[Federal Register Volume 79, Number 203 (Tuesday, October 21, 2014)]
[Notices]
[Pages 62985-62988]
[FR Doc No: 2014-24947]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-73359; File No. SR-BATS-2014-047]

Self-Regulatory Organizations; BATS Exchange, Inc.; Notice of
Filing and Immediate Effectiveness of a Proposed Rule Changes Related
to Fees for Use of BATS Exchange, Inc.

October 15, 2014.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on October 6, 2014, BATS Exchange, Inc. (the ``Exchange'' or
``BATS'') 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 prepared by the Exchange. The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of the
Substance of the Proposed Rule Change

    The Exchange filed a proposal to amend the fee schedule applicable
to Members \3\ and non-members of the Exchange pursuant to BATS Rules
15.1(a) and (c). Changes to the fee schedule pursuant to this proposal
are effective upon filing.
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    \3\ A Member is defined as ``any registered broker or dealer
that has been admitted to membership in the Exchange.'' See Exchange
Rule 1.5(n).
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    The text of the proposed rule change is available at the Exchange's
Web site at http://www.batstrading.com, at the principal office of the
Exchange, and at the Commission's Public Reference Room.

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

    In its filing with the Commission, the 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 parts of such
statements.

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

1. Purpose
    The Exchange proposes to modify the ``Options Pricing'' section of
its fee schedule effective immediately, in order to modify pricing
charged by the Exchange's options platform (``BATS Options'') for
orders routed away from the Exchange and executed at various away
options exchanges.
    The Exchange currently charges certain flat rates for routing to
other options exchanges that have been placed into groups based on the
approximate cost of routing to such venues. The grouping of away
options exchanges is based on the cost of

transaction fees assessed by each venue as well as costs to the
Exchange for routing (i.e., clearing fees, connectivity and other
infrastructure costs, membership fees, etc.) (collectively, ``Routing
Costs''). To address different fees at various other options exchanges,
the Exchange in most instances differentiates between either securities
subject to the options penny pilot program (``Penny Pilot Securities'')
and non-Penny Pilot Securities or between ``Make/Take issues'' and
``Classic issues.'' As set forth on the Exchange's fee schedule,
pricing in Make/Take issues is for executions at the identified
exchange under which rebates to post liquidity (i.e., ``Make'') are
credited by that exchange and fees to take liquidity (i.e., ``Take'')
are charged by that exchange; pricing in Classic issues applies to all
other executions at such exchanges. Routing charges are also
differentiated depending on whether they are for Customer \4\ orders or
for Professional,\5\ Firm, and Market Maker \6\ orders (collectively,
``non-Customer orders'').
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    \4\ As defined on the Exchange's fee schedule, a ``Customer''
order is any transaction identified by a Member for clearing in the
Customer range at the Options Clearing Corporation (``OCC''), except
for those designated as ``Professional''.
    \5\ The term ``Professional'' is defined in Exchange Rule 16.1
to mean any person or entity that (A) is not a broker or dealer in
securities, and (B) places more than 390 orders in listed options
per day on average during a calendar month for its own beneficial
account(s).
    \6\ As defined on the Exchange's fee schedule, the terms
``Firm'' and ``Market Maker'' apply to any transaction identified by
a member for clearing in the Firm or Market Maker range,
respectively, at the Options Clearing Corporation (``OCC'').
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    As noted previously and as set forth above, the Exchange's current
approach to routing fees is to set forth in a simple manner certain
flat fees that approximate the cost of routing to other options
exchanges. The Exchange then monitors the fees charged as compared to
the costs of its routing services, as well as monitoring for specific
fee changes by other options exchanges, and adjusts its flat routing
fees and/or groupings to ensure that the Exchange's fees do indeed
result in a rough approximation of overall Routing Costs, and are not
significantly higher or lower in any area. Over the last several
months, due to various increases in fees assessed by other options
exchanges as well as increases experienced by the Exchange with respect
to fees charged for clearing services and fees charged by the OCC, the
Exchange's overall Routing Costs have increased. As a result, and in
order to avoid subsidizing routing to away options exchanges and to
continue providing quality routing services, the Exchange proposes
relatively modest increases and adjustments to the charges assessed for
most orders routed to most options exchanges, as set forth below.
    The Exchange currently charges $0.10 per contract for all orders
(i.e., Customer and non-Customer) to buy or sell option contracts
overlying 10 shares of a security (``Mini Options'') that are routed to
and executed at an away options exchange. Due to the recent increases
in Routing Costs, the Exchange proposes to increase the fee for Mini
Options routed to and executed at an away options exchange to $0.12 per
contract.
    The Exchange currently charges $0.57 per contract for non-Customer
orders routed to and executed at the BOX Options Exchange LLC
(``BOX''). Due to the recent increases in Routing Costs, the Exchange
proposes to increase this fee to $0.65 per contract. This proposed
increase will also align such fee with the fee charged for most non-
Customer orders routed to and executed at other options exchanges, as
described below.
    The Exchange currently charges $0.11 per contract for Customer
orders and $0.60 per contract for non-Customer orders routed to and
executed at: (i) NYSE MKT LLC (``AMEX''); (ii) Chicago Board Options
Exchange, Incorporated (``CBOE''); (iii) the Miami International
Securities Exchange, LLC (``MIAX''); (iv) NASDAQ OMX BX, Inc. (``BX
Options'') in Penny Pilot Securities; and (v) the International
Securities Exchange, LLC (``ISE'') in non-Penny Pilot Securities. Due
to the recent increases in Routing Costs, the Exchange proposes to
increase the fee charged for orders routed to and executed at these
options exchanges to $0.12 per contract for Customer orders and $0.65
per contract for non-Customer orders.
    The Exchange currently charges $0.45 per contract for Customer
orders and $0.65 per contract for non-Customer orders routed to and
executed at NASDAQ OMX PHLX LLC (``PHLX'').\7\ In addition, the
Exchange currently charges $0.52 per contract for Customer orders and
$0.57 per contract for non-Customer orders routed to and executed at:
(i) NYSE Arca, Inc. (``ARCA'') in Penny Pilot Securities; (ii) the
NASDAQ Options Market (``NOM'') in Penny Pilot Securities; (iii) ISE in
Penny Pilot Securities; and (iv) Topaz Exchange, LLC (``ISE Gemini'')
in Penny Pilot Securities. The Exchange believes it is appropriate
based on a general similarity in Routing Costs for orders routed to and
executed at PHLX and these venues to add PHLX to this grouping. The
Exchange also proposes to increase the fee charged for non-Customer
orders from $0.57 per contract to $0.65 per contract. Thus, for
Customer orders routed to and executed at PHLX there will be an
increase from $0.45 per contract to $0.52 but no increase for non-
Customer orders, which are currently charged $0.65 per contract.
Similarly, there will be no fee increase for Customer orders to all
other options exchanges in the group, which are already charged $0.52
per contract, but non-Customer orders will be charged a fee of $0.65
per contract, which is an increase from the current fee of $0.57 per
contract.
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    \7\ As it has done before, despite identical fees, the Exchange
is maintaining separate references to Make/Take and Classic pricing
for orders routed to and executed PHLX because it believes that
participants that are accustomed to this distinction will be less
confused if it continues to separately list each category.
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    Finally, the Exchange currently charges a standard fee of $0.60 per
contract for directed intermarket sweep orders (``Directed ISOs'')
executed at most Member directed destinations when bypassing the BATS
Options order book. The Exchange proposes to increase its standard fee
for Directed ISOs to $0.65 per contract for reasons consistent with
those set forth above related to increasing Routing Costs incurred by
the Exchange. The Exchange also notes that, without adjustment, the
Routing Costs incurred by the Exchange for Directed ISOs in certain
securities sent on behalf of Professional, Firm, and Market Maker
participants would exceed the fee charged by the Exchange for Directed
ISOs. The Exchange notes that it is not proposing to modify fees for
Directed ISOs other than the proposed increase to the standard fee.
Thus, the Exchange is not proposing any changes to the lower than
standard charge per contract for Directed ISOs sent in Mini Options or
the higher than standard charge per contract for certain Directed ISOs
sent to certain away options exchanges.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the requirements of the Act and the rules and regulations
thereunder that are applicable to a national securities exchange, and,
in particular, with the requirements of Section 6 of the Act.\8\
Specifically, the Exchange believes that the proposed rule change is
consistent with Section 6(b)(4) of the Act,\9\ in that it provides for
the equitable allocation of reasonable dues, fees and other charges
among members and other persons using any facility or system which the
Exchange operates or

