[Federal Register Volume 81, Number 242 (Friday, December 16, 2016)]
[Proposed Rules]
[Pages 91068-91071]
[FR Doc No: 2016-28669]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2016-9435; Directorate Identifier 2016-NM-108-AD]
RIN 2120-AA64

Airworthiness Directives; Fokker Services B.V. Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to supersede Airworthiness Directive (AD) 2012-22-
15 for all Fokker Services B.V. Model F28 Mark 0070 and Mark 0100
airplanes. AD 2012-22-15 currently requires revising the maintenance
program to incorporate the limitations, tasks, thresholds, and
intervals specified in certain revised Fokker maintenance review board
(MRB) documents. Since we issued AD 2012-22-15, we received new
revisions of airworthiness limitations items (ALI) documents, which
introduce new and more restrictive maintenance requirements and
airworthiness limitations. This proposed AD would require revising the
maintenance or inspection program to incorporate new maintenance
requirements and airworthiness limitations. We are proposing this AD to
prevent the unsafe condition on these products.

DATES: We must receive comments on this proposed AD by January 30,
2017.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.

     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    For service information identified in this NPRM, contact Fokker
Services B.V., Technical Services Dept., P.O. Box 1357, 2130 EL
Hoofddorp, the Netherlands; telephone: +31 (0)88-6280-350; fax: +31
(0)88-6280-111; email<EMAIL_ADDRESS>Internet http://www.myfokkerfleet.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-2016-
9435; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this proposed AD, the regulatory evaluation, any comments
received, and other information. The street address for the Docket
Operations office (telephone<PHONE_NUMBER>) is in the ADDRESSES section.
Comments will be available in the AD docket shortly after receipt.

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

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2016-9435;
Directorate Identifier 2016-NM-108-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD based on those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    On October 30, 2012, we issued AD 2012-22-15, Amendment 39-17252
(77 FR 68063, November 15, 2012) (``AD 2012-22-15''). AD 2012-22-15
requires actions intended to address an unsafe condition on all Fokker
Services B.V. Model F28 Mark 0070 and Mark 0100 airplanes.
    Since we issued AD 2012-22-15, we received Fokker Services
Engineering Reports that consist of new and more restrictive
airworthiness limitations (ALS).
    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Union, has issued EASA
Airworthiness Directive AD 2016-0125, dated June 21, 2016 (referred to
after this as the Mandatory Continuing Airworthiness Information, or
``the MCAI''), to correct an unsafe condition for all Fokker Services
B.V. Model F28 Mark 0070 and Mark 0100 airplanes. The MCAI states:

    Fokker Services recently published issue 15 of Engineering
Report SE-623, containing Airworthiness Limitation Items (ALIs) and
Safe Life Items (SLIs). This report is Part 2 of the Airworthiness
Limitations Section (ALS Part 2) of the Instructions for Continued
Airworthiness, referred to in Section 06, Appendix 1, of the Fokker
70/100 Maintenance Review Board document.
    The complete ALS currently consists of:
    Part 1--Report SE-473, Certification Maintenance Requirements
(CMRs)--reference: EASA AD 2015-0027 [which corresponds to FAA AD
2016-11-22, Amendment 39-18549 (81 FR 36438, June 7, 2016)].
    Part 2--Report SE-623, ALIs and SLIs--reference: EASA AD 2014-
0224 [which corresponds to FAA AD 2012-22-15], and
    Part 3--Report SE-672, Fuel ALIs and CDCCLs--reference: EASA AD
2015-0032 [which corresponds to FAA AD 2016-11-15, Amendment 39-
18542 (81 FR 36447, June 7, 2016)].
    The instructions contained in those reports have been identified
as mandatory actions for continued airworthiness. Failure to
accomplish these actions could result in an unsafe condition.
    EASA previously issued AD 2014-0224, requiring the actions
described in ALS Part 1 (report SE-473 issue 10), Part 2 (report SE-
623 issue 13) and Part 3 (report SE-672 issue 4). Since that [EASA]
AD was issued, ALS Part 1 was revised (SE-473 issue 11) and EASA
issued AD 2015-0027 accordingly. ALS Part 3 was also revised (SE-672
issue 5) and EASA issued AD 2015-0032 accordingly.
    For the reasons described above, this [EASA] AD retains part of
the requirements of [EASA] AD 2014-0224, which is superseded, and
requires implementation of the maintenance actions as specified in
ALS Part 2 of the Instructions for Continued Airworthiness, Fokker
Services Engineering Report SE-623 at issue 15 (hereafter referred
to as `ALS Part 2' in this [EASA] AD).

    You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-
9435.

Related Service Information Under 1 CFR Part 51

    Fokker Services B.V. has issued Fokker Services B.V. Engineering
Report SE-623, ``Fokker 70/100 ALI's and SLI's,'' Issue 16, issued June
3, 2016. The service information describes new and more restrictive
maintenance requirements and airworthiness limitations. This service
information is reasonably available because the interested parties have
access to it through their normal course of business or by the means
identified in the ADDRESSES section.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with the State of Design Authority, we have
been notified of the unsafe condition described in the MCAI and service
information referenced above. We are proposing this AD because we
evaluated all pertinent information and determined an unsafe condition
exists and is likely to exist or develop on other products of the same
type design.
    This proposed AD would require revisions to certain operator
maintenance documents to include new actions (e.g., inspections).
Compliance with these actions is required by 14 CFR 91.403(c). For
airplanes that have been previously modified, altered, or repaired in
the areas addressed by this AD, the operator may not be able to
accomplish the actions described in the revisions. In this situation,
to comply with 14 CFR 91.403(c), the operator must request approval for
an alternative method of compliance according to paragraph (m)(1) of
this AD. The request should include a description of changes to the
required inspections that will ensure the continued operational safety
of the airplane.

Costs of Compliance

    We estimate that this proposed AD affects 15 airplanes of U.S.
registry.
    The actions required by AD 2012-22-15, and retained in this
proposed AD, take about 1 work-hour per product, at an average labor
rate of $85 per work-hour. Based on these figures, the estimated cost
of the actions that are

required by AD 2012-22-15 is $85 per product.
    We also estimate that it would take about 1 work-hour per product
to comply with the basic requirements of this proposed AD. The average
labor rate is $85 per work-hour. Based on these figures, we estimate
the cost of this proposed AD on U.S. operators to be $1,275, or $85 per
product.

Authority for This Rulemaking

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

Regulatory Findings

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

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13   [Amended]

0
2. The FAA amends Sec.  39.13 by removing Airworthiness Directive (AD)
2012-22-15, Amendment 39-17252 (77 FR 68063, November 15, 2012), and
adding the following new AD:

Fokker Services B.V.: Docket No. FAA-2016-9435; Directorate
Identifier 2016-NM-108-AD.

(a) Comments Due Date

    We must receive comments by January 30, 2017.

(b) Affected ADs

    (1) This AD replaces AD 2012-22-15, Amendment 39-17252 (77 FR
68063, November 15, 2012) (``AD 2012-22-15'').
    (2) This AD affects AD 2012-12-07, Amendment 39-17087 (77 FR
37788, June 25, 2012) (``AD 2012-12-07'').
    (3) This AD affects AD 2008-06-20 R1, Amendment 39-16089 (74 FR
61018, November 23, 2009) (``AD 2008-06-20 R1'').

