infants and children.
    Methyl mercaptan, also known as methanethiol, is a naturally
occurring compound. In its ambient state, it is a colorless gas that
smells like rotten cabbage. At lower temperatures, it can also be
expressed as a liquid. Methyl mercaptan is naturally found in the blood
and brain of humans and other animals, as well as in plant tissues. It
is excreted from the human and animal body in feces. It also occurs
naturally in certain foods, such as vegetables and some nuts and
cheeses, and, as such, is often consumed by humans.
    Methyl mercaptan has several commercial uses. Due to its strong
odor, it is commonly employed as a leak detector in natural gas lines.
Methyl mercaptan is also used in the production of plastics to moderate
the growth of free radical polymers. Most notably, methyl mercaptan is
used as a Food and Drug Administration-approved food additive to impart
an umami flavor and to act as an adjuvant (21 CFR 172.515).
    As a new biochemical pesticide, methyl mercaptan is intended for
use as a gopher repellent in irrigation/chemigation lines
(subterranean, surface drip, and micro irrigation systems). The
repellent mode of action is due to its noxious, putrid odor. Methyl
mercaptan is intended to be applied in trace amounts through
irrigation/chemigation lines (subterranean, surface drip, and micro
irrigation systems). No direct application to food is expected, but it
is possible that some trace amounts of the active ingredient may be
taken up into the plant.
    Overall, methyl mercaptan is considered to be of low toxicity
relative to its proposed pesticidal use. Based on the available
information and the fact that humans have been exposed to methyl
mercaptan in food and nonfood products, the compound is considered to
have a history of safe natural exposure. With specific regard to human
oral toxicity, EPA notes that the human digestive system is designed to
accommodate methyl mercaptan in its digestive processes. Notably,
significant levels of methyl mercaptan (in excess of 1,000 ppm) are
naturally produced by microflora within the human intestine. Even so,
only trivial amounts are absorbed into the body because methyl
mercaptan is readily oxidized in the human colon.
    Although the available data indicate moderate acute inhalation
toxicity, EPA does not expect any consumer exposures due to the
proposed use pattern in irrigation systems. In the 90-day inhalation
toxicity study, no adverse effects were identified.
    With regard to potential exposure from the use of methyl mercaptan
as a pesticidal active ingredient, EPA determined that expected
exposures will be minimal and dietary hazards negligible. Foremost, EPA
does not anticipate any significant dietary exposure due to the
physical properties of methyl mercaptan. One, methyl mercaptan, which
presents as a gas at ambient temperatures, is highly volatile and
dissipates rapidly in the atmosphere. Two, methyl mercaptan is readily
biodegradable in the soil.
    Based primarily on negligible exposure levels and additionally on
the active ingredient's volatility (short half-life), its
biodegradability, its capacity to be metabolized by humans, its history
of safe consumption in both naturally occuring foods (such as nuts and
cheeses) and foods containing methyl mercaptan as a food additive, and
its use as a food-grade compound in pesticide products, the remaining
toxicology data requirements were waived and no points of departure
were identified that would necessitate a quantitative dietary
assessment of methyl mercaptan.
    Therefore, due to the low toxicological profile of available methyl
mercaptan, its long history of safe exposure, and the minimal dietary
exposure anticipated from its use as an active ingredient, EPA
determined that the pesticidal use of methyl mercaptan (as a gopher
repellent) poses no significant dietary risk.
    As part of its risk assessment for methyl mercaptan, EPA further
considered the potential risks of residential exposures, aggregate
exposures, and cumulative risk. Based on methyl mercaptan's low
toxicity, anticipated negligible dietary exposure, and history of safe
use in consumer products, no risks of concern have been identified
relative to residential (non-occupational) pesticidal uses or any
aggregate of exposures to products containing methyl mercaptan. At this
time, no residential uses of methyl mercaptan are proposed. Similarly,
no risks of concern were identified for cumulative exposures to methyl
mercaptan, since no common mechanism of toxicity was identified for
either methyl mercaptan or its metabolites.
    Therefore, based on the expectation of negligible exposures and low
toxicity, EPA determined that there is a reasonable certainty that no
harm will result to the U.S. population, including infants and
children, from aggregate exposure to methyl mercaptan.
    A summary of the data upon which EPA relied and its risk assessment
based on those data can be found within the document entitled ``Federal
Food, Drug, and Cosmetic Act (FFDCA) Safety Determination for Methyl
Mercaptan.'' This document, as well as other relevant information, is
available in the docket for this action as described under ADDRESSES.
    Based on its safety determination, EPA is establishing an exemption
from the requirement of a tolerance for residues of methyl mercaptan in
or on all food commodities when methyl mercaptan is used as a gopher
repellent in irrigation lines in accordance with label directions and
good agricultural practices.

B. Analytical Enforcement Methodology

    The analytical method ``ASTM D 5504-12 using a gas chromatograph
equipped with a sulfur chemiluminescence detector (SCD)'' is available
to EPA for the detection and measurement of the pesticide residues.

IV. Statutory and Executive Order Reviews

    This action establishes an exemption from the requirement of a
tolerance under FFDCA section 408(d) in response to a petition
submitted to EPA. The Office of Management and Budget (OMB) has
exempted these types of actions from review under Executive Order
12866, entitled ``Regulatory Planning and Review'' (58 FR 51735,
October 4, 1993). Because this action has been exempted from review
under Executive Order 12866, this action is not subject to Executive
Order 13211, entitled ``Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use'' (66 FR
28355, May 22, 2001), or Executive Order 13045, entitled ``Protection
of Children from Environmental Health Risks and Safety Risks'' (62 FR
19885, April 23, 1997), nor is it considered a regulatory action under
Executive Order 13771, entitled ``Reducing Regulations and Controlling
Regulatory Costs'' (82 FR 9339, February 3, 2017). This action does not
contain any information collections subject to OMB approval under the
Paperwork Reduction Act, 44 U.S.C. 3501 et seq., nor does it require
any special considerations under Executive Order 12898, entitled
``Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations'' (59 FR 7629, February 16,
1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as

the tolerance exemption in this action, do not require the issuance of
a proposed rule, the requirements of the Regulatory Flexibility Act (5
U.S.C. 601 et seq.) do not apply.
    This action directly regulates growers, food processors, food
handlers, and food retailers, not States or Tribes. As a result, this
action does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, EPA determined that this action
will not have a substantial direct effect on States or Tribal
Governments, on the relationship between the National Government and
the States or Tribal Governments, or on the distribution of power and
responsibilities among the various levels of government or between the
Federal Government and Indian Tribes. Thus, EPA determined that
Executive Order 13132, entitled ``Federalism'' (64 FR 43255, August 10,
1999), and Executive Order 13175, entitled ``Consultation and
Coordination with Indian Tribal Governments'' (65 FR 67249, November 9,
2000), do not apply to this action. In addition, this action does not
impose any enforceable duty or contain any unfunded mandate as
described under Title II of the Unfunded Mandates Reform Act (2 U.S.C.
1501 et seq.).
    This action does not involve any technical standards that would
require EPA's consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (15 U.S.C. 272 note).

V. Congressional Review Act (CRA)

    Under the CRA (5 U.S.C. 801 et seq.), EPA will submit a rule report
to the U.S. Senate, the U.S. House of Representatives, and the
Comptroller General of the United States prior to publication of the
rule in the Federal Register. This action is not a ``major rule'' as
defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

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

    Dated: April 2, 2020.
Richard Keigwin,
Director, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority:  21 U.S.C. 321(q), 346a and 371.

0
2. Add Sec.  180.1375 to subpart D to read as follows:

Sec.  180.1375  Methyl mercaptan; exemption from the requirement of a
tolerance.

    Residues of methyl mercaptan are exempt from the requirement of a
tolerance in or on all food commodities, when methyl mercaptan is used
as a gopher repellent in irrigation lines in accordance with label
directions and good agricultural practices.

[FR Doc. 2020-08964 Filed 5-15-20; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: November 1, 2006 (Volume 71, Number 211)]
[Notices]
[Page 64268-64269]
[DOCID:fr01no06-66]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2006-0783; FRL-8095-4]

Bacillus thuringiensis Vip3A Protein and the Genetic Material
Necessary for its Production in Corn; Notice of Filing of a Pesticide
Petition to Establish a Temporary Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the initial filing of a pesticide
petition proposing the establishment of regulations for residues of
pesticide chemicals in or on various commodities.

DATES: Comments must be received on or before December 1, 2006.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2006-0783 and pesticide petition number (PP)
6G7091, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.

Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket telephone number is<PHONE_NUMBER>.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2006-0783. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line 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 whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The Federal regulations.gov Web site 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 e-mail comment directly to EPA without going through
regulations.gov, your e-mail address will be automatically captured and
included as part of the comment that is placed in the docket and made
available on the Internet. If you submit an electronic comment, EPA
recommends that you include your name and other contact information in
the body of your comment and with any disk or CD-ROM you submit. If EPA
cannot read your comment due to technical difficulties and cannot
contact you for clarification, EPA may not be able to consider your
comment. Electronic files should avoid the use of special characters,
any form of encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the docket index.
Although listed in the index, some information is not publicly
available, e.g., CBI or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either in the electronic docket at http://www.regulations.gov
, or, if only available in hard copy, at the OPP

Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South
Building), 2777 S. Crystal Drive, Arlington, VA. The hours of operation
of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday through
Friday, excluding legal holidays. The Docket telephone number is (703)
305-5805.

FOR FURTHER INFORMATION CONTACT: Alan Reynolds, Biopesticides and
Pollution Prevention Division (7511P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; fax
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, 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 e-mail. 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 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.

II. What Action is the Agency Taking?

    EPA is printing a summary of a pesticide petition received under
section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21
U.S.C. 346a, proposing the establishment or amendment of regulations in
40 CFR part 180 for residues of pesticide chemicals in or on various
food commodities. EPA has determined that this pesticide petition
contains data or information regarding the elements set forth in FFDCA
section 408(d)(2); however, EPA has not fully evaluated the sufficiency
of the submitted data at this time or whether the data support granting
of the pesticide petition. Additional data may be needed before EPA
rules on this pesticide petition.
    Pursuant to 40 CFR 180.7(f), a summary of the petition included in
this notice, prepared by the petitioner along with a description of the
analytical method available for the detection and measurement of the
pesticide chemical residues is available on EPA's Electronic Docket at
http://www.regulations.gov. To locate this information on the home page

of EPA's Electronic Docket, select ``Quick Search'' and type the OPP
docket ID number. Once the search has located the docket, clicking on
the ``Docket ID'' will bring up a list of all documents in the docket
for the pesticide including the petition summary.

III. New Exemption from Tolerance

    1. PP 6G7091. Syngenta Seeds, Inc., P.O. Box 12257, Research
Triangle Park, NC 27709, proposes to establish a temporary exemption
from the requirement of a tolerance for residues of the plant-
incorporated protectant, Bacillus thuringiensis Vip3A protein and the
genetic material necessary for its production in corn, in or on all
corn commodities. The petition includes a reference to a description of
the analytical methods available to EPA for the detection and
measurement of the pesticide chemical residues or an explanation of why
no such method is needed.

List of Subjects

    Environmental protection, Agricultural commodities, Feed additives,
Food additives, Pesticides and pests, Reporting and recordkeeping
requirements.

    Dated: October 3, 2006.
Janet L. Andersen,
Director, Biopesticides and Pollution Prevention Division.

[FR Doc. E6-18425 Filed 10-31-06; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register Volume 76, Number 55 (Tuesday, March 22, 2011)]
[Notices]
[Page 15986]
[FR Doc No: 2011-6623]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-1990-F-0390] (Formerly Docket No. 90F-0074)

Alpha Omega Technology, Inc.; Denial Without Prejudice of Food
Additive Petition

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is denying a food
additive petition (FAP 0M4181) proposing that the food additive
regulations be amended to provide for the safe use of a source of
irradiation to treat shellfish and finfish.

DATES: This order is effective June 20, 2011; except as to any
provisions that may be stayed by the filing of proper objections.
Submit either electronic or written objections and requests for a
hearing by April 21, 2011.

ADDRESSES: You may submit either electronic or written objections and
requests for a hearing, identified by FDA-1990-F-0390, by any of the
following methods:

Electronic Submissions

    Submit electronic objections in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.

Written Submissions

    Submit written objections in the following ways:
     FAX:<PHONE_NUMBER>.
     Mail/Hand delivery/Courier (for paper, disk, or CD-ROM
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Richard E. Bonnette, Center for Food
Safety and Applied Nutrition (HFS-255), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740-3835,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal
Register of March 15, 1990 (55 FR 9772), FDA announced that a food
additive petition (FAP 0M4181) had been filed by Alpha Omega
Technology, Inc., 1279 Route 46 East, Parsippany, NJ 07054. The
petition proposed to amend the food additive regulations in Sec.
179.26 Ionizing radiation for the treatment of food (21 CFR 179.26) to
provide for the safe use of a source of irradiation to treat finfish
and shellfish.
    For any food additive petition, the burden is on the petitioner to
submit to FDA data and information that are adequate for the Agency to
determine that the proposed use of the additive under the specified
conditions of use is safe (21 U.S.C. 348(c)(3)(A); 21 CFR 171.1). Alpha
Omega Technology, Inc., was informed of significant deficiencies in its
petition by letters from FDA dated May 28, 1992, September 15, 1993,
February 10, 1999, July 20, 2004, March 19, 2009, and May 22, 2009. The
deficiencies related primarily to the possibility of Clostridium
botulinum outgrowth in packaged products, especially where the normal
growth pattern of typical spoilage organisms could be changed by
irradiation, thus reducing perception of spoilage.
    FDA noted that the data provided in the petition indicated that
there was very little margin of safety with regard to the concern for
C. botulinum outgrowth and toxin elaboration, particularly in
irradiated fish stored at temperatures between 46 and 50 degrees
Fahrenheit. FDA therefore requested data demonstrating that products
irradiated at the maximum dose requested and subjected to some
temperature abuse would show evidence of spoilage before showing
evidence of toxicity.
    Alpha Omega Technology, Inc., has been unresponsive to these
requests, and other efforts to contact the petitioner regarding the
petition have not been successful. The petitioner has not provided
sufficient data and information for the Agency to conclude that the
proposed use of the food additive is safe in accordance with section
409 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21
U.S.C. 348). Consequently, FDA is denying the petition without
prejudice to a future filing (21 U.S.C. 348(c)(1)(B), 21 CFR
171.100(a)).
    This order is effective as shown in the DATES section of this
document; except as to any provisions that may be stayed by the filing
of proper objections. Any person who will be adversely affected by this
order may file with the Division of Dockets Management (see ADDRESSES)
either electronic or written objections. Each objection shall be
separately numbered, and each numbered objection shall specify with
particularity the provisions of the regulation to which objection is
made and the grounds for the objection. Each numbered objection on
which a hearing is requested shall specifically so state. Failure to
request a hearing for any particular objection shall constitute a
waiver of the right to a hearing on that objection. Each numbered
objection for which a hearing is requested shall include a detailed
description and analysis of the specific factual information intended
to be presented in support of the objection in the event that a hearing
is held. Failure to include such a description and analysis for any
particular objection shall constitute a waiver of the right to a
hearing on the objection. It is only necessary to send one set of
documents. It is no longer necessary to send three copies of all
documents. Identify documents with the docket number found in brackets
in the heading of this document. Any objections received in response to
the order may be seen in the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday. FDA will publish notice of the
objections that the Agency has received or lack thereof in the Federal
Register.

    Dated: March 15, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-6623 Filed 3-21-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 77, Number 78 (Monday, April 23, 2012)]
[Notices]
[Pages 24252-24253]
[FR Doc No: 2012-9741]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Notice of Release From Federal Grant Assurance Obligations for
Sacramento International Airport (SMF), Sacramento, CA

AGENCY: Federal Aviation Administration, US DOT.

ACTION: Notice of Request to Release Airport Land.

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

SUMMARY: The Federal Aviation Administration (FAA) proposes to rule and
invites public comment on the application for a release of two parcels
of land comprising approximately 6.50 acres of airport property at the
Sacramento International Airport, California. The County of Sacramento
proposes to release the 6.50 acres for sale to the California's
Reclamation District 1000 at fair market value. The two parcels of land
are occupied in their entirety by a storm water drainage canal and
pumping plant owned and operated by Reclamation District 1000 and do
not serve any aviation purposes. The property serves as a regional
drainage canal and pumping plant to support facilities for transporting
storm water away from developed and undeveloped property, including
part of the Sacramento International Airport in the southwest section
of the Natomas Basin.

DATES: Comments must be received on or before May 23, 2012.

FOR FURTHER INFORMATION CONTACT: Comments on the request may be mailed
or delivered to the FAA at the following address: Robert Y. Lee,
Airports Compliance Specialist, Federal Aviation Administration,
Airports Division, Federal Register Comment,1000 Marina Boulevard,
Suite 220, Brisbane, CA 94005. In addition, one copy of the comment
submitted to the FAA must be mailed or delivered to Mr. Greg Rowe,
Senior Environmental Analyst, County of Sacramento, 6900 Airport
Boulevard, Sacramento, California 95837.

