[Federal Register: July 19, 2007 (Volume 72, Number 138)]
[Notices]
[Page 39648-39650]
[DOCID:fr19jy07-80]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-56055; File No. SR-ISE-2007-52]

Self-Regulatory Organizations; International Securities Exchange,
LLC; Notice of Filing and Immediate Effectiveness of a Proposed Rule
Change as Modified by Amendment No. 1 Thereto Relating to Fee Waivers

 July 12, 2007.
    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 June 27, 2007, the International Securities Exchange, LLC (``ISE''
or ``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been substantially prepared by the
Exchange. On July 11, 2007, the Exchange filed Amendment No. 1 to the
proposed rule change. ISE has designated this proposal as one
establishing or changing a due, fee, or other charge imposed by ISE
under Section 19(b)(3)(A)(ii) of the Act \3\ and Rule 19b-4(f)(2)
thereunder,\4\ which renders the proposal effective upon filing with
the Commission. The Commission is publishing this notice to solicit
comments on the proposed rule change, as amended, from interested
persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \4\ 17 CFR 240.19b-4(f)(2).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    ISE proposes to amend its Schedule of Fees to extend two fee
waivers. The text of the proposed rule change is available at the
Commission's Public Reference Room, at the Exchange, and on its Web
site at http://www.ise.com.

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 purpose of this proposed rule change is to extend two fee
waivers. First, ISE currently waives most customer transaction fees,
with such waiver scheduled to expire on June 30, 2007.\5\ In order to
remain competitive in the marketplace, the Exchange proposes to extend
this waiver through June 30, 2008.
    Second, ISE currently has a pilot program that: (1) Caps and waives
execution and comparison fees for transactions in options on the
NASDAQ-100 Index Tracking Stock[supreg] (``QQQQ'') \6\ and the iShares
Russell 2000[supreg] Index Fund (``IWM'') \7\ when a member transacts a
certain number of QQQQ and IWM option contracts; and (2) reduces and
waives the facilitation execution and comparison fees when a member
transacts a certain number of contracts through the Exchange's
Facilitation Mechanism.
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    \5\ See Securities Exchange Act Release No. 53954 (June 7,
2006), 71 FR 34651 (June 15, 2006) (SR-ISE-2006-29).
    \6\ The Exchange instituted this pilot program in November 2003
and has since extended it on numerous occasions. See Securities
Exchange Act Release Nos. 49147 (January 29, 2004), 69 FR 5629
(February 5, 2004) (SR-ISE-2003-32); 49853 (June 14, 2004), 69 FR
35087 (June 23, 2004) (SR-ISE-2004-15); 50900 (December 21, 2004),
69 FR 78075 (December 29, 2004) (SR-ISE-2004-36); 52934 (December 9,
2005), 70 FR 74859 (December 16, 2005) (SR-ISE-2005-53); 54841
(November 30, 2006), 71 FR 71006 (December 6, 2006) (SR-ISE-2006-
69).
    \7\ See Securities Exchange Act Release No. 55973 (June 28,
2007), 72 FR 37063 (July 6, 2007) (SR-ISE-2007-39).
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    The Exchange's fee discount program applies to ISE Market Maker
orders and Firm Proprietary orders in QQQQ and IWM options. The
Exchange's current transaction fees for these order types are as
follows: for ISE Market Maker orders, the transaction fees range from
$.21 to $.12 per contract, depending on the Exchange's trading volume,
plus a comparison fee of $.03 per contract; and for Firm Proprietary
orders, the transaction fee is $.15 per contract, plus a comparison fee
of $.03 per contract.
    Under the QQQQ pilot program, when a member's average daily volume
(``A.D.V.'') in QQQQ options reaches 10,000 contracts, the member's
execution fee for the next 2,000 QQQQ option contracts is reduced by
$.10 per contract. Further, when a member's monthly A.D.V. in QQQQ
options reaches 12,000 contracts, the Exchange waives the entire
execution fee and the comparison fee for each QQQQ option contract
traded thereafter. Under the IWM pilot program, when a member's A.D.V.
in IWM options reaches 8,000 contracts, the member's execution fee for
the next 2,000 IWM option contracts is reduced by $.10 per contract.
Further, when a member's monthly A.D.V. in IWM options reaches 12,000
contracts, the Exchange waives the entire execution fee and the
comparison fee for each IWM option contract traded thereafter.
    The structure of the reduction and waiver of the facilitation
execution fee and the comparison fee is based on the structure of the
reduction and waiver of the QQQQ and IWM execution and comparison fees
noted above. That is, when a member's monthly A.D.V. in the
Facilitation Mechanism reaches 15,000 contracts, the member's
facilitation execution fee for the next 5,000 contracts transacted in
the Facilitation Mechanism are reduced by $.10 per contract. Further,
when a member's monthly A.D.V. in the Facilitation Mechanism reaches
20,000 contracts, the Exchange waives the entire facilitation execution
fee and the comparison fee for each contract transacted in the
Facilitation Mechanism thereafter.
    The Exchange notes that the current pilot program is set to expire
on June 30, 2007. The Exchange now proposes to extend the pilot program
for another year, until June 30, 2008. ISE seeks to extend this pilot
program for competitive reasons. This pilot program was initiated and
extended in an attempt to increase the Exchange's market share in QQQQ
and IWM options and to also encourage members to use the Exchange's
Facilitation Mechanism.
2. Statutory Basis
    The basis under the Act for this proposed rule change is the
requirement under Section 6(b)(4) of the Act \8\ that an exchange have
an equitable allocation of reasonable dues, fees, and other charges
among its members and other persons using its facilities. In
particular, these fees would extend current waivers, thus effectively
maintaining low fees.
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    \8\ 15 U.S.C. 78f(b)(4).
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B. Self-Regulatory Organization's Statement on Burden on Competition

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

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

    The Exchange has not solicited, and does not intend to solicit,
comments on this proposed rule change. The Exchange has not received
any unsolicited written comments from members or other interested
parties.

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

    The foregoing proposed rule change has been designated as a fee
change pursuant to Section 19(b)(3)(A)(ii) of the Act \9\ and Rule 19b-
4(f)(2) \10\ thereunder, because it establishes or changes a due, fee,
or other charge imposed by the Exchange. Accordingly, the proposal took
effect upon filing with the Commission. At any time within 60 days of
the filing of such proposed rule change the Commission may summarily
abrogate such rule change if it appears to the Commission that such
action is necessary or appropriate in the public interest, for the
protection of investors, or otherwise in furtherance of the purposes of
the Act.\11\
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    \9\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \10\ 17 CFR 240.19b-4(f)(2).
    \11\ For purposes of calculating the 60-day period within which
the Commission may summarily abrogate the proposed rule change under
Section 19(b)(3)(C) of the Act, the Commission considers the period
to commence on July 11, 2007, the date on which ISE filed Amendment
No. 1. See 15 U.S.C. 78s(b)(3)(C).
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IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml.
); or     Send an e-mail to<EMAIL_ADDRESS>Please include

File Number SR-ISE-2007-52 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-ISE-2007-52. This file
number should be included on the subject line if e-mail is used. To
help the

Commission process and review your comments more efficiently, please
use only one method. The Commission will post all comments on the
Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml).

Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for inspection and copying in the
Commission's Public Reference Room, 100 F Street, NE., Washington, DC
20549, on official business days between the hours of 10 a.m. and 3
p.m. Copies of such filing also will be available for inspection and
copying at the principal office of the Exchange. All comments received
will be posted without change; the Commission does not edit personal
identifying information from submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-ISE-2007-52 and should be submitted on
or before August 9, 2007.

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\12\
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    \12\ 17 CFR 200.30-3(a)(12).
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Nancy M. Morris,
Secretary.
 [FR Doc. E7-13959 Filed 7-18-07; 8:45 am]

BILLING CODE 8010-01-P


Peer Consultation Public Meeting on

The Material Characterization of Nanoscale Materials

Discussion Topics

Meeting Background and Purpose

	EPA is convening a public scientific peer consultation meeting on
material characterization for nanoscale chemical substances
(“nanoscale materials”) to inform the development of its Nanoscale
Materials Stewardship Program (NMSP) under the Toxic Substances Control
Act (TSCA).  The peer consultation is one of several actions EPA is
taking to better understand the potential risks and benefits of
nanotechnology.

	 On October, 18, 2006, EPA invited the public, industry, environmental
groups, other federal agencies and other stakeholders to participate in
the design, development and implementation of a stewardship program for
nanoscale materials.  On July 12, 2007, EPA announced the availability
of a NMSP concept paper and related documents and a public meeting on
August 2, 2007 to discuss and receive comments on these materials
(http://www.epa.gov/oppt/nano/nmspfr.htm).

 	The NMSP will complement and support the Agency's new and existing
chemical programs under TSCA and will help provide a firmer scientific
foundation for regulatory decisions by encouraging the development of
key scientific information and appropriate risk management practices for
new and existing chemical nanoscale materials.  The NMSP is intended to
include but not limited to engineered nanoscale materials manufactured
or imported for commercial purposes as defined in 40 CFR 720.3 (r).  The
NMSP is envisioned to have two parts: 1) a Basic Reporting Program and
2) an In-depth Program.  This discussion paper and the public peer
consultation meeting are intended to support the NMSP by identifying
material characterization data that participants could submit under the
Basic Program if they are in the participant’s possession or are
reasonably ascertainable as defined in 40 CFR 720.3 (p).  The data and
experience generated by the basic reporting phase will help to inform
the types of in-depth data to be developed.  In-depth data development
could begin at any time and would entail, among other types of data,
development of material characterization data in a greater amount of
detail.  In-depth data development could also include additional types
of material characterization data if they are identified.