(c) Applicability

    This AD applies to Fokker Services B.V. Model F28 Mark 0070 and
Mark 0100 airplanes, certificated in any category, all serial
numbers.

(d) Subject

    Air Transport Association (ATA) of America Code 05, Time Limits/
Maintenance Checks.

(e) Reason

    This AD was prompted by a revision of an airworthiness
limitations items (ALI) document, which introduces new and more
restrictive maintenance requirements and airworthiness limitations.
We are issuing this AD to prevent reduced structural integrity of
the airplane.

(f) Compliance

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

(g) Retained Maintenance Program Revision, With Revised Compliance
Language

    This paragraph restates the requirements of paragraph (i) of AD
2012-22-15, with revised compliance language. Within 3 months after
December 20, 2012 (the effective date of AD 2012-22-15), revise the
maintenance program to incorporate the airworthiness limitations
specified in Fokker Report SE-623, ``Fokker 70/100 Airworthiness
Limitation Items and Safe Life Items,'' Issue 13, released August
25, 2014 (``Fokker Report SE-623, Issue 13''). For all tasks and
retirement lives identified in Fokker Report SE-623, Issue 13, the
initial compliance times start from the later of the times specified
in paragraphs (g)(1) and (g)(2) of this AD, and the repetitive
inspections must be accomplished thereafter at the applicable
interval specified in Fokker Report SE-623, Issue 13. Accomplishing
the revision required by paragraph (k) of this AD terminates the
requirements of this paragraph.
    (1) Within 3 months after December 20, 2012 (the effective date
of AD 2012-22-15).
    (2) At the time specified in Fokker Report SE-623, Issue 13.

(h) Retained Corrective Actions, With Specific Delegation Approval
Language

    This paragraph restates the requirements of paragraph (j) of AD
2012-22-15, with specific delegation approval language. If any
discrepancy, as defined in Fokker Report SE-623, Issue 13, is found
during accomplishment of any task specified in Fokker Report SE-623,
Issue 13: Within the applicable compliance time specified in Fokker
Report SE-623, Issue 13, accomplish the applicable corrective
actions in accordance with Fokker Report SE-623, Issue 13.
    (1) If no compliance time is identified in Fokker Report SE-623,
Issue 13, accomplish the applicable corrective actions before
further flight.
    (2) If any discrepancy is found and there is no corrective
action specified in Fokker Report SE-623, Issue 13: Before further
flight, repair using a method approved by the Manager, International
Branch, ANM-116, Transport Airplane Directorate, FAA; or the
European Aviation Safety Agency (EASA); or Fokker Services' EASA
Design Organization Approval (DOA).

(i) Retained ``No Alternative Actions or Intervals,'' With a New
Exception

    This paragraph restates the requirements of paragraph (k) of AD
2012-22-15, with a new exception. Except as required by paragraph
(k) of this AD, after accomplishing the revision required by
paragraph (g) of this AD, no alternative actions (e.g., inspections)
or intervals may be used unless the actions or intervals are
approved as an alternative method of compliance (AMOC) in accordance
with the procedures specified in paragraph (m)(1) of this AD.

(j) Retained Method of Compliance With AD 2008-06-20, With Revised
Compliance Language

    This paragraph restates the requirements of paragraph (m) of AD
2012-22-15, with revised compliance language. Accomplishing the
actions specified in paragraph (g) of this AD terminates the
requirements of paragraphs (f)(1) through (f)(5) of AD 2008-06-20
R1.

(k) New Requirement of This AD: Maintenance or Inspection Program
Revision

    Within 30 days of the effective date of this AD, revise the
maintenance or inspection program, as applicable, to incorporate the
ALI instructions specified in Fokker Services B.V. Engineering
Report SE-623, ``Fokker 70/100 ALI's and SLI's,'' Issue 16, issued
June 3, 2016 (``Fokker Services B.V. Engineering

Report SE-623, Issue 16''). Accomplishing the revision required by
this paragraph terminates the requirements of paragraph (g) of this
AD. Accomplishing the revision required by this paragraph also
terminates the requirements of paragraph (g) of AD 2012-12-07.
    (1) The initial compliance times for the tasks specified in
Fokker Services B.V. Engineering Report SE-623, Issue 16, are at the
later of the applicable compliance times specified in Fokker
Services B.V. Engineering Report SE-623, Issue 16, or within 30 days
after the effective date of this AD, whichever is later.
    (2) If any discrepancy is found, before further flight, repair
using a method approved by the Manager, International Branch, ANM-
116, Transport Airplane Directorate, FAA; or the EASA; or Fokker
B.V. Service's EASA DOA.

(l) No Alternative Actions or Intervals

    After the maintenance or inspection program, as applicable, has
been revised as required by paragraph (k) of this AD, no alternative
actions (e.g., inspections) or intervals may be used unless the
actions or intervals are approved as an AMOC in accordance with the
procedures specified in paragraph (m)(1) of this AD.

(m) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
has the authority to approve AMOCs for this AD, if requested using
the procedures found in 14 CFR 39.19. In accordance with 14 CFR
39.19, send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the International Branch, send it to ATTN: Tom
Rodriguez, Aerospace Engineer, International Branch, ANM-116,
Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton,
WA 98057-3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>. Information
may be emailed to<EMAIL_ADDRESS>Before using any
approved AMOC, notify your appropriate principal inspector, or
lacking a principal inspector, the manager of the local flight
standards district office/certificate holding district office.
    (2) Contacting the Manufacturer: As of the effective date of
this AD, for any requirement in this AD to obtain corrective actions
from a manufacturer, the action must be accomplished using a method
approved by the Manager, International Branch, ANM-116, Transport
Airplane Directorate, FAA; or EASA; or Fokker B.V. Services' EASA
DOA. If approved by the DOA, the approval must include the DOA-
authorized signature.

(n) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
(MCAI) EASA AD 2016-0125, dated June 21, 2016, for related
information. You may examine the MCAI on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-
2016-9435.
    (2) For service information identified in this AD, contact
Fokker Services B.V., Technical Services Dept., P.O. Box 1357, 2130
EL Hoofddorp, the Netherlands; telephone: +31 (0)88-6280-350; fax:
+31 (0)88-6280-111; email<EMAIL_ADDRESS>Internet
http://www.myfokkerfleet.com. You may view this service information
at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW.,
Renton, WA. For information on the availability of this material at
the FAA, call<PHONE_NUMBER>.

