[Federal Register Volume 81, Number 13 (Thursday, January 21, 2016)]
[Rules and Regulations]
[Pages 3304-3306]
[FR Doc No: 2016-00371]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2015-0081; Directorate Identifier 2014-NM-170-AD;
Amendment 39-18371; AD 2016-01-12]
RIN 2120-AA64

Airworthiness Directives; Bombardier, Inc. Airplanes

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Final rule.

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SUMMARY: We are adopting a new airworthiness directive (AD) for certain
Bombardier, Inc. Model BD-700-1A10 and BD-700-1A11 airplanes. This AD
was prompted by reports of fluid entry and accumulation in the aft
equipment bay. This AD requires modifying the aft equipment bay. We are
issuing this AD to prevent excessive quantities of flammable fluid
accumulation in the aft equipment bay. Flammable fluid entry and
accumulation in the aft equipment bay, in excessive quantities, could
exceed safe levels maintained by the drainage and ventilation system.

DATES: This AD becomes effective February 25, 2016.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in this AD as of February 25,
2016.

ADDRESSES: You may examine the AD docket on the Internet at http://www.regulations.gov/#!docketDetail;D=FAA-2015-0081; or in person at the
Docket Management Facility, U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC.
    For service information identified in this final rule, contact
Bombardier, Inc., 400 C[ocirc]te-Vertu Road West, Dorval, Qu[eacute]bec
H4S 1Y9, Canada; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>; email
<EMAIL_ADDRESS>Internet http://www.bombardier.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<PHONE_NUMBER>. It
is also available on the Internet at http://www.regulations.gov by
searching for and locating Docket No. FAA-2015-0081.

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

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 by adding an AD that would apply to certain Bombardier, Inc.
Model BD-700-1A10 and BD-700-1A11 airplanes. The NPRM published in the
Federal Register on January 26, 2015 (80 FR 3924). The NPRM was
prompted by reports of fluid entry and accumulation in the aft
equipment bay. The NPRM proposed to require modifying the aft equipment
bay. We are issuing this AD to prevent excessive quantities of
flammable fluid accumulation in the aft equipment bay. Flammable fluid
entry and accumulation in the aft equipment bay, in excessive
quantities, could exceed safe levels maintained by the drainage and
ventilation system.
    Transport Canada Civil Aviation, which is the aviation authority
for Canada, has issued Canadian Airworthiness Directive CF-2014-25,
dated August 7, 2014 (referred to after this as the Mandatory
Continuing Airworthiness Information, or ``the MCAI''), to correct an
unsafe condition for certain Bombardier, Inc. Model BD-700-1A10 and BD-
700-1A11 airplanes. The MCAI states:

    There have been two reports of fluid entry and accumulation in
the aft equipment bay. The leaked fluid in the first incident was
fuel and the fluid in the second incident was test dye. Further
investigation revealed that leaked fluid from the aft fuel tank
drain entered the bay through the slot in the door latch mechanism.
    Flammable fluid entry and accumulation in the aft equipment bay,
in excessive quantities, could exceed safe levels maintained by the
drainage and ventilation system.
    Bombardier Inc. has issued several Service Bulletins (SB) to
modify the Aft Equipment Bay by installing a cover to the door latch
mechanism in order to reduce the risk of fuel entry into it. This
[Canadian] AD mandates the incorporation of the applicable
Bombardier Inc. SBs to rectify this problem.

    You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov/#!documentDetail;D=FAA-2015-0081-0002.

Comments

    We gave the public the opportunity to participate in developing
this AD. We received no comments on the NPRM (80 FR 3924, January 26,
2015) or on the determination of the cost to the public.

Conclusion

    We reviewed the relevant data and determined that air safety and
the public interest require adopting this AD as proposed except for
minor editorial changes. We have determined that these minor changes:
     Are consistent with the intent that was proposed in the
NPRM (80 FR 3924, January 26, 2015) for correcting the unsafe
condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM (80 FR 3924, January 26, 2015).

Related Service Information Under 1 CFR Part 51

    Bombardier has issued the following service information:
     Bombardier Service Bulletin 700-1A11-52-019, dated March
29, 2012.
     Bombardier Service Bulletin 700-52-042, dated March 29,
2012.
     Bombardier Service Bulletin 700-52-5007, dated March 29,
2012.
     Bombardier Service Bulletin 700-52-6007, dated March 29,
2012.
    The service information describes procedures for the modification
of the aft equipment compartment door. 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.

Costs of Compliance

    We estimate that this AD affects 60 airplanes of U.S. registry.
    We also estimate that it will take about 8 work-hours per product
to comply with the basic requirements of this AD. The average labor
rate is $85 per work-hour. Required parts will cost about $720 per
product. Based on these figures, we estimate the cost of this AD on
U.S. operators to be $84,000, or $1,400 per product.
    According to the manufacturer, some of the costs of this AD may be
covered under warranty, thereby reducing the cost impact on affected
individuals. We do not control warranty coverage for affected
individuals. As a result, we have included all costs in our cost
estimate.

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 AD will not have federalism implications
under Executive Order 13132. This AD will 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 that this AD:
    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.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov/#!docketDetail;D=FAA-2015-0081; 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 AD, the
regulatory evaluation, any comments received, and other information.
The street address for the Docket Operations office (telephone 800-647-
5527) is in the ADDRESSES section.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 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):

2016-01-12 Bombardier, Inc. Airplanes: Amendment 39-18371. Docket
No. FAA-2015-0081; Directorate Identifier 2014-NM-170-AD.

(a) Effective Date

    This AD becomes effective February 25, 2016.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Bombardier, Inc. Model BD-700-1A10 and BD-
700-1A11 airplanes, certificated in any category, serial numbers
9001 through 9476 inclusive and 9998.

(d) Subject

    Air Transport Association (ATA) of America Code 52, Doors.

(e) Reason

    This AD was prompted by reports of fluid entry and accumulation
in the aft equipment bay. We are issuing this AD to prevent
excessive quantities of flammable fluid accumulation in the aft
equipment bay. Flammable fluid entry and accumulation in the aft
equipment bay, in excessive quantities, could exceed safe levels
maintained by the drainage and ventilation system.

(f) Compliance

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

(g) Modification

    Within 24 months after the effective date of this AD, modify the
aft equipment bay, in accordance with the Accomplishment
Instructions of the applicable service information specified in
paragraphs (g)(1) through (g)(4) of this AD.
    (1) For Model BD-700-1A10 airplanes, serial numbers 9002 through
9312 inclusive, 9314 through 9380 inclusive, and 9384 through 9429
inclusive: Bombardier Service Bulletin 700-52-042, dated March 29,
2012.

    (2) For Model BD-700-1A10 airplanes, serial numbers 9381 and
9432 through 9476 inclusive: Bombardier Service Bulletin 700-52-
6007, dated March 29, 2012.
    (3) For Model BD-700-1A11 airplanes, serial numbers 9127 through
9383 inclusive, 9389 through 9400 inclusive, 9404 through 9431
inclusive, and 9998: Bombardier Service Bulletin 700-1A11-52-019,
dated March 29, 2012.
    (4) For Model BD-700-1A11 airplanes, serial numbers 9386, 9401,
and 9445 through 9474 inclusive: Bombardier Service Bulletin 700-52-
5007, dated March 29, 2012.

(h) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager, New
York Aircraft Certification Office (ACO), ANE-170, FAA, has the
authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19,
send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the ACO, send it to ATTN: Program Manager, Continuing
Operational Safety, FAA, New York ACO, 1600 Stewart Avenue, Suite
410, Westbury, NY 11590; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.
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, New York ACO,
FAA; or Transport Canada Civil Aviation (TCCA); or Bombardier,
Inc.'s TCCA Design Approval Organization (DAO). If approved by the
DAO, the approval must include the DAO-authorized signature.

(i) Related Information

    Refer to Mandatory Continuing Airworthiness Information (MCAI)
Canadian Airworthiness Directive CF-2014-25, dated August 21, 2014,
for related information. This MCAI may be found in the AD docket on
the Internet at http://www.regulations.gov/#!documentDetail;D=FAA-
2015-0081-0002.

