[Federal Register: July 8, 2008 (Volume 73, Number 131)]
[Notices]
[Page 39063]
[DOCID:fr08jy08-118]

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SECURITIES AND EXCHANGE COMMISSION

Submission for OMB Review; Comment Request

Upon written request, copies available from: Securities and Exchange
Commission, Office of Investor Education and Advocacy, Washington, DC
20549-0213.

Extension: Regulation S-T; OMB Control No. 3235-0424; SEC File No.
270-375

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') has submitted to the Office of Management
and Budget a request for extension of the previously approved
collection of information discussed below.
    Regulation S-T (17 CFR 232.10--232.313 and 232.401--232.402 and
232.501) sets forth the general rules and regulations for electronic
filings. Registrants who have to file electronically are the likely
respondents. Regulation S-T is only assigned one burden hour for
administrative convenience because it does not directly impose any
information collection requirements. The electronic filing requirement
is mandatory for all companies required to file electronically. All
information provided to the Commission is available to the public for
review.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid control number.
    Written comments regarding the above information should be directed
to the following persons: (i) Desk Officer for the Securities and
Exchange Commission, Office of Information and Regulatory Affairs,
Office of Management and Budget, Room 10102, Executive Office Building,
Washington, DC 20503 or send an e-mail to: Alexander_T._
<EMAIL_ADDRESS>and (ii) R. Corey Booth, Director/Chief Information
Officer, Securities and Exchange Commission, C/O Shirley Martinson,
6432 General Green Way, Alexandria, VA 22312; or send an e-mail to:
<EMAIL_ADDRESS>Comments must be submitted to OMB within 30 days
of this notice.

    Dated: June 30, 2008.
Florence E. Harmon,
Acting Secretary.
 [FR Doc. E8-15361 Filed 7-7-08; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 87, Number 13 (Thursday, January 20, 2022)]
[Notices]
[Pages 3107-3108]
[FR Doc No: 2022-00992]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9384-01-R8]

Administrative Settlement Agreement and Order on Consent: Rico-
Argentine Site, Rico, Dolores County, Colorado

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of proposed agreement; request for public comment.

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SUMMARY: In accordance with the requirements of the Comprehensive

Environmental Response, Compensation, and Liability Act of 1980, as
amended (``CERCLA''), notice is hereby given of the proposed settlement
under CERCLA, between the U.S. Environmental Protection Agency
(``EPA''), and Atlantic Richfield Company (``Settling Party'') to
resolve its alleged civil liability at the Rico-Argentine Site in
Dolores County, Colorado. For thirty (30) days following the date of
publication of this notice, the Agency will receive written comments
relating to the agreement. The Agency will consider all comments
received and may modify or withdraw its consent to the agreement if
comments received disclose facts or considerations that indicate that
the agreement is inappropriate, improper, or inadequate.

DATES: Comments must be submitted on or before February 22, 2022.

ADDRESSES: To reduce the risk of COVID-19 transmission, for this action
we do not plan to offer hard copy review of the docket. Comments and
requests for a copy of the proposed agreement should be addressed to
Anntasia Copeland, Enforcement Specialist, Superfund and Emergency
Management Division, Environmental Protection Agency--Region 8, Mail
Code 8SEM-PAB, 1595 Wynkoop Street, Denver, Colorado 80202, (303) 312-
6764, [email protected] and should reference the Rico-Argentine
Site.

FOR FURTHER INFORMATION CONTACT: Amelia Piggott, Senior Assistant
Regional Counsel, Office of Regional Counsel, Environmental Protection
Agency--Region 8, Mail Code 8ORC-LEC, 1595 Wynkoop Street, Denver,
Colorado 80202,<PHONE_NUMBER>, [email protected].

SUPPLEMENTARY INFORMATION: The proposed Settlement Agreement is for the
performance of a removal action by the Settling Party and the payment
of certain response costs incurred by the United States. This
Settlement supersedes and replaces in its entirety, and, as of the
Effective Date, terminates the Unilateral Administrative Order for
Removal Action, docket number CERCLA-08-2011-0005 (UAO) that EPA issued
to the Settling Party on March 17, 2011, under which Respondent has
implemented certain response actions, including addressing settling
ponds and constructing a pilot water treatment system to treat acid
mine drainage coming from the St. Louis Tunnel. The purpose of this
Settlement is to provide for: Settling Party's payment of certain past
response costs, as well as design, construction, operation, and
monitoring of a full-scale water treatment system to remove hazardous
substances from the St. Louis Tunnel discharge, hydraulic control
measures for the collapsed St. Louis Tunnel adit, and solids management
facilities; and EPA's oversight of the implementation of such Work at
the Site. The Settling Party consents to and will not contest the
authority of the United States to enter into the Agreement or to
implement or enforce its terms. The Settling Party recognizes that the
Agreement has been negotiated in good faith and that the Agreement is
entered into without the admission or adjudication of any issue of fact
or law.

Betsy Smidinger,
Division Director, Superfund and Emergency Management Division,
Environmental Protection Agency, Region VIII.
[FR Doc. 2022-00992 Filed 1-19-22; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 79, Number 208 (Tuesday, October 28, 2014)]
[Rules and Regulations]
[Pages 64088-64092]
[FR Doc No: 2014-25018]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2014-0581; Directorate Identifier 2014-NM-167-AD;
Amendment 39-17999; AD 2014-17-51]
RIN 2120-AA64

Airworthiness Directives; Bombardier, Inc. Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule; request for comments.

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SUMMARY: We are adopting a new airworthiness directive (AD) for certain
Bombardier, Inc. Model CL-600-2B16 airplanes. This emergency AD was
sent previously to all known U.S. owners and operators of these
airplanes. This AD requires inspecting the inboard flap fasteners of
the hinge-box forward fitting at Wing Station (WS) 76.50 and WS 127.25
to determine the orientation and condition of the fasteners, as
applicable, and replacement or repetitive inspections of the fasteners
if necessary. This AD also provides for optional terminating action for
the requirements of the AD. This AD was prompted by reports of
fractured fastener heads on the inboard flap hinge-box forward fitting
at WS 76.50 due to incorrect installation. We are issuing this AD to
detect and correct

incorrectly oriented or fractured fasteners, which could result in
premature failure of the fasteners attaching the inboard flap hinge-box
forward fitting. Failure of the fasteners could lead to the detachment
of the flap hinge box and the flap surface, and consequent loss of
control of the airplane.

DATES: This AD is effective November 12, 2014 to all persons except
those persons to whom it was made immediately effective by Emergency AD
2014-17-51, issued on August 19, 2014, which contained the requirements
of this amendment.
    The Director of the Federal Register approved the incorporation by
reference of certain publications identified in this AD as of November
12, 2014.
    The Director of the Federal Register approved the incorporation by
reference of certain other publications listed in this AD as of March
6, 2014 (79 FR 9389, February 19, 2014).
    We must receive comments on this AD by December 12, 2014.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, 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: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    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<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>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2014-
0581; or in person at the Docket Operations Office between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays. The AD docket
contains this AD, the regulatory evaluation, any comments received, and
other information. The street address for the Docket Operations Office
(phone:<PHONE_NUMBER>) is in the ADDRESSES section. Comments will be
available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Aziz Ahmed, Aerospace Engineer,
Propulsion and Services Branch, ANE-173, FAA, New York Aircraft
Certification Office (ACO), 1600 Stewart Avenue, Suite 410, Westbury,
NY 11590; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    On August 19, 2014, we issued Emergency AD 2014-17-51, which
requires inspecting the inboard flap fasteners of the hinge-box forward
fitting at WS 76.50 and WS 127.25 to determine the orientation and
condition of the fasteners, as applicable, and replacement or
repetitive inspections of the fasteners if necessary. Emergency AD
2014-17-51 also provides for optional terminating action for the
requirements of the AD. This emergency AD was sent previously to all
known U.S. owners and operators of these airplanes. This action was
prompted by reports of fractured fastener heads on the inboard flap
hinge-box forward fitting at Wing Station (WS) 76.50 due to incorrect
installation. This condition, if not corrected, could result in
premature failure of the fasteners attaching the inboard flap hinge-box
forward fitting. Failure of the fasteners could lead to the detachment
of the flap hinge box and the flap surface, and consequent loss of
control of the airplane.
    Transport Canada Civil Aviation (TCCA), which is the aviation
authority for Canada, has issued Canadian Emergency Airworthiness
Directive CF-2014-27, dated August 15, 2014 (referred to after this as
the Mandatory Continuing Airworthiness Information, or ``the MCAI''),
to correct an unsafe condition on certain Model CL-600-2B16 airplanes.
The MCAI states:

    There have been three in-service reports on 604 Variant
aeroplanes of a fractured fastener head on the inboard flap hinge-
box forward fitting at Wing Station (WS) 76.50, found during a
routine maintenance inspection. Investigation revealed that the
installation of these fasteners on the inboard flap hinge-box
forward fittings at WS 76.50 and WS 127.25, on both wings, does not
conform to the engineering drawings. Incorrect installation may
result in premature failure of the fasteners attaching the inboard
flap hinge-box forward fitting. Failure of the fasteners could lead
to the detachment of the flap hinge box and consequently the
detachment of the flap surface. The loss of a flap surface could
adversely affect the continued safe operation of the aeroplane.
    The original issue of AD CF-2013-39 [dated December 6, 2013]
[which corresponds to FAA AD 2014-03-17, Amendment 39-17754 (79 FR
9389, February 19, 2014)] mandated a detailed visual inspection
(DVI) of each inboard flap hinge-box forward fitting, on both wings,
and rectification as required. Incorrectly oriented fasteners
require repetitive inspections until the terminating action is
accomplished.
    After the issuance of AD CF-2013-39, there has been one reported
incident on a 604 Variant aeroplane where four fasteners were found
fractured on the same flap hinge-box forward fitting. The
investigation determined that the fasteners were incorrectly
installed.
    This [Canadian] AD is issued to reduce the initial and
repetitive inspection intervals previously mandated in AD CF-2013-
39, and to impose replacement of the incorrectly oriented fasteners
within 24 months. The CL-600-1A11, -2A12 and -2B16 (601-3A/-3R
Variant) aeroplanes are addressed through AD CF-2013-39R1 [dated
August 15, 2014].

You may examine the MCAI on the Internet at http://www.regulations.gov
by searching for and locating Docket No. FAA-2014-0581.

Relevant Service Information

    We reviewed the following service information:
     Bombardier Alert Service Bulletin A604-57-006, Revision
01, dated September 26, 2013, including Appendices 1 and 2, dated
September 26, 2013.
     Bombardier Alert Service Bulletin A604-57-006, Revision
02, dated January 22, 2014, including Appendices 1 and 2, dated
September 26, 2013.
     Bombardier Alert Service Bulletin A605-57-004, Revision
01, dated September 26, 2013, including Appendices 1 and 2, dated
September 26, 2013.
     Bombardier Alert Service Bulletin A605-57-004, Revision
02, dated January 22, 2014, including Appendices 1 and 2, dated
September 26, 2013.
    The actions described in this service information are intended to
correct the unsafe condition identified in the MCAI.
    Revision 02 of the service information instructs operators to
contact Bombardier for repair procedures for certain configurations;
paragraph (k)(2) of this AD addresses this issue.

FAA's Determination and AD Requirements

    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 issuing this AD
because we evaluated all pertinent information and determined the
unsafe condition exists and is likely to exist or develop on other
products of the same type design.
    Accomplishment of the requirements of this AD constitutes
terminating action for the requirements of AD 2014-03-17, Amendment 39-
17754 (79 FR 9389, February 19, 2014), for the airplanes identified in
paragraph (c) of this AD.
    FAA AD 2014-03-17, Amendment 39-17754 (79 FR 9389, February 19,
2014), corresponds to Canadian AD CF-2013-39, dated December 6, 2013.
FAA AD 2014-03-17 applies to Bombardier, Inc. Model CL-600-1A11 (CL-
600), CL-600-2A12 (CL-601), and CL-600-2B16 (CL-601-3A, CL-601-3R, and
CL-604 Variants) airplanes. Because of the urgency of this unsafe
condition for the CL-604 Variant airplanes, we have determined that it
is necessary to issue an emergency AD, only for CL-604 Variant
airplanes, to reduce the compliance times for the inspection required
by AD 2014-03-17.

Explanation of Applicability

    This AD applies to Bombardier, Inc. Model CL-600-2B16 airplanes
with certain serial numbers. The CL-605 is a marketing designation for
the Challenger CL-600-2B16, CL-604 Variant, with Modsums 604DX10000,
604DX20000, and 604DX30000 incorporated, beginning with serial numbers
5701 and subsequent. All CL-604 and CL-605 airplanes are type certified
as CL-600-2B16 airplanes. Therefore this AD applies to all CL-600-2B16
models in the specified serial-number range.

Differences Between This AD and the MCAI/Service Information

    Canadian Airworthiness Directive CF-2014-27, dated August 15, 2014,
specifies to replace all forward and aft fasteners at WS 76.50 and
127.25 within 24 months, if any incorrectly installed fasteners are
found. We are considering requiring this replacement, which would
terminate the actions required by this AD. However, the planned
compliance time for the replacement would allow enough time to provide
notice and opportunity for prior public comment on the merits of the
replacement.
    Although the service information identified previously specifies
that operators may contact the manufacturer for disposition of certain
repair conditions, this AD requires operators to repair those
conditions in accordance with a method approved by the FAA, or TCCA, or
Bombardier, Inc.'s TCCA Design Approval Organization (DAO).

FAA's Determination of the Effective Date

    An unsafe condition exists that requires the immediate adoption of
this AD. The FAA has found that the risk to the flying public justifies
waiving notice and comment prior to adoption of this rule because
incorrect installation of the fasteners attaching the inboard flap
hinge-box forward fitting may result in their premature failure, and
possible detachment of the flap hinge box and the flap surface, and
loss of control of the airplane. Therefore, we find that notice and
opportunity for prior public comment are impracticable and that good
cause exists for making this amendment effective in less than 30 days.

Comments Invited

    This AD is a final rule that involves requirements affecting flight
safety and was not preceded by notice and an opportunity for public
comment. 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 the docket number FAA-2014-0581 and
Directorate Identifier 2014-NM-167-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.

Costs of Compliance

    We estimate that this AD affects 285 airplanes of U.S. registry. We
estimate the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per       Cost on U.S.
              Action                        Labor cost            Parts cost        product         operators
----------------------------------------------------------------------------------------------------------------
Inspection........................  1 work-hour x $85 per                  $0              $85          $24,225
                                     hour = $85.
----------------------------------------------------------------------------------------------------------------

    We estimate the following costs to do any necessary replacements
that would be required based on the results of the inspection. We have
no way of determining the number of aircraft that might need these
replacements:

                                               On-Condition Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per
                  Action                                Labor cost                 Parts cost        product
----------------------------------------------------------------------------------------------------------------
Fastener replacement......................  Up to 58 work-hours x $85 per hour              $0           $4,930
                                             = $4,930.
----------------------------------------------------------------------------------------------------------------

    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

    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 DOT Regulatory Policies and
Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

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

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):

2014-17-51 Bombardier, Inc.: Amendment 39-17999; Docket No. FAA-
2014-0581; Directorate Identifier 2014-NM-167-AD.

