[Federal Register: July 8, 2010 (Volume 75, Number 130)]
[Notices]
[Page 39313-39314]
[DOCID:fr08jy10-138]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-62430; File No. SR-ISE-2010-69]

Self-Regulatory Organizations; International Securities Exchange,
LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule
Change Relating to Amending the Direct Edge ECN Fee Schedule

July 1, 2010.
    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 June 30, 2010, 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, II, and III below, which items have been prepared by the self-
regulatory organization. The Commission is publishing this notice to
solicit comments on the proposed rule change from interested persons.
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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 Direct Edge ECN's (``DECN'') fee
schedule for ISE Members \3\ to (i) eliminate a trading volume
threshold found in footnote 4 to the fee schedule and (ii) add
clarifying material to explain how certain volume thresholds will be
adjusted during the month of July 2010. All of the changes described
herein are applicable to ISE Members.
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    \3\ References to ISE Members in this filing refer to DECN
Subscribers who are ISE Members.
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    The text of the proposed rule change is available on the Exchange's
Internet Web site at http://www.ise.com, on the Commission's Internet
Web site at http://www.sec.gov, at ISE, and at the Commission's Public
Reference Room.

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

    In its filing with the Commission, the self-regulatory organization
included statements concerning the purpose of, and basis for, the
proposed rule change and discussed any comments it received on the
proposed rule change. The text of 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
    DECN, a facility of ISE, operates two trading platforms, EDGX and
EDGA.\4\
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    \4\ This fee filing relates to the trading facility operated by
ISE and not EDGA Exchange, Inc. and EDGX Exchange, Inc. Direct Edge
ECN LLC (EDGA and EDGX) will cease to operate in its capacity as an
electronic communications network following the commencement of
operations of EDGA Exchange, Inc. and EDGX Exchange, Inc. as
national securities exchanges.
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    The EDGA and EDGX Exchanges \5\ expect to begin operating as
national securities exchanges on July 2, 2010. Following the launch
date there will be a two-week phase-in period during which securities
currently trading on DECN will be moved from DECN to EDGA and EDGX
Exchanges. Once a symbol is migrated from DECN to EDGA and EDGX
Exchanges, it will no longer be available for trading on DECN and will
only be available for trading on the EDGA and EDGX Exchanges. Once the
EDGA and EDGX Exchanges begin trading their first security, they will
thus operate in conjunction with DECN until all symbols are fully
migrated.
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    \5\ See SR-EDGA-2010-04 and SR-EDGX-2010-04 for EDGA and EDGX
Exchange fee schedules.
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    As a result of the phased migration of symbols from DECN to EDGA
and EDGX Exchanges, three volume thresholds will need to be adjusted
for the month of July 2010 only to reflect the portion of the volume
that occurs on DECN during the month. The Exchange is proposing to
place clarifying language about how these rebates are calculated in
footnote numbers 1 and 2 to the DECN fee schedule. First, the removal
rate on EDGA (a rebate of $0.0002 per share) is currently contingent on
the attributed MPID adding (including hidden) and/or routing a minimum
average daily share volume, measured monthly, of 50,000 shares on EDGA.
Any attributed MPID not meeting the aforementioned minimum will be
charged $0.0030 per share for removing liquidity from EDGA (0.20% of
dollar value for stocks priced less than $1.00). However, the Exchange
is proposing that for the month of July 2010 only, the 50,000 average
daily volume threshold will be multiplied by a fraction, the numerator
of which shall be the sum of the daily consolidated volumes for each
DECN-traded symbol for all days that such symbol is traded on the DECN
during the month of July and the denominator of which shall be the
monthly consolidated volume for all DECN-traded symbols during the
month of July.
    Secondly, Members can qualify for a rebate of $0.0032 per share for
all liquidity posted on EDGX if they add or route at least 5,000,000
shares of average daily volume prior to 9:30 a.m. or after 4 p.m.
(includes all flags except 6) AND add a minimum of 50,000,000 shares of
average daily volume on EDGX in total, including during both market
hours and pre- and post-trading hours. The Exchange is proposing that
for the month of July 2010 only, these average daily volume thresholds
(5,000,000 and 50,000,000), will be multiplied by a fraction, the
numerator of which shall be the sum of the daily consolidated volumes
for each DECN-traded symbol for all days that such symbol is traded on
the DECN during the month of July and the denominator of which shall be
the monthly consolidated volume for all DECN-traded symbols during the
month of July.
    Third, the rebate for adding hidden orders is currently contingent
upon Members adding greater than 1,000,000 shares on a daily basis,
measured monthly. Members not meeting this minimum will be charged
$0.0030 per share. For the month of July 2010 only, the 1,000,000
monthly share volume threshold will be multiplied by a fraction, the
numerator of which shall be the sum of the daily consolidated volumes
for each DECN-traded symbol for all days that such symbol is traded on
the DECN during the month of July and the denominator of which shall be
the monthly consolidated volume for all DECN-traded symbols during the
month of July.
    Finally, the Exchange is proposing to eliminate the trading volume
threshold found in footnote 4 of the DECN fee schedule relating to
Flags E and 5. Currently, the lower rate of $0.000025 per share is
contingent upon meeting a 1,000,000 share volume threshold on a daily
basis, measured monthly. The Exchange proposes to eliminate the
1,000,000 share threshold in footnote 4 to the fee schedule and add
``intentionally omitted'' to the footnote