(j) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless this AD specifies otherwise.
    (i) Bombardier Service Bulletin 700-1A11-52-019, dated March 29,
2012.
    (ii) Bombardier Service Bulletin 700-52-042, dated March 29,
2012.
    (iii) Bombardier Service Bulletin 700-52-5007, dated March 29,
2012.
    (iv) Bombardier Service Bulletin 700-52-6007, dated March 29,
2012.
    (3) For service information identified in this AD, contact
Bombardier, Inc., 400 C[ocirc]te-Vertu Road West, Dorval,
Qu[eacute]bec H4S 1Y9, Canada; telephone<PHONE_NUMBER>; fax 514-855-
7401; email<EMAIL_ADDRESS>Internet http://www.bombardier.com.
    (4) 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
425-227-1221.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Renton, Washington, on December 31, 2015.
Philip Forde,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2016-00371 Filed 1-20-16; 8:45 am]
 BILLING CODE 4910-13-P


 ADVANCE \y63

	UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

	REGION III

1650 Arch Street

	Philadelphia, Pennsylvania  19103-2029

August 29, 2009

Mr. John Hanger, Secretary

Department of Environmental Protection

Rachel Carson State Office Building

P.O. Box 2063

Harrisburg, PA 17105-2063

Dear Secretary Hanger:

On March 11, 2009, U.S. Environmental Protection Agency (EPA) received a
revision to the Pennsylvania State Implementation Plan (SIP) from the
Department of Environmental Protection pertaining to amendments to
Subchapters B and C of Chapter 130 of 25 PaCode submitted by your March
4, 2009 letter.  EPA has determined that the submittal is
administratively and technically complete, and is reviewing it to
prepare a (Notice of Proposed Rulemaking (NPR).

If members of your staff have any questions, they may direct them to
Christopher Cripps, Air Quality Planning Branch, at<PHONE_NUMBER>.  He
is the principal contact for this rulemaking.

	Sincerely,

   /s/

          Diana Esher, Acting Director

                          			          Air Protection Division

cc:  Joyce Epps, PA-DEP

	Customer Service Hotline: 1-800-438-2474


[Federal Register: March 16, 2009 (Volume 74, Number 49)]
[Rules and Regulations]
[Page 11006-11009]
[DOCID:fr16mr09-4]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2009-0215; Directorate Identifier 2007-NM-278-AD;
Amendment 39-15850; AD 2009-06-13]
RIN 2120-AA64

Airworthiness Directives; Airbus Model A321-131 Airplanes

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Final rule; request for comments.

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SUMMARY: The FAA is adopting a new airworthiness directive (AD) for
certain Airbus Model A321-131 airplanes. This AD requires repetitive
ultrasonic inspections to detect cracks in the wing inner rear spars at
the attachment holes of the Main Landing Gear (MLG) forward pintle
fitting, the actuator cylinder anchorage fitting, and rib 5 fitting;
and repair of the sealant or repair of any crack. This AD results from
a finding that certain A321-131 airplanes may not reach the design life
goal due to differences in thickness of the inner rear spars and that
fatigue cracks may develop on inner rear spars starting from the
fastener holes for the attachment of gear rib 5, the forward pintle
fitting, and the actuating cylinder anchorage on these airplanes. We
are issuing this AD to detect and correct such fatigue cracks, which
could result in reduced structural integrity of the airplane.

DATES: This AD becomes effective March 31, 2009.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in the AD as of March 31,
2009.
    We must receive comments on this AD by April 15, 2009.

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 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
    For service information identified in this AD, contact Airbus,
Airworthiness Office--EAS, 1 Rond Point Maurice Bellonte, 31707 Blagnac
Cedex, France; fax +33 5 61 93 44 51; e-mail: account.airworth-
<EMAIL_ADDRESS>Internet http://www.airbus.com.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://
www.regulations.gov; 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 AD, the regulatory evaluation,
any comments received, and other information. The street address for
the Docket Office (telephone<PHONE_NUMBER>) is in the ADDRESSES section.
Comments will be available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Tim Dulin, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue, SW., Renton, Washington 98057-4056; telephone 425-
227-2141; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Community, notified us that
an unsafe condition may exist on certain Airbus Model A321-131
airplanes. EASA advises that two airplanes, manufacturer serial number
(MSN) 364 and 385, may not reach the design life goal due to
differences in thickness of the inner rear spars and that fatigue
cracks may develop on inner rear spars starting from the fastener holes
for the attachment of gear rib 5, the forward pintle fitting, and the
actuating cylinder anchorage on these airplanes. This condition, if not
detected and corrected, could result in reduced structural integrity of
the airplane.

Other Relevant Rulemaking

    We previously issued airworthiness directive (AD) 2006-04-11 R1,
amendment 39-14628 (71 FR 32807, June 7, 2006), applicable to certain
Airbus Model A321-111, -112, and -131 airplanes; MSNs 364 and 385 were
specifically excluded. That AD requires repetitive inspections to
detect fatigue cracking in the area surrounding certain attachment
holes of the forward pintle fittings of the main landing gear and the
actuating cylinder anchorage fittings on the inner rear spars; and
repair, if necessary. That AD also provides for optional terminating
action for the repetitive inspections, adds inspections of three
additional mounting holes, and revises the inspection thresholds
required by an earlier AD.

Relevant Service Information

    Airbus has issued Service Bulletin A320-57-1126, dated August 8,
2003. The service bulletin describes procedures for doing repetitive
ultrasonic inspections to detect cracks in the wing inner rear spars at
the attachment holes of the MLG forward pintle fitting, the actuator
cylinder anchorage fitting, and rib 5 fitting; and repairing of the
sealant if no cracks are found or contacting Airbus for repair
instructions if any cracks are found.
    The EASA mandated the service information and issued airworthiness
directive 2007-0162, dated June 12, 2007 (referred to after this as
``the MCAI''), to ensure the continued airworthiness of these airplanes
in the European Union. The EASA airworthiness directive also includes
requirements for other Model A321 airplanes; however, FAA AD 2006-04-11
R1, described previously, adequately addresses these other requirements
(as specified in paragraph 1 of the MCAI).

FAA's Determination and Requirements of This 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.
    Therefore, we are issuing this AD to detect and correct fatigue
cracks on the wing inner rear spars. This AD requires accomplishing the
actions specified in the service information described previously,
except as discussed under ``Difference Between the AD and Service
Bulletin.''

Difference Between the AD and Service Bulletin

    The service bulletin specifies to contact the manufacturer for
instructions on how to repair certain conditions, but this AD requires
repairing those conditions using a method approved by the FAA or EASA
(or its delegated agent). In light of the type of repair that is
required to address the unsafe condition, and consistent with existing
bilateral airworthiness agreements, we have determined that, for this
AD, a repair approved by the FAA or EASA (or its delegated agent) would
be acceptable for compliance with this AD.

Costs of Compliance

    None of the airplanes affected by this action are on the U.S.
Register. All airplanes affected by this AD are currently operated by
non-U.S. operators under foreign registry; therefore, they are not
directly affected by this AD action. However, we consider this AD
necessary to ensure that the unsafe condition is addressed if any
affected airplane is imported and placed on the U.S. Register in the
future.
    The following table provides the estimated costs to comply with
this AD for any affected airplane that might be imported and placed on
the U.S. Register in the future.

                                                                     Estimated Costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                            Average labor
                 Action                      Work hours     rate per hour           Parts cost                          Cost per airplane
--------------------------------------------------------------------------------------------------------------------------------------------------------
Inspection, per inspection cycle........               46              $80  None......................  $3,680 per inspection cycle.
--------------------------------------------------------------------------------------------------------------------------------------------------------

FAA's Determination of the Effective Date

    No airplane affected by this AD is currently on the U.S. Register.
Therefore, providing notice and opportunity for public comment is
unnecessary before this AD is issued, and this AD may be made effective
in less than 30 days after it is published in the Federal Register.

Comments Invited

    This AD is a final rule that involves requirements affecting flight
safety, and we did not provide you with notice and an opportunity to
provide your comments before it becomes effective. However, we invite
you to send any written data, views, or arguments about this AD. Send
your comments to an address listed under the ADDRESSES section. Include
``Docket No. FAA-2009-0215; Directorate Identifier 2007-NM-278-AD'' at
the beginning of your comments. We specifically invite comments on the
overall regulatory, economic, environmental, and energy aspects of this
AD. We will consider all comments received by the closing date and may
amend this AD because of 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 AD.

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 have determined that this AD will not have federalism
implications under Executive Order 13132. This AD will 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 that the regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979); and
    3. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared a regulatory evaluation of the estimated costs to
comply with this AD and placed it in the AD docket. See the ADDRESSES
section for a location to examine the regulatory evaluation.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

0
Accordingly, under the authority delegated to me by the Administrator,
the FAA amends 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 Federal Aviation Administration (FAA) amends Sec.  39.13 by
adding the following new airworthiness directive (AD):

2009-06-13 Airbus: Amendment 39-15850. Docket No. FAA-2009-0215;
Directorate Identifier 2007-NM-278-AD.