	EPA received input in November, 2005 from the National Pollution
Prevention and Toxics Advisory Committee (NPPTAC) regarding a voluntary
stewardship program for nanoscale materials.  A NPPTAC ad-hoc work group
on nanoscale materials developed an overview paper that stated that a
voluntary stewardship program should:

Give EPA, and the public to the extent possible recognizing legitimate
CBI issues, a better understanding of the types of engineered nanoscale
materials; the physical, chemical, hazard and exposure characteristics
of such substances; the volume of such substances; and the uses of such
substances;

Help EPA develop capacity and a process to identify and assess risks of
engineered nanoscale materials;

Help EPA determine what information it needs about engineered nanoscale
materials and articulate those information needs to industry and other
stakeholder groups;

Help EPA understand what risk management practices are being used at
production, processing, use and disposal stages, and what additional
risk management practices  need to be implemented;

Prompt or reinforce the implementation of risk management practices; and

Provide the information and experience needed to develop an overall
approach to the treatment of nanoscale chemical substances under TSCA
that builds public trust in nanoscale materials while enabling
innovation and responsible development.

	EPA will utilize all public input, including that from NPPTAC, other
stakeholders, public meetings and peer consultations to further inform
the development of its Nanomaterials Stewardship Program and TSCA
program for nanoscale materials.

Meeting Objectives

	The EPA public peer consultation meeting on material characterization
needs for nanoscale materials will help clarify which data and elements
should be included in the NMSP Basic Program and/or In-depth Program.
The goal is to have an applied discussion that considers 1) the
currently available understanding of material characterization as it
relates to nanoscale materials and 2) how this understanding can be used
to guide the Agency’s thinking regarding the material characterization
data elements that would be most useful and important to include in the
NMSP.  The specific objectives of the public peer consultation meeting
are as follows:

To inform industry and the public of EPA’s level of understanding of
the material characterization needs for nanoscale materials in general
and for the NMSP;

To further develop EPA’s understanding of how nanoscale materials are
engineered or manufactured to achieve specific properties and
characteristics;

To further develop EPA’s understanding of which chemical
identification elements and physical-chemical property data are
generally relevant in characterizing nanoscale materials and which
identification elements and property data are most important in
characterizing specific classes of nanoscale materials;

To discuss what analytical procedures and test methods are available for
acquiring these material characterization data, and where procedure and
method validation or development is needed;

To discuss how these material characterization data needs should be
prioritized for the NMSP Basic and/or In-depth Program;

Discussion Overview

Despite the rapid advancement of nanotechnology, the breadth of
nanoscale material types coupled with the limited hazard data available
for many of these materials pose a challenge in understanding and
measuring their benefits and risks.  Numerous efforts are underway to
begin to address these challenges.  The International Life Sciences
Institute (ILSI) Research Foundation/Risk Science Institute, for
example, convened an expert working group to develop a strategy for
identifying hazards associated with engineered nanoscale materials.
Focusing on the limited data available, the working group developed a
screening strategy for hazard identification (rather than a detailed
testing protocol) that includes a broad data gathering effort.

	The ILSI report describes the characterization of nanoscale materials,
in addition to in vitro and in vivo screening, as a key third aspect of
an overall screening strategy due to the likely dependence of the
biological activity of nanoscale materials on physical-chemical
properties not often considered in toxicity screening studies.
Additionally, given the difficulties associated with characterizing many
nanoscale materials, nanoscale material characterization is a subject
appropriate for detailed investigation and discussion.

Numerous national and international standards organizations, including
the American National Standards Institute (ANSI) and the International
Organization for Standardization (ISO), have also convened committees to
begin to address many of these same challenges and in particular the
need for methods standardization.  Several of these committees have
indicated that, given the breadth of nanotechnology and its data issues,
the initial products the committees develop may be in the form of best
practices rather than actual test protocols.

	The remainder of this paper discusses a proposed approach for the EPA
scientific peer consultation meeting on nanoscale material
characterization.  EPA recognizes that the different chemical classes of
nanoscale materials would make universal application of any particular
characterization endpoint or methodology impossible.  The premise of the
Basic Reporting phase of the NMSP is that some information is known or
reasonably ascertainable.  The approach for this panel is therefore to
discuss what data are known or reasonably ascertainable to characterize
nanoscale materials.  This will be followed by a discussion on the
methodology used to obtain and use characterization endpoints of
interest.

Discussion Topics

Characterization of Nanoscale Materials

1.	Description of nanoscale materials

Types/categories of nanoscale materials

2.	Physical-chemical properties of potential interest

Particle size and distribution

Particle shape and dimensions

Agglomeration and aggregation

Surface area

Surface charge

Surface chemistry

Chemical composition

Crystal structure

Impurity identification and levels

3.  Design to achieve unique properties

Manufacturing and processing methodologies

Chemical transformations

Methodologies for Characterizing Nanoscale Materials

Obtaining characterization data for nanoscale materials

Analytical methods for detecting and quantifying nanoscale materials

Analytical methods measuring physical-chemical properties (measurement
techniques and testing protocols)

Models to predict properties and effects

Metrology

Methods validation

Standards and harmonization

Prioritization of characterization data and data gaps

Miscellaneous – Do Panel members have additional topics to discuss?

Discussion

	This section provides additional information on specific technical
issues to facilitate discussion at the meeting.  The information will
include literature findings as well as questions on the specific
discussion topics.

Types of Nanoscale Materials & Their Structures and Chemical
Compositions

	Based on structure and chemical composition, EPA has grouped
nanomaterials into 4 distinct categories for purposes of this
discussion: 1) simple organic molecules; 2) simple inorganic molecules;
3) polymeric substance (including dendrimeric substances); and 4)
composites.  A fifth category, biological compounds will not be
addressed in the peer consultation.  While all of these categories can
be divided further, only the organic category will be divided further
into molecules based predominantly on carbon (e.g., fullerenes,
nanotubes) and all other organic substances (e.g., salts of carboxylic
acids).  This grouping is similar to the American National Standards
Institute Nanotechnology Standards Panel approach presented at the
September 2004 meeting at the National Institute of Standards and
Technology in Gaithersburg Maryland.

Question 1: Are there any other significant categories, based on
structure and chemical composition, that should be included in this
discussion because they are substantially different from the categories
mentioned (e.g., hybrids, self- assembly devices, others)?

Question 2: For the different categories of nanoscale materials, what is
the current state of knowledge about structure and chemical composition?

Question 3: Can structures and chemical composition be correlated to
specific properties and is this correlation quantifiable?

Physical-Chemical Properties

	The importance of nanoscale materials is due to their potential for
unique or greatly enhanced properties.  	EPA routinely uses a base set
of physical-chemical property data (e.g., melting point, boiling point,
vapor pressure, water solubility) for a variety of programs (e.g., High
Production Volume Challenge, New Chemicals) and decision-making.  As
mentioned previously, certain material properties are of significant
importance in characterizing nanoscale materials.  Recent research
suggests that particle size, surface area, and surface chemistry (or
surface activity) are initially some of the most important properties to
measure.

	As expected for most chemicals, class 1 substances having specific
molecular structures and formulas may be more readily studied and
characterized at the nanoscale than the polymer and composite
categories.  For example, carbon-based nanoscale materials as well as
metal oxide nanoscale chemicals are often well characterized.
Structural and physical-chemical property data therefore are likely to
be well documented for these types of materials.

Question 4: Which physical-chemical properties are relevant to nanoscale
materials and how?  Which are known or reasonably ascertainable and
which have data gaps?

Question 5: Are there properties that would have little or no relevance
under the NMSP?

Question 6: Which properties are associated with aggregated or
agglomerated nanoscale materials, as opposed to properties that are
inherent to the material regardless of physical form?

Question 7: Are there routine manipulations of nanoscale materials that
result in physical-chemical properties changes or other defining
characteristics (e.g., surface modifications of nanotubes to enhance
solvent dispersibility)?

Question 8: How should physical-chemical property data be prioritized
for the NMSP?  Based on availability, effect (toxicity or exposure
criteria), or other factors?

Nanoscale manufacturing and processing

	The number of manufacturing and processing methods for generating
nanoscale material continues to grow and become more sophisticated.  The
two primary areas for this discussion include physical reduction methods
(milling) and engineering methods (e.g., particle stabilization, vapor
deposition, self assembly).

Question 9: What are the common processes used to manufacture nanoscale
materials?

Question 10: How are processes used to produce specific characteristics
or properties?

Question 11: Which methods reduce particle size but do not result in
property changes?  Which methods reduce particle size and result in
property changes?

Impurities

	Impurity content is a growing area of interest in nanotechnology due to
improved performance observed in some cases (e.g., solar cells and
semiconductors) and deleterious effects observed in others (e.g.,
quantum dot quantum computers).  The confounding effects that impurities
have with respect to toxicological endpoints is also being studied
(National Nanotechnology Initiative 2006 Environmental Health and Safety
research report).

Question 12: How important are impurity identity and impurity levels to
the understanding and characterization of nanoscale materials?

Question 13: Are there routine purification procedures that can
effectively control or remove impurities, when desirable, for certain
classes of nanoscale materials?

Obtaining characterization data

	Determining identity, quantifying the nanoscale particle range, and
measuring physical-chemical properties for that identity and particle
range are essential to the characterization of nanoscale materials.
Because of the challenges associated with size, shape, surface
characteristics, and possibly other aspects of nanoscale materials, an
evaluation of existing measurement techniques is critical to nanoscale
material characterization.  The National Nanotechnology Initiative
report stated that “...Accurate and useful measurement techniques are
also important because agglomerated nano materials may either retain or
lose their emergent properties - or take on new properties - thus
affecting the potential biological response.”

Question 18: Are validated methods available for the different
categories of nanoscale materials?

Question 17: Are there techniques that can be universally applied?

Question 19: For small quantities of materials, are there sampling,
handling, and collection techniques as well as sample integrity,
accuracy and precision QA/QC methodologies available?

Question 20: What is the status of standardization efforts? Are these
efforts focused on broadly applicable characterization methods or
category-specific methods?

Question 21: What alternative or innovative methods or technologies can
be applied to nanomaterial analysis?

Modeling

Empirical modeling can be a useful approach to predict physical-chemical
properties when experimental data are not known or ascertainable.  The
initial problem with modeling is that, to accurately predict property
endpoints for a given category of substances, there must be some
experimental data available in the tool’s database for at least some
representative substances in that category.  For newly discovered or
studied materials, the minimum but necessary quantity and type of
experimental data often is not available to sufficiently populate a
tool’s database and allow accurate prediction by the tool.  Some
estimation methods have been developed for specific property endpoints,
but many others are lacking.