controls. The Exchange notes that it operates in a highly competitive
market in which market participants can readily direct order flow to
competing venues or providers of routing services if they deem fee
levels to be excessive.
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    \8\ 15 U.S.C. 78f.
    \9\ 15 U.S.C. 78f(b)(4).
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    As explained above, the Exchange generally attempts to approximate
the cost of routing to other options exchanges, including other
applicable costs to the Exchange for routing. The Exchange believes
that a pricing model based on approximate Routing Costs is a
reasonable, fair and equitable approach to pricing. Specifically, the
Exchange believes that its proposal to modify fees is fair, equitable
and reasonable because the fees are generally an approximation of the
cost to the Exchange for routing orders to such exchanges, and the
proposal is in response to various increases in fees assessed by other
options exchanges as well as increases experienced by the Exchange with
respect to fees charged for clearing services and fees charged by the
OCC. Accordingly, the Exchange believes that the proposed increases are
fair, equitable and reasonable because they will help the Exchange to
avoid subsidizing routing to away options exchanges and to continue
providing quality routing services. The Exchange believes that its flat
fee structure for orders routed to various venues is a fair and
equitable approach to pricing, as it provides certainty with respect to
execution fees at groups of away options exchanges. Under its flat fee
structure, taking all costs to the Exchange into account, the Exchange
may operate at a slight gain or slight loss for orders routed to and
executed at away options exchanges. As a general matter, the Exchange
believes that the proposed fees will allow it to recoup and cover its
costs of providing routing services to such exchanges. The Exchange
also believes that the proposed fee structure for orders routed to and
executed at these away options exchanges is fair and equitable and not
unreasonably discriminatory in that it applies equally to all Members.
    The Exchange has also proposed an increased fee for most Directed
ISOs routed to and executed at away options exchanges. This increase is
proposed because, without adjustment, the Routing Costs incurred by the
Exchange for Directed ISOs in certain securities sent on behalf of
Professional, Firm, and Market Maker participants would exceed the fee
charged by the Exchange for Directed ISOs. The Exchange believes that
the proposed fee structure for Directed ISOs is fair, equitable and
reasonable because the fees are an approximation of the cost to the
Exchange for routing such orders and will allow the Exchange to recoup
and cover the costs of providing routing services. The Exchange also
believes that the proposed fee structure for Directed ISOs is fair and
equitable and not unreasonably discriminatory in that it applies
equally to all Members.
    The Exchange reiterates that it operates in a highly competitive
market in which market participants can readily direct order flow to
competing venues if they deem fee levels to be excessive or providers
of routing services if they deem fee levels to be excessive. Finally,
the Exchange notes that it constantly evaluates its routing fees,
including profit and loss attributable to routing, as applicable, in
connection with the operation of a flat fee routing service, and would
consider future adjustments to the proposed pricing structure to the
extent it was recouping a significant profit or loss from routing to
away options exchanges.

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act. The proposed changes will
assist the Exchange in recouping costs for routing orders to other
options exchanges on behalf of its participants in a manner that is a
better approximation of actual costs than is currently in place and
that reflects pricing changes by various options exchanges as well as
increases to other Routing Costs incurred by the Exchange. The Exchange
also notes that Members may choose to mark their orders as ineligible
for routing to avoid incurring routing fees.\10\ As stated above, the
Exchange notes that it operates in a highly competitive market in which
market participants can readily direct order flow to competing venues
if they deem fee levels to be excessive or providers of routing
services if they deem fee levels to be excessive.
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    \10\ See BATS Rule 21.1(d)(8) (describing ``BATS Only'' orders
for BATS Options) and BATS Rule 21.9(a)(1) (describing the BATS
Options routing process, which requires orders to be designated as
available for routing).
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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 written comments from members or other interested parties.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A) of the Act \11\ and paragraph (f) of Rule 19b-4
thereunder.\12\ At any time within 60 days of the filing of the
proposed rule change, the Commission summarily may temporarily suspend
such rule change if it appears to the Commission that such action is
necessary or appropriate in the public interest, for the protection of
investors, or otherwise in furtherance of the purposes of the Act.
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    \11\ 15 U.S.C. 78s(b)(3)(A).
    \12\ 17 CFR 240.19b-4(f).
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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 email to<EMAIL_ADDRESS>Please include
File Number SR-BATS-2014-047 on the subject line.

Paper Comments

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

    All submissions should refer to File Number SR-BATS-2014-047. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet 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 Web site viewing and
printing in the Commission's Public Reference Room at 100 F Street NE.,

Washington, DC 20549-1090 on official business days between the hours
of 10:00 a.m. and 3:00 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-
BATS-2014-047, and should be submitted on or before November 12, 2014.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\13\
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    \13\ 17 CFR 200.30-3(a)(12).
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Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2014-24947 Filed 10-20-14; 8:45 am]
BILLING CODE 8011-01-P


Comparing the average F006 discharge for each region in the national sample and in the BRS sample, we found that, in general, there are no significant differences for most regions in these two samples. Only two regions (region 1 and region 5) out of ten in the National sample discharged significantly more F006 than the corresponding regions in the BRS sample. Note also that there were no samples taken from region 8 in the National survey.

C Comparison of the Regional Benchmarking Sampling data to the National Survey data The results of the test for all 10 groups along with the corresponding p values are attached. In order to compare the responses from the ALLDATA sample and the NATIONAL sample, we examine how much the mean and distribution of each analyte from the ALLDATA sample differ from those from the NATIONAL sample. The table below summarizes the results of statistical tests performed to compare the two samples. It contains p values for the analytes that are in both ALLDATA and NATIONAL samples. P values less than 0.05 indicate a statistically significant difference between the responses from the ALLDATA sample and the NATIONAL sample for a particular analyte.

From this table we conclude that the reported values are significantly different for Amenable Cyanide, Magnesium, Selenium, Total Cyanide, and Zinc from the TOTAL group. The results for other analytes do not show significant differences between the two samples under study. September 1998 149 F006 Benchmarking Study TCLP METALS TOTAL METALS ANALYTE P VALUE ANALYTE P VALUE BARIUM 0.0691 ALUMINUM 0.1407 CADMIUM 0.5960 AMENABLE CYANIDE 0.0084 CHROMIUM 0.0517 ANTIMONY 0.3772 LEAD 0.3126 ARSENIC 0.2715 MERCURY 0.1071 BARIUM 0.6320 SILVER 0.4097 BERYLLIUM 0.3729 BISMUTH 0.2239 CADMIUM 0.3766 CALCIUM 0.1183 CHLORIDE 0.4763 CHROMIUM 0.1502 CHROMIUM, HEXA 0.2812 COPPER 0.1159 FLUORIDE 0.1477 IRON 04179 LEAD 0.6072 MAGNESIUM 0.0044 MANGANESE 0.3262 MERCURY 0.2802 NICKEL 0.2023 SELENIUM 0.0365 SILVER 0.2741 SODIUM 0.6743 TIN 0.2546 TOTAL CYANIDE 0.0319 ZINC 0.0146


[Federal Register Volume 87, Number 83 (Friday, April 29, 2022)]
[Notices]
[Page 25509]
[FR Doc No: 2022-09269]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4520-DR; Docket ID FEMA-2022-0001]

Wisconsin; Amendment No. 10 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Wisconsin (FEMA-4520-DR), dated April 4, 2020, and
related determinations.

DATES: This change occurred on March 28, 2022.

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: The Federal Emergency Management Agency
(FEMA) hereby gives notice that pursuant to the authority vested in the
Administrator, under Executive Order 12148, as amended, Thomas C.
Sivak, of FEMA is appointed to act as the Federal Coordinating Officer
for this disaster.
    This action terminates the appointment of Moises Dugan as Federal
Coordinating Officer for this disaster.

    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.

Deanne Criswell,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2022-09269 Filed 4-28-22; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 77, Number 146 (Monday, July 30, 2012)]
[Notices]
[Pages 44647-44648]
[FR Doc No: 2012-18574]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID: FEMA-2012-0024; OMB Number 1660-0108]

Agency Information Collection Activities: Proposed Collection;
Comment Request, National Emergency Family Registry and Locator System
(NEFRLS)

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: The Federal Emergency Management Agency, as part of its
continuing effort to reduce paperwork and respondent burden, invites
the general public and other Federal agencies to take this opportunity
to comment on a revision of a currently approved information
collection. In accordance with the Paperwork Reduction Act of 1995,
this notice seeks comments concerning the FEMA National Emergency
Family Registry and Locator System (NEFRLS), which allows adults that
have been displaced by a Presidentially-declared disaster or emergency
to reunify with their families.

DATES: Comments must be submitted on or before September 28, 2012.

ADDRESSES: To avoid duplicate submissions to the docket, please use
only one of the following means to submit comments:
    (1) Online. Submit comments at www.regulations.gov under Docket ID
FEMA-2012-0024. Follow the instructions for submitting comments.
    (2) Mail. Submit written comments to Docket Manager, Office of
Chief Counsel, DHS/FEMA, 500 C Street SW., Room 835, Washington, DC
20472-3100.
    (3) Facsimile. Submit comments to<PHONE_NUMBER>.
    All submissions received must include the agency name and Docket
ID. Regardless of the method used for submitting comments or material,
all submissions will be posted, without change, to the Federal
eRulemaking Portal at http://www.regulations.gov, and will include any
personal information you provide. Therefore, submitting this
information makes it public. You may wish to read the Privacy Act
notice that is available via the link in the footer of
www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Earnest Poindexter, Information
Technology Specialist, Recovery Directorate, Individual Assistance
Division,<PHONE_NUMBER>. You may contact the Records Management
Division for copies of the proposed collection of information at
facsimile number<PHONE_NUMBER> or email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Post-Katrina Emergency Management Reform
Act of 2006, in Title VI of the DHS Appropriations Act of 2007 (the
Post Katrina Reform Act), Public Law 109-295, Section 689c, 120 Stat.
1355 at 1451 is the legal basis for FEMA to provide a National
Emergency Family Registry and Locator System (NEFRLS). NEFRLS allows
adults (including medical patients), that have been displaced by a
Presidentially-declared major disaster or emergency, to voluntarily
register by submitting personal information to be entered into a
database that could be used by others to help reunify them with their
families. Children who are traveling with their families during a
Presidentially-declared major disaster or emergency can be listed in
NEFRLS. NEFRLS allows a registrant to designate up to 7 individuals who
are authorized to search for and access the registrant's information in
the system. The ability to list children within NEFRLS is only to
indicate which family members are together and safe.