Effective Date

    (a) This AD becomes effective March 31, 2009.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to Airbus Model A321-131 airplanes,
certificated in any category, manufacturer serial numbers (MSNs) 364
and 385.

Subject

    (d) Air Transport Association (ATA) of America Code 57: Wings.

Unsafe Condition

    (e) This AD results from a finding that certain A321-131
airplanes may not reach the design life goal due to differences in
thickness of the inner rear spars and that fatigue cracks may
develop on inner rear spars starting from the fastener holes for the
attachment of gear rib 5, the forward pintle fitting, and the
actuating cylinder anchorage on these airplanes. We are issuing this
AD to detect and correct fatigue cracks on the wing inner rear
spars, which could result in reduced structural integrity of the
airplane.

Compliance

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

Repetitive Inspections

    (g) At the later of the times specified in paragraphs (g)(1) and
(g)(2) of this AD, do an ultrasonic inspection to detect cracks of
the left-hand and right-hand wing inner rear spars at the attachment
holes of the main landing gear (MLG) forward pintle fitting, the
actuator cylinder anchorage fitting, and gear rib 5 fitting, in
accordance with the Accomplishment Instructions of Airbus Service
Bulletin A320-57-1126, dated August 8, 2003. Repeat the inspection
thereafter at intervals not to exceed 3,600 flight cycles or 5,600
flight hours, whichever occurs first.
    (1) Before the accumulation of 24,000 total flight cycles or
39,400 total flight hours from first flight, whichever occurs first.
    (2) Within 6 months after the effective date of this AD.

Repair

    (h) If no crack is detected during any inspection required by
paragraph (g) of this AD, before further flight, repair the sealant
in the inspected areas in accordance with the Accomplishment
Instructions of Airbus Service Bulletin A320-57-1126, dated August
8, 2003.
    (i) If any crack is detected during any inspection required by
paragraph (g) of this AD, before further flight, repair the crack
using a method approved by either the Manager, International Branch,
ANM-116, Transport Airplane Directorate, FAA; or the European
Aviation Safety Agency (EASA) (or its delegated agent).

Alternative Methods of Compliance (AMOCs)

    (j) The Manager, International Branch, FAA, has the authority to
approve AMOCs for this AD, if requested using the procedures found
in 14 CFR 39.19. Send information to ATTN: Tim Dulin, Aerospace
Engineer, International Branch, ANM-116, Transport Airplane
Directorate, FAA, 1601 Lind Avenue, SW., Renton, Washington 98057-
4056; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>. Before using any
approved AMOC on any airplane to which the AMOC applies, notify your
principal maintenance inspector (PMI) or principal avionics
inspector (PAI), as appropriate, or lacking a principal inspector,
your local Flight Standards District Office.

Related Information

    (k) EASA airworthiness directive 2007-0162, dated June 12, 2007,
also addresses the subject of this AD.

Material Incorporated by Reference

    (l) You must use Airbus Service Bulletin A320-57-1126, dated
August 8, 2003, to do the actions required by this AD, unless the AD
specifies otherwise.
    (1) The Director of the Federal Register approved the
incorporation by reference of this service information under 5
U.S.C. 552(a) and 1 CFR part 51.
    (2) For service information identified in this AD, contact
Airbus, Airworthiness Office--EAS, 1 Rond Point Maurice Bellonte,
31707 Blagnac Cedex, France; fax +33 5 61 93 44 51; e-mail:
<EMAIL_ADDRESS>Internet http://www.airbus.com.
    (3) You may review copies of the service information that is
incorporated by reference at the FAA, Transport Airplane
Directorate, 1601 Lind Avenue, SW., Renton, Washington. For
information on the availability of this material at the FAA, call
425-227-1221 or<PHONE_NUMBER>.
    (4) You may also review copies of the service information at the
National Archives and Records Administration (NARA). For information
on the availability of this material at NARA, call<PHONE_NUMBER>, or
go to: http://www.archives.gov/federal_register/code_of_federal_
regulations/ibr_locations.html.

    Issued in Renton, Washington, on February 27, 2009.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
 [FR Doc. E9-5009 Filed 3-13-09; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register Volume 86, Number 222 (Monday, November 22, 2021)]
[Notices]
[Pages 66369-66373]
[FR Doc No: 2021-25352]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-93586; File No. SR-NYSEArca-2021-98]

Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change To Amend Rule 6.64-
O To Provide an Option for OTP Holders and OTP Firms To Instruct the
Exchange To Cancel Marketable Orders If a Series Is Not Opened Within a
Specified Time Period

November 16, 2021.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (the ``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby
given that on November 12, 2021, NYSE Arca, Inc. (``NYSE Arca'' or the
``Exchange'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I and II
below, which Items have been prepared by the self-regulatory
organization. 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\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

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

    The Exchange proposes to amend Rule 6.64-O (OX Opening Process) to
provide an option for OTP Holders and OTP Firms to instruct the
Exchange to cancel Marketable orders if a series is not opened within a
specified time period. The proposed rule change is available on the
Exchange's website at www.nyse.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 self-regulatory organization
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 those 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 the
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange proposes to amend Rule 6.64-O (OX Opening Process) to
provide an option for OTP Holders and OTP Firms to instruct the
Exchange to cancel Marketable \4\ orders if a series is not opened
within a specified time period. The Exchange notes that this proposal
is substantively identical to a recent rule change on NYSE American,
LLC.\5\
---------------------------------------------------------------------------

    \4\ The term ``Marketable'' is defined in Rule 6.1A-O(a)(7) to
mean, for a Limit Order, the price matches or crosses the NBBO on
the other side of the market. Market orders are always considered
marketable.
    \5\ See Securities Exchange Act Release No. 92668 (August 13,
2021), 86 FR 46746 (August 19, 2021) (SR-NYSEAMER-2021-36) (Notice
of filing and immediate effectiveness of proposed rule change to
amend Rule 952NY to provide an option for ATP Holders to instruct
the Exchange to cancel marketable orders if a series is not opened
within a specified time period) (``NYSE American Filing'').
---------------------------------------------------------------------------

    Rule 6.64-O sets forth the Exchange's process for opening and
reopening a series for trading. Rule 6.64-O(b) provides that the
Exchange will accept market and limit orders for inclusion in the
opening auction process (``Auction Process'') until such time as the
Auction Process is initiated in that option series. As further provided
for in Rule 6.64-O(b), once the primary market for the underlying
security disseminates a quote and a trade that is at or within the
quote, the Exchange will open the related option series automatically
based on the principles and procedures set forth in paragraphs (A)-(F)
of Rule 6.64-O(b). However, as described in Rule 6.64-O(b)(D), the
Exchange will not conduct an Auction Process if the bid-ask
differential for that series is not within an acceptable range, i.e.,
is not within the bid-ask differential guidelines established in Rule
6.37-O(b)(4). Because Rule 6.64-O(b)(D) cross-references the bid-ask
differential requirement of Rule 6.37-O(b)(4), which relates to the
obligations of Market Makers in appointed classes, the Exchange will
not open a series for trading if Market Makers have not entered
quotations in a series that are within such bid-ask differentials. If a
series does not open for trading, market and limit orders entered in
advance of the Auction Process will remain in the Consolidated Book and
will not be routed, even if another exchange opens that series for
trading and such orders become Marketable against an away market NBBO.
    The Exchange proposes to amend Rule 6.64-O to provide OTP Holders
and OTP Firms with an option to instruct the Exchange to cancel their
Marketable orders if an option series has not been opened within a
specified time period. As proposed, new subparagraph (d) to Rule 6.64-O
\6\ would provide that an OTP Holder or OTP Firm may instruct the
Exchange to cancel all Marketable orders in a series, including GTC
Orders, if that series has not opened within a designated time period
after the Exchange receives notification that the primary market for
the underlying security has disseminated a quote and a trade that is at
or within the quote. This proposed change is designed to provide OTP
Holders and OTP Firms that electronically enter orders before Core
Trading Hours \7\ begin in a multitude of option series with an
optional risk protection mechanism for the Exchange to automatically
cancel Marketable orders on their behalf. OTP Holders and OTP Firms
could submit requests to cancel such orders themselves, but would have
to monitor which series have been opened on the Exchange. The proposed
optional functionality would reduce operational risk for OTP Holders
and OTP Firms that sent orders in multiple series by providing them
with a bulk cancel feature that would instruct the Exchange to cancel
orders on their behalf if a series has not been opened by a specified
time. Specifically, rather than have Marketable orders remain
unexecuted on the Consolidated Book if the option series has not opened
on the Exchange within a specified time period, OTP Holders and OTP
Firms would have the option to instruct the Exchange to cancel such
orders back to the OTP Holder/OTP Firm. Once cancelled back, the OTP
Holder/OTP Firm could choose to re-enter such orders on an exchange
that has opened that series for trading.
---------------------------------------------------------------------------

