[Federal Register Volume 87, Number 18 (Thursday, January 27, 2022)]
[Notices]
[Pages 4274-4275]
[FR Doc No: 2022-01622]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2022-0002; Internal Agency Docket No. FEMA-B-2206]

Proposed Flood Hazard Determinations

AGENCY: Federal Emergency Management Agency, Department of Homeland
Security.

ACTION: Notice.

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

SUMMARY: Comments are requested on proposed flood hazard
determinations, which may include additions or modifications of any
Base Flood Elevation (BFE), base flood depth, Special Flood Hazard Area
(SFHA) boundary or zone designation, or regulatory floodway on the
Flood Insurance Rate Maps (FIRMs), and where applicable, in the
supporting Flood Insurance Study (FIS) reports for the communities
listed in the table below. The purpose of this notice is to seek
general information and comment regarding the preliminary FIRM, and
where applicable, the FIS report that the Federal Emergency Management
Agency (FEMA) has provided to the affected communities. The FIRM and
FIS report are the basis of the floodplain management measures that the
community is required either to adopt or to show evidence of having in
effect in order to qualify or remain qualified for participation in the
National Flood Insurance Program (NFIP).

DATES: Comments are to be submitted on or before April 27, 2022.

ADDRESSES: The Preliminary FIRM, and where applicable, the FIS report
for each community are available for inspection at both the online
location https://hazards.fema.gov/femaportal/prelimdownload and the
respective Community Map Repository address listed in the tables below.
Additionally, the current effective FIRM and FIS report for each
community are accessible online through the FEMA Map Service Center at
https://msc.fema.gov for comparison.
    You may submit comments, identified by Docket No. FEMA-B-2206, to
Rick Sacbibit, Chief, Engineering Services Branch, Federal Insurance
and Mitigation Administration, FEMA, 400 C Street SW, Washington, DC
20472,<PHONE_NUMBER>, or (email) [email protected].

FOR FURTHER INFORMATION CONTACT: Rick Sacbibit, Chief, Engineering
Services Branch, Federal Insurance and Mitigation Administration, FEMA,
400 C Street SW, Washington, DC 20472,<PHONE_NUMBER>, or (email)
[email protected]; or visit the FEMA Mapping and Insurance
eXchange (FMIX) online at https://www.floodmaps.fema.gov/fhm/fmx_main.html.

SUPPLEMENTARY INFORMATION: FEMA proposes to make flood hazard
determinations for each community listed below, in accordance with
section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C.
4104, and 44 CFR 67.4(a).
    These proposed flood hazard determinations, together with the
floodplain management criteria required by 44 CFR 60.3, are the minimum
that are required. They should not be construed to mean that the
community must change any existing ordinances that are more stringent
in their floodplain management requirements. The community may at any
time enact stricter requirements of its own or pursuant to policies
established by other Federal, State, or regional entities. These flood
hazard determinations are used to meet the floodplain management
requirements of the NFIP.
    The communities affected by the flood hazard determinations are
provided in the tables below. Any request for reconsideration of the
revised flood hazard information shown on the Preliminary FIRM and FIS
report that satisfies the data requirements outlined in 44 CFR 67.6(b)
is considered an appeal. Comments unrelated to the flood hazard
determinations also will be considered before the FIRM and FIS report
become effective.
    Use of a Scientific Resolution Panel (SRP) is available to
communities in support of the appeal resolution process. SRPs are
independent panels of experts in hydrology, hydraulics, and other
pertinent sciences established to review conflicting scientific and
technical data and provide recommendations for resolution. Use of the
SRP only may be exercised after FEMA and local communities have been
engaged in a collaborative consultation process for at least 60 days
without a mutually acceptable resolution of an appeal. Additional
information regarding the SRP process can be found online at https://www.floodsrp.org/pdfs/srp_overview.pdf.
    The watersheds and/or communities affected are listed in the tables
below. The Preliminary FIRM, and where applicable, FIS report for each
community are available for inspection at both the online location
https://hazards.fema.gov/femaportal/prelimdownload and the respective
Community Map Repository address listed in the tables. For communities
with multiple ongoing Preliminary studies, the studies can be
identified by the unique project number and Preliminary FIRM date
listed in the tables. Additionally, the current effective FIRM and FIS
report for each community are accessible online through the FEMA Map
Service Center at https://msc.fema.gov for comparison.

(Catalog of Federal Domestic Assistance No. 97.022, ``Flood
Insurance.'')

Michael M. Grimm,
Assistant Administrator for Risk Management, Department of Homeland
Security, Federal Emergency Management Agency.

------------------------------------------------------------------------
                                             Community map repository
               Community                             address
------------------------------------------------------------------------
            La Plata County, Colorado and Incorporated Areas
Project: 20-08-0039S Preliminary Date: February 10, 2021 and October 29,
                                  2021
------------------------------------------------------------------------
City of Durango........................  City Hall, 949 East 2nd Avenue,
                                          Durango, CO 81301.
Southern Ute Indian Tribe..............  Southern Ute Indian Tribe Annex
                                          Building GIS Group, 116
                                          Memorial Drive, Ignacio, CO
                                          81137.
Town of Bayfield.......................  Town Hall, 1199 Bayfield
                                          Parkway, Bayfield, CO 81122.
Town of Ignacio........................  Town Hall, 540 Goddard Avenue,
                                          Ignacio, CO 81137.
Unincorporated Areas of La Plata County  La Plata County Commissioner's
                                          Office, 1101 East 2nd Avenue,
                                          Durango, CO 81301.
------------------------------------------------------------------------

[FR Doc. 2022-01622 Filed 1-26-22; 8:45 am]
BILLING CODE 9110-12-P


[Federal Register Volume 79, Number 250 (Wednesday, December 31, 2014)]
[Notices]
[Page 78847]
[FR Doc No: 2014-30624]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

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

Filings Instituting Proceedings

    Docket Numbers: RP15-267-000.
    Applicants: Cimarron River Pipeline, LLC.
    Description: Sec.  4(d) rate filing per 154.204: Fuel Tracker--
Seasonal Change to be effective 1/18/2015.
    Filed Date: 12/18/14.
    Accession Number: 20141218-5120.
    Comments Due: 5 p.m. ET 12/30/14.

    Docket Numbers: RP15-234-000.
    Applicants: Millennium Pipeline Company, LLC.
    Description: Motion to Intervene by ConocoPhillips Company under
RP15-234.
    Filed Date: 12/19/14.
    Accession Number: 20141219-5375.
    Comments Due: 5 p.m. ET 12/31/14.

    Docket Numbers: RP15-268-000.
    Applicants: WBI Energy Transmission, Inc.
    Description: Sec.  4(d) rate filing per 154.204: Negotiated Rate
Agreement--MDU to be effective 12/19/2014.
    Filed Date: 12/19/14.
    Accession Number: 20141219-5095.
    Comments Due: 5 p.m. ET 12/31/14.

    Docket Numbers: RP15-269-000.
    Applicants: NGO Transmission, Inc.
    Description: Sec.  4(d) rate filing per 154.204: NGO Transmission,
Inc.--Negotiated Rate Filing to be effective 1/1/2015.
    Filed Date: 12/19/14.
    Accession Number: 20141219-5149.
    Comments Due: 5 p.m. ET 12/31/14.

    Docket Numbers: RP15-270-000.
    Applicants: Dominion Cove Point LNG, LP.
    Description: Sec.  4(d) rate filing per 154.204: DCP--December 19,
2014 Non-Conforming Service Agreement to be effective 1/20/2015.
    Filed Date: 12/19/14.
    Accession Number: 20141219-5204.
    Comments Due: 5 p.m. ET 12/31/14.

    Docket Numbers: RP15-271-000.
    Applicants: Columbia Gas Transmission, LLC.
    Description: Sec.  4(d) rate filing per 154.204: Non-Conforming
Service Agmt--PacSum to be effective 1/1/2015.
    Filed Date: 12/19/14.
    Accession Number: 20141219-5280.
    Comments Due: 5 p.m. ET 12/31/14.