Question 22: Are there models that are currently used to obtain property
data for nanoscale materials?  For which properties and which nanoscale
materials?

Question 23:  Has any validation work been conducted that compares
predicted values with measured data?  For which properties and which
nanoscale materials?

Question 24: Are there current significant characterization needs for
which the NMSP should investigate model development?

 http://www.particleand fibretoxicology.com/content/2/1/8

 http://www.ansi.org/standards_activities/standards_boards_panels/nsp/ov
erview.aspx?menuid=3

    HYPERLINK
"http://www.iso.org/iso/en/stdsdevelopment/tc/tclist/TechnicalCommitteeD
etailPage.TechnicalCommitteeDetail"
http://www.iso.org/iso/en/stdsdevelopment/tc/tclist/TechnicalCommitteeDe
tailPage.TechnicalCommitteeDetail ? COMMID=5932

    HYPERLINK
"http://publicaa.ansi.org/sites/apdl/Documents/Forms/AllItems.aspx"
http://publicaa.ansi.org/sites/apdl/Documents/Forms/AllItems.aspx

 Class 1 substances are distinct chemicals with known, non-variable
molecular structures

  http://www.nano.gov/NNI_EHS_research_needs.pdf

 PAGE

 PAGE   7

August 07, 2007


[Federal Register Volume 78, Number 134 (Friday, July 12, 2013)]
[Notices]
[Pages 41942-41943]
[FR Doc No: 2013-16673]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4122-DR; Docket ID FEMA-2013-0001]

Alaska; Major Disaster and Related Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This is a notice of the Presidential declaration of a major
disaster for the State of Alaska (FEMA-4122-DR), dated June 25, 2013,
and related determinations.

DATES:  Effective Date: June 25, 2013.

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

SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter
dated June 25, 2013, the President issued a major disaster declaration
under the authority of the Robert T. Stafford Disaster Relief and
Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the ``Stafford
Act''), as follows:

    I have determined that the damage in certain areas of the State
of Alaska resulting

from flooding during the period of May 17 to June 11, 2013, is of
sufficient severity and magnitude to warrant a major disaster
declaration under the Robert T. Stafford Disaster Relief and
Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the ``Stafford
Act''). Therefore, I declare that such a major disaster exists in
the State of Alaska.
    In order to provide Federal assistance, you are hereby
authorized to allocate from funds available for these purposes such
amounts as you find necessary for Federal disaster assistance and
administrative expenses.
    You are authorized to provide Individual Assistance and Public
Assistance in the designated areas and Hazard Mitigation throughout
the State. Direct Federal assistance is authorized. Consistent with
the requirement that Federal assistance is supplemental, any Federal
funds provided under the Stafford Act for Public Assistance, Hazard
Mitigation, and Other Needs Assistance will be limited to 75 percent
of the total eligible costs.
    Further, you are authorized to make changes to this declaration
for the approved assistance to the extent allowable under the
Stafford Act.

    The time period prescribed for the implementation of section
310(a), Priority to Certain Applications for Public Facility and Public
Housing Assistance, 42 U.S.C. 5153, shall be for a period not to exceed
six months after the date of this declaration.
    The Federal Emergency Management Agency (FEMA) hereby gives notice
that pursuant to the authority vested in the Administrator, under
Executive Order 12148, as amended, Dolph A. Diemont, of FEMA is
appointed to act as the Federal Coordinating Officer for this major
disaster.
    The following areas of the State of Alaska have been designated as
adversely affected by this major disaster:

    Alaska Gateway Regional Educational Attendance Area (REAA),
Lower Yukon REAA, Yukon Flats REAA, and the Yukon-Koyukuk REAA for
Individual Assistance.
    Alaska Gateway Regional Educational Attendance Area (REAA),
Copper River REAA, Lower Yukon REAA, Yukon Flats REAA, and the
Yukon-Koyukuk REAA for Public Assistance. Direct federal assistance
is authorized.
    All boroughs and REAAs within the State of Alaska are eligible
to apply for assistance under the Hazard Mitigation Grant Program.

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

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2013-16673 Filed 7-11-13; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 76, Number 92 (Thursday, May 12, 2011)]
[Proposed Rules]
[Pages 27615-27617]
[FR Doc No: 2011-11604]

========================================================================
Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.

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Federal Register / Vol. 76, No. 92 / Thursday, May 12, 2011 /
Proposed Rules

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2011-0470; Directorate Identifier 2010-NM-190-AD]
RIN 2120-AA64

Airworthiness Directives; Bombardier, Inc. Model DHC-8-400 Series
Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to adopt a new airworthiness directive (AD) for the
products listed above. This proposed AD results from mandatory
continuing airworthiness information (MCAI) originated by an aviation
authority of another country to identify and correct an unsafe
condition on an aviation product. The MCAI describes the unsafe
condition as:

    One in-service incident has been reported on [a] DHC-8 Series
400 aeroplane in which the right hand main landing gear (MLG) failed
to extend using the alternate gear extension system. * * * Failure
of [the] MLG to extend and lock could adversely affect the safe
landing of the aeroplane.
* * * * *
The proposed AD would require actions that are intended to address the
unsafe condition described in the MCAI.

DATES: We must receive comments on this proposed AD by June 27, 2011.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-40, 1200 New
Jersey Avenue, SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    For service information identified in this proposed AD, contact
Bombardier, Inc., Q-Series Technical Help Desk, 123 Garratt Boulevard,
Toronto, Ontario M3K 1Y5, Canada; telephone<PHONE_NUMBER>; fax 416-375-
4539; e-mail<EMAIL_ADDRESS>Internet http://www.bombardier.com. You may review copies of the referenced service
information at the FAA, Transport Airplane Directorate, 1601 Lind
Avenue, SW., Renton, Washington. For information on the availability of
this material at the FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Operations office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this proposed AD, the regulatory
evaluation, any comments received, and other information. The street
address for the Docket Operations office (telephone<PHONE_NUMBER>) is
in the ADDRESSES section. Comments will be available in the AD docket
shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Fabio Buttitta, Aerospace Engineer,
Airframe and Mechanical Systems Branch, ANE-171, FAA, New York Aircraft
Certification Office (ACO), 1600 Stewart Avenue, Suite 410, Westbury,
New York 11590; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2011-0470;
Directorate Identifier 2010-NM-190-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD based on those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    Transport Canada Civil Aviation (TCCA), which is the aviation
authority for Canada, has issued Canadian Airworthiness Directive CF-
2010-23, dated July 21, 2010 (referred to after this as ``the MCAI''),
to correct an unsafe condition for the specified products. The MCAI
states:

    One in-service incident has been reported on [a] DHC-8 Series
400 aeroplane in which the right hand main landing gear (MLG) failed
to extend using the alternate gear extension system. Investigation
determined that the tread on the outboard tire was catching on the
bumper plate located on the outboard MLG door that prevented the MLG
door to open following an extension attempt via the alternate
extension system. Failure of [the] MLG to extend and lock could
adversely affect the safe landing of the aeroplane.
    To prevent the potential jam condition between the bumper plate
and the MLG tires, Bombardier Aerospace has developed a modification
to trim the edge of the bumper plate to eliminate the possibility of
interference [Bombardier Modsum 4-113645].

The Modsum includes performing a detailed visual inspection for damage
or cracks of the bumper plate and base fitting and replacing any
damaged or cracked part with a new part, if necessary. You may obtain
further information by examining the MCAI in the AD docket.

Relevant Service Information

    Bombardier has issued Service Bulletin 84-32-74, Revision A, dated
May 17, 2010. The actions described in this service information are
intended to correct the unsafe condition identified in the MCAI.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with the State of Design Authority, we have
been notified of the unsafe condition described in the MCAI and service
information referenced above. We are proposing this

AD because we evaluated all pertinent information and determined an
unsafe condition exists and is likely to exist or develop on other
products of the same type design.

Differences Between This AD and the MCAI or Service Information

    We have reviewed the MCAI and related service information and, in
general, agree with their substance. But we might have found it
necessary to use different words from those in the MCAI to ensure the
AD is clear for U.S. operators and is enforceable. In making these
changes, we do not intend to differ substantively from the information
provided in the MCAI and related service information.
    We might also have proposed different actions in this AD from those
in the MCAI in order to follow FAA policies. Any such differences are
highlighted in a NOTE within the proposed AD.

Costs of Compliance

    Based on the service information, we estimate that this proposed AD
would affect about 65 products of U.S. registry. We also estimate that
it would take about 8 work-hours per product to comply with the basic
requirements of this proposed AD. The average labor rate is $85 per
work-hour. Required parts would cost about $479 per product. Where the
service information lists required parts costs that are covered under
warranty, we have assumed that there will be no charge for these costs.
As we do not control warranty coverage for affected parties, some
parties may incur costs higher than estimated here. Based on these
figures, we estimate the cost of the proposed AD on U.S. operators to
be $75,335, or $1,159 per product.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify this proposed
regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979); and
    3. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared a regulatory evaluation of the estimated costs to
comply with this proposed AD and placed it in the AD docket.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

    1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

    2. The FAA amends Sec.  39.13 by adding the following new AD:

Bombardier, Inc.: Docket No. FAA-2011-0470; Directorate Identifier
2010-NM-190-AD.

Comments Due Date

    (a) We must receive comments by June 27, 2011.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to Bombardier, Inc. Model DHC-8-400, -401,
and -402 airplanes, certificated in any category, having serial
numbers 4001 through 4247 inclusive.

Subject

    (d) Air Transport Association (ATA) of America Code 32: Landing
Gear.

Reason

    (e) The mandatory continuing airworthiness information (MCAI)
states:
    One in-service incident has been reported on [a] DHC-8 Series
400 aeroplane in which the right hand main landing gear (MLG) failed
to extend using the alternate gear extension system. * * * Failure
of [the] MLG to extend and lock could adversely affect the safe
landing of the aeroplane.
* * * * *

Compliance

    (f) You are responsible for having the actions required by this
AD performed within the compliance times specified, unless the
actions have already been done.