    \6\ The Exchange proposes a non-substantive amendment to Rule
6.64-O to renumber current subparagraph (d) to that Rule as
subparagraph (e).
    \7\ The term ``Core Trading Hours'' is defined in Rule 6.1A-
O(a)(3) to mean the regular trading hours for business set forth in
the rules of the primary markets underlying those option classes
listed on the Exchange.
---------------------------------------------------------------------------

    The Exchange further proposes to provide that the Exchange would
not cancel any Marketable orders received after the designated time
period ends, even if the series has not yet opened. The Exchange
believes that if an OTP Holder or OTP Firm sends an order in an option
series to the Exchange after Core Trading Hours begin, and more than
the designated time period after the primary market for the underlying
security has opened (i.e., the series open trigger), such OTP Holder/
OTP Firm should be aware that the Exchange has not opened that series
for trading when it sends the order to the Exchange, and therefore
intends for such order to be sent to the Exchange even though it has
not yet opened that series for trading.
    Proposed Rule 6.64-O(d) would also provide that the designated time
period would be two minutes, unless determined otherwise by the
Exchange and announced to OTP Holders and OTP Firms via Trader Update,
in which case the designated time period would not be greater than five
minutes. The Exchange believes that a two-minute period would provide
time for Market Makers to update their quotes after the Exchange
receives the series open trigger so that the bid-ask differential in an
option series can be within an acceptable range and therefore the
series can open for trading on the Exchange. Specifically, the Exchange
has observed that on a typical trading day, nearly 98% of all series
are opened by 9:32 a.m. Eastern Time, and nearly 99% of all series are
opened by 9:35 a.m. Eastern Time. By waiting two minutes before
cancelling orders, the Exchange believes that the majority of series
would be opened, thereby minimizing the number of series where there
would be a bulk cancel of Marketable orders. In addition, OTP Holders
and OTP Firms that want to cancel orders less than two minutes after
the series open trigger would still be able to submit requests to
cancel individual orders. The Exchange further believes that it is
appropriate to provide the Exchange with the ability to adjust the
designated time period via Trader Update to no more than five minutes
because it would provide additional flexibility for the Exchange to
respond to the needs of OTP Holders and OTP Firms to implement the
instruction to cancel Marketable orders on a different time basis. The
Exchange believes that a cap of five minutes would be reasonable
because very few series remain

unopened five minutes after the series open trigger. The Exchange notes
that this is an optional instruction, and therefore no OTP Holder nor
OTP Firm is required to use this proposed new risk feature. The
Exchange further notes that Exchange flexibility in connection with
designating time periods for risk limitation measures is consistent
with current Exchange rules.\8\
---------------------------------------------------------------------------

    \8\ See, e.g., Commentary .03 to Rule 6.40-O (Risk Limitation
Mechanism) (providing that the Exchange will ``specify via Trader
Update any applicable time period(s) for the Risk Limitation
Mechanisms; provided, however, that the Exchange will not specify a
time period of less than 100 milliseconds, inclusive of the duration
of any trading halt occurring within that time''). The Exchange also
provides for flexibility in its rules for other risk mechanism
parameters. See, e.g., Rule 6.60-O(b) (``Unless determined otherwise
by the Exchange and announced to OTP Holders and OTP Firms via
Trader Update, the specified percentage shall be as follows: 100%
for the contra-side NBB or NBO priced at or below $1.00; and 50% for
the contra-side NBB or NBO priced above $1.00.'')
---------------------------------------------------------------------------

    Finally, proposed Rule 6.64-O(d) would provide that this
instruction would not be available for orders entered by Floor Brokers
via the Electronic Order Capture System.\9\ The current EOC provider
could not systemically apply the proposed optional instruction on a
firm-by firm basis and therefore it would not be available to
individual Floor Brokers. The Exchange believes that because of the
unique role of Floor Brokers on the Exchange to provide manual, high-
touch services on behalf of customers, Floor Brokers should not need
this optional feature. Specifically, unlike an off-Floor OTP Holder/OTP
Firm that may be relying on an algorithm to send orders in a multitude
of series, a Floor Broker that provides high-touch services would be
present on the Trading floor and in a position to monitor whether the
Exchange has opened a series, and if not, whether to cancel an order
that becomes Marketable.
---------------------------------------------------------------------------

    \9\ As defined in Rule 6.1-O(b)(39), the term ``Electronic Order
Capture System'' or ``EOC'' means the Exchange's electronic audit
trail and order tracking system that provides an accurate time-
sequenced record of all orders and transactions on the Exchange. As
further defined, the EOC includes the electronic communications
interface between EOC booth terminals and the Floor Broker Hand Held
applications and also contains an electronic order entry screen.
---------------------------------------------------------------------------

    The Exchange will announce via Trader Update when this proposed
optional feature will be available, which, subject to effectiveness of
this proposed rule change, the Exchange anticipates will be in the
fourth quarter of 2021.
2. Statutory Basis
    For the reasons set forth above, the Exchange believes the proposed
rule change is consistent with Section 6(b) of the Act \10\ in general,
and furthers the objectives of Sections 6(b)(4) and (5) of the Act,\11\
in that it is designed to promote just and equitable principles of
trade, 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.
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78f(b).
    \11\ 15 U.S.C. 78f(b)(4) and (5).
---------------------------------------------------------------------------

    The Exchange believes that the proposed rule change would remove
impediments to and perfect the mechanism of a free and open market and
a national market system because it is designed to provide OTP Holders
and OTP Firms with an optional risk protection mechanism to instruct
the Exchange to cancel Marketable orders in an option series on their
behalf if that series has not opened on the Exchange within a specified
time period. The Exchange does not open a series if Market Makers have
not quoted within the acceptable range of bid-ask differentials as
specified in Rule 6.37-O(b)(4). However, it is possible that another
exchange, with different opening process rules, could have opened that
series for trading even if the Exchange does not. If an order that an
OTP Holder or OTP Firm sent to the Exchange before Core Trading Hours
begins becomes Marketable on another exchange before the Exchange opens
that series for trading, such OTP Holder/OTP Firm could choose to
cancel the order and then send it to the other exchange. By providing
OTP Holders and OTP Firms with an option to instruct the Exchange to
cancel their Marketable orders in a series under the specified
circumstances, the Exchange would perform this monitoring function on
behalf of OTP Holders and OTP Firms, thereby reducing their operational
risk.
    The Exchange believes that it would remove impediments to and
perfect the mechanism of a free and open market and a national market
system to provide that such instructions would not be applicable to
Marketable orders received after the designated time period ends
because the Exchange believes that OTP Holders and OTP Firms that send
orders to the Exchange more than a specified period after series open
trigger should be aware that the Exchange has not yet opened that
series for trading. Therefore, any orders sent after that designated
time period ends were likely purposefully directed to the Exchange even
though the Exchange has not yet opened that series for trading.
    The Exchange believes that the proposed designated time period of
two minutes would remove impediments to and perfect the mechanism of a
free and open market and a national market system because it is
designed to provide time for Market Makers to update their quotes so
that the bid-ask differential in an option series is within an
acceptable range and therefore the series can open for trading on the
Exchange. The Exchange believes that the proposed two-minute period is
reasonable because on a typical trading day, approximately 98% of all
series that trade on the Exchange are open. OTP Holders and OTP Firms
that want to cancel orders less than two minutes after the series open
trigger would still be able to submit requests to cancel individual
orders. The Exchange further believes that providing the Exchange with
flexibility to change the designated time period via Trader Update,
provided that it would never be longer than five minutes, would enable
the Exchange to respond to the needs of OTP Holders and OTP Firms to
implement the instruction to cancel Marketable orders on a different
time basis. The Exchange believes that the proposed cap of five minutes
would remove impediments to and perfect the mechanism of a free and
open market and a national market system because on a typical day,
approximately 99% of all series are opened by 9:35 a.m. Eastern Time.
The Exchange further notes that this proposed risk mechanism would be
optional, and therefore OTP Holders and OTP Firms would not be required
to request that the Exchange cancel unexecuted Marketable orders on
their behalf if a series has not opened within the designated time
period. In addition, Exchange flexibility in connection with
designating time periods for risk limitation measures is consistent
with current Exchange rules.\12\
---------------------------------------------------------------------------

    \12\ See supra note 8.
---------------------------------------------------------------------------

    Finally, the Exchange believes that the proposal that the optional
instruction would not be available for orders entered by Floor Brokers
via the EOC would remove impediments to and perfect the mechanism of a
free and open market and a national market system because the current
EOC provider could not systemically apply the proposed optional
instruction on a firm-by firm basis. The instruction could therefore
not be segregated by individual Floor Brokers that each use the EOC.
The Exchange believes that because of the unique role of Floor Brokers
on the Exchange to provide manual, high-touch services on behalf of
customers, Floor Brokers should not need this optional bulk-cancel
feature. Specifically, unlike an off-Floor OTP

Holder/OTP Firm that may be relying on an algorithm to send orders in a
multitude of series, a Floor Broker that provides high-touch services
would be present on the Trading floor and in a position to monitor
whether the Exchange has opened a series, and if not, whether to cancel
an order that becomes Marketable.