(a) Effective Date

    This AD is effective November 12, 2014 to all persons except
those persons to whom it was made immediately effective by Emergency
AD 2014-17-51, issued on August 19, 2014, which contained the
requirements of this amendment.

(b) Affected ADs

    The requirements of this AD terminate the requirements of AD
2014-03-17, Amendment 39-17754 (79 FR 9389, February 19, 2014), only
for the airplanes identified in paragraph (c) of this AD.

(c) Applicability

    This AD applies to Bombardier, Inc. Model CL-600-2B16 airplanes,
certificated in any category, serial numbers 5301 through 5665
inclusive, and 5701 through 5920 inclusive.

(d) Subject

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

(e) Unsafe Condition

    This AD was prompted by reports of fractured fastener heads on
the inboard flap hinge-box forward fitting at Wing Station (WS)
76.50 due to incorrect installation. We are issuing this AD to
detect and correct incorrectly oriented or fractured fasteners,
which could result in premature failure of the fasteners attaching
the inboard flap hinge-box forward fitting. Failure of the fasteners
could lead to the detachment of the flap hinge box and the flap
surface, and consequent loss of control of the airplane.

(f) Compliance

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

(g) Inspection: Airplanes Not Previously Inspected

    For airplanes on which the actions required by AD 2014-03-17,
Amendment 39-17754 (79 FR 9389, February 19, 2014), have not been
done as of the effective date of this AD: Within 10 flight cycles
after the effective date of this AD, or within 100 flight cycles
after March 6, 2014 (the effective date of AD 2014-03-17, Amendment
39-17754 (79 FR 9389, February 19, 2014)), whichever occurs first:
Do a detailed visual inspection of each inboard flap fastener of the
hinge-box forward fitting at WS 76.50 and WS 127.25, on both wings,
to determine if the fasteners are correctly oriented and intact
(non-fractured, with intact fastener head). Do the inspection in
accordance with the Accomplishment Instructions of Bombardier Alert
Service Bulletin A604-57-006, Revision 01, dated September 26, 2013,
including Appendices 1 and 2, dated September 26, 2013, or Revision
02, dated January 22, 2014, including Appendices 1 and 2, dated
September 26, 2013 (for serial numbers 5301 through 5665 inclusive);
or Bombardier Alert Service Bulletin A605-57-004, Revision 01, dated
September 26, 2013, including Appendices 1 and 2, dated September
26, 2013, or Revision 02, dated January 22, 2014, including
Appendices 1 and 2, dated September 26, 2013 (for serial numbers
5701 through 5920 inclusive).
    (1) If all fasteners are found intact and correctly oriented, no
further action is required by this AD.
    (2) If any fastener is found fractured: Before further flight,
remove and replace all forward and aft fasteners at WS 76.50 and WS
127.25, regardless of condition or orientation, on both wings, in
accordance with the Accomplishment Instructions of Bombardier Alert
Service Bulletin A604-57-006, Revision 01, dated September 26, 2013,
including Appendices 1 and 2, dated September 26, 2013, or Revision
02, dated January 22, 2014, including Appendices 1 and 2, dated
September 26, 2013 (for serial numbers 5301 through 5665 inclusive);
or Bombardier Alert Service Bulletin A605-57-004, Revision 01, dated
September 26, 2013, including Appendices 1 and 2, dated September
26, 2013, or Revision 02, dated January 22, 2014, including
Appendices 1 and 2, dated September 26, 2013 (for serial numbers
5701 through 5920 inclusive). After replacement of all fasteners as
required by paragraph (g)(2) of this AD, no further action is
required by this AD.
    (3) If any incorrectly oriented but intact fastener is found,
and no fractured fastener is found, repeat the inspection required
by paragraph (g) of this AD thereafter at intervals not to exceed 10
flight cycles, until the requirements of paragraph (i)(1) of this AD
have been done.

(h) Airplanes Previously Inspected, With Incorrectly Oriented
Fastener(s)

    For airplanes on which an inspection required by paragraph (g)
or (j) of AD 2014-03-17, Amendment 39-17754 (79 FR 9389, February
19, 2014), has been done as of the effective date of this AD, and on
which any incorrectly oriented fastener, but no fractured fastener,
was found: Except as provided by paragraph (i)(3) of this AD, do a
detailed visual inspection of all inboard flap fasteners of the
hinge-box forward fitting at WS 76.50 and WS 127.25, on both wings,
to determine if the fasteners are intact (non-fractured, with intact
fastener head). Inspect within 10 flight cycles after the effective
date of this AD, or within 100 flight cycles after the most recent
inspection done as required by AD 2014-03-17, whichever occurs
first. Inspect in accordance with the Accomplishment Instructions of
Bombardier Alert Service Bulletin A604-57-006, Revision 01, dated
September 26, 2013, including Appendices 1 and 2, dated September
26, 2013, or Revision 02, dated January 22, 2014, including
Appendices 1 and 2, dated September 26, 2013 (for serial numbers
5301 through 5665 inclusive); or Bombardier Alert Service Bulletin
A605-57-004, Revision 01, dated September 26, 2013, including
Appendices 1 and 2, dated September 26, 2013, or Revision 02, dated
January 22, 2014, including Appendices 1 and 2, dated September 26,
2013 (for serial numbers 5701 through 5920 inclusive).
    (1) If all fasteners are found intact, repeat the inspection
thereafter at intervals not to exceed 10 flight cycles, until the
requirements of paragraph (i)(1) of this AD have been done.
    (2) If any fastener is found fractured: Before further flight,
remove and replace all forward and aft fasteners at WS 76.50 and WS
127.25, regardless of condition or orientation, on both wings, in
accordance with the Accomplishment Instructions of Bombardier Alert
Service Bulletin A604-57-006,

Revision 01, dated September 26, 2013, including Appendices 1 and 2,
dated September 26, 2013, or Revision 02, dated January 22, 2014,
including Appendices 1 and 2, dated September 26, 2013 (for serial
numbers 5301 through 5665 inclusive); or Bombardier Alert Service
Bulletin A605-57-004, Revision 01, dated September 26, 2013,
including Appendices 1 and 2, dated September 26, 2013, or Revision
02, dated January 22, 2014, including Appendices 1 and 2, dated
September 26, 2013 (for serial numbers 5701 through 5920 inclusive).
After replacement of all fasteners as required by paragraph (h)(2)
of this AD, no further action is required by this AD.

(i) Terminating Action

    (1) Replacement of all forward and aft fasteners at WS 76.50 and
WS 127.25, on both wings, in accordance with the Accomplishment
Instructions of Bombardier Alert Service Bulletin A604-57-006,
Revision 01, dated September 26, 2013, including Appendices 1 and 2,
dated September 26, 2013, or Revision 02, dated January 22, 2014,
including Appendices 1 and 2, dated September 26, 2013 (for serial
numbers 5301 through 5665 inclusive); or Bombardier Alert Service
Bulletin A605-57-004, Revision 01, dated September 26, 2013,
including Appendices 1 and 2, dated September 26, 2013, or Revision
02, dated January 22, 2014, including Appendices 1 and 2, dated
September 26, 2013 (for serial numbers 5701 through 5920 inclusive);
terminates the requirements of this AD.
    (2) Accomplishment of the applicable requirements of this AD
constitutes terminating action for the requirements of AD 2014-03-
17, Amendment 39-17754 (79 FR 9389, February 19, 2014), for that
airplane only.
    (3) Replacement, before the effective date of this AD, of all
fractured and incorrectly oriented fasteners, as provided by
paragraph (i) or (k) of AD 2014-03-17, Amendment 39-17754 (79 FR
9389, February 19, 2014), is acceptable for compliance with the
requirements of this AD.