Actions

    (g) Within 2,000 flight hours after the effective date of this
AD: Incorporate Bombardier Modsum 4-113645, including performing a
detailed visual inspection for damage or cracks of the bumper plate
and base fitting and replacing any damaged or cracked part, in
accordance with the Accomplishment Instructions of Bombardier
Service Bulletin 84-32-74, Revision A, dated May 17, 2010. Do all
applicable replacements before further flight.
    (h) For airplanes on which a bumper plate having part number
85424082-101 or 85424082-103 is installed that has been reworked in
accordance with Bombardier Repair Drawing 8/4-54-553: Within 1,000
flight hours after the effective date of this AD, reidentify the
bumper plate, in accordance with paragraph 3.B., step (8) of the
Accomplishment Instructions of Bombardier Service Bulletin 84-32-74,
Revision A, dated May 17, 2010.

    Note 1: Bombardier Service Bulletin 84-32-74, Revision A, dated
May 17, 2010, includes an operational check of the alternate
extension system of the MLG. If the check fails, guidance on doing
corrective actions can be found in the Bombardier Q400 Dash 8
Aircraft Maintenance Manual.

Credit for Actions Accomplished in Accordance With Previous Service
Information

    (i) Incorporation of Bombardier Modsum 4-113645 before the
effective date of this AD in accordance with Bombardier Service
Bulletin 84-32-74, dated December 23, 2009, is considered acceptable
for compliance with the modification in paragraph (h) of this AD,
provided the action in paragraph (h) of this AD is done within the
compliance time specified in paragraph (h) of this AD.

FAA AD Differences

    Note 2: This AD differs from the MCAI and/or service information
as follows: No differences.

Other FAA AD Provisions

    (j) The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager, New
York Aircraft

Certification Office (ACO), ANE-170, FAA, has the authority to
approve AMOCs for this AD, if requested using the procedures found
in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request
to your principal inspector or local Flight Standards District
Office, as appropriate. If sending information directly to the New
York ACO, send it to ATTN: Program Manager, Continuing Operational
Safety, FAA, New York ACO, 1600 Stewart Avenue, Suite 410, Westbury,
New York, 11590; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>. Before
using any approved AMOC on any airplane to which the AMOC applies,
notify your principal maintenance inspector (PMI) or principal
avionics inspector (PAI), as appropriate, or lacking a principal
inspector, your local Flight Standards District Office. The AMOC
approval letter must specifically reference this AD.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.

Related Information

    (k) Refer to MCAI Canadian Airworthiness Directive CF-2010-23,
dated July 21, 2010; Bombardier Service Bulletin 84-32-74, Revision
A, dated May 17, 2010; for related information.

    Issued in Renton, Washington, on May 5, 2011.
Kalene C. Yanamura,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2011-11604 Filed 5-11-11; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 82, Number 184 (Monday, September 25, 2017)]
[Notices]
[Pages 44676-44677]
[FR Doc No: 2017-20359]

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SECURITIES AND EXCHANGE COMMISSION

Submission for OMB Review; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, 100 F Street NE., Washington, DC
20549-2736

Extension:
    Regulation S-X, SEC File No. 270-003, OMB Control No. 3235-0009.

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') has submitted to the Office of Management
and Budget (``OMB'') a request for extension of the previously approved
collection of information discussed below.
    Information collected and information prepared pursuant to
Regulation S-X focus on the form and content of, and requirements for,
financial statements filed with periodic reports and in connection with
the offer and sale of securities. Investors need reasonably current
financial statements to make informed investment and voting decisions.
    The potential respondents include all entities that file
registration statements or reports pursuant to the Securities Act of
1933 (15 U.S.C. 77a, et seq.), the Securities Exchange Act of 1934 (15
U.S.C. 78a, et seq.), or the Investment Company Act of 1940 (15 U.S.C.
80a-1, et seq.).
    Regulation S-X specifies the form and content of financial
statements when those financial statements are required to be filed by
other rules and forms under the federal securities laws. Compliance
burdens associated with the financial statements are assigned to the
rule or form that directly requires the financial statements to be
filed, not to Regulation S-X. Instead, an estimated burden of one hour
traditionally has been assigned to Regulation S-X for incidental
reading of the regulation. The estimated average burden hours are
solely for purposes of the Paperwork Reduction Act and are not derived
from a comprehensive or even a representative survey or study of the
costs of SEC rules or forms.
    Recordkeeping retention periods are based on the disclosure
required by various forms and rules other than Regulation S-X. In
general, balance sheets for the preceding two fiscal years, income and
cash flow statements for the preceding three fiscal years, and
condensed quarterly financial statements must be filed with the
Commission. Five year summary financial information is required to be
disclosed by some larger registrants.
    Filing financial statements, when required by the governing rule or
form, is mandatory. Because these statements are provided for the
purpose of disseminating information to the securities markets, they
are not kept confidential.
    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 control number.
    The public may view the information discussed in this notice at
www.reginfo.gov. Comments should be directed to: (i) Desk Officer for
the Securities and Exchange Commission, Office of Information and
Regulatory Affairs, Office of Management and Budget, Room 10102, New
Executive Office Building, Washington, DC 20503, or by sending an email
to<EMAIL_ADDRESS>and (ii) Pamela Dyson, Chief
Information Officer, Securities and Exchange Commission, c/o Remi
Pavlik-Simon, 100 F Street NE., Washington, DC 20549 or send an email

to<EMAIL_ADDRESS>Comments must be submitted to OMB within 30
days of this notice.

    Dated: September 19, 2017.
Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2017-20359 Filed 9-22-17; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 87, Number 229 (Wednesday, November 30, 2022)]
[Notices]
[Pages 73568-73569]
[FR Doc No: 2022-26106]

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SECURITIES AND EXCHANGE COMMISSION

[Investment Company Act Release No. 34759]

Notice of Applications for Deregistration Under Section 8(f) of
the Investment Company Act of 1940

November 25, 2022.
AGENCY: Securities and Exchange Commission (``Commission'' or ``SEC'')

ACTION: Notice of applications for deregistration under section 8(f) of
the Investment Company Act of 1940.

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    The following is a notice of applications for deregistration under
section 8(f) of the Investment Company Act of 1940 for the month of
November 2022. A copy of each application may be obtained via the
Commission's website by searching for the applicable file number listed
below, or for an applicant using the Company name search field, on the
SEC's EDGAR system. The SEC's EDGAR system may be searched at https://www.sec.gov/edgar/searchedgar/legacy/companysearch.html. You may also
call the SEC's Public Reference Room at<PHONE_NUMBER>. An order
granting each application will be issued unless the SEC orders a
hearing. Interested persons may request a hearing on any application by
emailing the SEC's Secretary at [email protected] and serving
the relevant applicant with a copy of the request by email, if an email
address is listed for the relevant applicant below, or personally or by
mail, if a physical address is listed for the relevant applicant below.
Hearing requests should be received by the SEC by 5:30 p.m. on December
20, 2022, and should be accompanied by proof of service on applicants,
in the form of an affidavit or, for lawyers, a certificate of service.
Pursuant to Rule 0-5 under the Act, hearing requests should state the
nature of the writer's interest, any facts bearing upon the
desirability of a hearing on the matter, the reason for the request,
and the issues contested. Persons who wish to be notified of a hearing
may request notification by writing to the Commission's Secretary at
[email protected].

ADDRESSES: The Commission: [email protected].

FOR FURTHER INFORMATION CONTACT:  Shawn Davis, Assistant Director, at
(202) 551-6413 or Chief Counsel's Office at<PHONE_NUMBER>; SEC,
Division of Investment Management, Chief Counsel's Office, 100 F Street
NE, Washington, DC 20549-8010.

Angel Oak Dynamic Financial Strategies Income Term Trust [File No. 811-
23491]

    Summary: Applicant, a closed-end investment company, seeks an order
declaring that it has ceased to be an investment company. The applicant
has transferred its assets to Angel Oak Financial Strategies Income
Term Trust, and on August 1, 2022 made a final distribution to its
shareholders based on net asset value. Expenses of $470,158.07 incurred
in connection with the reorganization were paid by the applicant and
the acquiring fund.
    Filing Date: The application was filed on September 27, 2022.
    Applicant's Address: [email protected].

Barings Funds Trust [File No. 811-22845]

    Summary: Applicant seeks an order declaring that it has ceased to
be an investment company. The applicant has transferred its assets to
Mass Mutual Advantage Funds, and MassMutual Premier Funds, and on
December 13, 2021 made a final distribution to its shareholders based
on net asset value. Expenses of $2,048,237.20 incurred in connection
with the reorganization were paid by the applicant's investment adviser
and the acquiring fund's investment adviser.
    Filing Dates: The application was filed on May 10, 2022, and
amended on September 23, 2022, and November 18, 2022.
    Applicant's Address: [email protected].

Capital Cash Management Trust [File No. 811-02481]

    Summary: Applicant seeks an order declaring that it has ceased to
be an investment company. On November 1, 2022, applicant made a
liquidating distribution to its shareholders based on net asset value.
No expenses were incurred in connection with the liquidation.
    Filing Date: The application was filed on November 4, 2022.
    Applicant's Address: [email protected].

Dreyfus BASIC Money Market Fund, Inc. [File No. 811-06604]

    Summary: Applicant seeks an order declaring that it has ceased to
be an investment company. On May 26, 2021, applicant made a liquidating
distribution to its shareholders based on net asset value. Expenses of
$5,161 incurred in connection with the liquidation were paid by the
applicant's investment advisor.
    Filing Date: The application was filed on August 31, 2022.
    Applicant's Address: [email protected].

MONY Variable Account S [File No. 811-06217]

    Summary: Applicant, a unit investment trust, seeks an order
declaring that it has ceased to be an investment company. On August 4,
2020, applicant made a liquidating distribution to its shareholders,
based on net asset value. Expenses of $7,500 incurred in connection
with the liquidation were paid by MONY Life Insurance Company.
    Filing Dates: The application was filed on July 29, 2022, and
amended on November 4, 2022.