Collection of Information

    Title: National Emergency Family Registry and Locator System.
    Type of Information Collection: Revision of a currently approved
information collection.
    OMB Number: 1660-0108.
    Form Titles and Numbers: None.
    Abstract: NEFRLS is a Web-based database enabling FEMA to provide a
nationally available and recognized database allowing adults (including
medical patients) that have been displaced by a Presidentially-declared
major disaster or emergency to voluntarily register via the Internet or
a toll-free number. This database will then allow designated
individuals to search for displaced friends, family, and household
members.
    Affected Public: Individuals and households.
    Number of Respondents: 56,000.
    Number of Responses: NEFRLS Tele-registration: 42,000; NEFRLS
Internet Registration: 14,000.
    Estimated Total Annual Burden Hours: 4,600 hours.
    Estimated Cost: There are no annual record keeping, capital,
startup, nor maintenance costs associated with this information
collection.

Comments

    Comments may be submitted as indicated in the ADDRESSES caption
above. Comments are solicited to (a) evaluate whether the proposed data
collection is necessary for the proper performance of the agency,
including whether the information shall have practical utility; (b)
evaluate the accuracy of the agency's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (c) enhance the quality, utility, and
clarity of the information to be collected; and (d) minimize the burden
of the collection of information on those who are to respond, including
through the use of appropriate automated, electronic, mechanical, or
other technological collection techniques or other forms of information
technology,

e.g., permitting electronic submission of responses.

    Dated: July 24, 2012.
Charlene D. Myrthil,
Director, Records Management Division, Mission Support Bureau, Federal
Emergency Management Agency, Department of Homeland Security.
[FR Doc. 2012-18574 Filed 7-27-12; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register: September 30, 2010 (Volume 75, Number 189)]
[Notices]
[Page 60493]
[DOCID:fr30se10-125]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Advisory Circular 120-79A, Developing and Implementing an Air
Carrier Continuing Analysis and Surveillance System

AGENCY: Federal Aviation Administration (FAA) DOT.

ACTION: Notice of Availability.

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SUMMARY: This notice announces the issuance and availability of
Advisory Circular (AC) 120-79A, ``Developing and Implementing an Air
Carrier Continuing Analysis and Surveillance System''. This new
advisory circular (AC) updates AC 120-79 originally issued on April 21,
2003. This new AC provides information on methods of developing and
implementing a Continuing Analysis and Surveillance System (CASS)
required for commercial operators and air carriers certificated under
Title 14 of the Code of Federal Regulations (14 CFR) part 119 and
conducting operations under either 14 CFR part 121 or 135. A CASS is a
system that air carriers and commercial operators use to monitor,
analyze, and optimize the performance and effectiveness of their air
carrier maintenance programs.

DATES: The Office of the Director, Flight Standards Service, AFS-1
issued Advisory Circular 120-79A, Developing and Implementing an Air
Carrier Continuing Analysis and Surveillance System on September 7,
2010.

FOR FURTHER INFORMATION CONTACT: Russell S. Unangst, Jr., Technical
Advisor, Airworthiness, AFS-305, Federal Aviation Administration,
Aircraft Maintenance Division, Flight Standards Service, 125B Summer
Lake Drive, West Columbia, SC 29170; telephone<PHONE_NUMBER>;
facsimile<PHONE_NUMBER>, e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    How To Obtain Copies: You can read or download this AC from the
Internet at http://rgl.faa.gov or http://www.faa.gov/regulations_
policies/advisory_circulars/ under the ``Advisory Circular''
hyperlink. In approximately 6-8 weeks from the date of issuance, you
may obtain paper copies of this AC from the U.S. Department of
Transportation, Subsequent Distribution Office, SVC-121.23, Ardmore
East Business Center, 3341Q 75th Avenue, Landover, MD 20785. Telephone:
301-322-4961. Fax:<PHONE_NUMBER>.
    You can also order paper copies of this publication from DOT's On
Line Publications Web site at http://isddc.dot.gov.

    Issued in Washington, DC on September 24, 2010.
Steven W. Douglas,
Deputy Division Manager, Aircraft Maintenance Division, Flight
Standards Service.
[FR Doc. 2010-24542 Filed 9-29-10; 8:45 am]
BILLING CODE P


From: Kissell. Mary@ epamail. epa. gov [ mailto: Kissell. Mary@ epamail. epa. gov] Sent: Monday, February 09, 2004 4: 40 PM To: Edmond_ Toy@ omb. eop. gov Cc: Jenkins. Scott@ epamail. epa. gov; Guinnup. Dave@ epamail. epa. gov; kphanks@ rti. org; Hustvedt. Ken@ epamail. epa. gov; Durkee. Stan@ epamail. epa. gov; Chamberlin. Johnb@ epamail. epa. gov; Johnson. Ann@ epamail. epa. gov; Talcott. Fred@ epamail. epa. gov; Mitchell. Ken@ epamail. epa. gov; Throwe. Scott@ epamail. epa. gov; thrift. mike@ epamail. epa. gov; Clemons. Teresa@ epamail. epa. gov; Hustvedt. Ken@ epamail. epa. gov Subject: draft Risk Assessment memo Please address questions to Scott Jenkins, ( 919) 541 1167. If you send e mail comments, please copy me so I can put them in the docket. Thanks.

( See attached file: plywoodmemo2604. wpd)( See attached file: Appendix A. wpd)( See attached file: PLYMASTERFINAL. xls)( See attached file: PLYHEMOUTPUTS. xls)( See attached file: Appendix D. wpd)( See attached file: Appendix D attachmA. xls)( See attached file: Appendix D attachmB. xls)( See attached file: Appendix D attachmC. wpd)( See attached file: Appendix E. wpd) Draft UNITED STATES ENVIRONMENTAL PROTECTION AGENCY OFFICE OF AIR QUALITY PLANNING AND STANDARDS EMISSION STANDARDS DIVISION RESEARCH TRIANGLE PARK, NC 27711 Februray 6, 2004 TO: Dave Guinnup, Leader Risk and Exposure Assessment Group ( C404 01)

FROM: Scott Jenkins Maria Pimentel Dennis Pagano Risk and Exposure Assessment Group ( C404 01)

SUBJECT: Risk assessment for the draft maximum achievable control technology ( MACT) rule for the plywood and composite wood products ( PCWP) source category Introduction The purpose of this memo is to describe the methodology and results of a risk assessment performed for the plywood and composite wood products ( PCWP) source category.

This assessment was performed in order to determine the magnitude of potential chronic human cancer and noncancer risks and the potential for acute non cancer risks and adverse environmental impacts associated with the sources in this source category. In addition, this assessment was used to evaluate the potential development of a low risk subcategory which could be delisted and thereby exempted from the regulatory process.

Background on Source Category Delisting The U. S. Environmental Protection Agency has proposed the national emission standards for hazardous air pollutant ( NESHAP) for the plywood and composite wood products ( PWCW) source category. Section 12( c)( 9)( B) allows for the removal of a source category from consideration in EPA's program to promulgate MACT standards. EPA interprets these provisions to apply to each listed subcategory as well.

To commence a proceeding to delete a category of subcategory on the Administrator's own motion, the Administrator most make an initial determination that no source in the category emits carcinogens in amounts that may result in a lifetime risk of cancer exceeding one in a million to the individual most exposed; emits noncarcinogens in amounts that exceed a level which is adequate to provide an ample margin of safety to protect the public health; and emits any HAP or combination of HAPs in amounts that will result in adverse environmental effects. Draft 3 1Baseline Emissions Estimates for the Plywood and Composite Wood Products Industry. Memorandum to Mary Tom Kissell, from Katie Hanks and David Bullock, Resarch Triangle Institute. June 9, 2000. Assessment Methodology 1. Scope The first step in conducting a risk assessment is to plan and scope the assessment. EPA provides guidance on this step in the Risk Characterization Handbook ( EPA, 2000) and Framework for Cumulative Risk Assessment ( EPA, 2003). The process of planning and scoping includes defining the overall factors that are to be considered in the assessment. In designing this assessment, we considered several factors, including, statutory requirements of the CAA section 112 ( c), the amount of available data for the source category, and available methods and models.

Based on these criteria, the risk assessment for the plywood and composite wood products source category was designed to evaluate potential cancer risks, and chronic non cancer hazards to humans from inhalation and ingestion pathways, as well as acute human health effects and the potential for adverse effects to the environment. Since data for individual sources in the category were limited, a combination of data, methods, models and assumptions were considered in developing an approach which would provide actual health protective results where data were unavailable. Thus, while some of the assumptions and modeling choices tend to overestimate the risks estimates, site specific information will provide a more accurate picture of the impacts and risks. Overall, we consider the predicted results on this assessment to be conservative; that is, the risks estimated are likely higher than those which would be expected to occur in the actual exposed population.

2. Source Category Characterization The analysis included emissions associated with the production of medium density fiberboard ( MDF), particleboard, hardboard, fiberboard, oriented strand board ( OSB), softwood plywood and veneer, hardwood plywood and veneer, and engineered wood products ( EWP). Estimates of emissions were generated to represent the level of pollution control that is actually used in facilities across the nation ( baseline emissions). A detailed explanation of the methodology utilized to identify and characterize the HAP emission sources and to calculate these emissions can be found in the Baseline Emissions Estimates for the Plywood and Composite Wood Products Industry Memorandum1. While emissions from some of these sources may vary temporally ( over hours or days), we do not include this variation when evaluating chronic impacts ( i. e., we only factor it in when assessing potential acute impacts).

The emissions data included site specific annual emission rates by HAP and map coordinates. Latitude and longitude coordinates were available for 223 facilities. The facility coordinates were valuated using geographic information systems software, ArcGIS ( version 8). Facilities where location data were ambiguous or where information was declared confidential were excluded from the analysis, leaving a total of 181 facilities in the assessment. Summaries of the emission site Draft 4 2 Printout of Risk Analysis Input Spreadsheets. Memorandum to Plywood and Composite Wood Products ( PCWP) Docket File from Katie Hanks, Resarch Triangle Institute. July 29,2002.