    Issued in Renton, Washington, on November 17, 2016.
Phil Forde,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2016-28669 Filed 12-15-16; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 78, Number 186 (Wednesday, September 25, 2013)]
[Proposed Rules]
[Pages 58960-58962]
[FR Doc No: 2013-23276]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2013-0793; Directorate Identifier 2012-NM-138-AD]
RIN 2120-AA64

Airworthiness Directives; BAE SYSTEMS (OPERATIONS) LIMITED
Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to adopt a new airworthiness directive (AD) for all
BAE SYSTEMS (OPERATIONS) LIMITED Model BAe 146 series airplanes and
Model Avro 146-RJ series airplanes. This proposed AD was prompted by
reports of excess solder deposited during overhaul on the frangible
plug of a fire extinguisher, which prevented the release of the
extinguishant. This proposed AD would require a one-time inspection of
certain engine and auxiliary power unit (APU) fire extinguishers to
determine if the fire extinguishers are affected by excessive solder
and corrective actions if necessary. We are proposing this AD to
prevent the failure of a fire extinguisher to discharge, which reduces
the ability of the fire protection system to extinguish fires in the
engine or APU fire zones, possibly resulting in damage to the airplane
and injury to the passengers.

DATES: We must receive comments on this proposed AD by November 12,
2013.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
     For BAE SYSTEMS (OPERATIONS) LIMITED service information
identified in this proposed AD, contact BAE SYSTEMS (OPERATIONS)
LIMITED, Customer Information Department,

Prestwick International Airport, Ayrshire, KA9 2RW, Scotland, United
Kingdom; telephone +44 1292 675207; fax +44 1292 675704; email
<EMAIL_ADDRESS>Internet http://www.baesystems.com/Businesses/RegionalAircraft/index.htm. For Kidde Graviner service
information identified in this proposed AD, contact Kidde Graviner
Limited, Methisen Way, Colnbrook, Slough, Berkshire, SL3 0HB, United
Kingdom; telephone +44 (0) 1753 683245; fax +44 (0) 1753 685040. You
may review copies of the referenced service information at the FAA,
Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For
information on the availability of this material at the FAA, call 425-
227-1221.

Examining the AD Docket

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

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

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2013-0793;
Directorate Identifier 2012-NM-138-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD based on those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Community, has issued EASA
Airworthiness Directive 2012-0126R1, September 10, 2012 (referred to
after this as the Mandatory Continuing Airworthiness Information, or
``the MCAI''), to correct an unsafe condition for the specified
products. The MCAI states:

    A fire handle on a BAe 146 aeroplane was operated on the ground
as a precautionary measure after the throttle cable on the affected
engine failed, due to corrosion. The extinguisher failed to
discharge.
    Investigation results revealed that excess solder, which had
been deposited during overhaul on the frangible plug of the
extinguisher, prevented the release of the extinguishant. Prompted
by this report, Kidde Graviner, the fire extinguisher manufacturer,
identified four further extinguishers of similar design that had the
same issue.
    This condition, if not detected and corrected, could result in
the failure of a fire bottle to discharge, which reduces the ability
of the fire protection system to extinguish fires in the engine or
Auxiliary Power Unit (APU) fire zones, possibly resulting in damage
to the aeroplane and injury to the occupants.
    For the reasons described above, EASA issued AD 2012-0126 to
require a one-time inspection of the affected Part Number (P/N)
57333 engine and APU fire extinguishers. In addition, this [EASA] AD
prohibited installation of a fire extinguisher, unless it has passed
the inspection as required by [EASA] AD 2012-0126.
    Revision 1 of this [EASA] AD is issued to clarify that new
extinguishers P/N 57333 may be fitted with no additional inspection
required by this [EASA] AD.

Required actions include installing a new unit or overhauling the unit
if any solder is found during the inspection. You may obtain further
information by examining the MCAI in the AD docket.

Relevant Service Information

    BAE SYSTEMS (OPERATIONS) LIMITED has issued Service Bulletin 26-
078, dated September 21, 2011. Kidde Graviner Limited has issued
Service Bulletin 26-080, Revision 1, dated July 27, 2011. The actions
described in this service information are intended to correct the
unsafe condition identified in the MCAI.

FAA's Determination and Requirements of This Proposed AD

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

Differences Between This Proposed AD and the MCAI or Service
Information

    Although the MCAI does not specify a corrective action if any
solder is found, this proposed AD would require an overhaul of affected
fire extinguishers or installation of new fire extinguishers, as
specified in Kidde Graviner Service Bulletin 26-080, Revision 1, dated
July 27, 2011.

Costs of Compliance

    Based on the service information, we estimate that this proposed AD
would affect about 1 product of U.S. registry. We also estimate that it
would take about 1 work-hour per product to comply with the basic
requirements of this proposed AD. The average labor rate is $85 per
work-hour. Based on these figures, we estimate the cost of the proposed
AD on U.S. operators to be $85.

Authority for This Rulemaking

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

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.

    For the reasons discussed above, I certify this proposed
regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979);
    3. Will not affect intrastate aviation in Alaska; and
    4. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared a regulatory evaluation of the estimated costs to
comply with this proposed AD and placed it in the AD docket.

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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 AD:

BAE SYSTEMS (OPERATIONS) LIMITED: Docket No. FAA-2013-0793;
Directorate Identifier 2012-NM-138-AD.

(a) Comments Due Date

    We must receive comments by November 12, 2013.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to BAE SYSTEMS (OPERATIONS) LIMITED Model BAe
146-100A, -200A, and -300A airplanes; and Model Avro 146-RJ70A, 146-
RJ85A, and 146-RJ100A airplanes; certificated in any category; all
models, all serial numbers.

(d) Subject

    Air Transport Association (ATA) of America Code 26, Fire
protection.

(e) Reason

    This AD was prompted by reports of excess solder deposited
during overhaul on the frangible plug of the extinguisher, which
prevented the release of the extinguishant. We are issuing this AD
to prevent the failure of a fire extinguisher to discharge, which
reduces the ability of the fire protection system to extinguish
fires in the engine or APU fire zones, possibly resulting in damage
to the airplane and injury to the passengers.

(f) Compliance

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

(g) Inspection and Corrective Action

    For airplanes equipped with fire extinguishers manufactured by
Kidde Graviner Limited having part number (P/N) 57333 (all dash
numbers): Within 12 months after the effective date of this AD, do
an x-ray inspection to determine if there is solder between the
operating head and container of the fire extinguishers in the engine
and auxiliary power unit, in accordance with the Accomplishment
Instructions of BAE SYSTEMS (OPERATIONS) LIMITED Service Bulletin
26-078, dated September 21, 2011; or Kidde Graviner Service Bulletin
26-080, Revision 1, dated July 27, 2011; as applicable.
    (1) If any solder is found, before further flight, do the action
specified in paragraph (g)(1)(i) or (g)(1)(ii) of this AD, in
accordance with the Accomplishment Instructions of Kidde Graviner
Service Bulletin 26-080, Revision 1, dated July 27, 2011.
    (i) Overhaul the fire extinguisher and install. An overhaul
includes the replacement of the operating head. Replacement of the
pressure relief plug assembly only is not considered an overhaul.
    (ii) Install a new fire extinguisher.
    (2) If no solder is found, no further action is required by this
paragraph.

(h) Parts Installation Limitation

    As of the effective date of this AD, no person may install a
Kidde Graviner Limited fire extinguisher having P/N 57333 (all dash
numbers), on any airplane, unless the fire extinguisher is new, or
it has been determined that there is no solder between the operating
head and container of the fire extinguishers as required by
paragraph (g) of this AD, or has been overhauled in accordance with
the Accomplishment Instructions of Kidde Graviner Service Bulletin
26-080, Revision 1, dated July 27, 2011.