    Applicant's Address: [email protected].

New Age Alpha Trust [File No. 811-23461]

    Summary: Applicant seeks an order declaring that it has ceased to
be an investment company. On July 18, 2022, applicant made a
liquidating distribution to its shareholders based on net asset value.
Expenses of $11,549.87 incurred in connection with the liquidation were
paid by the applicant's investment advisor.
    Filing Date: The application was filed on November 7, 2022.
    Applicant's Address: [email protected].

Uncommon Investment Funds Trust [File No. 811-23464]

    Summary: Applicant seeks an order declaring that it has ceased to
be an investment company. On July 29, 2022, applicant made a
liquidating distribution to its shareholders based on net asset value.
Expenses of $56,477.17 incurred in connection with the liquidation were
paid by the applicant's investment advisor.
    Filing Date: The application was filed on October 11, 2022.
    Applicant's Address: [email protected].

    For the Commission, by the Division of Investment Management,
pursuant to delegated authority.
Sherry R. Haywood,
Assistant Secretary.
[FR Doc. 2022-26106 Filed 11-29-22; 8:45 am]
BILLING CODE 8011-01-P


Page 1 of 19 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES July 24, 2002 MEMORANDUM FROM: Kathryn Boyle, CoChair IIFG and Kerry Leifer, CoChair IIFG TO: Robert Forrest, Chief Minor Use, Inerts, and Emergency Response Branch SUBJECT: IIFG Decision Documents on Reassessing Exemptions from the Requirement of a Tolerance for the Mineral Acids (Hydrochloric, Carbonic, Phosphoric, and Sulfuric) and their Ammonium, Calcium, Ferrous, Ferric, Magnesium, Potassium, Sodium, and/ or Zinc Salts Collectively these Decision Documents cover four mineral acids and the salts of these acids. The individual Decision Documents are: (1) Hydrochloric Acid and Salts, (2) Salts of Carbonic Acid, (3) Phosphoric Acid and Salts, and (4) Sulfuric Acid and Salts. The Inert Ingredient Focus Group reassessment is based on various conclusions of the FAO/ WHO Joint Expert Committee on Food Additives, conclusions of various FDA GRAS (Generally Recognized As Safe) Assessments, information previously used by OPP as part of the reregistration process, and other information available on government websites.

In total 46 exemptions from the requirement of a tolerance in 40 CFR 180 are reassessed. This total consists of 18 in the phosphoric acid document, nine in the hydrochloric acid document, six in the carbonic acid document, and 13 in the sulfuric acid document. Page 2 of 19 INERT INGREDIENT FOCUS GROUP DECISION DOCUMENT for Sulfuric Acid and Salts Petition No.: no Tolerance Reassessments?: yes Chemical Category/ Group: mineral acid and salts The following describes the various ways that sulfuric acid and its salts are used.

Table 1: Use Pattern (pesticidal  inert ingredient)

Chemical Name Inert PC Code 40 CFR 180.1001 Inert Use Pattern (Pesticidal) Current Inert List sulfuric acid 878001 (c) 0. 1% of pesticide formulation; pH control agent 3 ammonium sulfate 805601 (c) solid diluent, carrier 4B ferric sulfate 900332 (c) solid diluent, carrier 4B magnesium sulfate 850503 (c) solid diluent, carrier safener 4B potassium sulfate 805603 (c) solid diluent, carrier 4B sodium sulfate 805604 (c), (e) solid diluent, carrier 4B sodium bisulfate 873201 (d) acidifying/ buffering agent 4B zinc sulfate (basic and monohydrate) 889001 911567 (c), (c), (e) coating agent solid diluent, carrier water repellent, dessicant 3 There is also a tolerance exemption for ferrous sulfate in 40 CFR 180.2.

The tolerance exemption for calcium sulfate (40 CFR 180.1001( e)) was reassessed in the IIFG Decision Document "Weathered Materials", dated January 31, 2002. It is classified as List Page 3 of 19 4A.

At this time, only sulfuric acid, ferrous sulfate monohydrate, ferric sulfate, sodium bisulfate, and zinc sulfate are used as active ingredients. There are no longer any EPA registered active ingredient uses for any of the other above listed sulfate salts.

Table 2: Use Pattern (pesticidal  active ingredient)

Chemical Name. Active PC Code 40 CFR Number of Products Active Use Pattern (Pesticidal)

sulfuric acid 078001 180.1019 8 used to kill bacteria on potatoes, milking equipment and in food processing areas; as a dessicant ferrous sulfate monohydrate 180.2 15 used to kill moss and algae on ornamentals and turf ferric sulfate 034902 none 2 used to kill moss on ornamental lawns and turf sodium bisulfate 073201 none 3 used to kill bacteria on poultry , in toilet bowls, and in air treatment zinc sulfate monohydrate 527200 none 2 used to kill moss on wood and other surfaces Table 3: Use Pattern (FDA GRAS):

Chemical GRAS Citation GRAS Uses sulfuric acid 21 CFR 184.1095 pH control agent, processing aid ammonium sulfate 21 CFR 184.1143 dough strengthener, firming agent, processing aid ferrous sulfate 21 CFR 184.1315 nutrient supplements, processing aid, use in infant formula ferric sulfate 21 CFR 184.1307 flavoring agent magnesium sulfate 21 CFR 184.1443 flavor enhancer, nutrient supplement, processing aid Page 4 of 19 potassium sulfate 21 CFR 184.1643 flavoring agent and adjuvant zinc sulfate 21 CFR 182.8997 (no limitations specified)

Sulfuric acid also has uses in food contact surface sanitizing solutions under 21 CFR 178.1010.

Table 4: Use Pattern (non pesticidal)

Chemical Uses sulfuric acid used in fertilizers, chemicals, dyes and pigments, etchant, alkylation catalyst, electroplating baths, iron and steel, rayon and film, industrial explosives, lab reagent, nonferrous metallurgy ammonium sulfate manufacture of ammonia alum; in the manufacture of hydrogen sulfide to free it from nitrogen oxides; analytical uses; freezing mixtures; flameproofing fabrics and paper; manufacture of viscose silk; tanning, galvanizing iron; in fractionation of proteins. ferric sulfate preparation of iron alums, other iron salts and pigments; coagulant in water purification and sewage treatment; aluminum etching; pickling stainless steel and copper; as mordant in textile dyeing and calico printing; soil conditioners; polymerization catalyst. magnesium sulfate also known as epsom salts; as a cathartic and analgesic in medicine; finishing agent for textiles; as water correcting agent in brewing industry; component of fireproofing compositions, preservatives, tanning & coagulating agents; chemical intermediate for magnesium trisilicate; component of nickel baths for plating other metals; catalyst support for platinum in sulfuric acid production potassium sulfate fertilizer for chloride sensitive crops (tobacco); accelerator in wallboard (construction industry); agent in manufacture of glass; cathartic in human medicine; water corrective agent for foods (brewery water); setting expansion control agent for dental materials sodium sulfate tanning; pharmaceuticals; freezing mixtures; laboratory reagent zinc sulfate zinc sulfate & hydrated lime, 8 lb of each to 100 gal of water, are used to prepare spray called zinc lime which is the zinc equivalent of bordeaux mixt. Zinc lime is used extensively for control of bacterial spot disease of peaches.

depressant in froth flotation, eg, for lead zinc ores; component of spinning bath in manufacturer of rayon; chemical intermediate for manufacture of lithopone (pigment), carbamate fungicides (zineb), zinc metal, other zinc compounds (zinc stearate); component of zinc plating baths; chemical for water treatment; component of cosmetics (skin fresheners); reagent for paper bleaching; in manufacter of glue; accelerating agent in dental impression material; agent in textile dyeing and printing; preservative for wood and hides; fireproofing agent It should be noted that potassium sulfate has use as a fertilizer and sulfuric acid is used in the preparation of fertilizers. Plants need various elements (metals and non metals) for proper growth. Especially for agricultural crops, plants are supplied these elements as part of chemical Page 5 of 19 fertilizers. The most important elements for plant growth are nitrogen, phosphorus, and potassium. Other metals needed in the soil for plant up take are calcium, magnesium, iron, and trace elements such as zinc. Potassium sulfate is intentionally added to growing agricultural crops as needed to promote plant growth.

Assessment of Sulfuric Acid and its Salts Sulfuric acid and its ammonium, sodium, potassium, calcium, magnesium, iron, and zinc salts are being assessed as a group due to their chemical similarities. Due to its acidic nature the toxicity of sulfuric acid will be different from those of the more neutral sulfate salts. However, these sulfate salts all contain the sulfate ion (as either HSO4 1 or SO4 2 ), and thus share some common chemistries. A major focus of this assessment is the work previously performed by FDA in assessing the safety of these chemicals as food additives.

1. Physical/ Chemical Properties:

The physical and chemical properties of sulfuric acid and its various salts are described in the May 7, 2002 EFED Assessment. See attached.

2. Information Sources:

The following information was used in performing this assessment: The available information consisted of information retrieved from various websites, such as, °EPA( www. epa. gov), °NIOSH,( www. cdc. gov/ niosh/ ipcsneng/ neng1197.html), (www. cdc. gov/ niosh/ ipcsneng/ neng0362.html), (www. cdc. gov/ niosh/ 74 128.html) (www. cdc. gov/ niosh/ idlh/ 7664939.html) ° TOXNET ( www. toxnet. nlm. nih. gov.) ° NTP (ntp server. niehs. nih. gov/ NewHomeRoc/ 9RoCFacts. html) °WHO( www. inchem. org/ documents/ jecfa/ jecmono/ v05je83.htm) and (www. inchem. org/ documents/ jecfa/ jecmono/ 40abcj43.htm)

Various FDA GRAS Assessments were used, as well as, the FAO/ WHO Assessment for sodium sulfate.

3. NIOSH (National Institute for Occupational Safety and Health)

The NIOSH IDHL (immediately dangerous to life or health) Documentation and the International Chemical Safety Card for sulfuric acid indicate that it is a colorless, oily, odorless liquid. The IDHL is 15 mg/ m 3 . The TLV (Threshold Limit Value) is 1 mg/ m 3 (TWA). Sulfuric Page 6 of 19 acid reacts violently with water. It is corrosive to the skin and the respiratory tract, and on ingestion.