(j) Special Flight Permit

    Special flight permits to operate the airplane to a location
where the airplane can be repaired in accordance with sections
21.197 and 21.199 of the Federal Aviation Regulations (14 CFR 21.197
and 21.199) are not allowed.

(k) Other FAA Provisions

    (1) Alternative Methods of Compliance (AMOCs): The Manager, New
York Aircraft Certification Office, 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
Aircraft Certification Office, ANE-170, FAA; or the TCCA; or
Bombardier, Inc.'s TCCA Design Approval Organization (DAO). If
approved by the DAO, the approval must include the DAO-authorized
signature.

(l) Related Information

    Refer to Mandatory Continuing Airworthiness Information (MCAI)
Canadian Emergency Airworthiness Directive CF-2014-27, dated August
15, 2014, for related information. You may examine the MCAI on the
Internet at http://www.regulations.gov by searching for and locating
Docket No. FAA-2014-0581.

(m) 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 the AD specifies otherwise.
    (3) The following service information was approved for IBR on
November 12, 2014.
    (i) Bombardier Alert Service Bulletin A604-57-006, Revision 02,
dated January 22, 2014, including Appendices 1 and 2, dated
September 26, 2013.
    (ii) Bombardier Alert Service Bulletin A605-57-004, Revision 02,
dated January 22, 2014, including Appendices 1 and 2, dated
September 26, 2013.
    (4) The following service information was approved for IBR on
March 6, 2014 (79 FR 9389, February 19, 2014).
    (i) Bombardier Alert Service Bulletin A604-57-006, Revision 01,
dated September 26, 2013, including Appendices 1 and 2, dated
September 26, 2013.
    (ii) Bombardier Alert Service Bulletin A605-57-004, Revision 01,
dated September 26, 2013, including Appendices 1 and 2, dated
September 26, 2013.
    (5) 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.
    (6) 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.
    (7) 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 October 13, 2014.
Michael Kaszycki,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2014-25018 Filed 10-27-14; 8:45 am]
BILLING CODE 4910-13-P


United States

Environmental Protection

Agency

	Office of Prevention, Pesticides

And Toxic Substances

(7510P)		EPA 712-C-07-091

 	Product Performance Test Guidelines

		OPPTS 810.2300:

Sanitizers for Use on Hard Surfaces—Efficacy Data Recommendations

Public Review Draft

NOTICE

          This guideline is one of a series of test guidelines
established by the Office of Prevention, Pesticides and Toxic Substances
(OPPTS), United States Environmental Protection Agency for use in
testing pesticides and chemical substances to develop data for
submission to the Agency under the Toxic Substances Control Act (TSCA)
(15 U.S.C. 2601, et seq.), the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) (7 U.S.C. 136, et seq.), and section 408 of the
Federal Food, Drug, and Cosmetic (FFDCA) (21 U.S.C. 346a).

	The OPPTS test guidelines serve as a compendium of accepted scientific
methodologies and protocols that are intended to provide data to inform
regulatory decisions under TSCA, FIFRA, and/or FFDCA.  This document
provides guidance for conducting the test, and is also used by EPA, the
public, and the companies that are subject to data submission
requirements under TSCA, FIFRA and/or the FFDCA.  As a guidance
document, these guidelines are not binding on either EPA or any outside
parties, and the EPA may depart from the guidelines where circumstances
warrant and without prior notice.  The procedures contained in this
guideline are strongly recommended for generating the data that are the
subject of the guideline, but EPA recognizes that departures may be
appropriate in specific situations. You may propose alternatives to the
recommendations described in these guidelines, and the Agency will
assess them for appropriateness on a case-by-case basis.

	For additional information about OPPTS harmonized test guidelines and
to access the guidelines electronically, please go to   HYPERLINK
"http://www.epa.gov/oppts"  http://www.epa.gov/oppts  and select “Test
Methods & Guidelines” on the left side navigation menu.  You may also
access the guidelines in   HYPERLINK "http://www.regulations.gov"
http://www.regulations.gov  grouped by Series under Docket ID #s:
EPA-HQ-OPPT-2009-0150 through EPA-HQ-OPPT-2009-0159, and
EPA-HQ-OPPT-2009-0576.

DRAFT DOCUMENT DISCLAIMER:  This draft document is distributed solely
for the purpose of external review.  It has not been formally
disseminated by the EPA and should not be construed to represent any
Agency determination or policy.  The information correction process
under the Agency’s Information Quality Guidelines does not apply until
this document is formally disseminated by the EPA in its final form.
This draft document should only be cited or quoted in the context of
providing comments.

OPPTS 810.2300:  Sanitizers for use on hard surfaces - efficacy data
recommendations.

(a) Scope

(1) Applicability.  This guideline is intended to meet testing
requirements of the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA) (7U.S.C. 136, et seq.), and the Federal Food, Drug, and Cosmetic
Act (FFDCA) (21 U.S.C. 346a).  It addresses testing to demonstrate
effectiveness of products which are sanitizers.

(2) Background.  The source materials used in developing this OPPTS test
guideline are OPP guidelines 91-2: Products for use on hard surfaces and
91-30: Acceptable methods (Pesticide Assessment Guidelines, Subdivision
G, Product Performance.  EPA report 540/9-82-026, October 1982).

(b) Purpose.  This guideline addresses efficacy testing for
antimicrobial pesticides intended to be used on hard surfaces, namely
sanitizers in a variety of product types (water-soluble powders,
liquids, sprays, towelettes, etc.).

(c) General considerations

(1)  This guideline recommends tests to be conducted and data to be
submitted which the Agency believes will generally satisfy the
requirements for pesticide registration.  Studies conducted under this
guideline should be completed under EPA’s Good Laboratory Practice
regulations (40 CFR Part 160).  Note:  The Association of Official
Analytical Chemists (AOAC) recommended tests are expected to be
conducted as written.  For deviations (e.g., cultures grown with shaking
instead of static, dilution of culture prior to drying on carriers)
proposed to be used in the conduct of these tests, obtain written
approval from the Agency and document such deviations in the study
reports submitted to the Agency.  The Agency may consult with the AOAC
prior to accepting modification to their standardized methods.  Refer to
OPPTS Test Guideline 810.2000 for general testing recommendations prior
to initiating tests.

(2)  Confirmatory testing.  In certain situations an applicant may rely
on previously submitted efficacy data to support an application or
amendment for registration of a product and submit only confirmatory
efficacy data on his own product to demonstrate his ability to produce
an effective formulation. These situations are as outlined in paragraphs
(c)(2)(i) and (c)(2)(ii) in this guideline.

(i)  Duplicated Product Formulations. In this situation, the applicant
manufactures a formulation which duplicates a product that is already
registered with complete supporting efficacy data. The chemical
composition, manufacturing procedure, label claims, and directions for
use are identical in substance to those of the original registration,
and specific references (Master Record ID Numbers [MRIDs]) to the
supporting data developed for the original product are cited by the
applicant.

(ii)  Minor Formulation Change in a Registered Product. In this
situation, the change in the formulation is relatively minor, e.g., a
change of an inert ingredient. The label claims and directions for use
are unchanged from those accepted for the registered formulation, and
specific references (MRIDs) to the supporting data developed for the
original formulation are cited by the applicant.  The confirmatory data
should be developed on the applicant's own finished product. When the
test methodology utilized in deriving the original supporting efficacy
data were modified to include additional elements not specified in the
recommended method, such as organic soil, hard water, longer or shorter
contact time, etc., the confirmatory data should be produced under
similarly modified conditions.