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act. The Exchange does not
believe the proposed rule change would impose any burden on intermarket
competition, as the proposed rule change is designed to provide an
option for OTP Holders and OTP Firms to instruct the Exchange to cancel
Marketable orders if an option series does not open on the Exchange
within a designated time period. The Exchange believes that the
proposed rule change would promote intermarket competition because if
the Exchange cancels such orders on the instruction of an OTP Holder/
OTP Firm, such OTP Holder/OTP Firm could then choose to route such
orders to another exchange that has opened the option series for
trading.
    The Exchange does not believe that the proposed rule change would
impose any burden on intramarket competition that is not necessary or
appropriate in furtherance of the purposes of the Act because the
proposed rule change provides for optional functionality. OTP Holders
and OTP Firms would not be required to use this functionality. In
addition, the Exchange believes that because of the unique role of
Floor Brokers on the Exchange to provide manual, high-touch services on
behalf of customers, Floor Brokers should not need this optional bulk-
cancel feature and it would not impose any undue burden on intramarket
competition not to provide this optional feature to Floor Brokers.
Specifically, unlike an off-Floor OTP Holder/OTP Firm that may be
relying on an algorithm to send orders in a multitude of series, a
Floor Broker that provides high-touch services would be present on the
Trading floor and in a position to monitor whether the Exchange has
opened a series, and if not, whether to cancel an order that becomes
Marketable.

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

    No written comments were solicited or received with respect to the
proposed rule change.

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

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A) of the Act \13\ and Rule 19b-
4(f)(6) thereunder.\14\
---------------------------------------------------------------------------

    \13\ 15 U.S.C. 78s(b)(3)(A).
    \14\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change, along
with a brief description and text of the proposed rule change, at
least five business days prior to the date of filing of the proposed
rule change, or such shorter time as designated by the Commission.
The Exchange has satisfied this requirement.
---------------------------------------------------------------------------

    A proposed rule change filed under Rule 19b-4(f)(6) \15\ normally
does not become operative prior to 30 days after the date of the
filing. However, pursuant to Rule 19b-4(f)(6)(iii),\16\ the Commission
may designate a shorter time if such action is consistent with the
protection of investors and the public interest. The Exchange has
requested that the Commission waive the 30-day operative delay so that
the proposed rule change may become operative prior to 30 days after
the date of the filing. The Exchange states that waiver of the
operative delay would be consistent with the protection of investors
and the public interest because the proposed rule change, as described
above, would offer OTP Holders and OTP Firms an additional, and
optional, risk limitation feature to instruct the Exchange to cancel
their Marketable orders if the Exchange does not open an option series
within a designated time frame. The Exchange further states that the
technology supporting the proposed rule change will be available prior
to 30 days after the date of the filing, and the Exchange seeks to
implement the proposed rule change without delay. For these reasons,
the Commission believes that waiver of the 30-day operative delay is
consistent with the protection of investors and the public interest.
Accordingly, the Commission hereby waives the operative delay and
designates the proposed rule change operative upon filing.\17\
---------------------------------------------------------------------------

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

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings to
determine whether the proposed rule change should be approved or
disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
File Number SR-NYSEArca-2021-98 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-NYSEArca-2021-98. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE,

Washington, DC 20549 on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of the filing also will be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change. Persons submitting
comments are cautioned that we do not redact or edit personal
identifying information from comment submissions. You should submit
only information that you wish to make available publicly. All
submissions should refer to File Number SR-NYSEArca-2021-98, and should
be submitted on or before December 13, 2021.

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

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

J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2021-25352 Filed 11-19-21; 8:45 am]
BILLING CODE 8011-01-P


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[Federal Register Volume 79, Number 181 (Thursday, September 18, 2014)]
[Notices]
[Pages 56102-56104]
[FR Doc No: 2014-22264]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2014-0008]

Qualification of Drivers; Exemption Applications; Vision

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of final disposition.

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

SUMMARY: FMCSA announces its decision to exempt 5 individuals from the
vision requirement in the Federal Motor Carrier Safety Regulations
(FMCSRs). They are unable to meet the vision requirement in one eye for
various reasons. The exemptions will enable these individuals to
operate commercial motor vehicles (CMVs) in interstate commerce without
meeting the prescribed vision requirement in one eye. The Agency has
concluded that granting these exemptions will provide a level of safety
that is equivalent to or greater than the level of safety maintained
without the exemptions for these CMV drivers.

DATES: The exemptions were granted August 19, 2014. The exemptions
expire on August 19, 2016.

FOR FURTHER INFORMATION CONTACT: Elaine M. Papp, R.N., Chief, Medical
Programs Division,<PHONE_NUMBER><EMAIL_ADDRESS>FMCSA,
Department of Transportation, 1200 New Jersey Avenue SE., Room W64-224,
Washington, DC 20590-0001. Office hours are from 8:30 a.m. to 5 p.m.,
Monday through Friday, except Federal holidays. If you have questions
on viewing or submitting material to the docket, contact Docket
Services, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Electronic Access

    You may see all the comments online through the Federal Document
Management System (FDMS) at http://www.regulations.gov.
    Docket: For access to the docket to read background documents or
comments, go to http://www.regulations.gov and/or Room W12-140 on the
ground level of the West Building, 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.
    Privacy Act: Anyone may search the electronic form of all comments
received into any of DOT's dockets by the name of the individual
submitting the comment (or of the person signing the comment, if
submitted on behalf of an association, business, labor union, or other
entity). You may review DOT's Privacy Act Statement for the Federal
Docket Management System (FDMS) published in the Federal Register on
January 17, 2008 (73 FR 3316).

II. Background

    On July 17, 2014, FMCSA published a notice of receipt of exemption
applications from certain individuals, and requested comments from the
public (79 FR 41737). That notice listed 5 applicants' case histories.
The 5 individuals applied for exemptions from the vision requirement in
49 CFR 391.41(b)(10), for drivers who operate CMVs in interstate
commerce.
    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption
for a 2-year period if it finds ``such exemption would likely achieve a
level of safety that is equivalent to or greater than the level that
would be achieved absent such exemption.'' The statute also allows the
Agency to renew exemptions at the end of the 2-year period.
Accordingly, FMCSA has evaluated the 5 applications on their merits and
made a determination to grant exemptions to each of them.