SUPPLEMENTARY INFORMATION: In accordance with the Wendell H. Ford
Aviation Investment and Reform Act for the 21st Century (AIR 21),
Public Law 106-181 (Apr. 5, 2000; 114 Stat. 61), this notice must be
published in the Federal Register 30 days before the Secretary may
waive any condition imposed on a federally obligated airport by surplus
property conveyance deeds or grant agreements.
    The following is a brief overview of the request:
    The County of Sacramento, California requested a release from grant
assurance obligations for approximately 6.50 acres of land that is not
contiguous to the airport and located southwest of the airport between
the Sacramento River and Interstate Highway 5. The property was
originally acquired as two separate parcels, one measuring 6.27 acres
and the other 0.18 acres. The Federal Aviation Administration's Federal
Aid to Airports Program, FAAP 9-04-130-6401, provided partial grant
funding to acquire the property.
    Due to the parcels' location and use, the property has no
alternative airport use. The property was improved for flood control
purpose and continues to serve that purpose. The larger parcel

contains a drainage canal and the smaller parcel has a pumping plant
that pumps storm water and agricultural runoff into the Sacramento
River. The property also serves as a cross canal between the West
Drainage Canal and the Sacramento River. The area is zoned as
``Permanent Agricultural Zone,'' in conformity with most of the
surrounding area, which is farm land. Since the 1960's, the land has
been used as a regional drainage canal and pumping plant. The location,
size and dimensions of the two parcels are only suited as a drainage
canal and open space. With no contemplated commercial use, the land's
value is diminimus.
    The release will allow the title of the two parcels to be
transferred to the Reclamation District 1000 in exchange for storm
water drainage channel clearance services. The value of these services
will compensate the airport for the property's residual fair market
value. The channel clearance service is likely more beneficial to the
County Airport System than a diminimus payment. The release parcels
will continue to be utilized for drainage purposes and will benefit the
airport by increasing the airport's impervious surface runoff and
drainage needs. Furthermore, it represents a compatible land use that
will not interfere with the airport or its operation. Therefore, the
release is a benefit to civil aviation.

    Issued in Brisbane, California, on April 16, 2012.
Arlene Draper,
Acting Manager, San Francisco Airports District Office, Western-Pacific
Region.
[FR Doc. 2012-9741 Filed 4-20-12; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 81, Number 73 (Friday, April 15, 2016)]
[Notices]
[Pages 22278-22279]
[FR Doc No: 2016-08637]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0001]

Antimicrobial Drugs Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

    This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
    Name of Committee: Antimicrobial Drugs Advisory Committee.
    General Function of the Committee: To provide advice and
recommendations to the Agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on June 9, 2016, from 8:30
a.m. to 5 p.m.
    Location: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-
0002. Information regarding special accommodations due to a disability,
visitor parking, and transportation may be accessed at: http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
    Contact Person: Lauren D. Tesh, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
31, Rm. 2417, Silver Spring, MD 20993-0002,<PHONE_NUMBER>, FAX: 301-847-
8533<EMAIL_ADDRESS>or FDA Advisory Committee Information Line, 1-
800-741-8138<PHONE_NUMBER> in the Washington, DC area). A notice in the
Federal Register about last minute modifications that impact a
previously announced advisory committee meeting cannot always be
published quickly enough to provide timely notice. Therefore, you
should always check the Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate
advisory committee meeting link, or call the advisory committee
information line to learn about possible modifications before coming to
the meeting.
    Agenda: The committee will discuss biologics license application
(BLA) 761046, bezlotoxumab (MK-6072) injection, submitted by Merck
Sharpe & Dohme Corp., for the proposed indication of prevention of
Clostridium difficile infection recurrence.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting
link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before May
25, 2016. Oral presentations from the public will be scheduled between
approximately 1:30 p.m. and 2:30 p.m. Those individuals interested in
making formal oral presentations should notify the contact person and
submit a brief statement of the general nature of the evidence or
arguments they wish to present, the names and addresses of proposed
participants, and an indication of the approximate time requested to
make their presentation on or before May 17, 2016. Time allotted for
each

presentation may be limited. If the number of registrants requesting to
speak is greater than can be reasonably accommodated during the
scheduled open public hearing session, FDA may conduct a lottery to
determine the speakers for the scheduled open public hearing session.
The contact person will notify interested persons regarding their
request to speak by May 18, 2016.
    Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
disabilities. If you require accommodations due to a disability, please
contact Lauren D. Tesh at least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: April 11, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2016-08637 Filed 4-14-16; 8:45 am]
 BILLING CODE 4164-01-P


Page 1 of 15 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 April 22, 2004 MEMORANDUM SUBJECT: Revised Environmental Modeling for Zinc Omadine ( Zinc pyrithione)

From: Siroos Mostaghimi, Ph. D., Senior Scientist Risk Assessment and Science Support Branch ( RASSB) Antimicrobials Division ( 7510C)

To: Deborah Smegal, MPH, Toxicologist Risk Assessment and Science Support Branch ( RASSB) Antimicrobials Division ( 7510C)

Thru: Norm Cook, Chief Risk Assessment and Science Support Branch ( RASSB) Antimicrobials Division ( 7510C)

DP Barcode ( s): 301373 Pesticide Chemical No.: 088002 Review Time: 60 Hours MRID #: N/ A Attached please find the revised environmental modeling for the use of Zinc Omadine as an antifoulant. Page 2 of 15 INTRODUCTION In 2002 RASSB used the Luttic Johnson model to estimate the environmental concentrations of zinc Omadine as an antifoulant. Since then several new and more sophisticated models have been developed which could be used for estimating the concentration of antifoulants in water. The purpose of this report is to revisit the modeling issues related to zinc Omadine as an antifoulant.

RASSB has decided to use MAM PEC ( Marine Antifoulant Model Predicted Environmental Concentrations) which was developed by the van Huttum et al. ( 2002).

According to MAM PEC Manual, the model calculates adsorbed and dissolved concentrations of antifoulants in the environment. MAM PEC estimates environmental concentrations in the following marine environments:

1. Open Seas 2. Shipping lane 3. Estuary 4. Commercial harbor 5. Yachting marina In addition specific defined environments can be added to the model.

MAM PEC takes into account the following factors:

A. Emission Factors such as:

Leaching rates

Shipping intensities

Ship hull underwater surface areas

Residence time B. Compound Related Properties such as:

Hydrolysis

Photolysis

Bacterial degradation

Volatilization

Speciation

Kd

Kow

Koc C. Properties and Processes Related to the Specific Environment such as: Page 3 of 15

Suspended matter load

salinity

Tides

Currents The Arch Chemical Company in their response to the RASSB risk assessment have indicated that the leaching rate which we have used for modeling this compound is too high ( 12.5  g/ cm2/ day) and not a good representative for leaching of this compound. They also indicate that the high rate is because of the testing method. Dr. Najm Shamim has reviewed the new leaching data submitted to EPA and he reports the range of acceptable leaching rates for Zinc Omadine between 1.2  g / cm2 / day to 8.4  g / cm2 / day ( Please refer to the Environmental fate chapter for Zinc Omadine). Therefore, RASSB has decided to provide a range of PECs ( Predicted Environmental Concentrations) using the acceptable leaching rates. The default scenarios provided in MAM PEC were used and the only changes were the leaching rates.

RESULTS:

A. Summary:

The following table shows the leaching rates and their correspondents PECs as estimated by MAM PEC:

Leaching Rate (

g/ cm2/ day) Average Concentration (

g/ L)

1.2 ( Low) 0.0144 4.8 ( Average) 0.0576 8.4 ( High) 0.101 The followings provide a more detailed description of the scenarios as well as results obtained from MAM PEC runs. It should be noted that MAM PEC provides maximum, 95%, average, median and minimum concentrations. The average concentrations are reported in the aforementioned Table. The estimated concentrations according to leaching rates as well input scenarios used to run MAM PEC are provided bellow:

B. MAMPEC  Result Sheet for Leaching Rate of 1.2

g / cm2/ day Run : Zinc Omadine, Version : MamPec 1.4.16 Run date : 3/ 25/ 2004 8: 05: 10 AM Page 4 of 15 Input Environment : Default marina Compound : Zinc Omadine ( default) Emission : Default Marina biocide 100 % ( 1.2) Load : 8.07E+ 01: g/ d Results Total concentration in harbor Maximum concentration : 2.65E 02 : ug/ l 95 % concentration : 2.61E 02 : ug/ l Average concentration : 1.44E 02 : ug/ l Median concentration : 1.32E 02 : ug/ l Minimum concentration : 2.56E 03 : ug/ l Dissolved concentration in harbor Maximum concentration: 2.65E 02 : ug/ l 95 % concentration : 2.61E 02 : ug/ l Average concentration: 1.44E 02 : ug/ l Median concentration : 1.32E 02 : ug/ l Minimum concentration : 2.56E 03 : ug/ l Contaminant concentration on suspended solids Maximum concentration : 7.57E 04 : ug/ g dw 95 % concentration : 7.44E 04 : ug/ g dw Average concentration: 4.11E 04 : ug/ g dw Median concentration : 3.77E 04 : ug/ g dw Minimum concentration: 7.30E 05 : ug/ g dw Contaminant concentration in sediment after 1 year of use Maximum concentration : 3.40E 09 : ug/ g dw 95 % concentration : 3.34E 09 : ug/ g dw Average concentration: 1.85E 09 : ug/ g dw Median concentration : 1.70E 09 : ug/ g dw Minimum concentration: 3.28E 10 : ug/ g dw Contaminant concentration in sediment after 2 years of use Maximum concentration : 3.40E 09 : ug/ g dw 95 % concentration : 3.34E 09 : ug/ g dw Average concentration : 1.85E 09 : ug/ g dw Median concentration : 1.70E 09 : ug/ g dw Minimum concentration : 3.28E 10 : ug/ g dw Page 5 of 15 Contaminant concentration in sediment after 5 years of use Maximum concentration : 3.40E 09 : ug/ g dw 95 % concentration : 3.34E 09 : ug/ g dw Average concentration : 1.85E 09 : ug/ g dw Median concentration : 1.70E 09 : ug/ g dw Minimum concentration : 3.28E 10 : ug/ g dw Contaminant concentration in sediment after 10 years of use Maximum concentration : 3.40E 09 : ug/ g dw 95 % concentration : 3.34E 09 : ug/ g dw Average concentration : 1.85E 09 : ug/ g dw Median concentration : 1.70E 09 : ug/ g dw Minimum concentration : 3.28E 10 : ug/ g dw MAMPEC  Input data sheet Compound Name : Zinc pyrithione Description : Zinc Omadine ( default) Molecular mass : 317.7 : g/ Mol Vapor pressure : 1.00E 06 : Pa Solubility : 6.00E+ 00 : g/ m3 Octanol water coefficient : 9.30E 01 :() Log ( Kow) Kd : 0.00E+ 00 : m3/ kg Koc : 3.00E+ 00 :() Log( Koc), Koc expressed as l/ kg OrganicCarbon Henry's coefficient : 5.00E 05 : Pa. m3/ mol Melting temperature : 260.0 : oC pKa : 0.0 :() in water Biological degradation rate : 2.08E+ 00 : 1/ d Hydrolytic degradation rate : 5.40E 02 : 1/ d Photolytic degradation rate : 5.50E+ 00 : 1/ d in sediment Biological degradation rate : 7.90E+ 00 : 1/ d Hydrolytic degradation rate : 3.30E+ 01 : 1/ d Photolytic degradation rate : 0.00E+ 00 : 1/ d Environment Description : Default marina Silt concentration : 35.0 : g/ m3 Particular organic carbon conc : 1.0 : g Organic Carbon/ m3 Dissolved organic carbon conc : 2.0 : g/ m3 Temperature : 20.0 : oC Salinity : 3.40E+ 01 : s. e. Page 6 of 15 Depth well mixed sediment top layer : 1.00E 01 : m Sediment density : 1.000E+ 03 : kg/ m3 Fraction organic carbon in sediment : 3.00E 02 : kg/ m3 Nett sedimentation velocity : 5.00E 01 : m/ d pH : 8.0 :() Background concentrations : 0.00E+ 00 : ug/ l Length of river, not part of harbor ( x1) : 400 : m Length of harbor ( y1) ( Á river or coast) : 400 Width of harbor ( x2)(// river or coast) : 400 : m Width of river ( y2) : 400 : m Depth of harbor : 3.5 : m Length of open harbour mouth ( x3) : 100 : m Flow : 1 : m/ s Flow of flushing into harbor : 0 : m3/ s Tidal height : 1 : m Density difference : 0.1 : kg/ m3 Density difference flushing : 0 : kg/ m3 Tidal period : 12.41 : h Exchange surface : 350 : m2 Depth at harbour mouth : 3.5 : m Height underwater dam at mouth : 0 : m Width underwater dam at mouth : 0 : m Length selected area : 0 : m Width selected area : 0 : m Depth selected area : 0 : m Flow : 0 : m/ s Exchange volume in 1 tidal period : 243420: m3 Emission Description : Default Marina biocide 100 % ( 1.2) Load : 80.73 : g/ d Loading due to moving ships : 0 : g/ d Loading due to ships at berth : 80.73 : g/ d Leaching rate ships at berth : 1.2 : ug/ cm2/ d Leaching rate ships at berth : 1.2 : ug/ cm2/ d Number of ships at berth ( Class 1) : 0 Number of ships at berth ( Class 2) : 299 Number of ships at berth ( Class 3) : 0 Number of ships at berth ( Class 4) : 0 Number of ships at berth ( Class 5) : 0 Number of ships at berth ( Class 6) : 0 Number of ships at berth ( Class 7) : 0 Number of ships at berth ( Class 8) : 0 Number of ships at berth ( Class 9 : 0 Number of ships at berth ( Class 10) : 0 Number of moving ships ( Class 1) : 0 Number of moving ships ( Class 2) : 0 Number of moving ships ( Class 3) : 0 Number of moving ships ( Class 4) : 0 Number of moving ships ( Class 5) : 0 Page 7 of 15 Number of moving ships ( Class 6) : 0 Number of moving ships ( Class 7) : 0 Number of moving ships ( Class 8) : 0 Number of moving ships ( Class 9) : 0 Number of moving ships ( Class 10) : 0 Application factor ( Class 1) : 0 :% Application factor ( Class 2) : 100:% Application factor ( Class 3) : 0 :% Application factor ( Class 4) : 0 :% Application factor ( Class 5) : 0 :% Application factor ( Class 6) : 20 :% Application factor ( Class 7) : 20 :% Application factor ( Class 8) : 20 :% Application factor ( Class 9) : 20 :% Application factor ( Class 10) : 20 :% Underwater ship area ( Class 1) : 20 : m2 Underwater ship area ( Class 2) : 22.5: m2 Underwater ship area ( Class 3) : 450 : m2 Underwater ship area ( Class 4) : 3061 : m2 Underwater ship area ( Class 5) : 5999 : m2 Underwater ship area ( Class 6) : 9917 : m2 Underwater ship area ( Class 7) : 14814 : m2 Underwater ship area ( Class 8) : 22645 : m2 Underwater ship area ( Class 9) : 27547 : m2 Underwater ship area ( Class 10) : 39668 : m2 Ship Length ( Class 1) : 0 10 : m Ship Length ( Class 2) : 10 50 : m Ship Length ( Class 3) : 50 100 : m Ship Length ( Class 4) : 100 150 : m Ship Length ( Class 5) : 150 200 : m Ship Length ( Class 6) : 200 250 : m Ship Length ( Class 7) : 250 300 : m Ship Length ( Class 8) : 300 350 : m Ship Length ( Class 9) : 350 400 : m Ship Length ( Class 10) : > 400 : m C. MAMPEC  Result Sheet for Leaching Rate of 4.8