(3)  Table 1 provides a quick reference guide to testing for basic
claims described in this guideline. Consult the text for detailed
testing descriptions.

Table 1. Tests for basic claims described in this guideline.

Level of Efficacy	Test Methods	Test Organisms	No. of Batches/Carriers
Evaluation of Success

Non-food Contact Sanitizer	Water soluble powders/liquids

 Spray products	EPA Sanitizer Test or ASTM E-1153-03 	Staphylococcus
aureus (ATCC 6538) and Klebsiella pneumoniae (ATCC 4352) Enterobacter
aerogenes (ATCC 13048) may be substituted for K. pneumoniae.

	Three batches, one at least 60 days old.	99.9% reduction within 5
minutes.

	Towelettes	Reserved

	Food Contact Surface Sanitizer

Halide Products	Water soluble powders/liquids	AOAC International
Chlorine (Available) in Disinfectants Germicidal Equivalent
Concentration

Salmonella typhi (ATCC 6539) or S. aureus (ATCC 6538)	Three batches, one
at least 60 days old.	Test results should demonstrate product
concentrations equivalent in activity to 50, 100, and 200 ppm of
available chlorine.

Food Contact Surface Sanitizer

Non-Halide Products	Water soluble powders/liquids	AOAC International
Germicidal and Detergent Sanitizing Action of Disinfectants

Escherichia coli (ATCC 11229) and S. aureus (ATCC 6538)	Three batches,
one at least 60 days old.  	99.999% reduction in the number of each test
microorganism within 30 seconds.

	Towelettes	EPA Test

	Sanitizers for Urinal and Toilet Bowl Water and In-tank Sanitizers

	Water soluble powders/liquids/tablets	Simulated-use study

Enterococcus faecalis or Salmonella enterica	Three batches.	99.9%
reduction over parallel control counts.

Residual Self-sanitizing – wet surfaces

Simulated-use study	Representative gram positive and gram negative
organisms	Three batches, one at least 60 days old.	99.9% reduction over
parallel control counts.

(d) Sanitizers for nonfood contact surfaces (water soluble powders,
liquids, and spray products).  These products, when used as directed,
should reduce the number of test microorganisms on a treated surface
over those of an untreated control surface.  The following testing
recommendations apply to products bearing label claims for effectiveness
as sanitizers for inanimate hard surfaces other than those which come in
contact with food or beverages (e.g., floors, walls, furnishings).

(1) Test Procedures.

(i) The Agency recommends the test procedures in this paragraph:  The
Sanitizer Test for Inanimate Non-food Contact Surfaces (prepared by the
Registration Division, Office of Pesticide Programs, EPA, 1976) (Ref.
1).  The propagation of cultures and the use of subculture media and
other related equipment may be as specified in Official Methods of
Analysis of AOAC International, Chapter 6, Disinfectants (Ref. 3).
Three product samples, representing three different batches, one of
which should be at least 60 days old, should be tested against each test
bacterium on each representative test surface depending on the uses
proposed on the label (for hard, porous surface label claims use
unglazed ceramic tile) (for hard, nonporous surface label claims use
stainless steel carriers or glass slides), using 5 test carriers and 3
control carriers.  The test microorganisms are: Staphylococcus aureus
(S. aureus) (ATCC 6538) and Klebsiella pneumoniae (K. pneumoniae) (ATCC
4352).  Enterobacter aerogenes (E. aerogenes) (ATCC 13048) may be
substituted for K. pneumoniae.  The test elements in paragraphs
(d)(1)(A) through (d)(1)(I) of this paragraph should be used.

(A) Determine the bacterial count in an 18-24 hour broth culture and add
a 0.01- 0.03 mL quantity of the broth culture by spreading on a l x l
inch square of test surface using a bacteriological loop.

(B) If the product is intended to be represented as a cleaner-sanitizer,
an organic soil load, such as 5 percent blood serum, should be added to
the bacterial inoculum.

(C) The square of test surface should be dried for 40 minutes in a
bacteriological incubator at 30- 37 (C.

(D) A zero-time bacterial numbers recovery test (dried carrier count)
should be performed to demonstrate the efficiency of the recovery
process and should be reported.  The "zero-time" test is intended to
show the loss in viability that occurred during carrier drying.

(E) Apply the product to the inoculated test surfaces as directed on the
product label.

(F) Run parallel tests on the formulation with the active ingredients
omitted in an identical manner to serve as the control.  If such a
control solution is not suitable, use sterile distilled water to which
may be added 0.01percent isooctylphenoxypolyethoxyethanol (9-10 moles
oxyethylene, e.g., Triton X-100).

(G) After the label recommended exposure time, recover the test
organisms by washing the squares with agitation in media or dilution
fluid containing neutralizers

(H) Make plate counts on nutrient agar containing the same neutralizers
by the pour or spread plate technique.

(I) Exposure time intervals between 0-time and 5 minutes should be
tested for the product as well as the untreated controls.

(ii) The American Society for Testing and Materials (ASTM) Test Method
for Efficacy of Sanitizers Recommended for Inanimate Non-Food Contact
Surfaces (E1153-03) may be used (Ref. 2).  Three product samples,
representing three different batches, one of which should be at least 60
days old, should be tested against each test bacterium on each
representative test surface depending on the uses proposed on the label.
(for hard, porous surface label claims use unglazed ceramic tile)  (for
hard, nonporous surface label claims use stainless steel carrier or
glass slide), using 5 test carriers and 3 control carriers.  The test
microorganisms are: (S. aureus) (ATCC 6538) and (K. pneumoniae) (ATCC
4352).  E. aerogenes (ATCC 13048) may be substituted for K. pneumoniae.
The ASTM method states that the inoculum employed should provide a count
of at least 7.5 x 105 colony forming units per carrier.

(iii) Evaluation of sanitizing success for nonfood contact surface
sanitizers.  The results should demonstrate a reduction of at least
99.9% (a 3-log reduction) in the number of each test microorganism over
the parallel control count within 5 minutes.

(e)  Towelettes.  (Reserved.)

(f)  Sanitizers for Internal Toilet and Urinal Bowl Surfaces Above and
Below the Water Line

(1) Test Procedures. The Agency recommends the use of the Sanitizer Test
for Inanimate Non-food Contact Surfaces (prepared by the Registration
Division, Office of Pesticide Programs, EPA, 1976) (Ref. 1), or The
American Society for Testing and Materials (ASTM) Test Method for
Efficacy of Sanitizers Recommended for Inanimate Non-Food Contact
Surfaces (E1153-03) may be used (Ref. 2).  The contained bowl water (96
fl oz) should used to calculate the appropriate use dilution for
testing.

(2) Evaluation of sanitizing success for toilet and urinal bowl surface
sanitizers.  The results should demonstrate a reduction of at least
99.9% (a 3-log reduction) in the number of each test microorganism over
the parallel control count within 5 minutes.

(g)  Sanitizing rinses (soluble powders and liquids) for previously
cleaned food-contact surfaces.  This section addresses efficacy testing
for products with a label recommendation for the treatment of previously
cleaned, nonporous, food contact surfaces (e.g., eating and drinking
utensils and food processing equipment) as a terminal sanitizing rinse.

(1) Halide chemical products.  Sanitizing rinses formulated with
iodophors, mixed halides, and chlorine-bearing chemicals.