3 Documentation of Stack Parameters Provided in 2002 Submittal of National Emission Inventory ( NEI) Data and as Inputs for Risk Assessment. Memorandum to Project file 110168.1.003: Plywood and Composite Wood Products ( PCWP) NESHAP from Melissa Icenhour, Midwest Research Institute. February 20, 2002. specific data included in the assessment are documented in Printout of Risk Analysis Input Spreadsheets; Memorandum to Plywood and Composite Wood Products ( PCWP) Docket File2 and appendix B.

Additional data regarding source release characteristics ( e. g., stack heights and diameters, exit velocities, stack gas temperatures) are documented elsewhere3. Based on these characteristics, we developed one model facility consisting of two emission points for the chronic assessments. Two thirds ( 66%) of the model facility's emissions were assigned to a taller stack ( stack 1, dryer stack); the remaining emissions ( 34%) were assigned to the shorter stack ( stack 2, press stack). Although each stack was individually modeled, both were placed at the latitude and longitude of the center of the model facility. The release parameters for each stack are summarized as follows:

Stack 1 Stack 2 Stack height ( meters) 21.3 12.3 Stack diameter ( meters) 1.5 1.8 Stack gas exit velocity ( meters/ sec) 18.46 12.3 Stack gas temperature ( kelvin) 360.9 316.5 Building cross sectional area ( meters2) 100 100 Regulatory default dispersion modeling options were used for this analysis. All plants were assumed to be located in rural areas and no terrain elevation for sources or receptors was considered.

3. Selection of HAPS and Dose Response Information The analysis for this source category included all HAPs that were reported as emitted by any of the facilities. These HAPs are listed in Table 1, with their respective cancer and chronic noncancer, and acute dose response assessment values. These values are described in more detail in the EPA's Air Toxics Website at http:// www. epa. gov/ ttn/ atw/ toxsource/ summary. html The EPA is constantly evaluating new dose response values and other information and updating the recommended values accordingly. The dose response values used in the analyses and that is shown in Table 1 were current as of January 1, 2004. At that time, there was not a weight evidence conclusion on the potential human carcinogenicity of several HAPs evaluated. Therefore, that particular HAP was no considered in the analysis. Draft 5 4 : Unit risk estimate ( URE): The upper bound excess lifetime cancer risk estimated to result from continuous exposure to an agent at a concentration of 1 µ g/ m3 in air. The interpretation of unit risk would be as follows: if URE = 1.5 x 10 6 µ g/ m3, 1.5 excess tumors are expected to develop per 1,000,000 people if exposed daily for a lifetime to 1 µ g of the chemical in 1 m3 of inhaled air. " Upper bound" in this context is defined as a plausible upper limit to the true probability. An appropriate interpretation of upper bound unit risk estimates is that the true value is probably less, and probably not greater.

5 Reference Concentration ( RfC): An estimate ( with uncertainty spanning perhaps an order of magnitude) of a continuous inhalation exposure to the human population ( including sensitive subgroups) that is likely to be without an appreciable risk of deleterious effects during a lifetime. Dose response values and sources can be found at http:// www. epa. gov/ ttn/ atw/ toxsource/ summary. html. The values pr esented in Table 1 are current as of the time of the analysis. If there was not a weight evidence conclusion on the potential human carcinogenicity of a particular HAP, that was no considered in the analysis and dose response value was left blank.

6 Acute reference level ( ARL): A short term ( e. g., 1 h) inhalation exposure to the human population estimated to cause only mild, reversible adverse effects, or no adverse effects. Because EPA has not developed either ARLs or guidelines for their derivation, ARLs were selected from a number of publically available health effects reference values to assess " routine" acute or subchronic environmental exposures. These values were developed for slightly different purposes by different organizations, e. g., AEGLs, EPRGs and IDLH/ 10 address emergency situations often associated with industrial accidents while the more stringent RELs and MRLs address exposures of a non emergency nature. Therefore, the intended uses and derivations of the reference values are not always directly comparable and may provide varying degrees of protection. For this reason, the ARLs should be regarded as less certain than either UREs or RfCs. Table 1. Unit risk estimates4, reference concentrations5 ( or similar values), and acute reference levels6 used in the risk assessment for PCWP source category HAP URE 1/(

g/ m3) RfC or similar value (

g/ m3) ARL (

g/ m3)

Acetaldehyde 2.2E 06 9.0E+ 00 1.8E+ 04 Acrolein   2.0E 02 6.9E+ 01 Arsenic compounds 4.3E 03 3.0E 02 1.9E 01 Benzene 7.8E 06 3.0E+ 01 1.3E+ 03 Beryllium compounds 2.4E 03 2.0E 02 2.5E+ 01 Cadmium compounds 1.8E 03 2.0E 02 9.0E+ 03 Chromium ( Cr+ 6) 1.2E 02 1.0E 01 1.5E+ 03 Cobalt compounds   1.0E 01 2.0E+ 03 Cumene   4.0E 01 4.4E+ 05 Ethylbenzene   1.0E+ 03 3.5E+ 05 Formaldehyde 5.5E 09 9.8E+ 00 9.4E+ 01 Lead compounds 1.5E+ 00 1.0E+ 04 Manganese compounds   5.0E 02 5.0E+ 04 Mercury compounds   9.0E 02 1.8E+ 00 Methanol   4.0E+ 03 2.8E+ 04 Methyl ethyl ketone   5.0E+ 03 1.3E+ 04 Methyl isobutyl ketone   3.0E+ 03   Methylene chloride 4.7E 07 1.0E+ 03 1.4E+ 04 Draft 6 HAP URE 1/(

g/ m3) RfC or similar value (

g/ m3) ARL (

g/ m3)

Methylene dipheniyl diisocyanate   6.0E 01 2.0E+ 02 Nickel compounds 4.8E 04   6.0E+ 00 Phenol   2.0E+ 02 5.8E+ 03 Selenium compounds   2.0E+ 01 1.0E+ 02 Styrene   1.0E+ 03 2.1E+ 04 Toluene   4.0E+ 02 3.7E+ 04 Trichloroethylene 2.0E 06 6.0E+ 02   Xylenes ( mixed isomers)   1.0E+ 02 2.2E+ 04 4. Dispersion Modeling for Chronic Exposures.

The EPA Human Exposure Model ( HEM, 2000 Version) was used for the chronic portion of the assessment. A description of that model and how it is used in this type of assessment can be found in Using the Human Exposure Model ( Version 2000) for Residual Risk Tests and Other Risk Screening Assessments Memorandum. A copy of this memorandum is found in Appendix A.

5. Dispersion Modeling for Acute Exposures For the acute assessment, we utilized the SCREEN3 atmospheric dispersion model to predict maximum 1 hour exposures from a slightly modified model facility, which consisted of a single stack with averaged stack parameters ( stack height = 17 m, stack diameter = 1.1 m, exit gas velocity = 9.0 m/ sec, exit gas temperature = 293K, building cross sectional area = 100 m2). Hourly emission rates for the acute analyses were 40% higher than those used for the chronic analysis, based on an engineering examination of emissions data which revealed a maximum temporal variability in emission rates of 40%.

The acute analysis used worst case meteorology defaults, local flat terrain, and minimum distance to a facility fenceline of 200 m. The analysis assumed that an individual could be exposed for an hour at any location beyond the fenceline.

The acute hazard quotient ( HQ) for each HAP was calculated by dividing the maximum predicted concentration by the appropriate acute benchmark values. Benchmark values were obtained from the air toxics website cited elsewhere, and are listed as Acute Reference Levels ( ARL) in Table 1.

6. Multipathway Risk Analysis To evaluate the potential for the emitted HAPs from PCWP facilities to cause cancer risk or noncancer hazard to humans via ingestion, a screening level multipathway analysis was conducted. Draft 7 The analysis was designed to estimate the maximum risk to an individual exposed via routes other than inhalation ( e. g., ingestion of contaminated food).

The multipathway analysis considered exposures from ingestion from two of the emitted HAPs: cadmium and mercury. These HAPs were the only ones included in the multipathway analysis because they are the only ones considered to be persistent, bioaccumulative, and toxic ( PBT) substances under any of various EPA programs ( e. g., the Pollution Prevention Program, the Great Waters program, the Toxics Release Inventory). All other HAP emitted by this source category are considered to have insignificant non inhalation risks.

Very limited site specific data were available to allow us to predict potential multipathway impacts. Thus, we developed a model facility, with stack parameters the same as those used for the chronic assessment, which emitted the maximum amounts of cadmium and mercury seen across the entire source category and created a worst case farmer exposure scenario with this facility by placing it near a fictional working homestead. The resulting impact of the facility was then evaluated on livestock, produce and aquatic life by coupling the Industrial Source Complex Short Term ( ISCST3) air dispersion model with the Indirect Exposure Model ( IEM 2M) multipathway model. These impacts were utilized with dose response criteria to estimate human health and ecological risks.

To simulate meteorological variability, the farmer scenario was evaluated using meteorological data from six locations across the country: Montgomery, AL; Baton Rouge LA; Minneapolis, MN; Raleigh, NC; Salem, OR; and Allentown, PA.

The maximum air concentrations and deposition rate estimates at or beyond the facility fenceline of 200 meters were combined to estimate the impacts at the farm. The environmental fate and transport of the deposited HAP were then simulated using central tendency exposure factors for the subsistence farmer scenario for the following exposure pathways: inhalation, soil ingestion, produce ingestion, animal product ingestion ( including beef, dairy products, and pork), fish ingestion ( at a recreational fisher level) and drinking water ingestion. A summary of the modeling inputs to the ISCST3 and IEM 2M models are presented in Appendix E, along with a detailed explanation of the methodology used for the exposure assessment.