g/ cm2/ day Run : Zinc Omadine, Version : MamPec 1.4.16 Run date : 3/ 25/ 2004 8: 07: 39 AM Input Environment : Default marina Compound : Zinc Omadine ( default) Emission : Default Marina biocide 100 % ( 4.8) Load : 3.23E+ 02: g/ d Results Total concentration in harbor Page 8 of 15 Maximum concentration : 1.06E 01 : ug/ l 95 % concentration : 1.04E 01 : ug/ l Average concentration : 5.76E 02 : ug/ l Median concentration : 5.29E 02 : ug/ l Minimum concentration : 1.02E 02 : ug/ l Dissolved concentration in harbor Maximum concentration : 1.06E 01 : ug/ l 95 % concentration : 1.04E 01 : ug/ l Average concentration : 5.75E 02 : ug/ l Median concentration : 5.28E 02 : ug/ l Minimum concentration : 1.02E 02 : ug/ l Contaminant concentration on suspended solids Maximum concentration : 3.03E 03 : ug/ g dw 95 % concentration : 2.98E 03 : ug/ g dw Average concentration : 1.64E 03 : ug/ g dw Median concentration : 1.51E 03 : ug/ g dw Minimum concentration : 2.92E 04 : ug/ g dw Contaminant concentration in sediment after 1 year of use Maximum concentration : 1.36E 08 : ug/ g dw 95 % concentration : 1.34E 08 : ug/ g dw Average concentration : 7.38E 09 : ug/ g dw Median concentration : 6.78E 09 : ug/ g dw Minimum concentration : 1.31E 09 : ug/ g dw Contaminant concentration in sediment after 2 years of use Maximum concentration : 1.36E 08 : ug/ g dw 95 % concentration : 1.34E 08 : ug/ g dw Average concentration : 7.38E 09 : ug/ g dw Median concentration : 6.78E 09 : ug/ g dw Minimum concentration : 1.31E 09 : ug/ g dw Contaminant concentration in sediment after 5 years of use Maximum concentration : 1.36E 08 : ug/ g dw 95 % concentration : 1.34E 08 : ug/ g dw Average concentration : 7.38E 09 : ug/ g dw Median concentration : 6.78E 09 : ug/ g dw Minimum concentration : 1.31E 09 : ug/ g dw Contaminant concentration in sediment after 10 years of use Maximum concentration : 1.36E 08 : ug/ g dw 95 % concentration : 1.34E 08 : ug/ g dw Average concentration : 7.38E 09 : ug/ g dw Page 9 of 15 Median concentration : 6.78E 09 : ug/ g dw Minimum concentration : 1.31E 09 : ug/ g dw MAMPEC  Input data sheet Compound Name : Zinc pyrithione Description : Zinc Omadine ( default) Molecular mass : 317.7 : g/ Mol Vapor pressure : 1.00E 06 : Pa Solubility : 6.00E+ 00 : g/ m3 Octanol water coefficient : 9.30E 01 :() Log ( Kow) Kd : 0.00E+ 00 : m3/ kg Koc : 3.00E+ 00 :() Log( Koc), Koc expressed as l/ kg OrganicCarbon Henry's coefficient : 5.00E 05 : Pa. m3/ mol Melting temperature : 260.0 : oC pKa : 0.0 :() in water Biological degradation rate : 2.08E+ 00 : 1/ d Hydrolytic degradation rate : 5.40E 02 : 1/ d Photolytic degradation rate : 5.50E+ 00 : 1/ d in sediment Biological degradation rate : 7.90E+ 00 : 1/ d Hydrolytic degradation rate : 3.30E+ 01 : 1/ d Photolytic degradation rate : 0.00E+ 00 : 1/ d Environment Description : Default marina Silt concentration : 35.0 : g/ m3 Particular organic carbon conc : 1.0 : g Organic Carbon/ m3 Dissolved organic carbon conc : 2.0 : g/ m3 Temperature : 20.0 : oC Salinity : 3.40E+ 01 : s. e. Depth well mixed sediment top layer : 1.00E 01 : m Sediment density : 1.000E+ 03 : kg/ m3 Fraction organic carbon in sediment : 3.00E 02 : kg/ m3 Nett sedimentation velocity : 5.00E 01 : m/ d pH : 8.0 : () Background concentrations : 0.00E+ 00 : ug/ l Length of river, not part of harbor ( x1) : 400 : m Length of harbor ( y1) ( Á river or coast) : 400 Width of harbor ( x2)(// river or coast) : 400 : m Width of river ( y2) : 400 : m Depth of harbor : 3.5 : m Length of open harbor mouth ( x3) : 100 : m Flow : 1 : m/ s Flow of flushing into harbor : 0 : m3/ s Page 10 of 15 Tidal height : 1 m Density difference : 0.1 : kg/ m3 Density difference flushing : 0 : kg/ m3 Tidal period : 12.41 : h Exchange surface : 350 : m2 Depth at harbour mouth : 3.5 : m Height underwater dam at mouth : 0 : m Width underwater dam at mouth : 0 : m Length selected area : 0 : m Width selected area : 0 : m Depth selected area : 0 : m Flow : 0 : m/ s Exchange volume in 1 tidal period : 243420 : m3 Emission Description : Default Marina biocide 100 % ( 4.8) Load : 322.92 : g/ d Loading due to moving ships : 0 : g/ d Loading due to ships at berth : 322.92 : g/ d Leaching rate ships at berth : 4.8 : ug/ cm2/ d Leaching rate ships at berth : 4.8 : ug/ cm2/ d Number of ships at berth ( Class 1) : 0 Number of ships at berth ( Class 2) : 299 Number of ships at berth ( Class 3) : 0 Number of ships at berth ( Class 4) : 0 Number of ships at berth ( Class 5) : 0 Number of ships at berth ( Class 6) : 0 Number of ships at berth ( Class 7) : 0 Number of ships at berth ( Class 8) : 0 Number of ships at berth ( Class 9 : 0 Number of ships at berth ( Class 10): 0 Number of moving ships ( Class 1) : 0 Number of moving ships ( Class 2) : 0 Number of moving ships ( Class 3) : 0 Number of moving ships ( Class 4) : 0 Number of moving ships ( Class 5) : 0 Number of moving ships ( Class 6) : 0 Number of moving ships ( Class 7) : 0 Number of moving ships ( Class 8) : 0 Number of moving ships ( Class 9) : 0 Number of moving ships ( Class 10) : 0 Application factor ( Class 1) : 0 :% Application factor ( Class 2) : 100 :% Application factor ( Class 3) : 0 :% Application factor ( Class 4) : 0 :% Application factor ( Class 5) : 0 :% Application factor ( Class 6) : 20 :% Application factor ( Class 7) : 20 :% Application factor ( Class 8) : 20 :% Application factor ( Class 9) : 20 :% Application factor ( Class 10) : 20 :% Page 11 of 15 Underwater ship area ( Class 1) : 20 : m2 Underwater ship area ( Class 2) : 22.5 : m2 Underwater ship area ( Class 3) : 450 : m2 Underwater ship area ( Class 4) : 3061 : m2 Underwater ship area ( Class 5) : 5999 : m2 Underwater ship area ( Class 6) : 9917 : m2 Underwater ship area ( Class 7) : 14814 : m2 Underwater ship area ( Class 8) : 22645 : m2 Underwater ship area ( Class 9) : 27547 : m2 Underwater ship area ( Class 10) : 39668 : m2 Ship Length ( Class 1) : 0 10 : m Ship Length ( Class 2) : 10 50 : m Ship Length ( Class 3) : 50 100 : m Ship Length ( Class 4) : 100 150 : m Ship Length ( Class 5) : 150 200 : m Ship Length ( Class 6) : 200 250 : m Ship Length ( Class 7) : 250 300 : m Ship Length ( Class 8) : 300 350 : m Ship Length ( Class 9) : 350 400 : m Ship Length ( Class 10) : > 400 : m D. MAMPEC  Result Sheet for Leaching Rate of 8.4