(i) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, FAA, has the authority to approve
AMOCs for this AD, if requested using the procedures found in 14 CFR
39.19. In accordance with 14 CFR 39.19, send your request to your
principal inspector or local Flight Standards District Office, as
appropriate. If sending information directly to the International
Branch, send it to ATTN: Todd Thompson, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue SW., Renton, WA 98057-3356; telephone<PHONE_NUMBER>;
fax<PHONE_NUMBER>. Information may be emailed to<EMAIL_ADDRESS>Before using any approved AMOC, notify your
appropriate principal inspector, or lacking a principal inspector,
the manager of the local flight standards district office/
certificate holding district office. The AMOC approval letter must
specifically reference this AD.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.

(j) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
(MCAI) European Aviation Safety Agency (EASA) Airworthiness
Directive 2012-0126R1, dated September 10, 2012, for related
information, which can be found in the AD docket on the Internet at
http://www.regulations.gov.
    (2) For BAE SYSTEMS (OPERATIONS) LIMITED service information
identified in this AD, contact BAE SYSTEMS (OPERATIONS) LIMITED,
Customer Information Department, Prestwick International Airport,
Ayrshire, KA9 2RW, Scotland, United Kingdom; telephone +44 1292
675207; fax +44 1292 675704; email<EMAIL_ADDRESS>
Internet http://www.baesystems.com/Businesses/RegionalAircraft/index.htm. For Kidde Graviner service information identified in this
AD, contact Kidde Graviner Limited, Methisen Way, Colnbrook, Slough,
Berkshire, SL3 0HB, United Kingdom; telephone +44 (0) 1753 683245;
fax +44 (0) 1753 685040. You may review copies of the 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>.

    Issued in Renton, Washington, on September 13, 2013.
Jeffrey E. Duven,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2013-23276 Filed 9-24-13; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 81, Number 150 (Thursday, August 4, 2016)]
[Notices]
[Pages 51436-51437]
[FR Doc No: 2016-18489]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. CP14-517-000; CP14-518-000]

Golden Pass Pipeline, LLC; Golden Pass Products, LLC; Notice of
Availability of the Final Environmental Impact Statement for the
Proposed Golden Pass LNG Export Project

    The staff of the Federal Energy Regulatory Commission (FERC or
Commission) has prepared a final environmental impact statement (EIS)
for the Golden Pass Liquefied Natural Gas (LNG) Export Project,
proposed by Golden Pass Products, LLC and Golden Pass Pipeline, LLC
(collectively referred to as Golden Pass) in the above-referenced
docket. Golden Pass requests authorization to expand and modify the
existing Golden Pass LNG Import Terminal to allow the export of LNG,
which would require construction and operation of various liquefaction,
LNG distribution, and appurtenant facilities. The Project would also
include construction of approximately 2.6 miles of 24-inch pipeline,
three new compressor stations, and interconnections for bi-directional
transport of natural gas to and from the Golden Pass LNG Export
terminal.
    The final EIS assesses the potential environmental effects of the
construction and operation of the Golden Pass LNG Export Project in
accordance with the requirements of the National Environmental Policy
Act (NEPA). The FERC staff concludes that approval of the proposed
project, with the mitigation measures recommended in the EIS, would
result in some adverse environmental impact; however, those impacts
would not be significant with implementation of Golden Pass' proposed
mitigation and the additional measures recommended in the draft EIS.
    The U.S. Army Corps of Engineers, U.S. Coast Guard, U.S. Department
of Energy, U.S. Department of Transportation, and U.S. Environmental
Protection Agency participated as cooperating agencies in the
preparation of the EIS. Cooperating agencies have jurisdiction by law
or special expertise with respect to resources potentially affected by
the proposal and participate in the NEPA analysis. Although the
cooperating agencies provided input to the conclusions and
recommendations presented in the EIS, the agencies will present their
own conclusions and recommendations in their respective Records of
Decision for the project.
    The final EIS addresses the potential environmental effects of the
construction and operation of the following project facilities:
     Liquefaction facilities at the existing Golden Pass Export
Terminal including three liquefaction trains, a truck unloading
facility, refrigerant and condensate storage, safety and control
systems, and associated infrastructure;
     a supply dock and alternate marine delivery facilities at
the Terminal;

     three miles of a new 24-inch-diameter pipeline loop \1\
adjacent to the existing Golden Pass pipeline;
---------------------------------------------------------------------------

    \1\ A loop is a segment of pipe that is installed adjacent to an
existing pipeline and connected to it at both ends. A loop generally
allows more gas to move through the system.
---------------------------------------------------------------------------

     three new compressor stations;
     five new pipeline interconnections and modifications at
existing pipeline interconnections; and
     miscellaneous appurtenant facilities.
    The FERC staff mailed copies of the EIS to federal, state, and
local government representatives and agencies; elected officials;
environmental and public interest groups; Native American tribes;
potentially affected landowners and other interested individuals and
groups; newspapers and libraries in the project area; and parties to
this proceeding. Paper copy versions of this EIS were mailed to those
specifically requesting them; all others received a CD version. In
addition, the EIS is available for public viewing on the FERC's Web
site (www.ferc.gov) using the eLibrary link. A limited number of copies
are available for distribution and public inspection at: Federal Energy
Regulatory Commission, Public Reference Room, 888 First Street NE.,
Room 2A, Washington, DC 20426,<PHONE_NUMBER>.
    Additional information about the project is available from the
Commission's Office of External Affairs, at (866) 208-FERC, or on the
FERC Web site (www.ferc.gov) using the eLibrary link. Click on the
eLibrary link, click on ``General Search,'' and enter the docket number
excluding the last three digits in the Docket Number field (i.e., CP14-
517 or CP14-518). Be sure you have selected an appropriate date range.
For assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>or toll free at<PHONE_NUMBER>; for TTY,
contact<PHONE_NUMBER>. The eLibrary link also provides access to the
texts of formal documents issued by the Commission, such as orders,
notices, and rulemakings.
    In addition, the Commission offers a free service called
eSubscription which allows you to keep track of all formal issuances
and submittals in specific dockets. This can reduce the amount of time
you spend researching proceedings by automatically providing you with
notification of these filings, document summaries, and direct links to
the documents. Go to www.ferc.gov/docs-filing/esubscription.asp.