    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and Sec.  385.214) on or
before 5:00 p.m. Eastern time on the specified date(s). Protests may be
considered, but intervention is necessary to become a party to the
proceeding.

Filings in Existing Proceedings

    Docket Numbers: RP14-148-002.
    Applicants: Wyoming Interstate Company, L.L.C.
    Description: Compliance filing per 154.203: Rate Case Settlement
Third Compliance Filing in Docket No. RP13-184, to be effective 2/1/
2015.
    Filed Date: 12/19/14.
    Accession Number: 20141219-5214.
    Comments Due: 5 p.m. ET 12/31/14.

    Any person desiring to protest in any of the above proceedings must
file in accordance with Rule 211 of the Commission's Regulations (18
CFR 385.211) on or before 5:00 p.m. Eastern time on the specified
comment date.
    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: December 22, 2014.
 Nathaniel J. Davis, Sr.,
 Deputy Secretary.
[FR Doc. 2014-30624 Filed 12-30-14; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 174 (Thursday, September 8, 2016)]
[Proposed Rules]
[Pages 62035-62037]
[FR Doc No: 2016-21282]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2016-9071; Directorate Identifier 2016-NM-019-AD]
RIN 2120-AA64

Airworthiness Directives; Airbus Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to adopt a new airworthiness directive (AD) for
certain Airbus Model A318, A319, A320, and A321 series airplanes. This
proposed AD was prompted by an evaluation by the design approval holder
(DAH) which indicates that the main landing gear (MLG) does not comply
with certification specifications, which could result in a locking
failure of the MLG side stay. This proposed AD would require
modification or replacement of certain MLG side stay assemblies. We are
proposing this AD to prevent possible collapse of the MLG during
takeoff and landing.

DATES: We must receive comments on this proposed AD by October 24,
2016.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    For service information identified in this NPRM, contact Airbus,
Airworthiness Office--EIAS, 1 Rond Point Maurice Bellonte, 31707
Blagnac Cedex, France; telephone: +33 5 61 93 36 96; fax: +33 5 61 93
44 51; email<EMAIL_ADDRESS>Internet: http://www.airbus.com. You may view this referenced service information at the
FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA.
For information on the availability of this material at the FAA, call
425 227-1221.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-
9071; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this proposed AD, the regulatory evaluation, any comments
received, and other information. The street address for the Docket
Operations office (telephone:<PHONE_NUMBER>) is in the ADDRESSES
section. Comments will be available in the AD docket shortly after
receipt.

FOR FURTHER INFORMATION CONTACT: Sanjay Ralhan, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue SW., Renton, WA 98057-3356; telephone:<PHONE_NUMBER>;
fax:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2016-9071;
Directorate Identifier 2016-NM-019-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD based on those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Union, has issued EASA AD
2016-0018, dated January 19, 2016 (referred to after this as the
Mandatory Continuing Airworthiness Information, or ``the MCAI''), to
correct an unsafe condition for certain Airbus Model A318, A319, A320,
and A321 series airplanes. The MCAI states:

    During studies for a new landing gear design, it was discovered
that the single-locked upper and lower cardan joints of the MLG do
not comply with the certification specifications of (CS), (formerly
Joint Aviation Requirements (JAR)) Part 25.607.
    This condition, if not corrected, could lead to MLG side stay
locking failure that, during take-off and landing, may result in
damage to the aeroplane and detrimental effect on safe flight.
    To address this potential unsafe condition, the MLG manufacturer
developed a modification to change the single-locked MLG joint into
a double-locked one. This modification is available for in-service
application through Messier-Bugatti-Dowty (MBD) Service Bulletin
(SB) 200-32-315 or SB 201-32-63, or Airbus SB A320-32-1429.
    For the reasons described above, this [EASA] AD requires
modification or replacement of the MLG side stay assemblies to
introduce the double locking of the MLG upper and lower cardan
joints.

    You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-
9071.

Related Service Information Under 1 CFR Part 51

    We have reviewed the following service information. The service
information describes procedures for modifying the MLG side stay
assembly.
     Airbus Service Bulletin A320-32-1429, dated September 10,
2015.
     Messier-Bugatti-Dowty Service Bulletin 200-32-315, dated
April 24, 2015.
     Messier-Bugatti-Dowty Service Bulletin 201-32-63, dated
April 24, 2015.
    This service information is reasonably available because the
interested parties have access to it through their normal course of
business or by the means identified in the ADDRESSES section.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with the State of Design Authority, we have
been notified of the unsafe condition described in the MCAI and service
information referenced above. We are proposing this AD because we
evaluated all pertinent information and determined an unsafe condition
exists and is likely to exist or develop on other products of the same
type design.

Differences Between This Proposed AD and the MCAI or Service
Information

    The MCAI allows modification to the MLG in accordance with the
following Airbus service information or the applicable Messier-Bugatti-
Dowty service information:
     Airbus Service Bulletin A320-32-1429, dated September 10,
2015;
     Messier-Bugatti-Dowty Service Bulletin 200-32-315, dated
April 24, 2015;
     Messier-Bugatti-Dowty Service Bulletin 201-32-63, dated
April 24, 2015.
    This proposed AD would require that the MLG be modified in
accordance with the Airbus service information and the applicable
Messier-Bugatti-Dowty service information.

Costs of Compliance

    We estimate that this proposed AD affects 959 airplanes of U.S.
registry.
    We estimate the following costs to comply with this proposed AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per       Cost on U.S.
               Action                        Labor cost           Parts cost        product         operators
----------------------------------------------------------------------------------------------------------------
Replacement or Modification.........  9 work-hour x $85 per           $14,104          $14,869      $14,259,371
                                       hour = $765.
----------------------------------------------------------------------------------------------------------------

Authority for This Rulemaking

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

Regulatory Findings

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

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

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

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new Airworthiness
Directive (AD):

Airbus: Docket No. FAA-2016-9071; Directorate Identifier 2016-NM-
019-AD.

(a) Comments Due Date

    We must receive comments by October 24, 2016.

(b) Affected ADs

    None

(c) Applicability

    This AD applies to the airplanes identified in paragraphs
(c)(1), (c)(2), (c)(3), and (c)(4) of this AD, certificated in any
category, all manufacturer serial numbers.
    (1) Airbus Model A318-111, -112, -121, and -122 airplanes.
    (2) Airbus Model A319-111, -112, -113, -114, -115, -131, -132,
and -133 airplanes.
    (3) Airbus Model A320-211, -212, -214, -231, -232, and -233
airplanes.
    (4) Airbus Model A321-111, -112, -131, -211, -212, -213, -231,
and -232 airplanes.

(d) Subject

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

(e) Reason

    This AD was prompted by an evaluation by the design approval
holder (DAH) which indicates that the main landing gear (MLG) does
not comply with certification specifications, which could result in
a locking failure of the MLG side stay. We are issuing this AD to
prevent possible collapse of the MLG during takeoff and landing.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Modification or Replacement

    Within 66 months after the effective date of this AD, accomplish
the action specified in paragraph (g)(1) or (g)(2) of this AD.
    (1) Modify each MLG side stay assembly having a part number
listed in figure 1 to paragraphs (g), (h), and (i) of this AD, in
accordance with the Accomplishment Instructions of Airbus Service
Bulletin A320-32-1429, dated September 10, 2015, and the service
information specified in paragraph (g)(1)(i) or (g)(1)(ii) of this
AD, as applicable.
    (i) For Model A318 series airplanes; Model A319 series
airplanes; Model A320-211, -212, -214, -231, -232, and -233
airplanes: Messier-Bugatti-Dowty Service Bulletin 200-32-315, dated
April 24, 2015.
    (ii) For Model A321 series airplanes: Messier-Bugatti-Dowty
Service Bulletin 201-32-63, dated April 24, 2015.
    (2) Replace the MLG side stay assembly with a side stay assembly
that has been modified in accordance with paragraph (g)(1) of this
AD. Do the replacement using a method approved by the Manager,
International Branch, ANM-116, Transport Airplane Directorate, FAA;
or The European Aviation Safety Agency (EASA); or Airbus's EASA
Design Organization Approval (DOA).