The NIOSH International Chemical Safety Card for magnesium sulfate indicates that a TLV has not been established. No effects were noted.

4. Acid Characteristics An acid is a substance that when dissolved in water yields H + ions. The increase of the concentration of the H + ions lowers the pH. Mineral acids contain a non metal such as phosphorus, nitrogen, sulfur, or chlorine which may or may not be combined with oxygen. When combined with oxygen, these anions can be referred to as oxyanions. Strong acids are those acids that when dissolved completely transfer their H + ions to water. Sulfuric acid is an example of a strong acid.

5. Cations: Sodium, Potassium, Calcium, Magnesium, Iron, and Zinc Generally, a salt of a strong acid, such as sulfuric acid, when dissolved in water, dissociates to yield the sulfate anion (an anion which is negatively charged) and a positively charged cation. In the human body, these salts tend to dissociate and thus, for the most part, react in the body as the anion and the cation.

Metals such as calcium, sodium, magnesium, potassium, iron and zinc are required for proper functioning of human biological systems. For risk assessment purposes an important feature of these metals is that overall the body does have an effective means of processing them. The primary means of exposure to these cations is ingestion. Four of the most common cations required for functioning of human biology are: sodium, potassium, calcium and magnesium. Chemically, sodium and potassium belong to the same chemical family: calcium and magnesium belong to a different chemical family.

Sodium:

The average human body burden of sodium is approximately 20 grams (g) for a 70 kilogram (kg) adult. The sodium cation is necessary for the nerves and muscles to function properly. It is the principal cation of extracellular fluid, and helps to maintain the body's water balance. These electrolytes, the electrically charged ions in the body fluids, consist to a great extent of sodium and potassium. There is no Recommended Dietary Allowance (RDA) for sodium.

Potassium:

The average human body burden of potassium is approximately 140 g for a 70 kg adult. The potassium cation is important in regulating blood pressure, regulating cellular water content, maintaining proper pH balance, and transmission of nerve impulses. It helps to regulate the Page 7 of 19 electrical activity of the heart and muscles. The potassium RDA is 900 mg/ day.

Calcium:

The average human body burden of calcium is approximately 1 kg for a 70 kg adult; or 1/ 70th of our weight is calcium. The calcium cation is necessary for bone and teeth formation. It is also important to the proper functioning of nerves, enzymes, and muscles, and plays a role in blood clotting and the maintenance of cell membranes. The RDAs for calcium are 1000 mg/ day for adults aged 19 to 50 years and 1200 mg/ day for individuals older than 50 years.

Magnesium:

The average human body burden of magnesium is approximately 20 g for a 70 kg adult. The magnesium cation is also used in building bones. It plays a role in releasing energy from muscles and regulating body temperature. The RDA for magnesium is 310 to 320 mg/ day for adult females and 400 to 420 mg/ day for adult males with the RDA increasing with increasing age.

Two common metal cations that are needed for functioning of human biology, but in smaller amounts often referred to as trace, are iron and zinc.

Iron:

The human body burden of iron is approximately 4.1 g for a 70 kg adult. Iron functions as a carrier of oxygen. The hemoglobin molecule in blood transports oxygen from the lungs to the cells. The myoglobin molecule supplies oxygen to muscle cells. Iron deficiency is characterized by anemia, stunted growth, fatigue, and lowered resistance to infection. The RDAs for iron are 10 mg/ day [0. 14 mg/ kg/ day for an adult (70 kg) male (25 to 50 years)] and 15 mg/ day [0. 25 for an adult (60 kg) female (19 to 50 years)]. Pregnant and nursing woman have increased requirements for iron.

Dietary iron is poorly absorbed. The intestinal mucosa is a limiting factor in iron absorption. Normal absorption is about 1 mg/ day in an adult male, and about 1.4 mg/ day in an adult female. Absorption occurs in the divalent (ferrous) form, which must then be oxidized to the trivalent (ferric) form for use. Acute toxicity of iron ingested from normal dietary sources has not been reported. However, death especially in young children has resulted from ingestion of large overdoses of medicinal iron. (doses ranging from 40 to 1600 mg/ kg  average 900 mg/ kg). It is noted that the iron from ferric salts is less well absorbed than that from ferrous salts.

Zinc:

The average human body burden of zinc is approximately 100 milligram (mg) for a 70 kg adult. The zinc cation is a component of many enzymes and therefore has substantial involvement in many metabolic processes. It also assists in wound healing, blood formation, and general Page 8 of 19 growth and maintenance of the body's tissues. The RDAs for zinc are 15 mg/ day [0. 21 mg/ kg/ day for an adult (70 kg) male] and 12 mg/ day [0. 2 mg/ kg/ day for an adult (60 kg) female]. According to FDA, the average daily intake of zinc from food (including water) was 0. 23 mg/ kg/ day in the early 1980s. Consuming too much zinc (i. e. , 10 to 15 times the RDA) can cause health concerns such as anemia, pancreatic and kidney effects, and certain developmental effects. Consuming too little zinc can cause loss of appetite , decreased sense of taste and smell, decreased immune function, slow wound healing, skin sores, and developmental effects.

6. Ammonium Salt:

Ammonium sulfate dissociates to the negative anion and the positively charged ammonium cation (NH4 + ). Humans cannot convert atmospheric nitrogen to any form that can be used as part of any of the various metabolic cycles. Therefore, reduced nitrogen (NH4 + ) has to enter the body from an outside source. These sources are the nitrogen containing amino acids in protein which are consumed daily as part of the diet. Although the human body can produce some amino acids, ten amino acids are considered "essential" amino acids, i. e., they must be consumed in the diet.

Generally the body works to maintain a balance of nitrogen intake and nitrogen excretion. The estimated daily ammonia intake through food and drinking water is 18 mg. In contrast, 4000 mg of ammonia per day are produced endogenously in the human intestine.

Ammonia and the ammonium ion are integral components of normal human metabolic processes. Ammonia is released following deamination that occurs when protein is used by the body for energy production. The liver converts ammonia via the urea cycle into urea. According to FDA in the "Evaluation of the Health Aspects of Certain Ammonium Salts as Food Ingredients" (1974), "the normal liver so readily detoxifies ammonium ion from alimentary sources that blood concentrations of ammonium salts do not rise to the levels necessary to evoke toxic response." Approximately 80% of the body's excess nitrogen is eliminated through the kidneys as urea, approximately 25 to 30 grams per day. Page 9 of 19 7.

Toxicological Profile Table The Agency has not reviewed any of the toxicological studies in the following table for sulfuric acid or any of its salts. The reviews of these studies were obtained from Toxnet,

as well as other government websites. Table 5:

Toxicological Profile Chemical Toxicity Other Information Sulfuric Acid Solutions of greater than 10% are severely corrosive by all routes of exposure; Solutions of less than >10% are strong irritants; IARC: There is sufficient evidence that occupational exposure to strong

inorganic acid mists containing sulfuric acid is carcinogenic; ATSDR: No significant developmental or reproductive effects in mice or rabbits exposed to 20 mg/ m 3 sulfuric acid aerosols 7 hours per day on gestation days 6 to 15 CERCLA Reportable Quantity: greater than 1000 lb (454 kg); 1993 US production= 80.3 billion lbs; Ammonium Sulfate 13 week oral in rats;

doses 0,

0.38, 0.75, 1.5,

3.0%; NOEL =

1.5%

in males (886 mg/ kg/

day), 3%

in females (1975 mg/ kg/

day),

(HDT) Ferric Sulfate Irritant to skin, eyes and mucous membranes; Excessive iron intake may cause toxicity Primary use is in waste water treatment; Page 10 of 19 Magnesium Sulfate Cathartic; Massive doses may cause systemic toxicity primarily loss of fluid and electrolytes; Negative in Ames TA100,

TA1535, TA98 with and without activation; Negative in E.

coli with and without activiation; Lowest published oral toxic dose in humans: 428 mg/ kg (m) 351 mg/ kg( f); Changes in serum composition (f,

m),

muscle weakness (f,

m),

cardiac arrhythmias (f); Lowest published lethal dose in rats after oral exposure 5g/ kg US production 5.

7x10 11 g (1985) Potassium Sulfate Saline cathartic; Systemic toxicity unlikely unless massive doses consumed; Toxicity results from excessive loss of fluid and electrolytes.

1985 US production 2x10 11 g; EPA Drinking Water standard: 250,000 ug/ L sulfate ion Sodium Sulfate Mouse oral LD50 =

5989mg/ kg; Non toxic and non

irritating to skin and mucous membranes; Saline cathartic; systemic toxicity unlikely unless massive doses consumed; Toxicity results from excessive loss of fluid and electrolytes; Negative in cell transformation (viral enhanced)

in Syrian hamster embryo (SA7/ SHE) cells; Positive in Saccharomyces cerevisiae reverse gene mutation assay 1993 US production 1.

44billion lb; EPA Drinking Water standard: 250,000 ug/ L sulfate ion Zinc Sulfate Irritating to skin, eyes and mucous membranes; Use as an emetic may result in hemolytic and renal toxicity; Ames negative in TA97, TA102 with and without activation with S 9; Negative in Cell transformation with Syrian hamster embryo cells; Negative in Saccharomyces cerevisiae.

Regulated by Clean Water Act;

subject to effluent regulations: EPA DW 5000ug/ L ; US production 3.

5x10 10 g (1985) Page 11 of 19 8. OPP REDs (Reregistration Eligibility Decision Document)

Mineral Acid RED The following information on the acute toxicity of sulfuric acid was extracted from the 1993 Mineral Acid RED: The oral LD50 is 350 mg/ kg, toxicity category II. The dermal LD50 is > 2000 mg/ kg, toxicity category III. Sulfuric acid is toxicity category I for eye and dermal irritation. No other toxicological data were required based on the use patterns at the time of the issuance of the RED and the corrosiveness shown in the acute studies for dermal and eye irritation.