III. Vision and Driving Experience of the Applicants

    The vision requirement in the FMCSRs provides:
    A person is physically qualified to drive a commercial motor
vehicle if that person has distant visual acuity of at least 20/40
(Snellen) in each eye without corrective lenses or visual acuity
separately corrected to 20/40 (Snellen) or better with corrective
lenses, distant binocular acuity of a least 20/40 (Snellen) in both
eyes with or without corrective lenses, field of vision of at least
70[deg] in the horizontal meridian in each eye, and the ability to
recognize the colors of traffic signals and devices showing red, green,
and amber (49 CFR 391.41(b)(10)).
    FMCSA recognizes that some drivers do not meet the vision
requirement but have adapted their driving to accommodate their vision
limitation and demonstrated their ability to drive safely. The 5
exemption applicants listed in this notice are in this category. They
are unable to meet the vision requirement in one eye for various
reasons, including strabismus, cataract, optic nerve damage, complete
loss of vision, corneal scar, Coats' disease, and macular scar. In most
cases, their eye conditions were not recently developed. Four of the
applicants were either born with their vision impairments or have had
them since childhood.
    The one individual that sustained his vision condition as an adult
has had it for 5 years.
    Although each applicant has one eye which does not meet the vision
requirement in 49 CFR 391.41(b)(10), each has at least 20/40 corrected
vision in the other eye, and in a doctor's opinion, has sufficient
vision to perform all the tasks necessary to operate a CMV. Doctors'
opinions are supported by the applicants' possession of valid
commercial driver's licenses (CDLs) or non-CDLs to operate CMVs. Before

issuing CDLs, States subject drivers to knowledge and skills tests
designed to evaluate their qualifications to operate a CMV.
    All of these applicants satisfied the testing requirements for
their State of residence. By meeting State licensing requirements, the
applicants demonstrated their ability to operate a CMV, with their
limited vision, to the satisfaction of the State.
    While possessing a valid CDL or non-CDL, these 5 drivers have been
authorized to drive a CMV in intrastate commerce, even though their
vision disqualified them from driving in interstate commerce. They have
driven CMVs with their limited vision in careers ranging from 5 to 38
years. In the past 3 years, none of the drivers were involved in
crashes and none were convicted for moving violations in a CMV.
    The qualifications, experience, and medical condition of each
applicant were stated and discussed in detail in the July 17, 2014
notice (79 FR 41737).

IV. Basis for Exemption Determination

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption
from the vision requirement in 49 CFR 391.41(b)(10) if the exemption is
likely to achieve an equivalent or greater level of safety than would
be achieved without the exemption. Without the exemption, applicants
will continue to be restricted to intrastate driving. With the
exemption, applicants can drive in interstate commerce. Thus, our
analysis focuses on whether an equal or greater level of safety is
likely to be achieved by permitting each of these drivers to drive in
interstate commerce as opposed to restricting him or her to driving in
intrastate commerce.
    To evaluate the effect of these exemptions on safety, FMCSA
considered the medical reports about the applicants' vision as well as
their driving records and experience with the vision deficiency.
    To qualify for an exemption from the vision requirement, FMCSA
requires a person to present verifiable evidence that he/she has driven
a commercial vehicle safely with the vision deficiency for the past 3
years. Recent driving performance is especially important in evaluating
future safety, according to several research studies designed to
correlate past and future driving performance. Results of these studies
support the principle that the best predictor of future performance by
a driver is his/her past record of crashes and traffic violations.
Copies of the studies may be found at Docket Number FMCSA-1998-3637.
    FMCSA believes it can properly apply the principle to monocular
drivers, because data from the Federal Highway Administration's (FHWA)
former waiver study program clearly demonstrate the driving performance
of experienced monocular drivers in the program is better than that of
all CMV drivers collectively (See 61 FR 13338, 13345, March 26, 1996).
The fact that experienced monocular drivers demonstrated safe driving
records in the waiver program supports a conclusion that other
monocular drivers, meeting the same qualifying conditions as those
required by the waiver program, are also likely to have adapted to
their vision deficiency and will continue to operate safely.
    The first major research correlating past and future performance
was done in England by Greenwood and Yule in 1920. Subsequent studies,
building on that model, concluded that crash rates for the same
individual exposed to certain risks for two different time periods vary
only slightly (See Bates and Neyman, University of California
Publications in Statistics, April 1952). Other studies demonstrated
theories of predicting crash proneness from crash history coupled with
other factors. These factors--such as age, sex, geographic location,
mileage driven and conviction history--are used every day by insurance
companies and motor vehicle bureaus to predict the probability of an
individual experiencing future crashes (See Weber, Donald C.,
``Accident Rate Potential: An Application of Multiple Regression
Analysis of a Poisson Process,'' Journal of American Statistical
Association, June 1971). A 1964 California Driver Record Study prepared
by the California Department of Motor Vehicles concluded that the best
overall crash predictor for both concurrent and nonconcurrent events is
the number of single convictions. This study used 3 consecutive years
of data, comparing the experiences of drivers in the first 2 years with
their experiences in the final year.
    Applying principles from these studies to the past 3-year record of
the 5 applicants, none of the drivers were involved in crashes and none
were convicted of moving violations in a CMV. All the applicants
achieved a record of safety while driving with their vision impairment,
demonstrating the likelihood that they have adapted their driving
skills to accommodate their condition. As the applicants' ample driving
histories with their vision deficiencies are good predictors of future
performance, FMCSA concludes their ability to drive safely can be
projected into the future.
    We believe that the applicants' intrastate driving experience and
history provide an adequate basis for predicting their ability to drive
safely in interstate commerce. Intrastate driving, like interstate
operations, involves substantial driving on highways on the interstate
system and on other roads built to interstate standards. Moreover,
driving in congested urban areas exposes the driver to more pedestrian
and vehicular traffic than exists on interstate highways. Faster
reaction to traffic and traffic signals is generally required because
distances between them are more compact. These conditions tax visual
capacity and driver response just as intensely as interstate driving
conditions. The veteran drivers in this proceeding have operated CMVs
safely under those conditions for at least 3 years, most for much
longer. Their experience and driving records lead us to believe that
each applicant is capable of operating in interstate commerce as safely
as he/she has been performing in intrastate commerce. Consequently,
FMCSA finds that exempting these applicants from the vision requirement
in 49 CFR 391.41(b)(10) is likely to achieve a level of safety equal to
that existing without the exemption. For this reason, the Agency is
granting the exemptions for the 2-year period allowed by 49 U.S.C.
31136(e) and 31315 to the 5 applicants listed in the notice of July 8,
2014 (79 FR 41737).
    We recognize that the vision of an applicant may change and affect
his/her ability to operate a CMV as safely as in the past. As a
condition of the exemption, therefore, FMCSA will impose requirements
on the 5 individuals consistent with the grandfathering provisions
applied to drivers who participated in the Agency's vision waiver
program.
    Those requirements are found at 49 CFR 391.64(b) and include the
following: (1) That each individual be physically examined every year
(a) by an ophthalmologist or optometrist who attests that the vision in
the better eye continues to meet the requirement in 49 CFR
391.41(b)(10) and (b) by a medical examiner who attests that the
individual is otherwise physically qualified under 49 CFR 391.41; (2)
that each individual provide a copy of the ophthalmologist's or
optometrist's report to the medical examiner at the time of the annual
medical examination; and (3) that each individual provide a copy of the
annual medical certification to the employer for retention in the
driver's qualification file, or keep a copy in his/her driver's
qualification file if he/she is self-employed. The driver must have a
copy

of the certification when driving, for presentation to a duly
authorized Federal, State, or local enforcement official.

V. Discussion of Comments

    FMCSA received no comments in this proceeding.

IV. Conclusion

    Based upon its evaluation of the 5 exemption applications, FMCSA
exempts the following drivers from the vision requirement in 49 CFR
391.41(b)(10), subject to the requirements cited above (49 CFR
391.64(b)):

Christopher D. Bolomey (MO), Leamon V. Manchester (LA), Leverne F.
Schulte Jr. (OH), Paul M. Wooton (KY), Clark D. Workman (ID)

    In accordance with 49 U.S.C. 31136(e) and 31315, each exemption
will be valid for 2 years unless revoked earlier by FMCSA. The
exemption will be revoked if: (1) The person fails to comply with the
terms and conditions of the exemption; (2) the exemption has resulted
in a lower level of safety than was maintained before it was granted;
or (3) continuation of the exemption would not be consistent with the
goals and objectives of 49 U.S.C. 31136 and 31315.
    If the exemption is still effective at the end of the 2-year
period, the person may apply to FMCSA for a renewal under procedures in
effect at that time.

    Issued on: September 10, 2014.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2014-22264 Filed 9-17-14; 8:45 am]
BILLING CODE 4910-EX-P


The Board has attached a mark-up of the document with assorted suggested
word changes (Appendix A). In addition, the Board makes the following
comments:

1. It would be helpful if, somewhere near the beginning of the document,
there was a paragraph making it clear that the topics discussed in the
document are only a part of the rules that must be followed to assure
that research is conducted in an ethical manner, and that those other
rules (including local and state level regulations) are not being
discussed in this document. The paragraph could briefly list some of
those other rules, e.g., the need for appropriate study design, the
relationship of risks and benefits, the need to minimize risks to
subjects. It might also be appropriate to similarly mention the various
scientific issues that are not addressed in this report (e.g., exposure
and data collection methods and statistical issues), which issues may
often have a fundamental impact on whether or not a study is ethical.

2. Somewhere near the beginning of the document, it would also be
helpful to clarify that this guidance is specifically designed for
studies that fall under the definition of “intentional exposure”
studies as defined in the relevant sections of the federal regulations.