7. Ecological Risk Assessment A screening level ecological risk assessment was performed according to the EPA's Guidelines for Ecological Risks Assessment ( ISAPI 1998a, 1999) and using the methods and toxicological dose response screening values identified in the draft secondary lead smelters analysis. The screeninglevel risk assessment identifies HAPs posing potential risks to ecological receptors and the relative magnitude of those potential risks. The worst case media concentrations from the chronic multipathway human health analysis were used to perform the ecological analysis.

For screening endpoints, we use the structure and function of generic aquatic and terrestrial populations and communities, including threatened and endangered species, that might be exposed to HAP emissions from the model facility via contaminated soil or water. The HAPs included in the quantitative ecological assessment are the same evaluated in the multipathway human health Draft 8 analysis: cadmium and mercury. The exposure pathways were selected to mimic the potential routes of exposure through sediment, soil, water and air. Within these environments the receptors evaluated consisted of two main groups: terrestrial and aquatic ( i. e., including aquatic, benthic, and soil organisms; terrestrial plants and wildlife; and herbivorous and carnivorous wildlife).

The chronic ecological toxicity values used in the assessment were estimates of the maximum concentrations that would not be expected to affect survival, growth, or reproduction of sensitive species after long term exposure ( more than 30 days) to the HAPs. Individual HAPs, pathways and receptors were screened using the ecological HQ method, which calculates the ratio of the estimated environmental concentrations to the selected ecological screening values.

Inputs to the ecological analysis are included in Appendix D.

Results and Discussion Summary of Chronic Cancer Inhalation Risk Assessment The individual cancer risk results for the most exposed census blocks for each facility are summarized in tables 2. The cancer risks represent upper bound estimates for lifetime residents in the most impacted areas. For cancer risks, Table 2 shows 24 facilities with maximum individual cancer risks greater than or equal to 1 in 1 million. None of the facilities showed maximum individual risks in excess of 10 in 1 million. On the other hand, a total of 157 facilities were estimated to pose maximum individual lifetime cancer risks lower than 1 in 1 million. ( See Appendix C for HEM Output files).

The cancer risk estimates were dominated by contributions from acetaldehyde, benzene, arsenic, beryllium, cadmium, hexavalent chromium, lead, nickel subsulfide and formaldehyde. These HAPs contributed to at least 95% of cancer risk in all the facilities. Among them, acetaldehyde and arsenic the accounted for approximately 80% of this risk.

Table 2. Summary of results of cancer risk estimates for the plywood and composite wood products source category Cancer Risk Estimates Number of Facilities Greater than or equal to 1 in 1 million 24 Greater than or equal to 0.1 in 1 million 117 Greater than or equal to 0.01 in 1 million 179 Summary of Chronic Noncancer Inhalation Assessment Draft 9 The individual noncancer target organ specific HI results for the most exposed census blocks for each facility are summarized in Table 3. The noncancer impacts were dominated primarily by impacts to the respiratory system and secondarily by impacts to the central nervous system ( CNS). Other target organ systems were found to be negligibly impacted. The HAPs affecting the respiratory system included acetaldehyde, acrolein, cadmium, formaldehyde and methylene dipheniyl diisocyanate. The HAPs affecting the central nervous system included , phenol, lead, and manganese. Most of the facilities showed maximum offsite HI values below 1.0, with about half of the modeled facilities showing maximum HI values below 0.2.

Table 3. Summary of results of noncancer risk estimates for the plywood and composite wood products source category Chronic Noncancer Estimates Number of Facilities Maximum respiratory and CNS HI less than 10 179 Maximum respiratory and CNS HI less than 1.0 156 Maximum respiratory and CNS HI less than 0.5 137 Maximum respiratory and CNS HI less than 0.2 103 Summary of Acute Assessment Only 2 HAPs were identified as having the potential to cause risks due to acute exposures: acrolein and formaldehyde. The maximum acute HQ for acrolein was 1.4, and the maximum acute HQ for formaldehyde was 6.3.

Summary of Multipathway and Ecological Results The maximum multipathway risks were considerably lower than predicted maximum inhalation risks from the PCWP source category. The highest multipathway impacts were seen from the scenario using meteorological data from Oregon and Minnesota respectively. The facility located in Oregon exhibited the maximum cancer risk from inhalation, which was due to cadmium and it was 0.02 in one million. On the other hand, the highest noncancer hazard index was 0.0058, occurring in Minnesota, and was dominated by cadmium.

The ecological hazard quotients were all estimated to be significantly less than one. The maximum estimate was 0.043 for cadmium exposure to through surface water to aquatic life. We conclude that it is unlikely that any of the PCWP facilities would pose any significant ecological risks to any actual ecosystem or ecosystems nearby. We also conclude, given these low impacts from the 10 hypothetical worst case scenario, that it is unlikely that any potentially exposed threatened or endangered species would be adversely affected by HAP emissions from these facilities.

Detailed results of the multipathway human health and ecological assessments are presented in Appendix D.

Documentation utilized in this risk assessment is included in the following attachments:

Appexdix A Using the Human Exposure Model ( Version 2000) for Residual Risk Tests and Other Risk Screening Assessments. Memorandum to Maria Pimentel, U. S. Environmental Protection Agency, from Darcie Smith and Phil Norwood, EC/ R Incorporated. September 29, 2003.

Appexdix B HEM Inputs Appexdix C HEM Outputs Appendix D Draft Multipathway and Ecological Risks from Model PCWP Facilities. Memorandum to Dennis Pagan and Maria Pimentel, U. S. Environmental Protection Agency, from Nancy Jones and Lesley Stobert, EC/ R Incorporated. January 28, 2004.

Appendix E Human Health Effects of HAPs Considered in this Assessment References:

USEPA 2003: Framework for Commutative Risk Assessment, EPA/ 630/ P 02/ 001F, Office of Science Policy, Washington, D. C., May 2003.

USEPA 2000: Risk Characterization handbook, EPA 100 B 00 02, Office of Science Policy, Washington, D. C., December 2000.

USEPA 1998a: Guidelines for Ecological Risk Assessment, EPA 630/ R 95/ 002F.

USEPA 1999: Draft Screening Methodology for Ecological Risk Assessment, Manuscript. 1 MEMORANDUM Date: September 29, 2003 Subject: Using the Human Exposure Model ( Version 2000) for Residual Risk Tests and Other Risk Screening Assessments To: Maria Pimentel, EPA/ OAQPS/ ESD/ REAG From: Darcie Smith and Phil Norwood, EC/ R Incorporated The Human Exposure Model ( HEM, Version 2000) is a comprehensive tool that can be used to predict the human health risks from inhalation and population exposures due to emissions from industrial emission sources. However, there are limitations in HEM that make it more suitable for us in screening level assessments. One of these limitations is that HEM is designed to calculate impacts from a single pollutant. Since many facilities emit multiple pollutants which may combine to produce more serious health effects, an approach was developed to use HEM to estimate the human health risks and population exposures when a source emits multiple pollutants. Therefore, the purpose of this memorandum is to introduce HEM and it's limitations and to describe the approach to model multiple pollutants using HEM.

THE HUMAN EXPOSURE MODEL, 2000 VERSION The HEM is an excellent tool to quickly predict risks and population exposures from industrial sources. One of the original primary purposes of HEM was to predict nationwide impacts from a particular source category, and it continues to be useful for that purpose. It is also convenient for predicting maximum risks and population exposures from a single facility, or from several facilities located in close proximity to one another. The data inputs and the outputs of HEM are straightforward and simple, which results in advantages and disadvantages. The advantages are that the input data should be easier to obtain, and the basic outputs are generated in well organized output tables. Disadvantages include the fact that HEM is not equipped to consider more complex characteristics of the emission sources at the facility ( e. g., specific emission points locations, building downwash), characteristics of the pollutants ( e. g., dispersion characteristics, reactivity in the atmosphere), and characteristics of the area ( e. g., terrain), that can impact ground level concentrations. HEM also is only designed to estimate the risks from a single pollutant. In addition, while basic outputs are generated, HEM does not have the capability to create alternative outputs that may be needed such as outputs pinpointing causes of risk or identifying the location of areas of high risk.

An introduction to the HEM is provided below, along with a discussion of the limitations and their potential impacts on the results. An approach developed to address multiple pollutants is discussed in the next section. 2 The HEM contains the Industrial Source Complex Model Long Term Version 2 ( ISCLT2) air dispersion model, a database of meteorological files, and U. S. Census population data for the year 2000 at the census block level. Source data that are input into HEM include a single coordinate for the affected source and emission point specific emissions and release characteristics. Based on the affected source location, HEM retrieves a meteorological file from the nearest of the 348 stations ( primarily airports) in its database. The HEM estimates ground level concentrations for the gridded polar coordinates centered on the affected source at 16 radials and 10 distances ( 0.2, 0.5, 1, 2, 5, 10, 20, 30, 40, and 50 kilometers).

HEM does, however, have several limitations. Using the current interface for HEM, one cannot use deposition/ depletion algorithims to consider particles or consider reactivity and decay for reactive vapors. Therefore, it is assumed that all chemicals disperse and react similarly. HEM does have the option to use ISCST3 output files as inputs to the exposure part of HEM. In this case, one could enter the particle size distribution and/ or other necessary characteristics to utilize the depletion, deposition, and reactivity options. However, the interface ( Version 2000) does not successfully run at this point in time. It is possible that the current approach, assuming everything disperses similarly, may over or under estimate air concentrations and therefore risk. However, one of the main metrics used by EPA in the residual risk program is the risk to the individual most exposed ( maximum risk). Because the maximum risk usually occurs at a receptor very close to the emission source ( i. e., a " hot spot"), it is unlikely to be influenced by altered plume dispersion characteristics of this type. In a more refined assessment, these more time intensive modeling efforts may be performed.