    Note 1 to paragraph (g)(2) of this AD: Additional guidance for
the replacement can be found in Chapter 32 of the Airbus A318/A319/
A320/A321 Aircraft Maintenance Manual.

(h) Unaffected Airplanes

    An airplane on which Airbus modification (mod) 156646, Airbus
mod 161202, or Airbus mod 161346 has been embodied in production is
not affected by the requirements of paragraph (g) of this AD,
provided it is determined that no part having a part number
identified as listed in figure 1 to paragraphs (g), (h), and (i) of
this AD, has been installed on that airplane since the date

of issuance of the original certificate of airworthiness or the
original export certificate of airworthiness. A review of
maintenance records is acceptable to make this determination,
provided that these records are accurate and can be relied upon to
conclusively make that determination.

(i) Parts Installation Prohibition

    As of the effective date of this AD, do not install on any
airplane, an MLG side stay assembly having a part number, with the
strike number not cancelled, as identified in figure 1 to paragraphs
(g), (h), and (i) of this AD, unless it has been modified in
accordance with the requirements of paragraph (g) of this AD.

 Figure 1 to Paragraphs (g), (h), and (i) of This AD--Affected MLG Side
                             Stay Assemblies
------------------------------------------------------------------------
                                        Affected part
                                     numbers (the `xxx'
              Models                 used in this figure   Strike number
                                     can be any 3-digit    not cancelled
                                        combination)
------------------------------------------------------------------------
A318-111, -112, -121, and -122      201166001-xxx.......              12
 airplanes; A319-111, -112, -113, - 201166002-xxx.......              12
 114, -115, -131, -132, and -133    201166003-xxx.......              12
 airplanes; A320-211, -212, -214, - 201166004-xxx.......              12
 231, -232, and -233 airplanes.     201166005-xxx.......              12
                                    201166006-xxx.......              12
                                    201166007-xxx.......              12
                                    201166008-xxx.......              12
                                    201166009-xxx.......              12
                                    201166010-xxx.......              12
                                    201166011-xxx.......              12
                                    201166012-xxx.......              12
                                    201166013-000                     12
                                     through 201166013-
                                     030 inclusive.
                                    201166014-000                     12
                                     through 201166014-
                                     030 inclusive.
------------------------------------------------------------------------
A321-111, -112, and -131 airplanes  201390001-000                     15
                                     through 201390001-
                                     040 inclusive.
                                    201390002-000                     15
                                     through 201390002-
                                     040 inclusive.
                                    201527001-000                     15
                                     through 201527001-
                                     025 inclusive.
                                    201527002-000                     15
                                     through 201527002-
                                     025 inclusive.
------------------------------------------------------------------------
A321-211, -212, -213, -231, and -   201524001-000                     15
 232 airplanes.                      through 201524001-
                                     035 inclusive.
                                    201524002-000                     15
                                     through 201524002-
                                     035 inclusive.
                                    201660001-000                     15
                                     through 201660001-
                                     030 inclusive.
                                    201660002-000                     15
                                     through 201660002-
                                     030 inclusive.
------------------------------------------------------------------------

(j) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
has the authority to approve AMOCs for this AD, if requested using
the procedures found in 14 CFR 39.19. In accordance with 14 CFR
39.19, send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the International Branch, send it to ATTN: Sanjay
Ralhan, Aerospace Engineer, International Branch, ANM-116, Transport
Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-
3356; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>. Information may be
emailed to<EMAIL_ADDRESS>Before using any
approved AMOC, notify your appropriate principal inspector, or
lacking a principal inspector, the manager of the local flight
standards district office/certificate holding district office. The
AMOC approval letter must specifically reference this AD.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain corrective actions from a manufacturer, the action must be
accomplished using a method approved by the Manager, International
Branch, ANM-116, Transport Airplane Directorate, FAA; or The
European Aviation Safety Agency (EASA); or Airbus's EASA DOA. If
approved by the DOA, the approval must include the DOA-authorized
signature.
    (3) Required for Compliance (RC): If any service information
contains procedures or tests that are identified as RC, those
procedures and tests must be done to comply with this AD; any
procedures or tests that are not identified as RC are recommended.
Those procedures and tests that are not identified as RC may be
deviated from using accepted methods in accordance with the
operator's maintenance or inspection program without obtaining
approval of an AMOC, provided the procedures and tests identified as
RC can be done and the airplane can be put back in an airworthy
condition. Any substitutions or changes to procedures or tests
identified as RC require approval of an AMOC.

(k) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
(MCAI) EASA AD 2016-0018, dated January 19, 2016, for related
information. You may examine the MCAI on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-
2016-9071.
    (2) For service information identified in this AD, contact
Airbus, Airworthiness Office--EIAS, 1 Rond Point Maurice Bellonte,
31707 Blagnac Cedex, France; telephone: +33 5 61 93 36 96; fax: +33
5 61 93 44 51; email<EMAIL_ADDRESS>Internet:
http://www.airbus.com. You may view this service information at the
FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton,
WA. For information on the availability of this material at the FAA,
call<PHONE_NUMBER>.

    Issued in Renton, Washington, on August 19, 2016.
Dorr M. Anderson,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2016-21282 Filed 9-7-16; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 78, Number 60 (Thursday, March 28, 2013)]
[Notices]
[Page 18973]
[FR Doc No: 2013-07221]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER13-1151-000]

Alta Wind XI, LLC; Supplemental Notice That Initial Market-Based
Rate Filing Includes Request for Blanket Section 204 Authorization

    This is a supplemental notice in the above-referenced proceeding,
of Alta Wind XI, LLC's application for market-based rate authority,
with an accompanying rate schedule, noting that such application
includes a request for blanket authorization, under 18 CFR part 34, of
future issuances of securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability is April 11, 2013.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
5 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426.
    The filings in the above-referenced proceeding(s) are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive email notification
when a document is added to a subscribed docket(s). For assistance with
any FERC Online service, please email<EMAIL_ADDRESS>or
call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

    Dated: March 22, 2013.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2013-07221 Filed 3-27-13; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 132 (Monday, July 11, 2016)]
[Rules and Regulations]
[Pages 44797-44798]
[FR Doc No: 2016-15728]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 721

[EPA-HQ-OPPT-2015-0810; FRL-9947-33]
RIN 2070-AB27

Significant New Use Rules on Certain Chemical Substances;
Correction

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule; correction.

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SUMMARY: EPA issued a final rule in the Federal Register of May 16,
2016 for 55 chemical substances that were the subject of premanufacture
notices (PMNs). For the chemical substance identified generically as
aluminum calcium oxide salt (PMN P-15-328), EPA inadvertently omitted
the de minimus exemption from the worker protection requirements. Also
for the same chemical substance, a typographical error has been
identified within the hazard communication program requirements. This
document corrects the omission and the typographical error.

DATES: This correction is effective July 15, 2016.

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPPT-2015-0810, is available at
http://www.regulations.gov or at the Office of Pollution Prevention and
Toxics Docket (OPPT Docket), Environmental Protection Agency Docket
Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301
Constitution Ave. NW., Washington, DC. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the OPPT Docket is (202) 566-
0280. Please review the visitor instructions and additional information
about the docket available at http://www.epa.gov/dockets.

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

I. Does this action apply to me?

    The Agency included in the May 16, 2016 final rule a list of those
who may be potentially affected by this action.