3. Also at the beginning of the document, there could be a clarification
of the extent to which this document is intended to apply to studies
conducted outside of the United States.

4. In the discussion of equitable subject selection (page 2), it would
be appropriate to note that some of the rules intended to protect
vulnerable subjects might in some cases lead to under-representation of
such subjects. The document should mention that to assure adequate
inclusion of subjects from all appropriate groups, random sampling may
be required. Convenience sampling may not be appropriate. Further, lack
of representativeness should not only be required to be justified, but
should be treated in the analyses in such a way as a) to determine the
biases so associated and their effects on the analysis and conclusions,
and b) adjusted or considered in analyses in such a way as to determine
what the conclusions might have been if the sample was not biased and
not representative.

5. In the discussion of recruiting subjects who do not speak English
(page 3), the document should highlight the need for recruiting such
subjects, given the fact that the agricultural work force includes a
high proportion of such individuals. The default should be that such
subjects are included.

6. An important element that should be added to the document is a more
extended discussion of the need for input, in the design and conduct of
the study, from the community representing the group of subjects being
recruited (e.g., agricultural workers), and especially the vulnerable
members of that group. The document should discuss specific ways in
which that input might be obtained and used. There is a substantial
literature on the topic of community participation in research, some of
which is discussed in the EPA National Exposure Research Laboratory’s
Report on the Workshop to Discuss State-of-the-Science Approaches for
Observational Exposure Measurement Studies.

7. If there is a possibility that genetic information will be collected
in these studies, the special issues relating to informing subjects
about the consequences to them from such collection should be mentioned
in the discussion of informed consent. There may also be state
regulations applicable to such studies, and those regulations vary
widely.

8. Under the heading Essential Elements of a Consent Document (page 6),
where it refers to the qualifications of an investigator, you might
consider being somewhat more specific about what details regarding those
qualifications should be included in the consent form.

9. Also under the heading Essential Elements of a Consent Document (page
6), or perhaps a new heading, it would be appropriate to mention the
elements referred to in 40 CFR §26.1116(b) (the “additional elements
of informed consent” that are required, when appropriate).

10. In the discussion of Capacity to Make Decisions (page 6), it can be
noted that some state laws do not allow, under certain conditions,
enrollment of subjects who lack the capacity to make decisions.

11. In the last paragraph under Language of Informed Consent (page 7),
it would be helpful to include an example, or some discussion, of what
it means to include exculpatory language.

12. Under the heading Circumstances and Process (page 8), where the
second paragraph mentions the process of obtaining consent, it might be
helpful to give some details of what makes a good consent process, or
perhaps provide a brief case study highlighting key principles.

13. With regard to the first sentence under the heading Confirming
Understanding (page 9), the Board notes that the regulations do not
actually require that there be an investigator’s signature on a
consent form attesting to the subject’s understanding. However, this
is an excellent practice and it is welcome that the EPA wishes to adopt
it. It would be helpful if the line under the signature clearly states
what the signature means (e.g., “Signature of Investigator Confirming
that the Subject Appeared to Appropriately Understand the Information
Provided”).

14. On page 10, under the discussion of dependent relationships, the
standard that an employer should have “no” interest in the research
is a strict one. The Board merely points this out to the EPA.

15. In the discussion of Real Alternatives to Participation in Research
(page 11), the document asks a number of important questions, without
providing answers to most of them. It would be helpful, to the extent
possible, to state some ethical principles that might enable answers to
be provided in this document to many of these questions, and to provide
those answers if possible. For example, it might be noted that in
general, it would be inappropriate (and wrongly coercive) if, as a
result of the conduct of a study, a worker who chose not to participate
in the study would end up being worse off in any non-trivial manner
(e.g., he earns less money during the day the study is conducted than he
would have if the study had not been conducted).

16. It might be helpful to provide a conclusion or summary at the end of
the document.

In addition, with regard to possible sources of guidance that might be
useful to an investigator who is designing a process for recruiting and
enrolling subjects in handler exposure research (the second charge
question), here are some suggested web sites, listed by topic. In
addition, note that the web site for the Office of Human Subjects
Research, at http://www.hhs.gov/ohrp, contains information on all of the
topics listed below, in addition to the Institutional Review Board
Guidebook, at   HYPERLINK
"http://www.hhs.gov/ohrp/irb/irb_guidebook.htm"
http://www.hhs.gov/ohrp/irb/irb_guidebook.htm .

Ethical Principles

	The Belmont Report, available at   HYPERLINK
"http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm"
http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm

	Archival Documents relating to the Belmont Report, available at
HYPERLINK "http://www.hhs.gov/ohrp/belmontArchive.html"
http://www.hhs.gov/ohrp/belmontArchive.html

Informed Consent Process

	A Brief Introduction to Informed Consent, available at   HYPERLINK
"http://poynter.indiana.edu/sas/res/ic.pdf"
http://poynter.indiana.edu/sas/res/ic.pdf

	An Informed Consent Bibliography, prepared by the Department of
Veterans Affairs, available at   HYPERLINK
"http://www.research.va.gov/resources/pubs/informed_consent/"
http://www.research.va.gov/resources/pubs/informed_consent/

Capacity to Make Decisions

	A volume from a report by the National Bioethics Advisory Commission
containing papers relating to Research Involving Persons with Mental
Disorders That May Affect Decision-Making Capacity, available at
HYPERLINK
"http://www.georgetown.edu/research/nrcbl/nbac/capacity/volumeii.pdf"
http://www.georgetown.edu/research/nrcbl/nbac/capacity/volumeii.pdf

Language of Informed Consent

	Guidelines for writing informed consent documents prepared by the
Office of Human Subjects Research, National Institutes of Health,
available at   HYPERLINK "http://ohsr.od.nih.gov/info/sheet6.html"
http://ohsr.od.nih.gov/info/sheet6.html

Complexity of Consent Materials

 	Simplification of Informed Consent Documents, prepared by the National
Cancer Institute, available at   HYPERLINK
"http://www.cancer.gov/clinicaltrials/understanding/simplification-of-in
formed-consent-docs/page2"
http://www.cancer.gov/clinicaltrials/understanding/simplification-of-inf
ormed-consent-docs/page2

With regard to textbooks on some of these topics, the following books
are suggested:

Ethical Principles

	Principles of Biomedical Ethics (5th edition). Tom L. Beauchamp and
James F. Childress. Oxford University Press 2001

Informed Consent

	A History and Theory of Informed Consent. Ruth R. Faden and Tom L.
Beauchamp. Oxford University Press 1986

	Informed Consent: Legal Theory and Clinical Practice (2nd Edition).
Jessica W. Berg, Paul S. Appelbaum, Charles W. Lidz and Lisa S. Parker.
Oxford University Press 2001.

Capacity to Make Decisions

	Assessing Competence to Consent to Treatment. Thomas Grisso and Paul S.
Appelbaum. Oxford University Press 1998.

Follow-up on Agricultural Handler Exposure Task Force and Antimicrobial
Exposure Assessment Task Force Protocols

Charge to the Board

Recognizing that protocol-specific science and ethics issues will be
addressed in later HSRB meetings, EPA has attempted to explain the basis
for its conclusion that additional information on exposure for people
who mix, load, and apply pesticides (handlers) would be useful in EPA's
regulatory decision-making and therefore new research would be valuable.
 Do the materials provided by EPA regarding the quality of the
scientific data currently available for assessing exposures for handlers
contain useful information to establish the societal value of proposed
new handler exposure research, assuming individual protocols would
generate scientifically valid information?

Board Response to the Charge

The Board found that the joint U.S. EPA – California EPA – Health
Canada background document provided an excellent review of existing
handler data, and identified important limitations of these data. The
report from the January 2007 meeting of the EPA FIFRA Scientific
Advisory Panel (SAP) extended this analysis, and provided an excellent
rationale for the collection of new occupational handler exposure data
for use by EPA and other regulatory agencies. In summary, the materials
provided by EPA regarding the quality of the scientific data currently
available for assessing exposures for handlers provide a sound
justification for the societal value of proposed new handler exposure
research. The challenge as the Agency moves forward with the AHETF study
is to ensure that the study is designed and conducted in a way that
produces high quality exposure data suitable for use in Agency risk
assessments.

Charge to the Board

What additional information, if any, would the Board want with respect
either to handler research in general or to individual protocols?