g/ cm2/ day Run : Zinc Omadine Version : MamPec 1.4.16 Run date : 3/ 25/ 2004 7: 56: 12 AM Input Environment : Default marina Compound : Zinc Omadine ( default) Emission : Default Marina biocide 100 % ( 1) Load : 5.65E+ 02: g/ d Results Total concentration in harbor Maximum concentration : 1.86E 01 : ug/ l 95 % concentration : 1.83E 01 : ug/ l Average concentration : 1.01E 01 : ug/ l Median concentration : 9.26E 02 : ug/ l Minimum concentration : 1.79E 02 : ug/ l Dissolved concentration in harbor Maximum concentration : 1.85E 01 : ug/ l 95 % concentration : 1.82E 01 : ug/ l Average concentration : 1.01E 01 : ug/ l Median concentration : 9.24E 02 : ug/ l Minimum concentration : 1.79E 02 : ug/ l Page 12 of 15 Contaminant concentration on suspended solids Maximum concentration : 5.30E 03 : ug/ g dw 95 % concentration : 5.21E 03 : ug/ g dw Average concentration : 2.88E 03 : ug/ g dw Median concentration : 2.64E 03 : ug/ g dw Minimum concentration : 5.11E 04 : ug/ g dw Contaminant concentration in sediment after 1 year of use Maximum concentration : 2.38E 08 : ug/ g dw 95 % concentration : 2.34E 08 : ug/ g dw Average concentration : 1.29E 08 : ug/ g dw Median concentration : 1.19E 08 : ug/ g dw Minimum concentration : 2.30E 09 : ug/ g dw Contaminant concentration in sediment after 2 years of use Maximum concentration : 2.38E 08 : ug/ g dw 95 % concentration : 2.34E 08 : ug/ g dw Average concentration : 1.29E 08 : ug/ g dw Median concentration : 1.19E 08 : ug/ g dw Minimum concentration : 2.30E 09 : ug/ g dw Contaminant concentration in sediment after 5 years of use Maximum concentration : 2.38E 08 : ug/ g dw 95 % concentration : 2.34E 08 : ug/ g dw Average concentration : 1.29E 08 : ug/ g dw Median concentration : 1.19E 08 : ug/ g dw Minimum concentration : 2.30E 09 : ug/ g dw Contaminant concentration in sediment after 10 years of use Maximum concentration : 2.38E 08 : ug/ g dw 95 % concentration : 2.34E 08 : ug/ g dw Average concentration : 1.29E 08 : ug/ g dw Median concentration : 1.19E 08 : ug/ g dw Minimum concentration : 2.30E 09 : ug/ g dw MAMPEC  Input data sheet Compound Name : Zinc pyrithione Description : Zinc Omadine ( default) Molecular mass : 317.7 : g/ Mol Vapor pressure : 1.00E 06 : Pa Solubility : 6.00E+ 00 : g/ m3 Octanol water coefficient : 9.30E 01 :() Log ( Kow) Kd : 0.00E+ 00 : m3/ kg Page 13 of 15 Koc : 3.00E+ 00 :() Log( Koc), Koc expressed as l/ kg OrganicCarbon Henry's coefficient : 5.00E 05 : Pa. m3/ mol Melting temperature : 260.0 : oC pKa : 0.0 :() in water Biological degradation rate: 2.08E+ 00 : 1/ d Hydrolytic degradation rate: 5.40E 02 : 1/ d Photolytic degradation rate: 5.50E+ 00 : 1/ d in sediment Biological degradation rate: 7.90E+ 00 : 1/ d Hydrolytic degradation rate: 3.30E+ 01 : 1/ d Photolytic degradation rate: 0.00E+ 00 : 1/ d Environment Description : Default marina Silt concentration : 35.0 : g/ m3 Particular organic carbon conc : 1.0 : g Organic Carbon/ m3 Dissolved organic carbon conc : 2.0 : g/ m3 Temperature : 20.0 : oC Salinity : 3.40E+ 01 : s. e. Depth well mixed sediment top layer : 1.00E 01 : m Sediment density : 1.000E+ 03 : kg/ m3 Fraction organic carbon in sediment : 3.00E 02 : kg/ m3 Nett sedimentation velocity : 5.00E 01 : m/ d pH : 8.0 :() Background concentrations : 0.00E+ 00 : ug/ l Length of river, not part of harbor ( x1) : 400 : m Length of harbor ( y1) ( Á river or coast) : 400 Width of harbor ( x2)(// river or coast) : 400 : m Width of river ( y2) : 400 : m Depth of harbor : 3.5 : m Length of open harbor mouth ( x3) : 100 : m Flow : 1 : m/ s Flow of flushing into harbor : 0 : m3/ s Tidal height : 1 : m Density difference : 0.1 : kg/ m3 Density difference flushing : 0 : kg/ m3 Tidal period : 12.41 : h Exchange surface : 350 : m2 Depth at harbor mouth : 3.5 : m Height underwater dam at mouth : 0 : m Width underwater dam at mouth : 0 : m Length selected area : 0 : m Width selected area : 0 : m Depth selected area : 0 : m Flow : 0 : m/ s Exchange volume in 1 tidal period : 243420: m3 Emission Description : Default Marina biocide 100 % ( 1) Page 14 of 15 Load : 565.11 : g/ d Loading due to moving ships : 0 : g/ d Loading due to ships at berth : 565.11 : g/ d Leaching rate ships at berth : 8.4 : ug/ cm2/ d Leaching rate ships at berth : 8.4 : ug/ cm2/ d Number of ships at berth ( Class 1) : 0 Number of ships at berth ( Class 2) : 299 Number of ships at berth ( Class 3) : 0 Number of ships at berth ( Class 4) : 0 Number of ships at berth ( Class 5) : 0 Number of ships at berth ( Class 6) : 0 Number of ships at berth ( Class 7) : 0 Number of ships at berth ( Class 8) : 0 Number of ships at berth ( Class 9 : 0 Number of ships at berth ( Class 10) : 0 Number of moving ships ( Class 1) : 0 Number of moving ships ( Class 2) : 0 Number of moving ships ( Class 3) : 0 Number of moving ships ( Class 4) : 0 Number of moving ships ( Class 5) : 0 Number of moving ships ( Class 6) : 0 Number of moving ships ( Class 7) : 0 Number of moving ships ( Class 8) : 0 Number of moving ships ( Class 9) : 0 Number of moving ships ( Class 10) : 0 Application factor ( Class 1) : 0 :% Application factor ( Class 2) : 100:% Application factor ( Class 3) : 0 :% Application factor ( Class 4) : 0 :% Application factor ( Class 5) : 0 :% Application factor ( Class 6) : 20 :% Application factor ( Class 7) : 20 :% Application factor ( Class 8) : 20 :% Application factor ( Class 9) : 20 :% Application factor ( Class 10) : 20 :% Underwater ship area ( Class 1) : 20 : m2 Underwater ship area ( Class 2) : 22.5: m2 Underwater ship area ( Class 3) : 450: m2 Underwater ship area ( Class 4) : 306: m2 Underwater ship area ( Class 5) : 5999: m2 Underwater ship area ( Class 6) : 9917: m2 Underwater ship area ( Class 7) : 14814 : m2 Underwater ship area ( Class 8) : 22645 : m2 Underwater ship area ( Class 9) : 27547 : m2 Underwater ship area ( Class 10) : 39668 : m2 Ship Length ( Class 1) : 0 10 : m Ship Length ( Class 2) : 10 50 : m Ship Length ( Class 3) : 50 100: m Ship Length ( Class 4) : 100 150: m Ship Length ( Class 5) : 150 200: m Ship Length ( Class 6) : 200 250: m Ship Length ( Class 7) : 250 300: m Page 15 of 15 Ship Length ( Class 8) : 300 350: m Ship Length ( Class 9) : 350 400: m Ship Length ( Class 10) : > 400 : m E. References 1. B. van Hattum, A. C. Baart and J. G. Boon. 2002. Computer model to generate predicted environmental concentrations ( PECs) for antifouling products in the marine environment. 2nd edition accompanying the release pf MAM PEC version 1.4. B.

2. MAM PEC Manual 3. Arch Chemical Inc. 2004. Comments on the Zinc Omadine preliminary risk assessment.

File: c:\ Myfiles\ 2004 Reports\ Revised Environmental Modeling for Zinc Omadine. wpd cc: RASSB Chemical files Siroos Mostaghimi


[Federal Register Volume 85, Number 69 (Thursday, April 9, 2020)]
[Notices]
[Pages 19982-19984]
[FR Doc No: 2020-07432]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-88555; File No. SR-CboeEDGA-2020-010]

Self-Regulatory Organizations; Cboe EDGA Exchange, Inc.; Notice
of Filing and Immediate Effectiveness of a Proposed Rule Change To
Expand the Trading Hours Applicable to Managed Portfolio Shares To
Include All Trading Sessions

April 3, 2020.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on March 31, 2020, Cboe EDGA Exchange, Inc. (``Exchange'' or ``EDGA'')
filed with the Securities and Exchange Commission (``Commission'') the
proposed rule change as described in Items I and II below, which Items
have been prepared by the Exchange. The Commission is publishing this
notice to solicit comments on the proposed rule change from interested
persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    Cboe EDGA Exchange, Inc. (the ``Exchange'' or ``EDGA'') proposes to
expand the trading hours applicable to Managed Portfolio Shares to
include all trading sessions instead of just Regular Trading Hours.\3\
The text of the proposed rule change is provided in Exhibit 5.
---------------------------------------------------------------------------

    \3\ As defined in Rule 1.5(y), the term ``Regular Trading
Hours'' means the time between 9:30 a.m. and 4:00 p.m. Eastern Time.
---------------------------------------------------------------------------

    The text of the proposed rule change is also available on the
Exchange's website (http://markets.cboe.com/us/equities/regulation/rule_filings/edga/), at the Exchange's Office of the Secretary, 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 adopted new Rule 14.11 for the purpose of permitting
trading, pursuant to unlisted trading privileges,\4\ of Managed
Portfolio Shares, which are securities issued by an actively managed
open-end management investment company,\5\ on January 21, 2020.\6\ Rule
14.11(b)(2) currently provides that transactions in Managed Portfolio
Shares will occur only during Regular Trading Hours. On March 23, 2020,
Cboe BZX Exchange, Inc. (``BZX''), the listing market for Managed
Portfolio Shares, amended its rules to allow Managed Portfolio Shares
to trade during all sessions.\7\ Accordingly, the Exchange is now
proposing to change rule 14.11(b)(2) in order to allow for trading in
Managed Portfolio Shares during all trading sessions on the Exchange.
---------------------------------------------------------------------------

    \4\ As noted in Exchange Rule 14.1(a), the Exchange does not
list any Equity Securities, as defined in Rule 14.1(a). Therefore,
the provisions of Rules 14.2 through 14.11 only allow the trading of
such Equity Securities pursuant to unlisted trading privileges.
    \5\ As defined in Rule 14.11(c)(1), the term ``Managed Portfolio
Share'' means a security that (a) represents an interest in an
investment company registered under the Investment Company Act of
1940 (``Investment Company'') organized as an open-end management
investment company, that invests in a portfolio of securities
selected by the Investment Company's investment adviser consistent
with the Investment Company's investment objectives and policies;
(b) is issued in a Creation Unit (as defined in Rule 14.11(c)(6)),
or multiples thereof, in return for a designated portfolio of
instruments (and/or an amount of cash) with a value equal to the
next determined net asset value and delivered to the Authorized
Participant (as defined in the Investment Company's Form N-1A filed
with the Commission) through a Confidential Account; (c) when
aggregated into a Redemption Unit (as defined in Rule 14.11(c)(7)),
or multiples thereof, may be redeemed for a designated portfolio of
instruments (and/or an amount of cash) with a value equal to the
next determined net asset value delivered to the Confidential
Account (as defined in Rule 14.11(c)(4))for the benefit of the
Authorized Participant; and (d) the portfolio holdings for which are
disclosed within at least 60 days following the end of every fiscal
quarter.
    \6\ See Securities Exchange Act Release No. 88111 (February 3,
2020), 85 FR 7364 (February 7, 2020) (SR-CboeEDGA-2020-001).
    \7\ See Securities Exchange Act Release No. 88468 (March 25,
2020) 85 FR 17908 (March 31, 2020) (SR-CboeBZX-2020-028).
---------------------------------------------------------------------------

    The proposed amendment would allow trading in Managed Portfolio
Shares during all sessions including the Early Trading Session,\8\ the
Pre-Opening Session,\9\ Regular Trading Hours, and the Post-Closing
Session.\10\ The Exchange notes that Managed Portfolio Shares are
currently the only product-type that is not available for trading
during all trading sessions on the Exchange. As such, this proposal
would allow Managed Portfolio Shares to be traded, pursuant to unlisted
trading privileges, on the Exchange in a manner identical to all other
products traded on the Exchange.
---------------------------------------------------------------------------

    \8\ As defined in Rule 1.5(ii), the term ``Early Trading
Session'' shall mean the time between 7:00 a.m. and 8:00 a.m.
Eastern Time.
    \9\ As defined in Rule 1.5(s), the term ``Pre-Opening Session''
shall mean the time between 8:00 a.m. and 9:30 a.m. Eastern Time.
    \10\ As defined in Rule 1.5(r), the term ``Post-Closing
Session'' shall mean the time between 4:00 p.m. and 8:00 p.m.
Eastern Time.