(i) Test procedure. The Agency recommends the AOAC International
Chlorine (Available) in Disinfectants Germicidal Equivalent
Concentration test (Ref. 3).  Three samples, representing three
different batches, one of which should be at least 60 days old, should
be evaluated for efficacy against Salmonella enterica (S. enterica)
(formerly Salmonella typhi) (ATCC 6539) or S. aureus (ATCC 6538).  When
claims are made for the effectiveness of the product in hard water, all
data should be developed at the hard water tolerance claimed.

(ii) Evaluation of sanitizing success of halide formulations.  Test
results should demonstrate product concentrations equivalent in activity
to 50, 100, and 200 ppm of available chlorine.  The reference standard
is sodium hypochlorite.

(2) Confirmatory testing for halide chemical products

(i) Test procedure. The Agency recommends the AOAC International
Chlorine (Available) in Disinfectants Germicidal Equivalent
Concentration test (Ref. 3).  One sample should be evaluated for
efficacy against S. enterica (ATCC 6539) or S. aureus (ATCC 6538).  When
claims are made for the effectiveness of the product in hard water, all
data should be developed at the hard water tolerance claimed.

(ii) Evaluation of sanitizing success of halide formulations.  Test
results should demonstrate product concentrations equivalent in activity
to 50, 100, and 200 ppm of available chlorine.  The reference standard
is sodium hypochlorite.

(3)  Non-halide chemical products.  Sanitizing rinses formulated with
quaternary ammonium compounds, chlorinated trisodium phosphate, and
anionic detergent-acid formulations.

(i) Test procedure.  The Agency recommends the AOAC International
Germicidal and Detergent Sanitizing Action of Disinfectants test (Ref.
4).  Three samples, representing three different batches, one of which
should be at least 60 days old, should be evaluated for efficacy against
both Escherichia coli (E.coli) (ATCC 11229) and S. aureus (ATCC 6538).
When claims are made for the effectiveness of the product in hard water,
all data should be developed at the hard water tolerance claimed.

(ii) Evaluation of sanitizing success of non-halide formulations.
Acceptable results should demonstrate a 99.999% reduction in the number
of each test microorganism within 30 seconds.  The results should be
reported according to the actual count and percentage reduction over the
control.

(4) Confirmatory testing for non-halide products—(i) Test procedure.
The Agency recommends the AOAC International Germicidal and Detergent
Sanitizing Action of Disinfectants test (Ref. 4).  One sample should be
evaluated for efficacy against both E. coli (ATCC 11229) and S. aureus
(ATCC 6538).  When claims are made for the effectiveness of the product
in hard water, all data should be developed at the hard water tolerance
claimed.

(ii) Evaluation of sanitizing success of non-halide formulations.
Acceptable results should demonstrate a 99.999% reduction in the number
of each test microorganism within 30 seconds.  The results should be
reported according to the actual count and percentage reduction over the
control.

(h)  Towelette Sanitizers for Food Contact Surfaces.  This section
addresses efficacy testing for products with a label recommendation for
the treatment of hard, non-porous surfaces which may come into contact
with food.  Food Contact Surface (FCS) towelettes are intended to be
used to sanitize the following surfaces: hard non-porous tables,
countertops (stainless steel, laminated, sealed ceramic,) stove tops,
interior and exterior surfaces of microwaves and refrigerators.   FCS
towelettes may not be used to sanitize the following food contact
surfaces: utensils, glasses, food containers, dishes, cutting boards,
cutting blocks, drain boards, and food processing equipment.  This list
is not meant to be all-inclusive, but to serve as general guidance for
the appropriate use of this type of antimicrobial pesticide.  The Agency
reserves the right to accept or deny use sites for food contact surface
towelettes on a case-by-case basis.

(1) Test Procedure.  The Agency recommends the use of the Interim
Guidance for Non-Residual Sanitization of Hard Inanimate Food Contact
Surfaces Using Pre-Saturated Towelettes.  This guidance may be found at:
 http://www.epa.gov/oppad001/towelette.htm

Three samples, representing three different batches, one of which is at
least 60 days old, should be evaluated for efficacy against E. coli
(ATCC 11229) and S. aureus (ATCC 6538).

(2) Evaluation of towelette sanitizing success.  The product should
demonstrate at least a 99.999% reduction in the number of test
microorganisms (bacteria) within 30 seconds. The result should be
reported according to the actual count and percentage reduction over the
control.

(i) Sanitizers for Toilet and Urinal Bowl Water. This section addresses
efficacy testing for products with claims as sanitizers for toilet and
urinal bowl water.

(1) Test Procedure. A simulated-use study should be designed which
incorporates all of the elements listed in paragraphs (i)(1)(i) through
(i)(1)(iv) in this guideline.

(i)  The product should be added to samples of the bowl water from three
toilets or urinals at the use concentration employing the recommended
method of dispensing.  Untreated control samples from the three toilets
or urinals should also be included.

(ii)  Whether the product is automatically metered, or dispensed in some
other fashion, into the bowl water (or urinal trap), the consistent
accuracy of the concentration dispensed and maintained should be
documented.

(iii)  Inocula containing representative Gram-positive or Gram-negative
test bacteria should be added to the treated and control samples of the
bowl water from each of the toilets or urinals to provide a
concentration of at least 104 colony-forming units per milliliter.

(iv)  Microbial counts of the treated bowl water and the control bowl
water should be conducted at a minimum of three exposure intervals, in
addition to a 0-time control.

(2) Evaluation of Sanitizing Success.  The reduction of each test
microorganism should be at least 99.9% over the 0-time control and the
parallel untreated inoculated control.

(j) In-Tank Sanitizers.  This section addresses efficacy testing for
products which bear label claims for use as an automatically dispensed
in-tank sanitizer.

(1) Test Procedures. In-tank sanitizer products should be evaluated by a
preliminary simulated-use test followed by a laboratory efficacy test.
These tests should incorporate the elements in paragraphs (j)(1)(i)
through (j)(1)(i)(B).

(i) Preliminary simulated-use test.  The use-life of the in-tank product
should be documented for three product samples, each in a separate
toilet under the conditions in paragraphs (j)(1)(i)(A) and (j)(1)(i)(B)
of this guideline simulating actual usage.  Testing conducted with a 6
gallons/flush toilet may be used to generate data for low flush toilets
(3.5 gallons/flush).

(A) Number of flushes (dispensation of the dosage) per day per X weeks
(duration of effectiveness) with a non-chlorinated water supply at 25-30
(C (the warm water temperature extreme in summer).

(B) The bowl water should be analyzed at periodic intervals during the
testing indicated in paragraph (j)(1)(i)(A) in this guideline to
demonstrate the pH and concentration of the active ingredients.

(ii) Laboratory efficacy tests.  Bacteriologic assays should be
conducted on neutralized treated and untreated samples by standard
plating procedures employing:

(A) Samples of the residual bowl water from three toilets (at the
minimal use concentration) and corresponding untreated control samples
from three toilets at 10-.15 (C (the most stringent water temperature
for demonstrating efficacy).

(B)  Representative Gram-positive and Gram-negative bacteria (e.g.,
Enterococcus faecalis, Salmonella enterica) with an inoculum of at least
104CFU/mL.

(C)  A minimum of three exposure intervals, in addition to a 0-time
control.

(iii) Evaluation of in-tank sanitizing success.  The reduction of each
test microorganism should be at least 99.9% over the 0-time control and
the parallel untreated inoculated control.

(k) Residual self-sanitizing activity of dried chemical residues on
hard-inanimate surfaces - wet surfaces. This section addresses efficacy
testing for products which bear label claims to provide residual
self-sanitizing activity (e.g., significant reduction in numbers of
infectious microorganisms which may be present or subsequently
deposited) on treated surfaces that are likely to become and remain wet
under normal conditions of use.