There was also information on the acute toxicity of sodium bisulfate in the 1993 RED: The oral LD50 is 3000 mg/ kg, toxicity category III. The dermal LD50 is > 10,000 mg/ kg, toxicity category III. Sodium bisulfate is toxicity category I for eye irritation, and toxicity category IV for dermal irritation. No other toxicological data were required based on the use patterns at the time of the issuance of the RED and the fact that it forms ubiquitous metabolic products, sodium and sulfate, that are of little toxicological concern.

Iron Salts RED The Iron Salts RED (1993) contains toxicity information on ferric sulfate, ferrous sulfate monohydrate, and ferrous sulfate heptahydrate. The ferric sulfate oral LD50 is 1487 to 2101 mg/ kg, toxicity category III. The dermal LD50 is > 2000 mg/ kg, toxicity category III. The inhalation LC50 is > 1. 1 mg/ L, toxicity category III. Ferric sulfate is toxicity category I for eye irritation and toxicity category IV for dermal irritation. For ferrous sulfate heptahydrate the LD50 is 1520 mg/ kg. A sensitization study with ferric and ferrous sulfate found no indication of contact sensitization by this compound.

According to the RED, a "mutagenicity study in E. coli reported positive results at 30 umol/ L. With due regard for the continuing exposure that human beings have had to the iron and sulfate components of these chemicals over many generation, it is considered unlikely that this reported result in microorganisms has any bearing on probable effects in humans or other mammals at the levels expected from use of these compounds as pesticides."

Zinc Salts RED The following information on the acute toxicity of zinc sulfate was extracted from the 1992 Zinc Salts RED: The oral LD50 is > 2949 mg/ kg, toxicity category III. Zinc sulfate acid is classified as toxicity category I for eye irritation based on one study in which "severe irritation was found when 0.09 g of 99% zinc sulfate was applied to rabbit eyes. In another study, the application of 420 ug zinc sulfate to the rabbit eye found moderate irritation." Zinc sulfate is toxicity category IV for dermal irritation (very slight irritation).

In a chronic study, "zinc sulfate caused hematological changes in rats and dogs fed about Page 12 of 19 100 ppm in the diet. ... In another report, mice given up to 5000 ppm of zinc as zinc sulfate in drinking water showed no evidence of carcinogenicity and no differences between treated and control groups."

"When rats were given 333 mg/ kg zinc sulfate orally on days 1 18 of pregnancy, there was post implantation mortality. Teratologic studies with oral zinc sulfate in three species of animals were negative for effects on pregnancy, maternal or fetal survival, or abnormalities. In these studies mice were given up to 30 mg/ kg/ day for days 6 15 of gestation, rats were given up to 42.5 mg/ kg/ day for days 6 15 of gestation, and hamsters were given up to 88 mg/ kg/ day for days 6 10 of gestation.

According to the RED, "[ p] ositive results have been seen with zinc sulfate in some studies, including a Drosophila melanogaster sex chromosome assay with an oral 5 mmol/ L dose and a mutation assay with Saccharomyces cerevisiae at 100 mmol/ L. DNA inhibition was seen in human HeLa cells at 1 umol/ L/ 4 hours and oncogenic transformation occurred at 200 umol/ L with hamster embryo."

It was concluded that: "Although some positive mutagenicity studies have been reported, there is no indication of mutagenic effects in normal living organisms from everyday exposure. Living organisms have long been exposed to the components of zinc [sulfate] without such exposure being attributed to mutagenicity."

9. FDA GRAS (Generally Recognized As Safe) Assessments Ammonium Sulfate In the FDA Assessment titled "Evaluation of the Health Aspects of Certain Ammonium Salts as Food Ingredients" (1974), the following general conclusion on ammonium compounds was reached:

"Ammonia and ammonium ion are integral components of normal metabolic processes and play an essential role in the physiology of man. Although there have been no significant feeding studies specifically designed to ascertain the safety threshold of ammonium compounds as food ingredients, numerous metabolic studies have been reported in the scientific literature. Extrapolation of these findings to the concentrations of ammonium compounds normally present in foods does not suggest that there would be untoward effects at such levels."

Ammonium sulfate was evaluated in the "FDA Assessment titled Evaluation of the Health Aspects of Sulfuric Acid and Sulfates as Food Ingredients." (1975) Ammonium sulfate has been used in food in the US since 1957. For infants (0 to 23 months) the average daily intake of ammonium sulfate in 1975 ranged from 0.53 to 2.58 mg/ kg. For adults, it was 1.01 mg/ kg.

Magnesium Sulfate Page 13 of 19 The FDA Assessment is titled "Evaluation of the Health Aspects of Magnesium Salts as Food Ingredients" (1976). Magnesium is (1) a dietary essential, (2) involved in many metabolic reactions, (3) important in electrolyte balance, and (4) present in fruits, vegetables, grains, milk, meat and fish. There are no chronic toxicity data. The "status of magnesium as a ubiquitous and essential dietary ingredient for the maintenance of homeostatic and bioenergetic mechanisms leads to the opinion that none of the available evidence suggests any probable hazard when any of the GRAS compounds of magnesium is used as a food ingredient." It was concluded that there was no available information on magnesium sulfate that "demonstrates, or suggests reasonable grounds to suspect, a hazard to the public when they are used at levels that are now current and in the manner now practiced, or which might reasonably be expected in the future."

Potassium and Sodium Sulfate The FDA Assessment is titled "Evaluation of the Health Aspects of Sulfuric Acid and Sulfates as Food Ingredients." (1975). For infants (0 to 23 months) the average daily intake of potassium sulfate in 1975 ranged from 0.05 to 0.49 mg/ kg. For adults, it was 0.17 mg/ kg. No information was given for sodium sulfate.

Sulfates are present in many foods. Several amino acids contain sulfur. "Sulfates are not rapidly absorbed from the gastrointestinal tract." In a metabolism studies in rats, mice and dogs, it was observed that most sulfate (in rats greater than 80% ) was excreted in 24 hours, most of it in the urine.

"Sulfates are natural constituents of foods and normal products of sulfur metabolism in animals..... it is evident that the toxic manifestations following oral administration of the sulfates considered in this report appear only at levels that are many times greater than those to which man is exposed in his daily diet." It was concluded that: "There is no evidence in the available information on sulfuric acid, and on ammonium, calcium, potassium, and sodium sulfates that demonstrates, or suggests reasonable grounds to suspect, a hazard to the public when they are used at levels that are now current or that might reasonably be expected in future."

Zinc Sulfate In the "GRAS (Generally Recognized As Safe) Food Ingredients  Zinc Salts" document (1972), the available information related to the safety of zinc sulfate as a food ingredient is summarized. However, the document offered no conclusions.

10. FAO/ WHO Expert Committee on Food Additives WHO performed an assessment on sodium sulfate in 2000. This assessment references an evaluation of the sulfate ion at the twenty ninth meeting (Annex 1, reference 70). At that time an ADI of "not specified" was established based on the fact that "sulfate is a natural constituent of food and is a product of sulfur metabolism in animals." Sodium sulfate was not included in that Page 14 of 19 ADI: at the time, there was no information to indicate the sodium sulfate was being used as a food grade material.

Various studies were described including those on renal clearance and laxative trials in humans, and long term and developmental studies in mice. It was concluded:

"... that the results of the published studies in experimental animals do not raise concern about the toxicity of sodium sulfate. The compound has a laxative action, which is the basis for its clinical use. The minor adverse effects reported after use of ingested purgative preparations containing sodium sulfate may not be due to the sodium sulfate itself.

In the absence of any evidence of toxicity, the Committee allocated a temporary ADI `not specified'..... The ADI was made temporary because no information was available on the functional effect and actual uses of sodium sulfate in foods."

11. Human Health Hazard Characterization:

Sulfuric acid in its concentrated form is highly corrosive. Due to this property toxicity testing can only be performed on dilute concentrations or on neutralized forms of the acid such as a salt. The consequences of acute exposure to sulfuric acid are well understood. "Concentrated sulfuric acid has an extremely irritant, corrosive, and destructive action on all living matter including human tissues, not by virtue of its acidity (in concentrated form it is only slightly ionized) but because of its affinity for water. The affinity is so strong that it will remove the elements of water from even anhydrous organic matter such as carbohydrates, resulting in charring or carbonization with the liberation of heat. In sulfuric acid splashing accidents, the heat liberated by dilution of the concentrated acid with water used to flush the affected areas, can add thermal burn to chemical injury of the body." Thus sulfuric acid "can burn and char the skin. It is even more rapidly injurious to the mucous membranes, and exceedingly dangerous to the eyes. Dilute sulfuric acid, while it does not possess this charring property, irritates the skin and mucous membranes by virtue of its acidity and can cause dermatitis."

Exposure to a mist of sulfuric acid can cause irritant effects on the mucous membranes and chemical corrosive effects upon the teeth. Strong inorganic acid mists containing sulfuric acid are listed as known human carcinogens.

Exposure to sulfuric acid in pesticide products as an inert ingredient would be in the role of a pH adjuster, that is, a liquid form, not a mist. This is indicative of the use of small amounts of sulfuric acid that are incorporated in a pesticide product to lower the pH . After the pH adjustment is performed, the sulfuric acid would be neutralized. As an active ingredient sulfuric acid is subject to FIFRA registration requirements and various labeling language as specified in the RED (Reregistration Eligibility Decision). Sulfuric acid must be used and applied according Page 15 of 19 to good manufacturing or good agricultural practices. However, there are no significant adverse effects, to the general public or any population subgroup from consumption of residues of sulfuric acid resulting from such uses.

As a group these salts of sulfuric acid constitute a group of chemicals with many uses including direct use in the food supply. The available toxicity data indicates that the human body metabolizes sulfate, ammonium, calcium, iron, magnesium, potassium, sodium and zinc ions through well understood pathways. In fact, all are necessary human nutrients. Various salts of sulfuric acid have been used in the food supply for a number of years. There are no available data to indicate any significant adverse effects to the general public or any population subgroup from consumption of residues of the ammonium, calcium, iron, magnesium, potassium, sodium, and zinc salts of sulfuric acid resulting from pesticide product uses.