II. What does this correction do?

    EPA issued a final rule in the Federal Register of May 16, 2016 (81
FR 30477) (FRL-9944-77) for significant new uses for 55 chemical
substances that were the subject of PMN notices. EPA omitted the de
mimimus exemption of 1.0% from the worker protection requirements for
Sec.  721.10908(a)(2)(i). EPA also, within the hazard communication
program requirements for Sec.  721.10908(a)(2)(ii), misspelled a word.
In that section, the word ``trhough'' should read ``through.'' This
action corrects the omission and the typographical error.

III. Why is this correction issued as a final rule?

    Section 553 of the Administrative Procedure Act (APA) (5 U.S.C.
553(b)(3)(B)) provides that, when an

Agency for good cause finds that notice and public procedure are
impracticable, unnecessary or contrary to the public interest, the
Agency may issue a final rule without providing notice and an
opportunity for public comment. EPA has determined that there is good
cause for making this correction final without prior proposal and
opportunity for comment. The TSCA section 5(e) consent order for P-15-
378 that is the basis for the SNUR at Sec.  721.10908 contains the de
minimus exemption of 1.0% that is missing from the worker protection
requirements for Sec.  721.10908(a)(2)(i). The typographical error
corrects a spelling mistake for the word ``through.'' EPA finds that
this constitutes good cause under 5 U.S.C. 553(b)(3)(B).

IV. Do any of the statutory and Executive Order reviews apply to this
action?

    No. For a detailed discussion concerning the statutory and
executive order review, refer to Unit XII. of the May 16, 2016 final
rule.

V. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).
    In FR Doc. 2016-11121, published in the Federal Register of May 16,
2016 (81 FR 30452), make the following correction:

0
1. On page, 30477, in the second and third columns, in Sec.  721.10908,
paragraphs (a)(2)(i) introductory text and (a)(2)(ii) are corrected to
read as follows:

Sec.  721.10908  Aluminum calcium oxide salt (generic).

    (a) * * *
    (2) * * *
    (i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(4), (a)(6)(ii), (a)(6)(v), (a)(6)(vi), (b) (concentration set
at 1.0 percent), and (c). When determining which persons are reasonably
likely to be exposed as required for Sec.  721.63(a)(4), engineering
control measures (e.g., enclosure or confinement of the operation,
general and local ventilation) or administrative control measures
(e.g., workplace policies and procedures) shall be considered and
implemented to prevent exposure, where feasible. The following National
Institute for Occupational Safety and Health (NIOSH)-certified
respirators with an Assigned Protection Factor (APF) of at least 10
meet the requirements of Sec.  721.63(a)(4):
* * * * *
    (ii) Hazard communication program. Requirements as specified in
Sec.  721.72(a) through (f)(concentration set at 1.0 percent),
(g)(1)(ii), (g)(2) (When using this substance avoid breathing the
substance, and use respiratory protection, or maintain workplace
airborne concentrations at or below an 8-hour time-weighted average of
5 mg/m\3\.) and (g)(5).
* * * * *

List of Subjects in 40 CFR Part 721

    Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.

    Dated: June 23, 2016.
Maria J. Doa,
Director, Chemical Control Division, Office of Pollution Prevention and
Toxics.

[FR Doc. 2016-15728 Filed 7-8-16; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 81, Number 244 (Tuesday, December 20, 2016)]
[Notices]
[Pages 92883-92885]
[FR Doc No: 2016-30554]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-79548; File No. SR-CBOE-2016-085]

Self-Regulatory Organizations; Chicago Board Options Exchange,
Incorporated; Notice of Filing and Immediate Effectiveness of a
Proposed Rule Change To Amend the Fees Schedule

December 14, 2016.
    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 December 1, 2016, Chicago Board Options Exchange, Incorporated
(the ``Exchange'' or ``CBOE'') filed with the Securities and Exchange
Commission (the ``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.
---------------------------------------------------------------------------

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

    The Exchange proposes to amend its Fees Schedule. The text of the
proposed rule change is also available on the Exchange's Web site
(http://www.cboe.com/AboutCBOE/CBOELegalRegulatoryHome.aspx), at the
Exchange's Office of the Secretary, and at the Commission's Public
Reference Room.

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

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

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

1. Purpose
    The Exchange proposes to amend its Fees Schedule. Specifically, the
Exchange proposes to increase the transaction fee for electronic
executions by broker-dealers, non-Trading Permit Holder (``non-TPH'')
Market-Makers, Professionals/Voluntary Professionals and Joint Back-
Offices (``JBOs'') in Penny Pilot equity, ETF, ETN and index options
(excluding Underlying Symbol List A) classes from $0.45 per contract to
$0.47 per contract. The Exchange notes that this increase is in line
with the amount assessed by another exchange for similar
transactions.\3\
---------------------------------------------------------------------------

    \3\ See e.g., NASDAQ PHLX Pricing Schedule, Section II, Multiply
Listed Options Fees.
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2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
the Securities Exchange Act of 1934 (the ``Act'') and the rules and
regulations thereunder applicable to the Exchange and, in particular,
the requirements of Section 6(b) of the Act.\4\ Specifically, the
Exchange believes the proposed rule change is consistent with the
Section 6(b)(5) \5\ requirements that the rules of an exchange be
designed to prevent fraudulent and manipulative acts and practices, to
promote just and equitable principles of trade, to foster cooperation
and coordination with persons engaged in regulating, clearing,
settling, processing information with respect to, and facilitating
transactions in securities, to remove impediments to and perfect the
mechanism of a free and open market and a national market system, and,
in general, to protect

investors and the public interest. Additionally, the Exchange believes
the proposed rule change is consistent with Section 6(b)(4) of the
Act,\6\ which requires that Exchange rules provide for the equitable
allocation of reasonable dues, fees, and other charges among its
Trading Permit Holders and other persons using its facilities.
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    \4\ 15 U.S.C. 78f(b).
    \5\ 15 U.S.C. 78f(b)(5).
    \6\ 15 U.S.C. 78f(b)(4).
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    Increasing the fee for electronic executions by broker-dealers,
non-TPH Market-Makers, Professionals/Voluntary Professionals and JBOs
in Penny Pilot equity, ETF, ETN and index options (excluding Underlying
Symbol List A) classes is reasonable because the proposed fee amount is
in line with the amount assessed by another exchange for similar
transactions.\7\ The Exchange believes that this proposed change is
also equitable and not unfairly discriminatory because the Exchange
will assess broker-dealers, non-TPH Market-Makers, Professionals/
Voluntary Professionals and JBOs the same electronic options
transaction fees in Penny Pilot options classes. The Exchange notes
that it does not assess Customers the electronic options transaction
fees in Penny Pilot options because Customer order flow enhances
liquidity on the Exchange for the benefit of all market participants.
Specifically, Customer liquidity benefits all market participants by
providing more trading opportunities, which attracts Market-Makers. An
increase in the activity of these market participants in turn
facilitates tighter spreads, which may cause an additional
corresponding increase in order flow from other market participants.
The Exchange notes that Market-Makers are assessed lower electronic
options transaction fees in Penny Pilot options as compared to
Professionals, JBOs, Broker Dealers and non-Trading Permit Holder
Market-Makers because they have obligations to the market and
regulatory requirements, which normally do not apply to other market
participants (e.g., obligations to make continuous markets). Clearing
Trading Permit Holder Proprietary orders are assessed lower options
transaction fees in Penny Pilot options because they also have
obligations, which normally do not apply to other market participants
(e.g., must have higher capital requirements, clear trades for other
market participants, must be members of OCC). Accordingly, the
differentiation between electronic transaction fees for Customers,
Market-Makers, Clearing Trading Permit Holders and other market
participants recognizes the differing obligations and contributions
made to the liquidity and trading environment on the Exchange by these
market participants.
---------------------------------------------------------------------------

    \7\ See NASDAQ PHLX Pricing Schedule, Section II, Multiply
Listed Options Fees.
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B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that are [sic] not necessary or
appropriate in furtherance of the purposes of the Act. The Exchange
does not believe that the proposed rule change will impose any burden
on intramarket competition that is not necessary or appropriate in
furtherance of the purposes of the Act because, while the proposed fee
increase applies only to certain market participants, the other market
participants have different obligations and different circumstances (as
described in the ``Statutory Basis'' section above). For example,
Clearing TPHs have clearing obligations that other market participants
do not have. Market-Makers have quoting obligations that other market
participants do not have. There is also a history in the options
markets of providing preferential treatment to Customers. The Exchange
does not believe that the proposed change will cause any unnecessary
burden on intermarket competition because the proposed change only
affects trading on CBOE. To the extent that the proposed changes make
CBOE a more attractive marketplace for market participants at other
exchanges, such market participants are welcome to become CBOE market
participants.