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

2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
the Securities Exchange Act of 1934 (the ``Act'') and the rules and
regulations thereunder applicable to the Exchange and, in particular,
the requirements of Section 6(b) of the Act.\11\ Specifically, the
Exchange believes the proposed rule change is consistent with the
Section 6(b)(5) \12\ 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.
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78f(b).
    \12\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    In particular, the Exchange believes that allowing Managed
Portfolio Shares to trade during all trading sessions on the Exchange
will remove impediments to and perfect a national market system by
reducing the complexity and potential investor confusion that could be
associated with limiting the trading hours for one product type.
Furthermore, the proposal is consistent with a recent changed made by
the listing market for Managed Portfolio Shares, BZX, and thus would
eliminate complexity and potential investor confusion related to which
platforms are offering trading in Managed Portfolio Shares at different
times of the day.

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 Exchange notes that the
proposed rule change, rather, will facilitate the trading of Managed
Portfolio Shares in a manner that is consistent with other product
types traded on the Exchange as well as on other trading platforms,
enhancing competition among market participants, product types, and
platforms, to the benefit of investors and the marketplace.

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

    The Exchange neither solicited nor received comments on the
proposed rule change.

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 \13\ and Rule 19b-
4(f)(6) thereunder.\14\
---------------------------------------------------------------------------

    \13\ 15 U.S.C. 78s(b)(3)(A).
    \14\ 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) \15\ normally
does not become operative for 30 days after the date of the filing.
However, pursuant to Rule 19b-4(f)(6)(iii),\16\ 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 so that the proposal
may become operative immediately upon filing. The Exchange states that
waiver of the operative delay would allow trading of Managed Portfolio
Shares on the Exchange during all trading sessions as soon as possible,
making the treatment of Managed Portfolio Shares consistent with all
other product types as well as the listing market, and reducing
confusion and complexity associated with Managed Portfolio Shares. In
addition, the Exchange states that the proposal raises no novel or
unique issues in that it would allow Managed Portfolio Shares to trade
in a manner identical to all other products traded on the Exchange and
consistent with the exemptive relief granted by the Commission. For
these reasons, the Commission believes that waiver of the 30-day
operative delay is consistent with the protection of investors and the
public interest. Accordingly, the Commission waives the 30-day
operative delay and designates the proposed rule change operative upon
filing.\17\
---------------------------------------------------------------------------

    \15\ 17 CFR 240.19b-4(f)(6).
    \16\ 17 CFR 240.19b-4(f)(6)(iii).
    \17\ 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.

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-CboeEDGA-2020-010 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-CboeEDGA-2020-010. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549 on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal

office of the Exchange. All comments received will be posted without
change. Persons submitting comments are cautioned that we do not redact
or edit personal identifying information from comment submissions. You
should submit only information that you wish to make available
publicly. All submissions should refer to File Number SR-CboeEDGA-2020-
010 and should be submitted on or before April 30, 2020.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\18\
---------------------------------------------------------------------------

    \18\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2020-07432 Filed 4-8-20; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 81, Number 114 (Tuesday, June 14, 2016)]
[Notices]
[Page 38699]
[FR Doc No: 2016-13960]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL16-65-000]

Northampton Generating Company, L.P.; Notice of Institution of
Section 206 Proceeding and Refund Effective Date

    On June 3, 2016, the Commission issued an order in Docket No. EL16-
65-000, pursuant to section 206 of the Federal Power Act (FPA), 16
U.S.C. 824e (2012), instituting an investigation into the justness and
reasonableness of Northampton Generating Company, L.P.'s reactive power
rates. Northampton Generating Co., 155 FERC 61,242 (2016).
    The refund effective date in Docket No. EL16-65-000, established
pursuant to section 206(b) of the FPA, will be the date of publication
of this notice in the Federal Register.

    Dated: June 3, 2016.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2016-13960 Filed 6-13-16; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 16 (Wednesday, January 25, 2012)]
[Notices]
[Pages 3768-3770]
[FR Doc No: 2012-1235]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2011-0709; FRL-9328-9]

Agency Information Collection Activities; Proposed Collection;
Comment Request

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act (PRA) (44
U.S.C. 3501 et seq.), this document announces that EPA is planning to
submit a request to renew an existing approved Information Collection
Request (ICR) to the Office of Management and Budget (OMB). This ICR,
titled: ``Partial Update of the TSCA Section 8(b) Inventory Data Base,
Production and Site Reports'' and identified by EPA ICR No. 1884.07 and
OMB Control No. 2070-0162, is scheduled to expire on September 30,
2012. Before submitting the ICR to OMB for review and approval, EPA is
soliciting comments on specific aspects of the proposed information
collection.

DATES: Comments must be received on or before March 26, 2012.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2011-0709, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Document Control Office (7407M), Office of Pollution
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001.
     Hand Delivery: OPPT Document Control Office (DCO), EPA
East, Rm. 6428, 1201 Constitution Ave. NW., Washington, DC. Attention:
Docket ID

Number EPA-HQ-OPPT-2011-0709. The DCO is open from 8 a.m. to 4 p.m.,
Monday through Friday, excluding legal holidays. The telephone number
for the DCO is<PHONE_NUMBER>. Such deliveries are only accepted during
the DCO's normal hours of operation, and special arrangements should be
made for deliveries of boxed information.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPPT-
2011-0709. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line 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 whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or
email. The regulations.gov Web site 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 regulations.gov, your
email address will be automatically captured and included as part of
the comment that is placed in the docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the docket index
available at http://www.regulations.gov. Although listed in the index,
some information is not publicly available, e.g., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, will be publicly available only
in hard copy. Publicly available docket materials are available
electronically at http://www.regulations.gov, or, if only available in
hard copy, at the OPPT Docket. The OPPT Docket is located in the EPA
Docket Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301 Constitution
Ave. NW., Washington, DC. The EPA/DC Public Reading Room hours of
operation are 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding
legal holidays. The telephone number of the EPA/DC Public Reading Room
is<PHONE_NUMBER>, and the telephone number for the OPPT Docket is
(202) 566-0280. Docket visitors are required to show photographic
identification, pass through a metal detector, and sign the EPA visitor
log. All visitor bags are processed through an X-ray machine and
subject to search. Visitors will be provided an EPA/DC badge that must
be visible at all times in the building and returned upon departure.

FOR FURTHER INFORMATION CONTACT: For technical information contact:
Susan Sharkey, Chemical Control Division (7405M), Office of Pollution
Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number:
(202) 564-8789; fax number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>    For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. What information is EPA particularly interested in?

    Pursuant to section 3506(c)(2)(A) of PRA, EPA specifically solicits
comments and information to enable it to:
    1. 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.
    2. Evaluate the accuracy of the Agency's estimates of the burden of
the proposed collection of information, including the validity of the
methodology and assumptions used.
    3. Enhance the quality, utility, and clarity of the information to
be collected.
    4. 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. In particular, EPA is requesting comments from
very small businesses (those that employ less than 25) on examples of
specific additional efforts that EPA could make to reduce the paperwork
burden for very small businesses affected by this collection.

II. What should I consider when I prepare my comments for EPA?

    You may find the following suggestions helpful for preparing your
comments:
    1. Explain your views as clearly as possible and provide specific
examples.
    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data you used
that support your views.
    4. If you estimate potential burden or costs, explain how you
arrived at the estimate that you provide.
    5. Provide specific examples to illustrate your concerns.
    6. Offer alternative ways to improve the collection activity.
    7. Make sure to submit your comments by the deadline identified
under DATES.
    8. To ensure proper receipt by EPA, be sure to identify the docket
ID number assigned to this action in the subject line on the first page
of your response. You may also provide the name, date, and Federal
Register citation.