    Dated: July 29, 2016.
Kimberly D. Bose,
Secretary.
[FR Doc. 2016-18489 Filed 8-3-16; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 190 (Wednesday, October 1, 2014)]
[Notices]
[Pages 59335-59336]
[FR Doc No: 2014-23316]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-73221; File No. SR-BYX-2014-023]

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

September 25, 2014.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on September 12, 2014, BATS Y-Exchange, Inc. (the ``Exchange'' or
``BYX'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I, II
and III below, which Items have been prepared by the Exchange. The
Exchange has designated the proposed rule change as one establishing or
changing a member due, fee, or other charge imposed by the Exchange
under Section 19(b)(3)(A)(ii) of the Act \3\ and Rule 19b-4(f)(2)
thereunder,\4\ which renders the proposed rule change effective upon
filing with the Commission. The Commission is publishing this notice to
solicit comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \4\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

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

    The Exchange filed a proposal to amend the fee schedule applicable
to Members \5\ and non-members of the Exchange pursuant to BYX Rules
15.1(a) and (c). Changes to the fee schedule pursuant to this proposal
are effective upon filing.
---------------------------------------------------------------------------

    \5\ A Member is defined as ``any registered broker or dealer
that has been admitted to membership in the Exchange.'' See Exchange
Rule 1.5(n).
---------------------------------------------------------------------------

    The text of the proposed rule change is available at the Exchange's
Web site at http://www.batstrading.com, at the principal office of the
Exchange, and at the Commission's Public Reference Room.

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

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

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

1. Purpose
    The Exchange recently filed a proposed rule change to adopt a new
routing option called ``RMPT''.\6\ RMPT is a routing option under which
a Mid-Point Peg Order \7\ checks the System \8\ for available shares
and any remaining shares are then sent to destinations on the System
routing table that support midpoint eligible orders.
---------------------------------------------------------------------------

    \6\ See SR-BYX-2014-021, filed on September 11, 2014, available
at http://www.batstrading.com/regulation/rulefilings/byx/.
    \7\ Mid-Point Peg Orders are defined in Rule 11.9(c)(9).
    \8\ System is defined in Rule 1.5(aa).
---------------------------------------------------------------------------

    The Exchange now proposes to modify its fee schedule to adopt fees
applicable to the RMPT routing strategy. For orders routed pursuant to
the RMPT routing strategy and executed on an away trading venue, the
Exchange proposes to charge $0.0012 per share in securities priced at
or above $1.00 and 0.29% of the total dollar value of the execution for
securities priced below $1.00. The proposed fees are intended to
approximate the cost for executions of midpoint orders on away trading
venues.
    The Exchange proposes to implement the amendments to its fee
schedule effective immediately.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the requirements of the Act and the rules and regulations
thereunder that are applicable to a national securities exchange, and,
in particular, with the requirements of Section 6 of the Act.\9\
Specifically, the Exchange believes that the proposed rule change is
consistent with Section 6(b)(4) of the Act,\10\ in that it provides for
the equitable allocation of reasonable dues, fees and other charges
among members and other persons using any facility or system which the
Exchange operates or controls. The Exchange notes that it operates in a
highly competitive market in which market participants can readily
direct order flow to competing venues if they deem fee levels at a
particular venue to be excessive.
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78f.
    \10\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

    The Exchange believes that the proposed changes to the Exchange's
fee schedule to add fees for the RMPT routing strategy represents an
equitable allocation of reasonable dues, fees, and other charges among
Members and other persons using its facilities because they are in line
with the fees charged for executions through other low-price routing
strategies and approximate the cost to the Exchange of executing
midpoint orders on away trading venues. Lastly, the Exchange notes that
the use of the RMPT routing strategy is

voluntary and believes that the proposed change is non-discriminatory
because it applies uniformly to all Members.

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

    The Exchange does not believe that the proposed rule change will
result in any burden on competition that is not necessary or
appropriate in furtherance of the purposes of the Act, as amended.
Because the market for order execution is extremely competitive,
Members may readily opt to disfavor the Exchange's routing services if
they believe that alternatives offer them better value. For orders
routed through the Exchange through the RMPT routing strategy the
proposed fees are in line with the fees charged for executions through
other low-price routing strategies and approximate the cost to the
Exchange of executing midpoint orders on away trading venues. As stated
above, the Exchange notes that it operates in a highly competitive
market in which market participants can readily direct order flow to
competing venues if they deem fee structures to be unreasonable or
excessive.

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

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

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A) of the Act \11\ and paragraph (f) of Rule 19b-4
thereunder.\12\ At any time within 60 days of the filing of the
proposed rule change, the Commission summarily may temporarily suspend
such rule change if it appears to the Commission that such action is
necessary or appropriate in the public interest, for the protection of
investors, or otherwise in furtherance of the purposes of the Act.
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78s(b)(3)(A).
    \12\ 17 CFR 240.19b-4(f).
---------------------------------------------------------------------------

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-BYX-2014-023 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-BYX-2014-023. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of the filing also will be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-BYX-2014-023, and should be
submitted on or before October 22, 2014.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\13\
---------------------------------------------------------------------------

    \13\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2014-23316 Filed 9-30-14; 8:45 am]
BILLING CODE 8011-01-P


Comment Info: =================

General Comment:To:
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, rm. 1061
Rockville, MD 20852.
RE: Docket No. FDA- 2014-N-0189

RE: “Deeming Tobacco Products to Be Subject to the Federal Food, Drug and Cosmetic Act,” Docket No. FDA- 2014-N-0189 request for extended comment period.

Dear Director Zeller:

I am writing as an individual consumer to request an extension of the comment period for the Food and Drug Administration’s (“FDA”) Proposed Rule Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking and Prevention and Tobacco Control Act (the “Proposed Rule”) published at 79 Fed. Reg. 23,142 and Federal Register No. 2014-09491. On behalf of myself, I am requesting that the comment period for the Proposed Rule be extended by the FDA for an additional 105 days, from its current 75-day period, to 180 days. I wish to provide you with my personal story, as well as science and evidence-based responses to your questions so that you can take my comment into account. I realize that the FDA has the authority under 21 CFR 10.40 to extend this time frame and that the FDA has exercised this authority on numerous occasions in the past.

I am an electronic cigarette user. After smoking cigarettes for nearly 40 years and trying every means to quit, e-cigarettes are the only thing that worked for me. I started using e-cigs on 8/24/2012 and have not had a conventional cigarette since, nor do I have any desire for them. I feel so much better and am convinced that electronic cigarettes have saved my life, and the lives of many many others already. If given a fair chance, I know they can save the lives of thousands more.  I do realize that they need to be regulated for the safety of all concerned, but this needs to be done in a responsible and fair way. Let the users and vendors of e-cigarettes have their fair say in this: after all, we know these products better than anyone. I chose to ingest these products, so you can bet that I have read every study and research paper out there.
 Also, please remember that big pharma and big tobacco have a vested interest in keeping these life saving devices from cutting into their profits. They commonly resort to data twisting, fear mongering, and outright lies to realize their own financial agendas, Please discard the junk and concentrate on the real science such as peer reviewed studies by neutral sources.

I appreciate the opportunity to respond to the Food and Drug Administration’s (FDA or the Agency) request for comments on the proposed rule for “Deeming Tobacco Products to Be Subject to the Federal Food, Drug and Cosmetic Act,” Docket No. FDA- 2014-N-0189.  I am in the process of preparing detailed comments in response to the FDA’s numerous requests in the proposed rule, but am very concerned that I will not be able to adequately respond to those requests in the 75-day comment period (i.e., by July 9, 2014).  There are many requests for comments in the proposed rule that I am considering responding to on behalf of consumers of e-cigarette /refillable e-liquid products, many of which require obtaining, summarizing and providing supporting scientific research and other evidence.  The 75-day comment period does not allow sufficient time to develop meaningful or thoughtful responses to many of the questions raised in the proposed rule.  Accordingly, I respectfully urge the Agency extend the current comment period by, at the very least, an additional 105-days (so that comments would be due by October 22, 2014), to provide ample time for stakeholders to provide constructive and valuable feedback on the issues raised in the proposed rule.  I do not believe that such an extension would significantly delay any potential regulatory action on these important issues, and can only aid in providing the FDA with the information that it needs to regulate the growing refillable e-liquid industry in a responsible manner.