Along with the limitations mentioned above, the current version of HEM does not allow building characteristics to be entered, so building wake and downwash effects are not considered. Elevated terrain is also not considered, as the land around the sources is assumed to be flat. These conditions may under or over estimate the ground level air concentration and therefore the risk. As mentioned, ISCST3 does have the ability to utilize information on elevated terrain and buildings, however, the interface does not currently accept ISCST3 output files as input to the exposure portion of HEM. In a more refined assessment, these more time intensive modeling efforts may be performed.

The HEM uses the estimated ground level concentrations of a pollutant together with population data to estimate exposure. For receptors within 0.5 kilometers of the affected source, the population is estimated at points where the concentration is calculated. For receptors further than 0.5 kilometers away from the affected source, the concentration is estimated, via interpolation, at the census block geographic centroids. All people residing in a census block are assumed to be exposed to the concentration estimated at the center of the block. Exposure estimates are created by multiplying the concentration for the census block by the associated population. The HEM calculates the risk to the associated population by multiplying the estimated concentration by a dose response value, which must be entered by the user.

Two of the primary outputs of interest to the EPA in making regulatory decisions are the excess lifetime cancer risk and the noncancer hazard index. Cancer risks are expressed as the 3 probability of an individual developing cancer in their lifetime, and are calculated by multiplying the estimated exposure concentration of a pollutant by its inhalation unit risk estimate ( URE). Therefore, to estimate cancer risks, the URE for a pollutant is entered into HEM as the doseresponse value. This value is then multiplied by the estimated exposure concentration in HEM to estimate the risk for that pollutant.

Unlike cancer risks, noncancer effects are not typically expressed as a probability of an individual suffering an adverse effect. Rather, the estimated exposure concentration is compared with a noncancer dose response value, such as a reference concentration ( RfC). The hazard quotient ( HQ) is the ratio of the estimated exposure concentration to the RfC. Therefore, an HQ greater than 1.0 means that the estimated exposure concentration exceeds the RfC.

As noted above, HEM multiplies the exposure concentration by the entered dose response value. Since the HQ is the concentration divided by the RfC, the reciprocal of the RfC is entered into HEM as the dose response value for noncancer runs.

The HEM is designed to calculate impacts from a single pollutant, as evidenced by the fact that only one dose response value can be entered for each HEM run. However, many industrial facilities emit more than one HAP. Since more than one HAP can result in similar impacts, only considering the risk posed individually by each HAP likely underestimates the risk to an exposed individual.

MODELING MULTIPLE POLLUTANTS USING HEM As discussed above, HEM only allows one dose response value to be input. In order to be able to consider the impact of multiple HAP, an approach was developed. In this approach, a dose response value of 1.0 is selected and entered into HEM and emissions are " normalized" using chemical specific dose response values. For cancer, the emissions are multiplied by the HAPspecific unit risk estimate ( URE). Table 1 illustrates this scenario for a fictional emission point.

Table 1. Normalized Emissions Calculation for Cancer Risk From a Fictional Emission Point Pollutant Emissions ( kg/ yr) URE ( µ g/ m3) 1 Normalized Emissions ( kg/ yr)*( m3/ µ g)

Carbon Tetrachloride 65,646 1.5x10 5 0.985 Chlorine 1,431  0 Chloroform 24,031 2.3x10 5 0.553 Hydrochloric Acid 2,585  0 TOTAL 93,693  1.537 4 Therefore, the emission rate input into HEM for this emission point would be 1.537 with the corresponding URE entered of 1.0 ( µ g/ m3) 1.

We conducted a test to demonstrate this approach. One emission point was modeled with 9,678 kg/ yr of 1,3 butadiene emissions. The currently accepted URE for 1,3 butadiene ( 3x10 5 ( µ g/ m3) 1) was used and entered into HEM. The maximum cancer risk was 1.5x10 5.

This same emission point was then modeled using the normalized emissions approach. Normalized emissions of 0.2903 ( kg/ yr)/( µ g/ m3) were calculated by multiplying 9,678 kg/ yr by 3x10 5 ( µ g/ m3) 1 and entered into HEM, along with a URE of 1.0. The maximum cancer risk was also 1.5x10 5. In fact, all results were identical, some of which are shown in Table 2. Attachment A presents the results of the cancer test HEM runs.

Table 2. Comparison of Cancer Risk Results for a Fictional Emission Point Result Using " Real" Emissions and URE Using " Normalized" Emissions and a URE of 1.0 Maximum risk 1.54 x 10 5 1.54 x 10 5 Number of people exposed to maximum risk 132 132 Number of people exposed to a risk greater than 1x10 6 56,400 56,400 Cancer incidence ( cases/ year) 0.011 0.011 For noncancer, the approach is similar. Because the units of the dose response value in HEM are ( µ g/ m3) 1, the inverse of the reference concentration ( RfC) must be used in units of m3/ µ g to calculate a hazard index. The emissions for each record are divided by the RfC. Table 3 presents this scenario for a fictional emission point. 5 Table 3. Normalized Emissions Calculation for Noncancer Risk From a Fictional Emission Point Pollutant Emissions ( kg/ yr) RfC ( µ g/ m3) a Normalized Emissions ( kg/ yr)/( µ g/ m3)

Hydrochloric Acid 334,278 20 16,714 Methyl Chloride 356,689 90 3,963 N Hexane 282,674 200 1,413 TOTAL 973,641  22,090 a Typically, RfCs are reported in units of mg/ m3. However, since the concentration units estimated by HEM are in units of µ g/ m3, the RfCs are shown in those units.

A similar test was conducted for this approach for noncancer risks. One emission point was modeled with 10,394 kg/ yr of 1,3 butadiene emissions. The RfC recommended by the EPA at the time of this test was 0.02 mg/ m3 ( the currently accepted value is 0.002 mg/ m3). This value was converted to

g/ m3, and the inverse, 0.05 (

g/ m3) 1, entered into HEM as the dose response value. The maximum hazard quotient predicted by the HEM was 0.05.

This same emission point was then modeled using the normalized emissions approach. Normalized emissions of 520 ( 10,394 kg/ yr * 0.05 m3/ µ g ) and a dose response value of 1.0 were entered into HEM. The maximum hazard quotient was also 0.05. In both the " real" and " normalized" emission cases, 2 people were exposed to this maximum noncancer hazard level. Attachment B presents the results of the noncancer test.

This approach allows the use of HEM to calculate a noncancer hazard index for all chemicals emitted. However, it can also be used to calculate target organ specific hazard indices. This would be done by only calculating the normalized emission rate for those chemicals affecting the same target organ. Returning to the example in Table 3, since methyl chloride and n hexane both impact the nervous system, HEM could estimate a target organ specific hazard index by using the sum of the normalized emissions for these two pollutants. In other words, use of a normalized emission rate of 5,376 {( kg/ yr)/(

g/ m3)} and a dose response value of 1.0 would give a target organ specific hazard index for the nervous system.

SUMMARY For the most part, all of the limitations of HEM will likely result in overestimates of risk. For the residual risk test, this is preferred. The residual risk test is the first step in a residual risk project to determine if additional work needs to be done to develop a residual risk standard to reduce the risks from the source category. If the risk test determines that any facility in the source category could reasonably be expected to impose an individual lifetime cancer risk of one in a million ( 1 x 10 6) or greater, or an individual noncancer risk above a target organ specific hazard G The 0.2 hazard index level is a policy limit being used as a protective threshold to attempt to account for exposures from sources other than those being analyzed.

6 index level of 0.2, G the project will move to the more refined assessments. However, if the risk test shows that no facility poses risks above these thresholds, then the analysis will stop and no residual risk standards will be developed for this category. Therefore, it is important that the risk test be conservative to avoid the possibility of a " false negative" finding.

The exception to these limitations is the fact that HEM is not designed to estimate the risk from multiple pollutants. However, use of the normalized emissions approach discussed in this memorandum will allow HEM to be used as an effective and efficient tool for residual risk tests and other screening level assessments. Attachment A Results of Normalized Emissions Approach for Cancer Risks Attachment B Results of Normalized Emissions Approach for Noncancer Risks HEM Results Using Normalized Emissions ALL Table 1. HAP Metals ( lb/ yr)

{ For HAP metals: Baseline = MACT floor and Reduction = 0}.