(1) Test procedure.  Residual self-sanitizing products for use on hard,
inanimate surfaces should be evaluated for efficacy using a controlled
in-use study or simulated in-use study. The design of the study should
be done in consultation with the Agency and should include the basic
elements: in paragraphs (k)(1)(i) through (k)(1)(vii) of this guideline.

(i) The test microorganisms employed in the study should be pathogens
that are likely to be encountered in the environment in which the
product is to be used.

(ii) The starting inocula of the test microorganisms for both initial
and subsequent challenges should be of sufficient concentration to
provide at least 104 survivors on the parallel control surface.

(iii) Subsequent challenges should be of sufficient frequency to
accurately represent normal conditions of use.

(iv) Quantitative bacteriological sampling should be conducted at
frequent and regular intervals for the length of time the residual
activity can be expected to exist under the expected use conditions.

(v) The same types of surfaces without the treatment should be employed
in the test and inoculated in a manner and over an exposure period
identical to the use pattern for which the product is intended.

(vi) The environmental conditions (e.g., relative humidity and
temperature) should be the same as those likely to be encountered under
normal conditions of product use.  Tests should also include those
environmental conditions that would act to reduce the effective
concentration of the product on the inanimate surface (e.g., rinsing,
abrasion, organic load, repeated challenges by microorganisms, etc.).

(vii) The length of time the residual activity can be expected to exist
under the expected use conditions should be documented.

(2) Evaluation of success of residual self-sanitizing action.  For
residual self-sanitizing claims, it should be demonstrated that a
product is capable of reducing the number of test microorganisms on the
test surface by 99.9% over that of the parallel control surfaces.

(l) Residual self-sanitizing activity of dried chemical residues on
hard-inanimate surfaces - dry surfaces.  This section addresses efficacy
testing for products which bear label claims to provide residual
self-sanitizing activity (e.g., significant reduction in numbers of
infectious microorganisms which may be present or subsequently
deposited) on treated dry surfaces.

(1) Test Procedure.  The Agency recommends the use of the Protocol for
Residual Self-Sanitizing Activity of Dried Chemical Residues on Hard
Non-Porous Surfaces.  This guidance may be found at:
http://www.epa.gov/oppad001/regpolicy.htm.

(2) Evaluation of residual self-sanitizing success.  The product should
demonstrate that it is capable of reducing the number of test
microorganisms on the test surface by 99.9% over that of the parallel
control surfaces within 5 minutes for a 24 hour period.

(m)  Data collection and reporting

(1) General.  To assist in the proper review and evaluation of product
performance, complete descriptions of the test employed and the results
obtained should be submitted to the Agency.  All test reports should
include, at the least, what is in paragraphs (m)(1)(i) through
(m)(1)(xiv) of this guideline:

(i) Study title;

(ii) Product identity;

(iii) Guideline number;

(iv) Identification of the testing laboratory or organization;

(v) Location where the test was performed;

(vi) Name(s) of the person(s) responsible for the test;

(vii) Good Laboratory Practice compliance;

(viii) Purpose of the study;

(ix) Date and time of the start and end of the test;

(x) Statistical treatment of the data;

(xi) Conclusions;

(xii) References;

(xiii) Appendices;

(xiv) Certification.

The applicant is encouraged to use the EPA’s standard efficacy report
format, which may be found at
http://www.epa.gov/oppad001/efficacystudystandards.htm

(2) Data for recommended methods.  When recommended methods from the
Official Methods of Analysis of AOAC International; the Annual Book of
Standards of the American Society for Testing and Materials; or, EPA
methods are used to develop efficacy data, certain minimal information,
in addition to that described in this guideline, should be provided in
the test report.  The report should include, but is not limited to, the
material in paragraphs (m)(2)(i) through (m)(2)(xii) in this guideline:

(i) Test employed, and any modifications thereto (e.g., organic soil,
hard water, etc);

(ii) Test microorganisms employed, including identification of the
specific strain (ATCC or other);

(iii) Description of the test substance, including the percent of active
ingredient;

(iv) Concentration or dilution of the product tested and how prepared;

(v) Number of samples, batches and replicates tested;

(vi) Preparation dates of each product batch (individually formulated
preparation of the product);

(vii) Identification of all material or procedural options employed,
where such choice is permitted or recommended in the test method
selected (e.g., growth media, drying  time for inoculated carriers,
neutralization confirmation and/or subculture media, secondary
subculturing);

(viii) Test exposure conditions (e.g., contact time, temperature, and
relative humidity);

(ix) Complete reports of results obtained for each replication;

(x) Any control data essential to establish the validity of the test;

(xi) Carrier counts;

(xii) Any additional data pertinent for specific tests described in this
guideline.

(3) Data for modifications of recommended methods.  Where recommended
methods are modified to support specific claims and/or use patterns for
a product, the protocol, identifying and describing each modification,
should be provided in specific detail with the test report.  The
applicant is encouraged to submit the proposed modification to the
Agency for review and evaluation prior to initiation of the test.

(4) Data for other methods.  When recommended methods, or modifications
thereto, are not employed to develop efficacy data (such as actual
in-use or many kinds of simulated-use testing), complete testing
protocols should be submitted with the test reports.  All materials and
procedures employed in testing should be described in a manner
consistent with original research reports published in technical or
scientific journals.  Where references to published reports or papers
are made, copies or reprints of such references should be provided with
the test reports.  The applicant should to submit the proposed testing
protocols for in-use or simulated-use studies to the Agency for review
and evaluation prior to initiation of the test.

(n) References:  The following references may be consulted for
additional background information:

(1) Environmental Protection Agency, Sanitizer Test for Hard, Inanimate
Nonfood Contact Surfaces Modified to Include Organic Soil. (Registration
Division, Office of Pesticide Programs, 1976).

(2) Annual Book of Standards, Test Method for Efficacy of Sanitizers
Recommended for Inanimate Non-Food Contact Surfaces, Designation
E1153-03.  American Society for Testing and Materials, 100 Barr Harbor
Drive, West Conshohocken, PA 19428.

(3) Official Methods of Analysis of the AOAC International, Chapter 6,
Disinfectants, Official Method 955.16 Chlorine (Available) in
Disinfectants, Germicidal Equivalent Concentration.  Eighteenth edition.
 AOAC International, Suite 500, 481 North Frederick Avenue,
Gaithersburg, MD 20877-2417.

(4) Official Methods of Analysis of the AOAC International, Official
Method 960.09 Germicidal and Detergent Sanitizing Action of
Disinfectants.  Eighteenth edition.  AOAC International, Suite 500, 481
North Frederick Avenue, Gaithersburg, MD 20877-2417.

 PAGE  9


[Federal Register Volume 77, Number 248 (Thursday, December 27, 2012)]
[Notices]
[Pages 76334-76335]
[FR Doc No: 2012-31123]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-68491; File No. SR-ISE-2012-101]

Self-Regulatory Organizations; International Securities Exchange,
LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule
Change To Amend ISE Rule 504(f) To Permit the Exchange To List
Additional Strike Prices Until the Close of Trading on the Second
Business Day Prior to Monthly Expiration in Unusual Market Conditions

December 20, 2012.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act'' or ``Exchange Act''),\1\ and Rule 19b-4 thereunder,\2\
notice is hereby given that on December 19, 2012, the International
Securities Exchange, LLC (the ``Exchange'' or the ``ISE'') filed with
the Securities and Exchange Commission (``Commission'') the proposed
rule change as described in Items I and II below, which items have been
prepared by the Exchange. The Commission is publishing this notice to
solicit comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend ISE Rule 504(f) to permit the
Exchange to list additional strike prices until the close of trading on
the second business day prior to monthly expiration. The text of the
proposed rule change is available on the Exchange's Web site
www.ise.com, at the principal office of the Exchange, and at the
Commission's Public Reference Room.