If you have any questions or concerns, please do not hesitate to contact me.  I thank FDA for the opportunity to provide my views on the proposed rule.


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF

PREVENTION, PESTICIDES  AND

TOXIC SUBSTANCES

Date: 03/30/2005

MEMORANDUM

SUBJECT:	Tributyltin maleate (TBTM): Non-Dietary Residential Exposure  Considerations for Proposed Registration of  Ultra-Fresh® DM-50 as a New Indoor Use Pattern for TBTM,

FROM:	Jeff Evans, Biologist

Chemistry and Exposure Branch

Health Effects Division (7509C)

TO:		Meta Bonner, Ph.D., Toxicologist

Registration Action Branch 3

Health Effects Division (7509C)

THRU:	David J. Miller., Acting Branch Chief

Chemistry and Exposure Branch

Health Effects Division (7509C)

PC Code (s).:		083118

DP Barcode:		314711

MRID:		45746801, 45746802

INGREDIENT PROFILE

Summary of Registered/Proposed Uses tc \l2 "Summary of Registered/Proposed Uses

Ultra-Fresh® DM-50 (EPA Reg. No. 10466-28) containing 25% ai tri-n-butyltin maleate, is currently registered for use as a bacteriostat and fungistat preservative finish for textiles (fabrics, water-based emulsion/adhesives, and vinyl polymer materials) at applications levels ranging from 0.08 to 0.4% (w/w).

The proposed new registration (File Symbol 10466-GO) is for dust mite control in treated finished carpets and rug backings and fibers bearing the label Ultra-Fresh® DM-50 Dust Mite Treated Carpeting.  Labeled finished carpets and rugs backings and fibers are intended to contain  0.075% tri-n-butyltin maleate (TBTM) [File Symbol 10466-??].   [NOTE: RD has indicated the registrant will be required to propose a registration of a separate manufacturing use product containing 0.075% tri-n-butyl maleate].

Submitted Data

Thompson Research Associates has submitted data to support a Section 3 registration of a non-food use product intended to control dust mites when incorporated into various materials (fibers, backing) and fabrics during the carpet manufacturing process.  Some of the data submitted were conducted in accordance with protocols submitted and reviewed by the Agency in a memorandum dated 12, December, 2001. {K. O’Rourke to George LaRocca, Ultra-Fresh DM-50 (tri-n-butyltin maleate [TBTM]): Review of 2 Study Protocols for Product Integrity on Treated Carpet Materials (D273967)}.  The two study protocols are as follows:

Transfer of TBTM by Abrasion from Carpet Samples Treated with Ultra-Fresh DM-50, Experiment Number: RG-2001-01-001; and

Leaching of TBTM from a Nylon Carpet Sample Treated with Ultra-Fresh DM-50 Using Acidic, Neutral and Alkaline Artificial Sweat, RG-2000-01-004.

In the protocol review, it was suggested that the registrant provide the  analytical methods for verification by the Agency and justification for the types of carpet materials selected for use in the proposed carpet residue studies.  Subsequent to the protocol review, Laird’s Regulatory Consultants, Inc. submitted two fabric leaching studies on behalf of Thompson Research Associates.   These studies are:

Klein, D (2002) Leaching of TBTM from a Nylon Carpet Sample Treated with Ultra-Fresh DM-50 Using Acidic, Neutral and Alkaline Artificial Sweat: Final Report: Lab Project Number: RG-2000-01-004.  Unpublished study prepared by Thompson research Associates [MRID 45746802].

Yau, L (1982) Exposure of Product on Carpet: (Ultra Fresh DM-50): Lab Project Number: CM501:94.  Unpublished study prepared by Thompson Research Associates.[MRID 45746801].

The first study, MRID 45746802, appears to be the study RG-2000-01-004 addressed in the aforementioned  protocol review.   The study RG-2001-01-001, a potentially more useful for exposure assessments (carpet wipes), was not  submitted.   The studies reported by Kline and Yau.[MRID 45746801], analyze carpet samples (swatches) taken from carpets treated with Ultra Fresh DM-50.   The Ultra Fresh DM-50 formulation intermediate used during the carpet manufacturing process contains 25% TBTM.

Both studies involve the immersion of carpet swatches in various artificial sweat solutions and saline control solutions.   The pH of human sweat varies from 4.5 to7.5.  http://www.mercksource.com/pp/us/cns/cns_home.jsp.   The study designs were intended to determine maximum levels of tributyltin maleate that may leach from carpets treated with Ultra-Fresh® DM-50.  It should be noted that the description of the carpet sample treatment concentrations varies in the two studies.   It is recommended that these concentration rates be verified by the registrant.

MRID 45746802

In the study report authored by Klein, artificial sweat leaching solutions were prepared in accordance with formulations described in the American Association of Textile Colorists and Chemists (AATCC), Test Method 15-1994 (Colorfastness to Prespiration).  In this study, saline solutions, acid sweat (pH 3.6), neutral sweat (pH 7.0) and alkaline sweat (pH 9.2) were prepared.  Swatch samples (2.5 cm2 x  2.5 cm2) collected from a nylon carpet were immersed in the respective solutions.  Concentrations of tributyltin maleate measured after 2 and 24 hours of immersion are presented in Table 1.   The carpet samples were taken from a commercial production facility during routine testing (0.03% Ultra-Fresh® DM-50 (based on the total weight of the carpet (fibers, latex, backing)).

Table 1: Reported Parts per Million (µg/g)  Tributyltin Maleate/Nylon Carpet Sample Treated with 0.03% Ultra-Fresh® DM-50 (Klein 2002)

Solution Type

	2 Hours of Immersion

	24 Hours of Immersion

	µg/g

	mean + SD

	µg/g

	mean + SD

Saline

	5.5

	5.2 + 0.4

	6.9

	7.2 + 0.2

	4.7

	7.3

	5.3

	7.3

Acidic Sweat

(pH 3.6)

	4.1

	3.3 + 1.1

	3.9

	3.8 + 0.1

	3.8

	3.7

	2.1

	3.9

Neutral Sweat

(pH 7.0)

	1.4

	2.2 + 1.1

	4.6

	5.3 + 0.8*

	3.5

	6.1

	1.7

	5.3

Alkaline Sweat

(pH 9.2)

	4.8

	4.7 + 2.6

	10.9

	10.6 + 0.6

	2.0

	9.9

	7.2

	11.1

	* Used in exposure assessment.