[Federal Register: July 7, 2006 (Volume 71, Number 130)]
[Notices]
[Page 38635-38637]
[DOCID:fr07jy06-60]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. PF06-29-000]

Gulfstream Natural Gas System, L.L.C.; Notice of Intent To
Prepare an Environmental Assessment for the Proposed Gulfstream Phase
IV Expansion Project and Request for Comments on Environmental Issues

June 28, 2006.
    The staff of the Federal Energy Regulatory Commission (FERC or
Commission) will prepare an environmental assessment (EA) that will
discuss the environmental impacts of Gulfstream Natural Gas System,
L.L.C.'s (Gulfstream) planned Phase IV Expansion Project located in
Florida and Alabama. This notice announces the opening of the scoping
process we will use to gather input from the public and interested
agencies on the projects. Your input will help the Commission staff
determine which issues need to be evaluated in the EA. Please note that
the scoping period will close on July 31, 2006.
    This notice is being sent to affected landowners; Federal, State,
and local government representatives and agencies; environmental and
public interest groups; Native American tribes; other interested
parties in this proceeding; and local libraries and newspapers. We
encourage government representatives to notify their constituents of
this planned project and encourage them to comment on their areas of
concern.
    At this time we request that comments be submitted in written form.
Further details on how to submit written comments are provided in the
public participation section of this notice. For further information
and an opportunity to provide comments, you are invited to attend
Gulfstream's public open house meetings that are scheduled as follows:

Tuesday, July 11, 2006, 6-8 p.m.: Hillsborough County Commission
Building, 601 East Kennedy Blvd., 18th Floor, Tampa, FL 33602.
Wednesday, July 12, 2006, 6-8 p.m.: Weedon Island Preserve, Cultural
and Natural History Center, 1800 Weedon Drive, St. Petersburg, FL
33702.
Thursday, July 13, 2006, 6-8 p.m.: Manatee Civic Center, Palma Sola
Room, One Haben Blvd., Palmetto, FL 34221.
    The primary purpose for the open house sessions is to identify
potential siting issues so that they could be appropriately addressed.
At the open houses, Gulfstream representatives will be available to
discuss the various aspects of the project (e.g., land, construction,
environmental, design/engineering, and operations) and will meet
individually with attendees to outline how pipelines and related
facilities are sited, approved, built, and operated. Aerial photography
and offshore survey maps showing route alternatives will be made
available to encourage comments on the proposed project. Information on
the FERC process will also be available.
    In addition to the open houses, Gulfstream has established a toll-
free phone number (888-GAS-4-FLA), an e-mail address
gulfstream@williams.com), and has developed a project Web site (http://www.gulfstreamgas.com/phase4.htm
). Information included on the project

Web site includes: The route selection process; the regulatory
overview, with links to the FERC Web site; construction procedures;
pipeline safety; and contact information.

Summary of the Proposed Project

    Progress Energy Florida, Inc. (Progress Energy) is scheduled to re-
power its Bartow Power Plant. The 472-megawatt (MW) oil-fired plant is
scheduled to be re-powered with three combined cycle gas turbines that
will generate 1,100 MW of power. Progress Energy has requested, and
Gulfstream has agreed to provide 0.155 billion cubic feet per day of
firm natural gas transportation service to the Bartow Plant. In order
to provide the requested transportation service, it is necessary for
Gulfstream to expand its current system, as described below.
    Gulfstream is proposing to construct approximately 17.74 miles of
20-inch-diameter offshore pipeline from a proposed underwater hot tap
with the existing 36-inch-diameter Gulfstream Pipeline (Line 200) in
Hillsborough County waters of Tampa Bay and connecting to the existing
Progress Energy Bartow Power Plant (Bartow Plant) on the east shore of
St. Petersburg in Pinellas County, Florida. The project would also
require the installation of

45,000 horsepower (hp) of new compression. One 15,000 hp compressor
unit would be added at Gulfstream's existing compressor station in
Coden, Alabama and a new compressor station with two 15,000-hp units
would be constructed at an existing pressure reduction station site in
Manatee County, Florida.
    The proposed offshore pipeline would head north-northeast from the
proposed hot tap location and would cross Port Manatee channel, cross
Cut ``C'' of Tampa Bay channel, turn in a north-northwest direction,
cross Cut ``G'' of Tampa Bay channel and Cut ``K'' of Tampa Bay
channel, enter Pinellas County waters, turn almost due west, cross the
Bartow Channel and enter the south side of the Bartow Plant. The
pipeline would be buried to maintain a minimum of 3 feet of cover
between the top of the pipeline and the natural bay bottom, in
accordance with U.S. Department of Transportation regulations. The four
channel crossings would be installed by horizontal directional drills
(HDD) under each channel and would be buried with a cover of 10 or more
feet below the design bottom of each channel. The shore approach to the
Bartow Plant would also be installed by HDD and would start at the
Bartow Channel, thereby avoiding sensitive nearshore habitats.
    In order to meet the in-service dates requested by Progress Energy,
Gulfstream intends to place the proposed pipeline in service by
September 1, 2008, and the compression in service by January 1, 2009.
    Location maps depicting Gulfstream's proposed facilities are
provided in Appendix 1.\1\
---------------------------------------------------------------------------

    \1\ The appendices referenced in this notice are not being
printed in the Federal Register. Copies are available on the
Commission's Web site (excluding maps) at the ``eLibrary'' link or
from the Commission's Public Reference Room or call<PHONE_NUMBER>.
For instructions on connecting to eLibrary refer to the end of this
notice. Copies of the appendices were sent to all those receiving
this notice in the mail.
---------------------------------------------------------------------------

Currently Identified Environmental Issues

    At this time no formal application has been filed with the FERC.
For this project, the FERC staff has initiated its NEPA review prior to
receiving the application. The purpose of our Pre-Filing Process is to
involve interested stakeholders early in project planning and to
identify and resolve issues before an application is filed with the
FERC.
    We have already identified several issues that we think deserve
attention based on a preliminary review of the proposed facilities,
environmental information provided by Gulfstream, and comments provided
by other agencies. This preliminary list of issues may be changed based
on your comments and our analysis.;
     Potential indirect impacts (e.g., turbidity and
sedimentation) to submerged aquatic vegetation;
     Safety and noise concerns for the new compressor station
facilities;
     Potential conflicts with future ship channel improvements;
     Potential impacts to aquatic preserves;
     Net benefits to air quality;
     Potential impacts to manatees, sea turtles, and sawfish.

The EA Process

    The FERC will use the EA to consider the environmental impact that
could result if it issues Gulfstream a Certificate of Public
Convenience and Necessity.
    This notice formally announces our preparation of the EA and the
beginning of the process referred to as ``scoping.'' We \2\ are
soliciting input from the public and interested agencies to help us
focus the analysis in the EA on the potentially significant
environmental issues related to the proposed action.
---------------------------------------------------------------------------

    \2\ ``We,'' ``us,'' and ``our'' refer to the environmental staff
of the Office of Energy Projects.
---------------------------------------------------------------------------

    Our independent analysis of the issues will be included in an EA
that will be prepared for the project. Our evaluation will also include
possible alternatives to the proposed project or portions of the
project, and we will make recommendations on how to lessen or avoid
impacts on the various resource areas of concern.
    The EA will be mailed to Federal, State, and local government
agencies; elected officials; environmental and public interest groups;
Native American tribes; affected landowners; other interested parties;
local libraries and newspapers; and the FERC's official service list
for this proceeding. A 30-day comment period will be allotted for
review of the EA. We will consider all comments submitted on the EA in
any Commission Order that is issued for the project.
    We are currently involved in discussions with other jurisdictional
agencies to identify their issues and concerns. These agencies include
the U.S. Army Corps of Engineers, National Oceanic and Atmospheric
Administration, U.S. Fish and Wildlife Service, Florida Department of
Environmental Protection, and the U.S. Department of Transportation. By
this notice, we are asking these and other Federal, State, and local
agencies with jurisdiction and/or special expertise with respect to
environmental issues to formally cooperate with us in the preparation
of the EA. Agencies that would like to request cooperating status
should follow the instructions for filing comments provided below.

Public Participation

    You can make a difference by providing us with your specific
comments or concerns about the proposals. Your comments should focus on
the potential environmental effects, reasonable alternatives and
measures to avoid or lessen environmental impact. The more specific
your comments, the more useful they will be. To ensure that your
comments are timely and properly recorded, please mail your comments so
that they will be received in Washington, DC on or before July 31, 2006
and carefully follow these instructions:
     Send an original and two copies of your letter to: Magalie
R. Salas, Secretary, Federal Energy Regulatory Commission, 888 First
St., NE., Room 1A, Washington, DC 20426;
     Label one copy of the comments for the attention of Gas
Branch 3, DG2E; and
     Reference Docket No. PF06-29-000 on the original and both
copies.
    Please note that the Commission encourages electronic filing of
comments. See 18 Code of Federal Regulations 385.2001(a)(1)(iii) and
the instructions on the Commission's Internet Web site at http://www.ferc.gov
 under the ``eFiling'' link and the link to the User's

Guide. Prepare your submission in the same manner as you would if
filing on paper and save it to a file on your hard drive. Before you
can file comments you will need to create an account by clicking on
``Login to File'' and then ``New User Account.'' You will be asked to
select the type of filing you are making. This filing is considered a
``Comment on Filing.''
    When Gulfstream submits its application for authorization to
construct and operate the Phase IV Expansion Project, the Commission
will publish a Notice of Application in the Federal Register and will
establish a deadline for interested persons to intervene in the
proceeding. Because the Commission's Pre-filing Process occurs before
an application to begin a proceeding is officially filed, petitions to
intervene during this process are premature and will not be accepted by
the Commission.

Environmental Mailing List

    If you wish to remain on the environmental mailing list, please

return the Mailing List Retention Form included in Appendix 2. If you
do not return this form, you will be taken off our mailing list.

Availability of Additional Information

    Additional information about the project is available from the
Commission's Office of External Affairs at 1-866-208 FERC (3372) or on
the FERC Internet Web site (http://www.ferc.gov). Using the

``eLibrary'' link, select ``General Search'' from the eLibrary menu,
enter the selected date range and ``Docket Number'' (i.e., PF06-29-
000), and follow the instructions. Searches may also be done using the
phrase ``Gulfstream Phase IV Expansion'' in the ``Text Search'' field.
For assistance with access to eLibrary, the helpline can be reached at
1-866-208-3676, TTY<PHONE_NUMBER>, or at<EMAIL_ADDRESS>
The eLibrary link on the FERC Internet Web site also provides access to
the texts of formal documents issued by the Commission, such as orders,
notices, and rulemakings.
    In addition, the FERC now offers a free service called
eSubscription that allows you to keep track of all formal issuances and
submittals in specific dockets. This can reduce the amount of time you
spend researching proceedings by automatically providing you with
notification of these filings, document summaries, and direct links to
the documents. To register for this service, go to http://www.ferc.gov/esubscribenow.htm
.