Board Response to the Charge

The Agency brought the AHETF study to the Board’s attention because it
considered this study to fall within the boundaries of “intentional
exposure” as defined in the EPA’s Human Studies Rule. Substantial
discussion occurred at the June 2006 meeting and again at this meeting
regarding the Agency’s decision process for classifying human studies
as intentional or observational. The Board would appreciate the
opportunity to learn more about the Agency’s approach to this issue,
and contribute to this discussion at a future HSRB meeting, particularly
in regard to occupational exposure studies.

The Board praised EPA’s decision to obtain a review and report of
worker exposure methods from the EPA FIFRA SAP. The Board found the
meeting presentations by Drs. Heeringa and Popendorf of the EPA SAP
particularly helpful in providing guidance on the AHETF task force
study.

The Board commended EPA’s response to its questions regarding use of
diazinon in the AHE37 protocol.  The Board understands that the Agency
will require AHETF to identify a pesticide other than diazinon to use in
this protocol to assess exposures associated with open pour activities,
and that EPA will ensure that future protocols comply with the most
current risk mitigation measures.

Overarching Concerns

At its June 2006 meeting, the Board recommended development of a
“governing document” that would frame the entire study in regard to
its purpose, general methodological approach, and general analytical
plan. Agency and SAP presentations at the April 2007 meeting indicated
that substantial progress had been made in this regard, both within the
Agency and within the Task Force. The Agency indicated that additional
information to address this concern would be presented at the June 2007
HSRB meeting.

More specifically, the Board recommended development of a clear and
appropriate plan for the collection and handling of the data being
collected, including sample size and statistical analysis. The Board
recognized that this is a complex and iterative task. It would be most
helpful to have a timeline for development of the analytical and
statistical plan.

At the April 2007 meeting, the Board indicated that there will be
two-tiers to its evaluation of submitted protocols, namely whether the
model and general plan are scientifically and ethically valid and how
the protocol will be implemented at each site, i.e., how issues such as
compliance with data collection and entry will be managed, subject
safety, and monitoring of recruitment.

The Board recommended that the Agency and AHETF develop a clear
narrative regarding the uses to which the data would be applied. The
Agency and SAP reports submitted to the Board for this meeting provided
substantial additional information regarding the use of data.
Articulation of these plans in a short draft document would likely move
this process forward.

The Board also recommended that the Agency consider development of
protocols for repeated measures to appropriately estimate exposures
within individuals. Such studies on at least a small subset of the study
population would allow adjustment for this source of variability in
statistical analysis. The SAP report addressed this issue in some
detail, and has provided the Agency with very useful guidance on this
issue.

The Board discussed the potential value of examining the ways in which
the Agency has used the Agricultural Reentry Task Force (ARTF) database
in its risk assessments. This database has the same scenario-based
structure as the databases under review, and used the same methods to
measure dermal exposure. The Board suggested that the Agency share with
the Board its experience with the ARTF database to identify “lessons
learned” and possible pitfalls in the use of such databases.

Methodological Concerns Issues

The Board reaffirmed its interest in two recommendations from the June
2006 HSRB meeting:

The Board recommended additional validation studies to determine the
extent to which dermal exposure measurements may underestimate true
exposure. The Board would appreciate an update on plans, if any, to
address this recommendation.

The Board recommended that the Agency consider broadening participation
in its discussions of the Agricultural Handler Exposure Database,
including additional members of the scientific community, as well as
parties with a direct interest in the database project, such as the
labor community. The Board would appreciate an update on plans, if any,
to address this recommendation.

At the April 2007 meeting, the Board also recommended that the following
methodological be considered in the development of documents and
protocols:

A description of how EPA will evaluate its linear model assumption
(exposure vs. amount of active ingredient handled), given the SAP’s
recommendations;

Information on sampling frame and where to focus data collection, based
on usage patterns for products; how sample size would be determined;
strategies for replacement of missing or partial data;

A statistical analysis plan including identification of covariates to be
collected and a rationale for emphasis on some covariates versus others;

Whether the Agency plans to include biomonitoring data in the task force
activities as a means of evaluating the validity of passive dosimetry
measurements;

How the protocols represent, as closely as possible, the conditions of a
true work day including documented reasons for and proposed duration of
the study.

Plans, if any, to meet the requirements established in the 40CFR26, as
recommended by the Board.

HSRB Consensus and Rationale

The HSRB concluded that the materials provided by EPA regarding the
quality of the scientific data currently available for assessing
exposures for handlers provide a sound justification for the societal
value of proposed new handler exposure research. In addition, the review
and recommendations of the EPA FIFRA SAP provide an excellent starting
point for some methodological decisions and for the identification of
issues still to be addressed. The challenge as the Agency moves forward
with the AHETF study is to ensure that the study is designed and
conducted in a way that produces high quality exposure data suitable for
use in Agency risk assessments.

The Board recommended development of a “governing document” that
would frame the entire plan for the collection and statistical analysis
of the data, and a clear narrative regarding the uses to which the data
would be put. The Board also recommended that studies be conducted as a
part of this project to determine the accuracy of dermal exposure
measurements. The Board further recommended that the Agency consider
broadening participation in its discussions of the Agricultural Handler
Exposure Database, including additional members of the scientific
community, as well as parties with a direct interest in the database
project, such as the labor community. Finally, The Board recommended
that the Agency draw upon its experience with the Agricultural Reentry
Task Force database to clarify how such data are used in its risk
assessments, to capture the key “lessons learned” from this
experience, and to avoid possible pitfalls in the use of such databases.

REFERENCES

Carley, J.M. 2007a. Ethics Review of EMD-003.3 Report of Completed
Efficacy Study for Aerosol Tick Repellent Containing IR-3535. Dated
March 14, 2007.  Unpublished document prepared by Office of Pesticide
Programs, United States Environmental Protection Agency.

Carley, J.M. 2007b. Ethics Review of EMD-004.3 Report of Completed
Efficacy Study for Aerosol Mosquito Repellent Containing IR-3535. Dated
March 14, 2007.  Unpublished document prepared by Office of Pesticide
Programs, United States Environmental Protection Agency.

Carroll, S. 2007a. Test of Personal Insect Repellents: Study EMD-003.3
(Aerosol) – Revised. Dated February 5, 2007.  Unpublished document
prepared by Carroll-Loye Biological Research.

Carroll, S. 2007b. Test of Personal Insect Repellents: Study EMD-004.3
(Aerosol) – Revised. Dated February 5, 2007.  Unpublished document
prepared by Carroll-Loye Biological Research.

Carley, J.M. 2007c . Ethics Review a Completed Human Study of Dermal
Irritation of Two Repellent Products. Dated March 15, 2007.  Unpublished
document prepared by Office of Pesticide Programs, United States
Environmental Protection Agency.

Carley, J.M. 2007d . Ethics Review a Completed Human Repeated Insult
Patch Test (RIPT) of Two Repellent Products. Dated March 15, 2007.
Unpublished document prepared by Office of Pesticide Programs, United
States Environmental Protection Agency.

EMD 003.3 (Aerosol).  2007.  EMD Chemicals.

EPA HSRB. 2007. January 24, 2007 EPA Human Studies Review Board Meeting
Report. Washington, DC: Environmental Protection Agency.  April 16,
2007.  EPA-HSRB-07-01

Georgeian K and Dosik JS. 2007a. Primary Irritation Patch Study
[redacted] Supplemented with Additional Supporting Materials Satisfying
40 CFR 26.1303 for [redacted] [Repellent Code] 1000718-008, concentrate
of 1000718-009. Volumes 1 and 2. Unpublished document prepared by
toXcel, LLC. February 1, 2007.

Georgeian K and Dosik JS. 2007b. Primary Irritation Patch Study
[redacted] Supplemented with Additional Supporting Materials Satisfying
40 CFR 26.1303 for [redacted] [Repellent Code] 1004006-005. Volumes 1
and 2. Unpublished document prepared by toXcel, LLC. February 1, 2007.

Georgeian K and Dosik JS. 2007c. Repeated Insult Patch Study [redacted]
Supplemented with Additional Supporting Materials Satisfying 40 CFR
26.1303 for [redacted] [Repellent Code] 1000718-008, concentrate of
1000718-009. Volumes 1 and 2. Unpublished document prepared by toXcel,
LLC. February 1, 2007.

Georgeian K and Dosik JS. 2007d. Repeated Insult Patch Study [redacted]
Supplemented with Additional Supporting Materials Satisfying 40 CFR
26.1303 for [redacted] [Repellent Code] 1004006-005. Volumes 1 and 2.
Unpublished document prepared by toXcel, LLC. February 1, 2007.

Proposed Final Draft v 1 Dated June 13, 2007; Do Not Cite or Quote

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