The calculations used to derive the parts per million tributyltin maleate leached from the carpet samples presented in Table 1 and reported in Klein are as follows:

µg Tributlytin Maleate/ gram of carpet at 2 hours =

ppm Tin2 hrs x 3.4131 x Solution Weight2 hours / Sample Weight

µg Tributlytin Maleate/ gram of carpet at 24 hours =

[(ppm Tin2 hrs x Solution Weight Removed 2 hours) + (ppm Tin24 hrs x 3.4131 x Solution Weight24 hours)] x 3.4131/ Sample Weight

The percent values presented in Table 2 and reported in Klein are calculated as follows:

ppm tin presented in 0.03% Ultra-Fresh® DM-50 = 0.03 x 250000*/ 100/3.4134 = 21.97

Percent Tributyltin Maleate leached at 2 hours =

(ppm Tin2 hrs x Solution Weight2 hours)/ (21.97 x Sample Weight) x 100

Percent Tributyltin Maleate leached at 24 hours =

[(ppm Tin2 hrs x Solution Weight Removed2 hours)+(ppm Tin24 hrs x Solution Weight24 hours)] / (21.97 x Sample Weight) x 100

*25%

The value of 3.4131 is assumed to be a correction factor (ratio) for estimating tributyltin maleate concentrations from measurements of tin.  It should be noted that the standard operating procedures delineating the analysis and calculations were not available in the package as requested by the Agency.  Therefore the calculations and results are presented in this memorandum as verbatim from the report submitted by Laird’s Regulatory Associates.  Table 2 presents the percent tributyltin maleate leached from the swatches.

Table 2: Percentage of Ultra-Fresh® DM-50 Leached from a Nylon Carpet Sample Treated with 0.03% Ultra-Fresh® DM-50 (Klein 2002)

Solution Type

	2 Hour

	24 Hour

	percent

	mean + SD

	percent

	mean + SD

Saline

	7.3

	6.6 + 0.5

	9.2

	9.5 + 0.3

	6.3

	9.7

	7.0

	9.7

Acidic Sweat

(pH 3.6)

	5.5

	4.4 + 1.5

	5.2

	5.1 + 0.2

	5.0

	4.9

	2.7

	5.2

Neutral Sweat

(pH 7.0)

	1.9

	2.9 + 1.5

	6.2

	7.1 + 1.0

	4.6

	8.1

	2.3

	7.1

Alkaline Sweat

(pH 9.2)

	6.5

	6.3 + 3.5

	14.6

	14.2 + 0.9

	2.7

	13.2

	9.6

	14.8

Klein asserts that the leaching results presented in Tables 1 and 2 are based on extreme conditions and that exposure to treated carpets, under normal use conditions, would result in contact measurements below the detection limit of current analytical methodologies.  The highest average amount leached from the carpet samples was 10.6 µg of tributyltin maleate per gram of sample under alkaline conditions for a period of 24 hours (14.2% Ultra-Fresh® DM-50).   Since the pH of human sweat varies from 4.5 to7.5, the mean value from the neutral sweat samples (5.3 µg) appears to be an appropriate value for use in the assessment.  The samples however, were from a carpet treated at a lower concentration than proposed for dust mites.  Artificial saliva formulations are acidic (pH between 5.2 - 5.5).

In a similar study conducted in 1982, Yau addressed the leaching potential of tributyltin maleate from carpets treated at higher rates - similar to the proposed application rate.   Total tin measurements in the treated carpet swatches were reported based on results using AATCC extraction method 94 (identification of various finishing components).   In this study, the carpet samples were treated at 0.1 and 0.2 percent Ultra-Fresh® DM-50 (dry weight of face fibers) held in the respective saline and acidic sweat liquors at a ratio of 20:1 for periods of 24 and 48 hours.  Analysis of the liquor samples (pH unspecified) indicated zero ppm, tributyltin maleate (TBTM) had leached from the swatches.  The swatches were 5 cm2 x 5 cm2.  Results of the analysis are presented in Table 3.

Table 3: Removal of TBTM from treated Carpets (Yau 1982)

Carpet Samples (total amount in carpet)

Percent DM-50

Contact Hours

Saline (ppm)

Sweat (ppm)

0.1

0

257

257

24

252

254

48

253

252

0.2

0

515

515

24

511

514

48

517

513

Liquor Samples

0.1

24

0

0

48

0

0

0.2

24

0

0

48

0

0

Yau also reported a separate leaching study in which 100% nylon swatch samples (20 cm2 x 16 cm2) were immersed in similar saline and sweat solutions as described in Klein, for periods of 2 and 5 hours.  The fabric was treated with a 0.2% aqueous solution of Ultra Fresh 50® followed by 15 minutes of drying at 90 C.  After treatment and drying, the swatches were cut (12 separate pieces) and immersed in the respective solutions.  There is no referenced AATCC method cited in this report for extracting tributyltin maleate from the nylon swatches.   Rather, the reports states that the method was done in accordance with directions provided in an EPA letter dated April 5, 1982.  The results of this third trial are presented in Table 4.   It is not clear in the report whether the described nylon swatch treatment was performed in a laboratory or in a manufacturing facility.

Table 4: Parts per Billion Tin (Sn) Leached from Nylon Swatches Immersed in Solutions for 2 and 5 Hours.

Solution Type

First Reading

Second Reading

Saline

Sample ID’s

100N S 1 2

200

220

100N S 1 5

320

305

100N S 2 2

360

345

100N S 2 5

430

420

100N S 3 2

480

465

100N S 3 5

590

590

Sweat

pH 3.6

100N 4 1 2

130

110

100N 4 1 5

130

140

100N 4 2 2

120

150

100N 4 2 5

160

170

100N 4 3 2

140

126

100N 4 3 5

170

165

Sweat

pH 7.01

100N 7 1 2

70

70

100N 7 1 5

180

185

100N 7 2 2

80

75

100N 7 2 5

90

95

100N 7 3 2

30

45

100N 7 3 5

100

100

Sweat

pH 9.2

100N 9 1 2

113

119

100N 9 1 5

108

112

100N 9 2 2

101

100

100N 9 2 5

104

106

100N 9 3 2

101

99

100N 9 3 5

107

109

The author concludes that none of the samples indicated more than 8 ppm of Ultra Fresh DM-50 (590 ppb x 3.41 (  25% = 8048 ppb).

Postapplication Exposure

 The postapplication scenarios assessed in this memorandum are potential incidental oral ingestion from mouthing hands that may contact the impregnated carpet and potential dermal exposure.  Because tributyltin maleate is bound to carpet materials, postapplication exposure via the inhalation route is considered to be negligible.

The assessment utilized chemical-specific exposure data submitted by Laird’s Regulatory Consultants, Inc. on behalf of Thompson Research Associates (MRIDs 45746802 and 45746801).  The studies involve the immersion of treated carpet swatches in alkaline, acidic and neutral artificial sweat solutions and saline control solutions. The study designs were intended to determine maximum levels of tributyltin maleate that may leach from carpets treated with Ultra-Fresh® DM-50.  Overall, it appears that the Klein data, provide a reliable screening level value for use in a Tier 1 exposure/risk assessment.  To establish a flux rate (FR), a 24 hour concentration was selected from Klein (2002) using the average value of 5.3 ppm TBTM (µg/g) measured in swatches immersed in neutral sweat (see Table 1).