    Public meetings or site visits will be posted on the Commission's
calendar located at http://www.ferc.gov/EventCalendar/EventsList.aspx

along with other related information. As indicated previously,
Gulfstream has established an Internet Web site for its project at
http://www.gulfstreamgas.com/phase4.htm. The Web site includes a

project overview, contact information, regulatory overview, and
construction procedures.

Magalie R. Salas,
Secretary.
[FR Doc. E6-10618 Filed 7-6-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 194 (Tuesday, October 12, 2021)]
[Notices]
[Pages 56711-56713]
[FR Doc No: 2021-22109]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0966]

Closer to Zero Action Plan: Impacts of Toxic Element Exposure and
Nutrition at Different Crucial Developmental Stages; Public Meeting;
Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the
following virtual public meeting entitled ``Closer to Zero Action Plan:
Impacts of Toxic Element Exposure and Nutrition at Different Crucial
Developmental Stages.'' The purpose of the public meeting is to discuss
the scope of the Closer to Zero action plan as it relates to the
impacts of toxic element exposure and nutrition at different crucial
developmental stages, including discussion of the key nutrients in food
for growth and development, foods commonly consumed by babies and young
children, and exposure risks of toxic elements.

DATES: The public meeting will be held on November 18, 2021, from 10
a.m. to 4 p.m. Eastern Time. FDA is

establishing a docket for public comment on this meeting. The docket
number is FDA-2021-N-0966. The docket will close on December 20, 2021.
Submit electronic or written comments on this public meeting by
December 20, 2021. See ``Participating in the Public Meeting'' in the
SUPPLEMENTARY INFORMATION section of this document for closing dates
for advanced registration and other information regarding meeting
participation.

ADDRESSES: Due to the impact of the COVID-19 pandemic, this meeting
will be held virtually to help protect the public and limit the spread
of the virus.
    You may submit comments as follows. Please note that late, untimely
filed comments will not be considered. Electronic comments must be
submitted on or before December 20, 2021. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of December 20, 2021. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2021-N-0966 for ``Closer to Zero Action Plan: Impacts of Toxic
Element Exposure and Nutrition at Different Crucial Developmental
Stages.'' Received comments, those filed in a timely manner (see
ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' We will review
this copy, including the claimed confidential information, in our
consideration of comments. The second copy, which will have the claimed
confidential information redacted/blacked out, will be available for
public viewing and posted on https://www.regulations.gov. Submit both
copies to the Dockets Management Staff. If you do not wish your name
and contact information to be made publicly available, you can provide
this information on the cover sheet and not in the body of your
comments and you must identify this information as ``confidential.''
Any information marked as ``confidential'' will not be disclosed except
in accordance with 21 CFR 10.20 and other applicable disclosure law.
For more information about FDA's posting of comments to public dockets,
see 80 FR 56469, September 18, 2015, or access the information at:
https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: For general questions about the public
meeting or for special accommodations due to disability: Juanita Yates,
Center for Food Safety and Applied Nutrition (HFS-009), Food and Drug
Administration, 5001 Campus Dr., College Park, MD 20740,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    On April 8, 2021, FDA announced the Closer to Zero (C2Z) action
plan (available at: https://www.fda.gov/food/metals-and-your-food/closer-zero-action-plan-baby-foods#Introduction) for reducing exposure
to toxic elements from foods for babies and young children (see ``FDA
Releases Action Plan for Reducing Exposure to Toxic Elements from Foods
for Babies, Young Children,'' available at: https://www.fda.gov/news-events/press-announcements/fda-releases-action-plan-reducing-exposure-toxic-elements-foods-babies-young-children). We have prioritized
reducing exposure to toxic elements from foods for babies and young
children because their smaller body sizes and rapid development make
them more vulnerable to the harmful effects of these toxic elements.
Exposure to toxic elements, including arsenic, lead, cadmium, and
mercury, from foods depends on the levels of the elements in the food
and the amount of the food consumed. Nutrient exposures can interact
with the uptake of these elements and the nutrient status of children
can modulate the effects of these elements. The levels of toxic
elements in foods depend on many factors, including:
     The levels of these elements in the air, water, and soil
used to grow the crops, which vary depending on factors such as
geographical differences and past or current contamination,
     The type of food crop and how much ``uptake'' there is of
specific elements from the environment, and
     Industrial, manufacturing, and agricultural processes.
    The C2Z action plan sets forth our approach to reducing exposure to
toxic elements in foods commonly eaten by babies and young children to
the lowest possible levels. FDA's goal is to reduce the levels of
arsenic, lead, cadmium, and mercury in these foods to the greatest
extent possible without setting levels that are not currently feasible
and without reducing the availability of nutritious, affordable foods
on which

many families rely. The C2Z action plan outlines a multi-phase,
science-based iterative approach to achieving our goal of getting
levels of toxic elements in food closer to zero over time.
    Closer to Zero includes research and evaluation of changes in
dietary exposures to toxic elements, setting action levels (recommended
limits of toxic elements in foods that can be achieved by industry and
progressively lowered as appropriate), encouraging adoption of best
practices by industry, and monitoring progress.

II. Purpose and Format of the Public Meeting

    We are holding our first C2Z action plan meeting to get stakeholder
input regarding the plan's scope. We will discuss foods commonly
consumed by babies and young children, the impacts of toxic element
exposures at different crucial developmental stages, and the
interaction of nutrients and nutrient status as co-exposures to lead,
arsenic, cadmium, and mercury on growth and development.
    We will outline the C2Z plan including FDA's four-stage approach
for continual improvement and additional work related to levels of
toxic elements in food. Stakeholder panels will provide perspectives on
the various issues needed to fulfill the C2Z plan. We will provide an
opportunity for questions as well as an opportunity for open public
comment. We expect this meeting to be the first of several regarding
the C2Z action plan.

III. Participating in the Public Meeting

    Registration: Registration is free and early registration is
recommended. To register to attend the public meeting on ``Closer to
Zero Action Plan: Impacts of Toxic Element Exposure and Nutrition at
Different Crucial Developmental Stages,'' by webcast, please register
at https://www.fda.gov/news-events/fda-meetings-conferences-and-workshops by November 12, 2021 at 11:59 p.m. Eastern Time. Registrants
will receive confirmation when they have been accepted and will be
provided the webcast link.
    Table 1 provides information on participation in the public
meetings.

 Table 1--Information on Participating in the Public Meeting and on Submitting Comments to Closer to Zero Action
 Plan: Impacts of Toxic Element Exposure and Nutrition at Different Crucial Developmental Stages for Babies and
                                                 Young Children
----------------------------------------------------------------------------------------------------------------
             Activity                        Date              Electronic address          Other information
----------------------------------------------------------------------------------------------------------------
Public Meeting....................  November 18, 2021....  Webcast information will    Webcast will have closed
                                                            be provided prior to the    captioning.
                                                            meeting.
Advance Registration..............  By November 12, 2021.  https://www.fda.gov/news-   There is no registration
                                                            events/fda-meetings-        fee for the public
                                                            conferences-and-workshops.  meeting. Early
                                                                                registration is
                                                                                recommended.
Request to make oral presentation.  By November 1, 2021..  https://www.fda.gov/news-events/fda-meetings-conferences-and-workshops.
Notice confirming opportunity to    By November 4, 2021..  ..........................  An FDA representative
 make oral presentation.                                                                will confirm the
                                                                                opportunity to make an
                                                                                oral presentation and
                                                                                will provide the
                                                                                approximate time on the
                                                                                public meeting agenda to
                                                                                do so.
Submitting either electronic or     Submit comments by     https://                    See ADDRESSES for
 written comments.                   December 20, 2021.     www.regulations.gov.        addition information on
                                                                                submitting comments.
----------------------------------------------------------------------------------------------------------------

    Requests for Oral Presentations: During online registration, you
may indicate if you wish to present oral comments during the public
comment session, and you may indicate which topic(s) you would like to
address. FDA will do its best to accommodate requests to make public
comments. We seek a broad representation of ideas and issues presented
at the meeting.
    All requests to make oral presentations must be received by
November 1, 2021, 11:59 p.m. Eastern time. We urge individuals and
organizations with common interests to consolidate or coordinate their
presentations and request time for a joint presentation. Following the
close of registration, we will determine the amount of time allotted to
each presenter and the approximate time each presentation is to begin,
and we will select and notify participants by November 4, 2021.
Typically, presentations are between 3 and 5 minutes. No commercial or
promotional material will be permitted to be presented at the public
meeting. Actual presentation times may vary based on how the meeting
progresses in real time.
    An agenda for the public meeting and any other background materials
will be made available at least 5 days before the meeting at https://www.fda.gov/news-events/fda-meetings-conferences-and-workshops. Those
without internet or email access can register and/or request to
participate by contacting Juanita Yates (see FOR FURTHER INFORMATION
CONTACT) no later than November 1, 2021.
    Transcripts: Please be advised that as soon as a transcript of the
public meeting is available, it will be accessible at https://www.regulations.gov and https://www.fda.gov/news-events/fda-meetings-conferences-and-workshops. You may also view the transcript at the
Dockets Management Staff (see ADDRESSES).

    Dated: October 5, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-22109 Filed 10-8-21; 8:45 am]
BILLING CODE 4164-01-P