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

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

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A) of the Act \8\ and paragraph (f) of Rule 19b-4 \9\
thereunder. At any time within 60 days of the filing of the proposed
rule change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission will institute proceedings to
determine whether the proposed rule change should be approved or
disapproved.
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    \8\ 15 U.S.C. 78s(b)(3)(A).
    \9\ 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-CBOE-2016-085 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-CBOE-2016-085. 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, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of the filing also will be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-CBOE-2016-085, and should be
submitted on or before January 10, 2017.
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    \10\ 17 CFR 200.30-3(a)(12).

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    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\10\
Robert W. Errett,
Deputy Secretary.
[FR Doc. 2016-30554 Filed 12-19-16; 8:45 am]
 BILLING CODE 8011-01-P


1 FIFRA Scientific Advisory Panel Background Document May 4 6, 2004 meeting Proposed Hazard Identification Methodology for Assessment of Dermal Sensitization Risk Timothy F. McMahon, Ph. D. Jonathan Chen, Ph. D. Antimicrobials Division Office of Pesticide Programs U. S. Environmental Protection Agency Washington, D. C. 20460 2 Introduction Among the many types of risk assessments conducted in the EPA's Office of Pesticide Programs ( OPP) is an assessment of the dermal sensitization potential of pesticide chemicals. As noted in 40 CFR 798.4100, " Information derived from tests for skin sensitization serves to identify the possible hazard to a population repeatedly exposed to a test substance." Information from this test is qualitatively assessed and, if appropriate, precautionary language is included on the pesticide label as well as the Occupational Safety and Health Administration's Material Data Safety Sheets ( MSDS). Occupational dermal exposures to known or suspected dermal sensitizing pesticide chemicals can be then dealt with appropriately, either through engineering controls or use of personal protective equipment. Non occupational exposures can normally be dealt with through precautionary label statements.

Data available through the National Institute for Occupational Safety and Health ( NIOSH)

indicate that occupational exposure to dermal irritants and contact allergens accounts for a significant number of occupational illness and that chemical agents are the most frequent cause of such illness. Specific national occupational disease and illness data are available from the U. S.

Bureau of Labor Statistics ( BLS). The BLS conducts annual surveys of approximately 174,000 employers, selected to represent all private industries in the U. S. The goal is to ascertain the total numbers and incidence rates of occupational injuries and illnesses. The survey results are then projected to estimate the numbers and incidence rates of injuries and illnesses in the American working population. All occupational skin diseases or disorders, including occupational contact dermatitis ( OCD), are tabulated in this survey. In 1999, of over 372,000 occupational illnesses reported, 12% were reported as skin diseases/ disorders, making this the most common non 3 trauma related occupational illness ( NIOSH, 2001). The economic impact of occupational skin diseases/ disorders is also significant. As measured by direct medical cost and worker compensation, the total annual cost of occupational skin disease may range from $ 222 million to $ 1 billion ( NIOSH, 2001).

While pesticide chemicals can usually be labeled to warn of potential dermal sensitization effects,

there also exists the manufacture of " treated articles or substances" ( 40 CFR 152.25), in which a registered pesticide is incorporated into the article to protect the integrity of the article or substance itself ( such as paint treated with a pesticide to protect the paint coating or wood products treated to protect the wood against fungal or insect decay). Under such circumstances of use, the general public may unknowingly be exposed to pesticide chemical residue in the treated article. Therefore, prior to such use, the pesticide chemical must first be registered under FIFRA, which requires that the manufacturer of the pesticide demonstrate that it can be used without unreasonable risks to humans or the environment. Treated articles such as preserved wood, however, do not bear a pesticide label or effectively use other communication methods to inform and protect people against potential hazards, including the potential for dermal sensitization Purpose The focus of this paper is on the Agency's interest in developing the foundation of a scientifically sound approach to quantitative assessment of dermal sensitization risk to pesticide chemicals,

including pesticide chemicals that are incorporated into other materials ( i. e. treated articles). The 4 Agency is interested in obtaining expert advice on methods published in the scientific literature that have been proposed for use in determining induction thresholds and elicitation thresholds for chemicals known or suspected of causing allergic contact dermatitis. The Agency is also interested in seeking advice on whether there are any susceptibility issues in the general population with respect to development of allergic contact dermatitis, including any potential special sensitivity of children. The Agency will present hexavalent chromium as a case study of a known dermal sensitizer, and possible approaches to quantitating risk of allergic contact dermatitis from exposure to hexavalent chromium.

Dermal Sensitization Dermal sensitization, also known as allergic contact dermatitis ( ACD), delayed contact hypersensitivity, or Type IV allergic contact dermatitis, is defined by Marzulli and Maibach ( 1996)

as a delayed, immunologically mediated, inflammatory skin disease consisting of various degrees of erythema, edema, and vesiculation. Kimber ( 2004) has also defined sensitization as " stimulation by chemical allergen ( in an inherently susceptible individual) of an immune response of the quality and vigor required to permit the provocation of an elicitation reaction upon subsequent encounter with the same chemical." ACD is typically characterized by two phases,

termed induction and elicitation. Induction occurs when there is an exposure of sufficient magnitude and/ or duration to activate specific immune mechanisms resulting in the acquisition of sensitization, while elicitation occurs from a subsequent exposure to the same chemical allergen.

As it is generally recognized that a certain level of allergen exposure must be attained to induce immune activation in susceptible individuals, dermal sensitization is characterized as a threshold 5 type of response. However, dose response relationships are observed for both the induction and elicitation phases of ACD ( Gerberick and Robinson, 2000; Kimber et al., 2003; Scott et al.,

2002), and thresholds for induction can be reached following either a single sufficiently high amount of exposure to the allergenic chemical, or after contact with a large area of skin, or as a consequence of repeated skin applications ( Marzulli and Maibach, 1996). Experiments with 2,4

dinitrochlorobenzene ( DNCB) and other sensitizers have shown that a single contact can be sufficient for sensitization, but less data exist of the relationship between lower area doses and repeated contacts over a longer time period ( Griem et al., 2003). A study summarized by Griem et al., ( 2003) and conducted by Vandenburg and Epstein ( 1963) in which previously non sensitized persons were exposed to nickel chloride suggested that subclinical sensitization occurred in some of the subjects who responded negatively from the first test, as an increased percentage of nonsensitized subjects responded positively upon a repetition of the test four months later. More studies are needed in this area.

To be capable of inducing an allergenic response, the chemical itself must possess certain characteristics. Those chemicals able to cause sensitization are usually low molecular weight protein reactive substances that can gain access to the viable epidermis via the stratum corneum,

and are also able to cause sufficient local trauma to induce cutaneous cytokines and be inherently antigenic and recognized by responsive T lymphocytes.