Given the long history of safe use, the available toxicity data, an understanding of the human body's ability to metabolize these chemicals, and the evaluations by FDA and WHO, the IIFG believes that ammonium, sodium, potassium, magnesium, calcium, iron, and zinc sulfate salts are of low oral toxicity.

12. Type of Risk Assessment/ Risk Characterization:

The toxicity of these chemicals derives from the irritation and caustic effects; therefore, a qualitative assessment for all pathways of human exposure (food, drinking water, and residential) is appropriate.

Given the widespread occurrence of sulfuric acid and its salts in the existing food supply, the amounts that can be applied to food as a result of a use in a pesticide product would not be expected to significantly increase the existing amounts in the food supply. There is no available information on any of the salts of sulfuric acid considered in this document indicative of a human health hazard resulting from the EPA regulated uses as well as the FDA GRAS uses to the general public or any population subgroup. No additional information is needed to assess their safety.

13. Sensitivity of Infants and Children:

Due to its acidic nature, its corrosive potential, there is high acute toxicity for sulfuric acid. Sulfuric acid must be used in pesticide products according to good manufacturing or good agricultural practices. The ammonium, sodium, potassium, magnesium, calcium, iron, and zinc salts of sulfuric acid have low toxic potential. At this time, there is no concern for potential sensitivity to infants and children. A safety factor analysis has not been used to assess the risk. For the same reasons the additional tenfold safety factor is unnecessary.

14. Environmental Fate and Ecotoxicity Assessment/ Characterization: Page 16 of 19 In general, the constituents of the mineral acids, such as sulfuric acid, are commonly found in soil and water in the environment suggesting that releasing low levels of these chemicals would not normally be expected to adversely effect wildlife or water resources. Large releases may adversely affect wildlife and water resources either directly or indirectly. Direct effects may result from exceeding toxicity thresholds of specific chemicals. Indirect effects may be manifested through disrupting ecosystems through altering pH or increasing availability of algal nutrients.

Sulfuric acid is a strong acid. The magnitude of the pH changes, and thus the magnitude of effects, would depend on a number of factors including the amount of material released and the buffering capacity of the exposed soil or water. Normal aquatic pHs range from 5 to 9. EPA's Office of Water recommended water quality criteria for pH are 6. 5 to 9 for freshwater and 6. 5 to 8.5 for saltwater. At higher or lower pH aquatic life is expected to be adversely impacted. In addition, rapid changes in pH can also be detrimental to aquatic life. Sulfuric acid is not expected to be persistent in the environment. Instead it is expected to dissociate, react with organic or inorganic materials, and complex with ionic substrates.

The magnesium, sodium, potassium, iron, and zinc salts of sulfuric acid should dissociate in water resulting in a positively charged (cation) metal in solution. Dissociation is frequently dependent on pH, with lower (more acidic) pHs resulting in higher levels of dissociation and greater solubility. Aquatic toxicity of metals varies with the species of metal and its concentration. EPA's freshwater water quality criteria for iron is 1 ppm implying relatively low toxicity. Zinc has recommended criteria implying these metals are more toxic. Metals do not degrade and thus are permanent in the environment. They are likely to dissipate by being sequestered in soil, sediment, and plants.

15. Cumulative Exposure:

Section 408( b)( 2)( D)( v) requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider "available information" concerning the cumulative effects of a particular pesticide chemical's residues and "other substances that have a common mechanism of toxicity." The chemicals considered in this document are structurally related; however, all of the salts are low toxicity chemicals. Therefore, the resultant risks separately and/ or combined should also be low. EPA does not have, at this time, available data to determine whether these pesticide chemicals have a common mechanism of toxicity with other substances or how to include these pesticide chemicals in a cumulative risk assessment.

16. Determination of Safety:

Based on its review and evaluation of the available information, EPA concludes that there is a reasonable certainty that no harm will result to the general population, and to infants and children from aggregate exposure to residues of sulfuric acid and its ammonium, sodium, potassium, calcium, magnesium, iron, and zinc salts. Therefore, the following exemptions from the requirement of a tolerance are reassessed: In 40 CFR 180.2 ferrous sulfate. In 40 CFR 180.1001 (c) ammonium sulfate, ferric sulfate, magnesium sulfate, potassium sulfate, sodium Page 17 of 19 sulfate, sulfuric acid, zinc sulfate (basic and monohydrate), and zinc sulfate (basic and monohydrate). In 40 CFR 180.1001 (d) sodium bisulfate. In 40 CFR 180.1001 (e) sodium sulfate and zinc sulfate (basic and monohydrate). Also sulfuric acid in 40 CFR 180.1019.

17. List Reclassifications:

The following List reclassifications are made or confirmed:

Sulfuric acid: List 4B. With the restriction of use as a pH control agent; current limitation remains in place Ammonium sulfate: List 4B Ferrous sulfate: List 4B Ferric sulfate: List 4B Magnesium sulfate: List 4A, given its neutral pH in solution Potassium sulfate: List 4A, given its neutral pH in solution Sodium sulfate: List 4A, given its neutral pH in solution Sodium bisulfate: List 4B, given its acidic nature, similar to that of sulfuric acid Zinc sulfate: List 4B The following table lists the various chemical names, CAS Reg. No., and CAS Index Names that will be used for listing in 40 CFR. 180. Note that both the anhydrous and the hydrated forms are included. The Agency sees no reason to distinguish between these chemicals given that the only difference is the attachment of the water molecules.

Chemical Name CAS. Reg. No. Chemical Abstacts Index Name Sulfuric acid 7664 93 9 Sulfuric acid (8CI, 9CI)

Ammonium sulfate 7783 20 2 Sulfuric acid diammonium salt (8CI, 9CI)

Ammonium bisulfate 7803 63 6 Sulfuric acid, monoammonium salt (8CI, 9CI)

Calcium sulfate 7778 18 9 Sulfuric acid, calcium salt (1: 1) (8CI, 9CI)

Calcium sulfate ½ hydrate {CaSO4 . 1/ 2H20} 10034 76 1 Sulfuric acid, calcium salt, hydrate (2: 2: 1) (9CI)

Calcium sulfate dihydrate {CaSO4 . 2H20} 10101 41 4 Sulfuric acid, calcium salt (1: 1), dihydrate (8CI, 9CI)

Ferric sulfate 10028 22 5 Sulfuric acid, iron( 3+) salt (3: 2) (8CI, 9CI)

Iron( II) sulfate 7720 78 7 Sulfuric acid, iron( 2+) salt (1: 1) (8CI, 9CI) Chemical Name CAS. Reg. No. Chemical Abstacts Index Name Page 18 of 19 Iron( II) sulfate dihydrate 10028 21 4 Sulfuric acid, iron( 2+) salt (1: 1), dihydrate (9CI)

Iron (II) sulfate heptahydrate {FeSO4 . 7H20} 7782 63 0 Sulfuric acid, iron( 2+) salt (1: 1), heptahydrate (8CI, 9CI)

Iron (II) sulfate pentahydrate {FeSO4 . 5H20} 13450 80 1 Sulfuric acid, iron( 2+) salt (1: 1), pentahydrate (8CI, 9CI)

Iron (II) sulfate tetrahydrate {FeSO4 . 4H20} 20908 72 9 Sulfuric acid, iron( 2+) salt (1: 1), tetrahydrate (8CI, 9CI)

Iron (II) sulfate ennahydrate {FeSO4 . 9H20} 73248 92 7 Sulfuric acid, iron( 2+) salt (1: 1), nonahydrate (9CI)

Magnesium sulfate 7487 88 9 Sulfuric acid magnesium salt (1: 1) (8CI, 9CI)

Magnesium sulfate heptahydrate (epsom salt) {MgSO4 . 7H2O} 10034 99 8 Sulfuric acid magnesium salt (1: 1), heptahydrate (8CI, 9CI)

Magnesium sulfate monohydrate {MgSO4 . H2O} 14168 73 1 Sulfuric acid magnesium salt (1: 1), monohydrate (8CI, 9CI)

Potassium pyrosulfate {K2S2O7} 7790 62 7 Disulfuric acid, dipotassium salt (9CI)

Potassium hydrogen sulfate {KHSO4} 7646 93 7 Sulfuric acid, monopotassium salt (8CI, 9CI)

Potassium sulfate 7778 80 5 Sulfuric acid dipotassium salt (8CI, 9CI)

Sodium sulfate 7757 82 6 Sulfuric acid disodium salt (8CI, 9CI)

Sodium sulfate decahydrate {Na2SO4 .10H2O} 7727 73 3 Sulfuric acid disodium salt, decahydrate (8CI, 9CI)

Sodium sulfate heptahydrate {Na2SO4 .7H2O} 13472 39 4 Sulfuric acid disodium salt, heptahydrate (8CI, 9CI)

Sodium pyrosulfate {Na2S2O7} 13870 29 6 Disulfuric acid, disodium salt (9CI)

Sodium sulfate hydrogen monohydrate {NaHSO4 .H2O} 10034 88 5 Sulfuric acid, monosodium salt, monohydrate (8CI, 9CI)

Sodium bisulfate 7681 38 1 Sulfuric acid, monosodium salt (8CI, 9CI)

Zinc sulfate (basic and monohydrate) 68813 94 5 Sulfuric acid, zinc salt, basic (9CI) Chemical Name CAS. Reg. No. Chemical Abstacts Index Name Page 19 of 19 7446 19 7 Sulfuric acid, zinc salt (1: 1), monohydrate (8CI, 9CI)

Zinc sulfate 7733 02 0 Sulfuric acid, zinc salt (1: 1) (8CI, 9CI)

Zinc sulfate heptahydrate {ZnSO4 . 7H2O} 7446 20 0 Sulfuric acid, zinc salt (1: 1), heptahydrate (8CI, 9CI)

Zinc sulfate hexahydrate 13986 24 8 Sulfuric acid, zinc salt (1: 1), hexahydrate (8CI, 9CI)

Attachment:

EFED Review of Mineral Acids (Birchfield; May 7, 2002)