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

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

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

1. Purpose
    ISE proposes to amend ISE Rule 504(f) to permit the Exchange to
list additional strike prices until the close of trading on the second
business day prior to monthly expiration. This is a competitive filing
that is based on proposals recently approved by NYSE MKT LLC (``MKT'')
\3\ and NYSE Arca, Inc. (``Arca'').\4\
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    \3\ See Securities Exchange Act Release No. 68460 (December 18,
2012) (SR-NYSEMKT-2012-41).
    \4\ See Securities Exchange Act Release No. 68461 (December 18,
2012) (SR-NYSEARCA-2012-94).
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    ISE Rule 504 currently permits the Exchange to open additional
series of options on individual stocks and exchange-traded funds (ETFs)
until the beginning of the month in which the option expires or until
five business days prior to expiration if unusual market conditions
exist.\5\ Options market participants generally prefer to focus their
trading in strike prices that immediately surround the price of the
underlying security. However, if the price of the underlying stock
moves significantly, there may be a market need for additional strike
prices to adequately account for market participants risk management
needs in a stock. In these situations, the Exchange has the ability to
add additional series at strike prices that are better tailored to the
risk management needs of market participants.\6\ The Exchange may make
the determination to open additional series for trading when the
Exchange deems it necessary to maintain an orderly market, to meet
customer demand, or when certain price movements take place in the
underlying market.\7\ If the market need occurs prior to five business
days prior to expiration, then the market participants may have access
to an option contract that is more tailored to the movement in the
underlying stock.\8\ However, if the market need to manage risk due to
unusual market conditions comes to light anytime from five to two days
prior to expiration, then market participants are left without a
contract that is tailored to manage their risk.\9\
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    \5\ See ISE Rule 504(f). `Until the fifth business day prior'
generally means up through the end of the day on the Friday of the
week prior to expiration week.
    \6\ See ISE Rule 504.
    \7\ See ISE Rule 504(c).
    \8\ Id.
    \9\ While these situations are relatively rare, the Exchange
represents that approximately two times a month there is a
legitimate need to add additional strikes closer to expiration than
the five business day limitation permits, due to it being necessary
to maintain an orderly market, to meet customer demand, or when
certain price movements take place in the underlying market.
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    The Exchange proposes to permit the listing of additional strikes
until the close of trading on the second business day prior to
expiration in unusual market conditions. Since expiration of the
monthly contract is on a Saturday, the close of trading on the second
business day will typically fall on a Thursday. However, in the cases
where Friday is a holiday during which the Exchange is closed, the
close of trading on the second business day will occur on a Wednesday.
The Exchange will continue to make the determination to open additional
series for trading when the Exchange deems it necessary to maintain an
orderly market, to meet customer demand, or when certain price
movements take place in the underlying market. The proposed change will
provide an additional four days to the Exchange to gauge market impact
of the underlying stock and to react to any market conditions that
would render additional series prior to expiration beneficial to market
participants. The Exchange believes that the impact on the market from
the proposed change will be very minimal to market participants,
however it will be extremely beneficial in that minority of situations
where unusual market conditions dictate immediately prior to
expiration. The proposal would simply allow participants to adjust
their risk exposure in narrow situations when an unusual market event
occurred on trading days 2, 3, 4, 5 prior to expiration.
    This proposal does not raise any capacity concerns on the Exchange,
because the changes have no material difference in impact from the
current rules. The Exchange notes the proposed change allows for new
strikes that would otherwise be permitted to add under existing rules
either on the fifth day prior or immediately after expiration.\10\ A
strike which opens two days prior to expiration will have minimal
impact on quoting, as it adds two series out of hundreds of thousands,
and only for a small number of days.\11\ Thus, any additional strikes
that may be added under the proposed change

would have no measurable effect on systems capacity.
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    \10\ Any new strikes added under this proposal would be added in
a manner consistent with the range limitations described in ISE Rule
504A.
    \11\ In the case of a multi-stock event where multiple stocks
may be subject to unusual market conditions, a strike which opens
two days prior to expiration will also have minimal impact on
quoting, as it adds two series per stock out of hundreds of
thousands, and only for a small number of days.
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2. Basis
    The Exchange believes that the proposed rule change is consistent
with the Securities Exchange Act of 1934 \12\ (the ``Act'') in general,
and furthers the objectives of Section 6(b)(5) of the Act \13\ in
particular, in that it is designed to prevent fraudulent and
manipulative acts and practices, to promote just and equitable
principles of trade, to foster cooperation and coordination with
persons engaged in facilitating transactions in securities, to remove
impediments to and perfect the mechanism of a free and open market and
a national market system, and, in general to protect investors and the
public interest.
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    \12\ 15 U.S.C. 78f(b).
    \13\ 15 U.S.C. 78f(b)(5).
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    The Exchange believes that providing an additional four days to the
Exchange to gauge market impact and to react to any market conditions
prior to expiration beneficial will result in a continuing benefit to
investors by giving them more flexibility to closely tailor their
investment decisions and hedging decisions prior to expiration. The
Exchange also believes that the additional four days will provide the
investing public and other market participants with additional
opportunities to hedge their investment thus allowing these investors
to better manage their risk exposure with additional in the money
series. While the four additional days may generate additional quote
traffic, the Exchange does not believe that this increased traffic will
become unmanageable since the proposal remains limited to the narrow
situations when an unusual market event occurred on trading days 2, 3,
4, 5 prior to expiration.

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

    This proposed rule change does not impose any burden on competition
that is not necessary or appropriate in furtherance of the purposes of
the Exchange Act. In this regard and as indicated above, the Exchange
notes that the rule change is being proposed as a competitive response
to filings submitted by MKT and Arca that were recently approved by the
Commission.\14\ ISE believes this proposed rule change is necessary to
permit fair competition among the options exchanges and to establish
uniform rules regarding the listing of strike prices.
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    \14\ See supra, notes 3 and 4.
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C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants or Others

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

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

    Because the foregoing proposed rule change does not significantly
affect the protection of investors or the public interest, does not
impose any significant burden on competition, and, by its terms, does
not 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 \15\ and Rule 19b-
4(f)(6) thereunder.\16\
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    \15\ 15 U.S.C. 78s(b)(3)(A).
    \16\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii)
requires the Exchange to give the Commission written notice of the
Exchange's 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.
---------------------------------------------------------------------------

    The Exchange has requested that the Commission waive the 30-day
operative delay. The Commission believes that waiver of the operative
delay is consistent with the protection of investors and the public
interest because the proposal is substantially similar to those of
other exchanges that have been approved by the Commission and would
permit the Exchange to list additional strike prices until the close of
trading on the second business day prior to monthly expiration in
unusual market conditions.\17\ Therefore, the Commission designates the
proposal operative upon filing.\18\
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    \17\ See supra notes 3 and 4.
    \18\ For purposes only of waiving the 30-day operative delay,
the Commission has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
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    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form http://www.sec.gov/rules/sro.shtml); or
     Send an Email to<EMAIL_ADDRESS>Please include
File No. SR-ISE-2012-101 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-ISE-2012-101. 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 Commissions Internet Web site (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for inspection and copying in the
Commission's Public Reference Room on official business days between
10:00 a.m. and 3:00 p.m. Copies of such filing also will be available
for inspection and copying at the principal office of the ISE. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-ISE-2012-101 and should be
submitted by January 17, 2013.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\19\
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    \19\ 17 CFR 200.30-3(a)(12).
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Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2012-31123 Filed 12-26-12; 8:45 am]
BILLING CODE 8011-01-P