Once through the stratum corneum, the allergen makes contact with the Langerhans cell, a member of the bone marrow derived dendritic cell family whose function is to act as a ` sentinel'

cell and serve as a trap for antigens entering the skin ( Kimber, in Marzulli and Maibach, 1996). 6 ELICITATION INDUCTION LOW MOLECULAR WT ALLERGEN MIGRATION TO LOCAL LYMPH NODE IL 1  , IL 6, IL 12 IL 1  , TNF  , GM CSF T CELL LYMPHOCYTE PROLIFERATION ICAM 1 LANGERHANS CELL ( LC)

" PRIMED" LYMPHOCYTES SPECIFIC INFLAMMATORY RESPONSE CYTOKINES, COSTIMULATORY, ADHESION MOLECULES INCREASE CELLULAR INFLUX * Illustration by D. Sailstad EDEMA AND ERYTHEMA Langerhans cells then direct the allergen to a regional lymph node, where interaction with T lymphocytes occurs, followed by proliferation of lymphocytes that have been ` primed' to react against the presented antigen. A subsequent contact with the allergen will result in elicitation of the sensitization response due to the reaction of sensitized lymphocytes with the allergen. The process is illustrated in the following diagram:

From: Sailstad, D. M. ( 2003): Allergic Contact Hypersensitivity: Mechanisms and Methods. In: Alternative Toxicological Methods. Harry Salem and Sidney Katz, eds. , CRC Press, Boca Raton, Florida. Pages 193 205. 7 It should also be noted that in addition to Langerhans cells, epidermal cytokines and chemokines may also play a role in the development of the sensitization response. This is based on the observation that the functional activity of Langerhans cells and presumably other cutaneous antigen presenting cells, is regulated largely by the availability of cytokines ( Kimber, in Marzulli and Maibach, 1996).

While it is generally accepted that the necessary exposure for induction of dermal sensitization is greater than the exposure needed to elicit sensitization, it is important to recognize that thresholds are largely determined by the potency of the chemical allergen and that induction and elicitation thresholds vary among individuals ( Kimber et al., 2003). It is thus necessary to consider doseresponse relationships in establishing " safe" levels for prevention of induction and elicitation. A recent investigation by Scott et al. ( 2002) examined the quantitative relationship between sensitization and elicitation concentrations and the ability to elicit an ACD reaction in murine models. Using two established sensitizers ( DNCB and squaric acid dibutyl ester ( SADBE),

doseresponse relationships were determined using the LLNA to derive EC3 values for both chemicals.

Then, for DNCB, various elicitation concentrations were tested in mice that had been induced to various concentrations of DNCB. As the sensitizing concentration of DNCB increased, it was observed that the concentration required to elicit measurable sensitization in sensitized mice decreased. That is, mice who had been sensitized to higher concentrations of DNCB required less DNCB to elicit a measurable sensitization response. For SADBE, two different elicitation 8 concentrations were compared over a range of induction concentrations. The group given the higher elicitation concentration showed measurable sensitization at lower induction concentrations. The results of this study suggested that, as the induction dose was increased ( using DNCB), the concentration required for elicitation was decreased. Correspondingly, as the elicitation concentration was increased ( using SADBE), the concentration required for induction was decreased.

Hazard Identification It is desirable to be able to conduct quantitative assessments for dermal sensitization in order to prevent consumers especially from developing ACD when dermal contact, including repeated dermal contact, could not be completely avoided ( Griem et al., 2003). In the case of hexavalent chromium as a component of treated wood, this is important, as there would be repeated dermal contact with the treated wood surface when this treated wood is used in residential decking and playground structures.

There are several accepted methods for hazard identification of dermal sensitization, including the Buehler occluded patch test, the guinea pig maximization test, and the murine local lymph node assay ( LLNA). The guinea pig maximization test and the Buehler test, while providing reliable information on whether a substance is a skin sensitizer or not, are best suited only for hazard identification. 9 By contrast with the Buehler test and maximization test, the Mouse Local Lymph Node Assay ( LLNA) is a more recent test method for assessing the allergic contact dermatitis ( skin sensitization) potential of chemicals, specifically the induction phase of sensitization. Using the incorporation of radiolabeled thymidine or iododeoxyuridine into DNA, the LLNA measures lymphocyte proliferation in the draining lymph nodes of mice topically exposed to the test article.

The stimulation index ( ratio of lymphocyte proliferation in treated mice compared to controls) is used as the indicator of potential sensitization. In 1998, following review by the FIFRA Scientific Advisory Panel ( SAP), the LLNA was incorporated as a screening test in OPPTS Test Guideline 870.2600 Skin Sensitization. In 1999, the Interagency Coordinating Committee on the Validation of Alternative Methods ( ICCVAM) Immunotoxicity Working Group ( IWG)

recommended the LLNA as a stand alone alternative for contact sensitization hazard assessment, provided that certain protocol modifications were made. Following additional studies to validate the method, the FIFRA SAP agreed with the Agency proposal that the LLNA was applicable for testing chemicals to elicit contact sensitization and should be considered a preferred, stand alone assay. The OPPTS guideline 870.2600 ( Skin Sensitization) has been revised to include the LLNA as a stand alone assay for appropriate applications. The OPPTS guideline has also been harmonized with OECD's Guideline 429 for LLNA, which was adopted in April 2002.

Although the LLNA has not been validated for determination of sensitization potency of chemical allergens and sensitization to metals has not been extensively studied , approaches for determination of quantitative assessment of sensitization induction thresholds have been proposed in the scientific literature using LLNA data ( Gerberick 2000, 2001; Griem et al., 2003). It may 10 therefore be useful to consider data from the LLNA as a starting point for quantitation of induction thresholds, as dose response data can be generated from this assay, and a NOAEL can potentially be identified ( Felter et al., 2003). However, while the LLNA has been validated and accepted as a stand alone test method for assessment of dermal sensitization potential by the Interagency Coordinating Committe on the Validation of Alternative Test Methods ( ICCVAM ,

1999), the test itself has not been validated for its utility in dermal risk assessment ( Felter et al.,

2003). It has been proposed to group sensitizing chemicals according to relative potency as determined in the LLNA, and then compare these categories with the relative sensitization potency in humans on the basis of clinical experience and/ or prevalence of ACD in the population ( Griem et al, 2003). While a good correlation between LLNA results and sensitization potency in humans has been reported ( Griem et al., 2003), there is not yet general agreement on categories and ranges that should be used in classification of relative potency.

Induction Threshold Methods Gerberick ( 2000, 2001) proposed a methodology for determination of a ` sensitization reference dose' for sensitizers in consumer products. The lower boundary of the potency category for a sensitizing chemical is used as the starting point, with application of uncertainty factors for interindividual variability, product matrix effects, and use pattern. This approach was applied to the fragrance component cinnamic aldehyde and the preservative methylchloroisothiazolinone/ methylisothiazolinone for which both LLNA and human sensitization potency were available ( Griem et al., 2003). 11 A use for the LLNA in quantitative risk assessment was investigated by Griem et al ( 2003).

Identification of known human sensitizing chemicals for which both an EC3 value from an LLNA test and a NOAEL or LOAEL from human repeat insult patch tests ( HRIPT) or the human maximization test ( HMT) were available were identified. The reported concentrations were converted into specific and molar area doses. Comparison of the area doses of the LLNA and human test results indicated that sensitization thresholds were similar in mice and humans despite the fact that the area doses for different chemicals ranged over several orders of magnitude ( Griem et al., 2003). It was concluded from this analysis that the LLNA EC3 value is a useful measure of sensitizing potency in humans, and that the EC3 value can be used as a surrogate value for the human NOAEL which, in turn, can be used as a starting point in quantitative risk assessment.

Elicitation threshold Methods The above approaches describe methods that may be used to estimate thresholds for safe area doses that are considered protective against induction of sensitization. There are also proposed approaches for estimation of safe area doses that are considered protective against elicitation of sensitization in already sensitized persons. By inference, protection against elicitation would also be protective of induction, as thresholds for induction are generally higher than those for elicitation ( Kimber et al., 2003).