This value was selected because it appears to be the most representative of the range of pH values reported for human sweat (4.5  to 7.5).  The swatches, measuring 2.5 cm x 2.5 cm (6.25 cm2) reportedly weigh ~2 grams.  Therefore, the swatch contained 5.3 ppm TBTM (µg/g) or 0.848 µg/cm2 (5.3 µg/g  ( 6.25 cm2/g).  Thus, the value 8.48 mg/m2 can be used as the flux rate (FR) in the following formula from HED’s Residential SOP’s for assessing exposure to impregnated articles such as mattresses:

PDR = FR * SA * ET * CF1

Where:

PDR	=	potential dose rate (mg/day)

FR	=	flux rate for pesticide of concern (mg/m2/day)

SA	=	body surface area (m2)

ET	=	exposure time (hours/day)

CF1	=	time unit conversion factor (day/24 hours)

In this assessment, a young child in direct contact with the carpet was selected as a representative scenario.  The short and intermediate term endpoint selected for this assessment is the BMD10 of 0.03 mg/gk/day.  The dermal absorption value is 15%.  When using the flux rate SOP to assess short- and intermediate-term exposures via the dermal and non-dietary ingestion pathways, body surface areas (SA) are needed.  For non-dietary ingestion via hand-to-mouth behavior, a surface area of 0.04 m2 has been selected to represent the palmar surface area of finger tips of young children coming in contact with the carpet.   For short term exposure durations, the residential SOPs suggest 20 contacts per hour (90th percentile) with a surface area of 20 cm2 (400 cm2 = 0.04 m2).  Since the endpoints for short term and intermediate term exposure were the same, only short term durations were assessed.  Furthermore, in this assessment the PDR in the above formula is adjusted to account for a reduction in the amount of transfer of residues from fingers by 50 percent given the reduced extraction efficiency of saliva.

To assess dermal exposure of  young children in direct contact with the carpet product, a surface area of 900 cm2 or 0.09 m2 representing half the exposed area of a child wearing shorts and short sleeved shirt was used.   This is based on EPA’s Exposure Factors Handbook recommending a value of  25% of a child’s skin being exposed while wearing short sleeved shirts, short pants and shoes.   The surface area of a 3 to 4 year old child is ~6000 cm2 or 0.6 m2.  In this assessment, an exposed surface area of 30 percent was used in lieu of shoes being worn.  Given the conservative nature of the assumed concentration coming in contact with the skin, clothing penetration is not considered at this time.  Both dermal and hand-to-mouth surface area values can be used with the Antimicrobial Division’s SOP using a flux rate method for individuals contacting impregnated materials.

Exposure durations are for 2 hours as presented in the Antimicrobial Division’s memorandum dated July 2, 2004. (D. Aviado to D. Edwards re: Proposed Registration for AZOXYSTROBIN MOLD_RETARDANT 2.08 SC End-Use Product as a New Indoor, Non-Agricultural Use Pattern for the Azoxystrobin Active Ingredient: Non-Dietary Occupational/ Residential Exposure Considerations).   HED typically uses 8 hours and 4 hours contact time for exposure to residues collected by surface wipes for carpets and hard surfaces respectively.  For this assessment, the 2 hour duration used by AD appears to be a reasonable amount of time to be spent on a carpet formulated with tributyltin maleate.  In particular, given the extreme measurements of tributyltin maleate used in this assessment which rely on immersion of carpet swatches in simulated sweat for a 24 hour period.   Finally, a body weight of 15 kg was use used in this assessment.  The results are presented in Table 5.

Table 5:  Screening Level Exposure Estimates.

FR: flux rate

(mg/m2/day)

SA: body surface area (m2)

ET: exposure time (hours)

CF1: conversion factor (day/ hours)

PDR (mg/day)

Daily Dose (mg/kg/day)

	Short- and intermediate-term: hand-to-mouth exposure

8.48

0.04

2

24

0.014*

0.0009

	Short- and intermediate-term: dermal exposure

8.48

0.09

2

24

0.0095**

0.0006

* Includes 50% extraction efficiency of saliva

** Includes a dermal absorption factor of 15%

These exposure estimates are likely to overestimate exposure, considering the input values are from the extraction of swatches immersed in sweat solutions for up to 24 hours.  These values represent a steady state extraction process that may not be representative of typical human intermittent contact with carpet surfaces but rather may be indicative of the removal of TBTM by shampooing.   The registrant suggests that the carpet may not be efficacious after 12 carpet shampoo treatments.

 The three studies submitted present confounding conclusions which may be due to different carpet materials, treatment methods and concentrations.   In the study conducted by Klein, residues were extracted using standard sweat liquors.   In an older study reported by Yau, no residues were detected in the sweat liquors.   This may be due to different treatment rates or it may be a function of the types of carpets sampled.  In the third study discussed in Yau, too few details regarding the test material (100% nylon) were provided to make these data useful in an exposure assessment.  In addition, 24 hour samples are needed for estimation of exposure via the flux rate SOP used by the Antimicrobials Division. In this study, a maxim of 5 hours duration was selected..

 tc \l1 " A screening-level assessment was conducted for children’s dermal and incidental oral exposure to TBTM impregnated carpet. Because of the highly conservative nature of these single route exposure inputs, children’s non-dietary ingestion and dermal exposures were not combined. A separate assessment was not conducted for adults because the child’s mouthing behaviors and surface to body weight parameters represent the most highly exposed population. Exposure inputs obtained from the carpet leaching study very likely overestimate the potential for exposure.  After continuous 24 hour immersion in saline solution, a mean of 7.1% of the TBTM was leached from treated carpet indicating that TBTM, although potentially available in low amounts, is tightly bound to the textile matrix.  Comparison of the benchmark dose (BMD10) of 0.03 mg/kg/day to the estimated exposure levels gives MOEs 33 and 50 for short and intermediate term exposure for the hand-to-mouth and dermal pathways respectively.   Two 10x safety factors addressing intra and inter species variability were assigned for TBTM.   An additional toxicology database uncertainty factor (10x) was also added.

A benchmark dose (BMD) is a measure of exposure to a dose of a chemical that relies on a modeled mathematical fit of all the dose response data within a toxicology study.   Generally, the BMD is set in a range of 1 to 10% of a health effect.  The BMD 10 for TBTM is 0.03 mg/kg/day based on  immunosuppression observed in an oral 18-month immunotoxicity study in the rat.

Table 5.  Summary of Daily Doses and MOEs for Residential Exposures to TBTM

Exposure Scenario

Daily Dose (mg/kg/day)

MOE

(LOC=1000)

Short- and intermediate-term incidental oral

0.0009

33

Short- and intermediate term dermal

0.0006

50

Based on the data collected by Klein, the MOEs presented above indicate that margins of exposure (MOE) do not meet or exceed 1000 indicating that these estimates are estimates of concern.   It is suggested that the registrant:

 clarify the carpet treatment rates used in the submitted studies; and

consider submitting the carpet wipe study discussed in the protocol review (or consider other wipe sample studies in consultation with HED).

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