III. What information collection activity or ICR does this action apply
to?

    Affected entities: Entities potentially affected by this ICR are
manufacturers, processors or importers of chemical substances, mixtures
or categories listed on the TSCA Chemical Inventory and regulated under
TSCA section 8.
    Title: Partial Update of the TSCA Section 8(b) Inventory Data Base,
Production and Site Reports.
    ICR number: EPA ICR No. 1884.07.
    OMB control number: 2070-0162.
    ICR status: This ICR is currently scheduled to expire on September
30, 2012. 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. The OMB control numbers for EPA's
regulations in title 40 of the Code of Federal Regulations (CFR), after
appearing in the Federal Register when approved, are listed in 40 CFR
part 9, are displayed either by publication in the Federal Register or
by other appropriate means, such as on the related collection
instrument or form, if applicable. The display of OMB control numbers
for certain EPA regulations is consolidated in 40 CFR part 9.
    Abstract: The Toxic Substances Control Act (TSCA) requires EPA to
compile and keep current a complete list of chemical substances
manufactured or processed in the United States. EPA updates this
inventory of chemicals every 4 years by

requiring manufacturers, processors and importers to provide production
volume, plant site information and site-limited status information.
This information allows EPA to identify what chemicals are or are not
currently in commerce and to take appropriate regulatory action as
necessary. EPA also uses the information for screening chemicals for
risks to human health or the environment, for priority-setting efforts,
and for exposure estimates. This ICR addresses the collection of
inventory-related information.
    Responses to the collection of information are mandatory (see 40
CFR part 711). Respondents may claim all or part of a notice
confidential. EPA will disclose information that is covered by a claim
of confidentiality only to the extent permitted by, and in accordance
with, the procedures in TSCA section 14 and 40 CFR part 2.
    Burden statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average 40.1
hours per response. Burden means the total time, effort, or financial
resources expended by persons to generate, maintain, retain, or
disclose or provide information to or for a Federal agency. This
includes the time needed to review instructions; develop, acquire,
install, and utilize technology and systems for the purposes of
collecting, validating, and verifying information, processing and
maintaining information, and disclosing and providing information;
adjust the existing ways to comply with any previously applicable
instructions and requirements which have subsequently changed; train
personnel to be able to respond to a collection of information; search
data sources; complete and review the collection of information; and
transmit or otherwise disclose the information.
    The ICR provides a detailed explanation of this estimate, which is
only briefly summarized here:
    Estimated total number of potential respondents: 4,289.
    Frequency of response: Once every 4 years.
    Estimated total average number of responses for each respondent:
3.7.
    Estimated total annual burden hours: 642,823 hours.
    Estimated total annual costs: $40,796,621. This includes an
estimated burden cost of $40,796,621 and an estimated cost of $0 for
capital investment or maintenance and operational costs.

IV. Are there changes in the estimates from the last approval?

    There is a decrease of 16,920 hours (from 659,743 hours to 642,823
hours) in the total estimated respondent burden compared with that
identified in the ICR currently approved by OMB. This decrease reflects
EPA's revised estimates to the number of affected sites and the number
of responses per site, and adjusting burden estimates to capture burden
reductions resulting from experiences with past reporting. The
Supporting Statement provides additional detail. This change is an
adjustment.

V. What is the next step in the process for this ICR?

    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 pursuant to 5 CFR 1320.12. EPA will issue another
Federal Register notice pursuant to 5 CFR 1320.5(a)(1)(iv) to announce
the submission of the ICR to OMB and the opportunity to submit
additional comments to OMB. If you have any questions about this ICR or
the approval process, please contact the technical person listed under
FOR FURTHER INFORMATION CONTACT.

List of Subjects

    Environmental protection, Reporting and recordkeeping requirements.

    Dated: January 10, 2012.
James Jones,
Acting Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
[FR Doc. 2012-1235 Filed 1-24-12; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 81, Number 72 (Thursday, April 14, 2016)]
[Notices]
[Pages 22074-22075]
[FR Doc No: 2016-08608]

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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: RP16-822-000.
    Applicants: East Cheyenne Gas Storage, LLC.
    Description: Compliance filing ECGS 2016 Operational Purchase and
Sales Report filing.
    Filed Date: 4/5/16.
    Accession Number: 20160405-5084.
    Comments Due: 5 p.m. ET 4/18/16.

    Docket Numbers: RP16-823-000.
    Applicants: Iroquois Gas Transmission System, L.P.
    Description: Sec.  4(d) Rate Filing: 04/05/16 Negotiated Rates--
Consolidated Edison Energy Inc. (HUB) 2275-89 to be effective 4/4/2016.
    Filed Date: 4/5/16.
    Accession Number: 20160405-5092.
    Comments Due: 5 p.m. ET 4/18/16.

    Docket Numbers: RP16-824-000.
    Applicants: Questar Pipeline Company.
    Description: Sec.  4(d) Rate Filing: Statement of Negotiated Rates
Version 12.0.0, North Shore E&P to be effective 3/1/2016.
    Filed Date: 4/5/16.
    Accession Number: 20160405-5188.
    Comments Due: 5 p.m. ET 4/18/16.

    Docket Numbers: RP16-825-000.
    Applicants: Natural Gas Pipeline Company of America.
    Description: Sec.  4(d) Rate Filing: Nicor Negotiated Rate to be
effective 5/5/2016.
    Filed Date: 4/5/16.
    Accession Number: 20160405-5190.
    Comments Due: 5 p.m. ET 4/18/16.

    Docket Numbers: RP16-826-000.
    Applicants: Iroquois Gas Transmission System, L.P.
    Description: Sec.  4(d) Rate Filing: 04/06/16 Negotiated Rates--
Consolidated Edison Energy Inc. (HUB) 2275-89 to be effective 4/5/2016.
    Filed Date: 4/6/16.
    Accession Number: 20160406-5162.
    Comments Due: 5 p.m. ET 4/18/16.

    Docket Numbers: RP16-827-000.
    Applicants: Rockies Express Pipeline LLC.
    Description: Sec.  4(d) Rate Filing: Neg Rate 2016-04-06 CP to be
effective 4/7/2016.
    Filed Date: 4/6/16.
    Accession Number: 20160406-5166.
    Comments Due: 5 p.m. ET 4/18/16.

    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 Sec.  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.

Filings in Existing Proceedings

    Docket Numbers: RP16-497-001.
    Applicants: Bluewater Gas Storage, LLC.
    Description: Compliance filing Bluewater Gas Storage, LLC--Order
No. 587-W Directed Changes to be effective 4/1/2016.
    Filed Date: 4/5/16.
    Accession Number: 20160405-5145.
    Comments Due: 5 p.m. ET 4/18/16.

    Docket Numbers: RP16-504-001.
    Applicants: Pine Prairie Energy Center, LLC.
    Description: Compliance filing Pine Prairie Energy Center, LLC--
Order No. 587-W Directed Changes to be effective 4/1/2016.
    Filed Date: 4/5/16.
    Accession Number: 20160405-5146.
    Comments Due: 5 p.m. ET 4/18/16.

    Docket Numbers: RP16-524-002.
    Applicants: SG Resources Mississippi, L.L.C.
    Description: Compliance filing SG Resources Mississippi, L.L.C.--
Order No. 587-W Directed Changes to be effective 4/1/2016.
    Filed Date: 4/5/16.
    Accession Number: 20160405-5137.
    Comments Due: 5 p.m. ET 4/18/16.

    Docket Numbers: RP16-451-001.
    Applicants: Golden Pass Pipeline LLC.
    Description: Report Filing: Supplemental to Revised Filing per
Order 587-W Letter Order dated 03/29/2016.

    Filed Date: 4/6/16.
    Accession Number: 20160406-5170.
    Comments Due: 5 p.m. ET 4/18/16.

    Docket Numbers: RP16-604-001.
    Applicants: Wyckoff Gas Storage Company, LLC.
    Description: Compliance filing Order 587-W Compliance to be
effective 4/1/2016.
    Filed Date: 4/6/16.
    Accession Number: 20160406-5143.
    Comments Due: 5 p.m. ET 4/18/16.

    Docket Numbers: RP16-459-001.
    Applicants: Equitrans, L.P.
    Description: Compliance filing Compliance Filing--Order Nos. 587-W
and 809 to be effective 4/1/2016.
    Filed Date: 4/7/16.
    Accession Number: 20160407-5044.
    Comments Due: 5 p.m. ET 4/19/16.

    Docket Numbers: RP16-465-001.
    Applicants: Rager Mountain Storage Company LLC.
    Description: Compliance filing Compliance Filing--Order Nos. 587-W
and 809 to be effective 4/1/2016.
    Filed Date: 4/7/16.
    Accession Number: 20160407-5046.
    Comments Due: 5 p.m. ET 4/19/16.

    Any person desiring to protest in any of the above proceedings must
file in accordance with Rule 211 of the Commission's Regulations (18
CFR 385.211) on or before 5:00 p.m. Eastern time on the specified
comment date.
    The filings are accessible in the Commission's eLibrary system by
clicking on the links or 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: April 07, 2016.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2016-08608 Filed 4-13-16; 8:45 am]
 BILLING CODE 6717-01-P