An approach to estimate an acceptable area dose for protection against elicitation is the concept of the Minimum Elicitation Threshold, or MET. This approach has been discussed in 12 previous publications ( Nethercott et al., 1994; Zewdie, 1998; NJDEP, 1998; Basketter et al.,

2003) specifically with respect to hexavalent chromium. The concept behind the MET is that there is an ` elicitation threshold' below which no sensitization reaction is expected; thus, the MET is analogous to an RfD ( Horowitz and Finley, 1994). The estimation of an MET is usually based on the results of tests in previously sensitized individuals; thus, the MET is considered protective of elicitation reactions. However, there has not been an extensive discussion of the criteria for employing this concept for purposes of risk assessment. Nethercott ( 1994) calculated a value of 0.089 ug/ cm2 as a 10% MET ( i. e. the concentration at which 10% of the study group responded)

based on results of a human repeat insult patch test in 54 chromium sensitized volunteers and claimed that this value should be protective against ACD for hexavalent chromium in at least 99.99% of the population exposed to contaminated soil. Paustenbach ( 1992) estimated a 10%

threshold response of 54 parts per million for hexavalent chromium in soil, but no discussion of the relevance of the 10% response level was presented. Two states ( Massachusetts and New Jersey) have proposed soil cleanup standards based on an ACD endpoint using either the human patch test data of Nethercott ( 1994) or the human forearm water exposure data of Fowler ( 2000).

Griem et al. ( 2003) also proposed an approach for derivation of a safe area dose at which ACD would not be manifest in sensitized individuals. As several of the factors that influence induction of sensitization ( skin penetration, uptake by antigen presenting cells, metabolism) are also relevant for elicitation, it was postulated that a correlation between the induction potency and elicitation potency of a chemical could be established. However, comparison of induction and elicitiation area doses from limited data in humans did not show an obvious correlation. While induction 13 threshold doses spanned five orders of magnitude, values for elicitation were mainly within one order of magnitude. Using the log transformation of the ratio of induction/ elicitation to elicitation, it was proposed that the ratio of the induction/ sensitization threshold could be predicted on the basis of an established sensitization ( induction) threshold. Examples of the derivation of safe area doses for three chemicals ( MCI/ MI, a preservative in many cosmetics and household products; cinnamic aldehyde, a fragrance and flavor ingredient; and nickel) were presented. For strong sensitizers such as MCI/ MI, it was demonstrated that the safe area doses for induction and elicitation were close together, while for relatively weaker sensitizers such as nickel, the safe area doses for induction and elicitation were farther apart, consistent with the mathematical relationship of the ratio of induction/ elicitation threshold vs. sensitization threshold.

That is, for lower potency sensitizers, a relatively high area dose may be needed to cause induction of sensitization, but elicitation may be possible with much lower area doses, while for a potent sensitizer, the area dose needed for induction is close to the area dose that will elicit the reaction in a sensitized individual.

Uncertainty After the appropriate level of concern has been identified ( e. g. NOAEL determination, for example), areas of uncertainty need to be considered in extrapolating the result to conditions relevant to the human exposure of interest. Areas of uncertainty that have been identified for dermal risk assessment include ( 1) interspecies variability/ susceptibility ( i. e. extrapolation from animals to humans); ( 2) intra species variations in response within humans; ( 3) vehicle or product matrix effects; and ( 4) exposure considerations ( i. e., area of the body exposed, repeated 14 exposures). Briefly, and as discussed in more detail by Felter et al. ( 2002) and Griem et al.

( 2003), the inter individual variation in response to induction and elicitation of dermal sensitization must be taken into account, as there may be differences in response based on age,

sex, and genetic factors, or health status of the skin. In addition, formulation of chemical allergens into product matrices that may result in an enhancement or inhibition of ACD must be considered in the risk assessment paradigm, as must also extrapolating from experimental conditions to realworld exposure conditions, i. e. site of the body exposed , effects of occlusion, and environmental conditions ( temperature, humidity, and repeated dermal exposures). For each of the 4 areas, a range from 1 10 has been suggested for uncertainty in each area.

Populations of Concern Approaches to estimating safe area doses for ACD have been proposed using EC3 values derived from the murine LLNA ( Gerberick and Robinson, 2000; Felter et al., 2003, and MET values from human repeat insult patch tests ( Nethercott et al., 1994; Basketter et al., 2001; Hansen et al.,

2003). Approaches using the results of murine LLNA data are intended to estimate area doses that are protective against induction of ACD, while use of the MET approach is intended to be protective against elicitation of ACD in sensitized persons. Griem et al. ( 2003) have also proposed an approach for calculation of safe area doses designed to be protective against both induction and elicitation of ACD through use of appropriate uncertainty factors applied to the results of murine LLNA or human patch test study results. This proposal is worth examining, as it has been acknowledged in the past for sensitizing chemicals such as nickel and hexavalent 15 chromium that it is difficult to protect individuals who are already sensitized ( Felter et al., 2003;

USEPA, 1998).

In addition, consideration should be given to whether there are potentially susceptible subpopulations who may be more susceptible to the induction and/ or elicitation of ACD.

Paustenbach et al. ( 1992) and Felter et al. ( 2002) have discussed the issue of whether children are more or less at risk for development of ACD. Paustenbach et al. addressed this issue specifically for hexavalent chromium, and it was concluded that risk to children ages 3 to 8 is not likely to be greater than risk to adults as there is no evidence that repeated exposures to hexavalent chromium places a person at greater risk of sensitization. Felter et al. suggested that infants and children may actually be at lower risk for development of ACD based on data gathered from dinitrochlorobenzene and pentadecylcatechol ( poison ivy allergen). These views are somewhat counter to the opinion of Griem et al. ( 2003) who suggested a possible higher sensitizing potency of a chemical upon repeated exposures. This would make sense in the case of hexavalent chromium, as the significant irritancy of the chemical could lend itself to an increased sensitizing potency by allowing more chemical to penetrate the stratum corneum.

Case Study Hexavalent Chromium As noted in the 1998 IRIS Toxicological Review for hexavalent chromium ( USEPA, 1998) as well as in numerous publications, hexavalent chromium is one of the most common and potent contact sensitizers. Exposures to hexavalent chromium occur in a number of occupational settings including including chrome plating baths, chrome colors and dyes, cement, tanning agents, wood preservatives, anticorrosive agents, welding fumes, lubricating oils and greases, 16 cleaning materials, and textiles and furs ( USEPA, 2003). Non occupational exposures to hexavalent chromium have also been noted in household detergents ( Basketter et al., 2003; Stern et al., 1993) as well as in cement.

Elicitation thresholds in persons sensitized to hexavalent chromium have been described in the literature ( Nethercott, 1994; Fowler, 2000). However, there are no recent data on induction thresholds for hexavalent chromium. Some investigation has been performed on the question of induction thresholds in general, as it has been stated ( Marzulli and Maibach, 1996; Griem et al.,

2003) that repeated dermal contact over a longer time period may also result in a threshold for induction. Although more work is needed in this area, Griem ( 2003) proposed an uncertainty factor be applied for repeated dermal contact with chemical allergens, as there may be a higher sensitizing potency of a chemical upon repeated exposure.

The Antimicrobials Division of OPP is concerned with the risk from dermal exposure that may occur from dermal contact with hexavalent chromium on the surface of wood treated with a wood preservative product containing hexavalent chromium, as hexavalent chromium is known to be a potent dermal irritant and sensitizing agent. The Antimicrobials Division, using existing science policies in OPP, currently performs hazard and risk assessments for non cancer endpoints through selection of a level of concern ( e. g., a NOAEL or LOAEL value) and compares this level of concern to estimated or actual exposures to derive a Margin of Exposure. The Margin of Exposure is then weighed against the " acceptable" Margin of Exposure, which takes into account uncertainties in the risk assessment ( e. g., inerspecies differences in response, intraspecies 17 differences in sensitivity).

Hazard Identification for hexavalent chromium Murine LLNA hazard data reported by Kimber et al. ( 1995) from five different laboratories reported EC3 values for hexavalent chromium using potassium dichromate as the test substance.

These data are shown below:

laboratory A B C D E Avg. US Avg country UK US UK US US area dose µ g/ cm2 5.12 11.56 13.24 10.77 11.2 10.36 11.15 Several published studies ( Nethercott et al., 1994; Basketter et al., 2001; Hansen et al., 2003)

have reported elicitation thresholds in persons previously sensitized to chromium. In the study by Nethercott et al., a 10% MET of 0.089 µ g/ cm2 was reported from results of patch testing using 54 human volunteers known to be sensitized to hexavalent chromium. The lowest dose tested in this study, 0.018 µ g/ cm2, also showed evidence of elicitation in one subject.

Basketter et al. ( 2001) reported elicitation reactions to potassium dichromate in 17 volunteers giving fully informed consent using closed patch and open appliation techniques. Skin pre treated with 0.2% sodium lauryl sulfate showed reaction to potassium dichromate at 1 ppm, with a doseresponse evident at the higher concentrations. Using open application techniques, 3 of 15 18 volunteers reacted to a level of 5 ppm potassium dichromate. To protect those already sensitized to chromium as well as to prevent development of additional chromium sensitive subjects, a chromium contamination level of 1 ppm was suggested on the basis of this study.

Hansen et al. ( 2003) compared the 10% MET for both hexavalent and trivalent chromium in 18 volunteers known to have chromium allergy. The results of this study indicated a 10% MET of 0.03 µ g/ cm2 for hexavalent chromium and 0.18 µ g/ cm2 for trivalet chromium, and suggest that both trivalent and hexavalent chromium should be taken into consideration when characterizing chromium skin allergy.

The data reported above using human volunteers are from subjects previously sensitized to hexavalent chromium and give some indication of an elicitation threshold, while the LLNA data reported in Kimber et al. ( 1995) show induction thresholds in the murine LLNA test.

Estimation of ` safe' area doses for protection from hexavalent chromium ACD can be performed in both cases using published methdologies. For the LLNA study results, uncertainty factors for interspecies extrapolation, intraspecies variation, product matrix, and exposure considerations should be taken into account. For the interspecies uncertainty factor, Griem et al. ( 2003)

proposed a factor of 3 based on comparison of human and murine data showing that sensitizing doses are within a factor of 3 of each other, and that skin penetration tends to be higher in rodents than in humans. An uncertainty factor of 10 is proposed for intraspecies variation in humans, as there are few data on induction thresholds in humans. A product matrix uncertainty factor of 10 is proposed for hexavalent chromium. The LLNA assay is performed using an acetone/ olive oil vehicle, while the wood preservative formulation containing hexavalent chromium is likely more 19 complex and could affect the availability and potency of the allergen. An exposure uncertainty factor of 10 is proposed based on uncertainty regarding the repeated dermal exposure that could occur to the treated wood and how this would affect the potency of hexavalent chromium as a dermal sensitizer. The total uncertainty factor from this analysis is 3000 applied to the calculated area dose from the average of 5 LLNA assays to yield a ` sensitization reference dose.'

This is illustrated below:

laboratory A B C D E Avg. US Avg country UK US UK US US area dose µ g/ cm2 5.12 11.56 13.24 10.77 11.2 10.36 11.15 interspecies extrapolation UF 3 3 3 3 3 3 3 intraspecies variation UF 10 10 10 10 10 10 10 matrix UF 10 10 10 10 10 10 10 exposure UF 10 10 10 10 10 10 10 S RfD µ g/ cm2 0.0017 0.0038 0.0044 0.0035 0.0037 0.0034 0.0038 The S RfD can then be compared to estimated or measured human exposure to determine if the Margin of Safety is adequate. If, as suggested by Griem et al. ( 2003) that the maximum uncertainty factor should be no greater than 1000, then the S RfD values shown above, using the maximum uncertainty factor of 1000, would be 0.005, 0.01, 0.013, 0.01, and 0.01 µ g/ cm2 respectively for the five studies, with an average U. S. value of 0.01 µ g/ cm2. 20 A similar approach can be applied to the MET values from the Nethercott et al., Hansen et al.,

and Basketter et al. studies. As the data are from human studies, the interspecies extrapolation factor could be reduced to 1. An intraspecies uncertainty factor of 3 is proposed based on the use of sensitized persons, as elicitation thresholds have been found to be less variable than induction thresholds. An uncertainty factor of 3 is also applied for the use of LOAEL values, as the studies were not designed for specific determination of a NOAEL. An uncertainty factor of 1 is proposed for exposure considerations, based on the use of a sensitized study group. The total uncertainty factor of 10 applied to the reported human LOAEL valuesof 0.018 µ g/ cm2 , 0.01 µ g/ cm2, and 0.03 µ g/ cm2, results in ` safe' area doses of 0.0018, 0.001, and 0.003 µ g/ cm2 for persons previously sensitized to hexavalent chromium.

Comparison of the values derived from the induction studies using the LLNA and the patch test data shows under the current scheme that induction and elicitation does for hexavalent chromium do not differ appreciably, consistent with the fact that hexavalent chromium is a potent sensitizer and that induction and elicitation doses will not differ widely, as discussed by Griem et al ( 2003). This factor could change from application of uncertainty factors of differing magnitude; a reasonable case has been presented using the available data.

Environmental Exposures Application of the experimental data to environmental exposures is also a significant aspect of the risk assessment, as for hexavalent chromium, there will be dermal contact not only with the treated wood product, but with soil in contact with or in proximity to the treated wood structure. 21 As the experimental hazard dose metric ( i. e., the area dose) for induction and/ or elicitation of dermal sensitization may differ according to the matrix of exposure, it is desirable to characterize as accurately as possible the influence of the exposure matrix variables on determination of an acceptable area dose level. For contact with a wood matrix into which a chemical allergen is incorporated, the Office of Pesticide Programs estimates a safe area dose from available scientific data and compares that level of concern to the estimated or measured level of exposure to calculate an acceptable Margin of Exposure. Variables that influence the calculation of the exposure to the chemical on the surface of wood include transfer efficiency of the chemical from the wood to the skin, number of dermal contact events, surface area of skin exposure, and level of the chemical on the surface of the wood. Approaches to assessing treated wood exposures have been considered recently by the FIFRA SAP in a December, 2003 meeting in which the SHEDS model was presented and considered as a probabilistic approach to assessing exposures to arsenic and chromium in treated wood, including children's exposures.

For determination of an acceptable area dose from contact with a chemical in a soil matrix, many of the variables are similar to the wood matrix. However, other soil matrix properties may have a greater impact on the transfer of the chemical from the soil to the skin. Additional variables are taken into account in calculating skin contact dose, such as skin surface area of contact, soil adherence to skin, contact frequency ( important for determination of children's potential hazard and risk), bioavailability of the chemical in soil, physio chemical properties of the soil ( i. e.

moisture content, soil type), valence or complex state of the chemical, and chemical solubility in sweat. Guidance for determination of acceptable soil levels for Superfund cleanup sites is found 22 at the following web address: http:// www. epa. gov/ superfund/ resources/ soil/ ssgmarch01. pdf. It is noted here that soil cleanup values estimated for dermal contact in the Superfund program are based upon systemic effects resulting from dermal exposures, although dermal sensitization effects should also be considered in the assessment.

Water also represents a matrix of exposure that is different than wood or soil, in that it represents a three dimensional matrix of contact ( i. e. µ g/ cm3) vs. a two dimensional matrix of contact ( i. e. µ g/ cm2). Activities such as showering represent exposure scenarios where potential dermal sensitization hazard may need to be characterized, but as with soil, other variables may influence the estimation of a safe area dose in this matrix. Thus, while the experimental hazard data for hexavalent chromium indicate that low levels are adequate to induce and/ or elicit sensitization, the actual concentration necessary for such reactions may differ according to the matrix in which the chromium is found.

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