in order to keep the current footnote numbering intact. The Exchange
believes that the elimination of such threshold will enable it to avoid
having to adjust the threshold calculation for the month of July 2010.
This will result in an administratively easier process for both the
Exchange and Members during the migration of symbols from DECN to EDGA
and EDGX Exchanges.
    The changes discussed in this filing will become operative on July
1, 2010.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the objectives of Section 6 of the Act,\6\ in general, and
furthers the objectives of Section 6(b)(4),\7\ in particular, as it is
designed to provide for the equitable allocation of reasonable dues,
fees and other charges among its members and other persons using its
facilities. ISE notes that DECN 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.
The proposed rule change reflects a competitive pricing structure
designed to incent market participants to direct their order flow to
DECN. ISE believes the fees and credits remain competitive with those
charged by other venues and therefore continue to be reasonable and
equitably allocated to those members that opt to direct orders to DECN
rather than competing venues. The ISE also believes that the proposed
rates are equitable in that they apply uniformly to all Members.
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    \6\ 15 U.S.C. 78f.
    \7\ 15 U.S.C. 78f(b)(4).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    The proposed rule change does not impose any burden on competition
that is not necessary or appropriate in furtherance of the purposes of
the Act.

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.

II. 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) of the Act \8\ and Rule 19b-4(f)(2) \9\ thereunder. At any
time within 60 days of the filing of such proposed rule change, the
Commission may summarily abrogate such rule change if it appears to the
Commission that such action is necessary or appropriate in the public
interest, for the protection of investors, or otherwise in furtherance
of the purposes of the Act.
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    \8\ 15 U.S.C. 78s(b)(3)(A). [sic]
    \9\ 17 CFR 19b-4(f)(2).
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III. 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 e-mail to<EMAIL_ADDRESS>Please include
File Number SR-ISE-2010-69 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-ISE-2010-69. This file
number should be included on the subject line if e-mail 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
a.m. and 3 p.m. Copies of the 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-2010-69 and should be
submitted on or before July 29, 2010.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\10\
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    \10\ 17 CFR 200.30-3(a)(12).
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Elizabeth M. Murphy,
Secretary.
[FR Doc. 2010-16668 Filed 7-7-10; 8:45 am]
BILLING CODE 8010-01-P


[Federal Register Volume 82, Number 67 (Monday, April 10, 2017)]
[Notices]
[Page 17239]
[FR Doc No: 2017-07086]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. NJ17-12-000]

Oncor Electric Delivery Company LLC; Notice of Filing

    Take notice that on April 3, 2017, Oncor Electric Delivery Company
LLC submitted its tariff filing: Oncor Tex-La Tariff Rate Changes, to
be effective 3/27/2017.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date. On or
before the comment date, it is not necessary to serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 5 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive email
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern Time on April 24, 2017.

    Dated: April 4, 2017.
Kimberly D. Bose,
Secretary.
[FR Doc. 2017-07086 Filed 4-7-17; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 9 (Thursday, January 14, 2021)]
[Rules and Regulations]
[Pages 2961-2964]
[FR Doc No: 2021-00807]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2020-1172; Project Identifier MCAI-2020-01661-T;
Amendment 39-21388; AD 2021-02-05]
RIN 2120-AA64

Airworthiness Directives; Airbus SAS Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule; request for comments.

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SUMMARY: The FAA is adopting a new airworthiness directive (AD) for all
Airbus SAS Model A330-200, -200 Freighter, -300, -800, and -900 series
airplanes; Model A340-200 and -300 series airplanes; and Model A340-541
and A340-642 airplanes. This AD was prompted by a report that an
erroneous torque value for the attachment nuts to install a pitot probe
was included in the affected Aircraft Maintenance Manual (AMM) task.
This AD requires re-torqueing the attachment nuts of each affected
part. In addition, this AD prohibits the use of the affected AMM task,
as specified in a European Union Aviation Safety Agency (EASA) AD,
which is incorporated by reference. The FAA is issuing this AD to
address the unsafe condition on these products.

DATES: This AD becomes effective January 29, 2021.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of January 29,
2021.
    The FAA must receive comments on this AD by March 1, 2021.

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 https://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 material incorporated by reference (IBR) in this AD, contact
the EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; telephone +49
221 8999 000; email<EMAIL_ADDRESS>internet www.easa.europa.eu.
You may find this IBR material on the EASA website at https://ad.easa.europa.eu. You may view this IBR material at the FAA,
Airworthiness Products Section, Operational Safety Branch, 2200 South
216th St., Des Moines, WA. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>. It is also available in the AD
docket on the internet at https://www.regulations.gov by searching for
and locating Docket No. FAA-2020-1172.

Examining the AD Docket

    You may examine the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2020-
1172; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this AD, any comments received, and other information. The street
address for Docket Operations is listed above. Comments will be
available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Vladimir Ulyanov, Aerospace Engineer,
Large Aircraft Section, International Validation Branch, FAA, 2200
South 216th St., Des Moines, WA 98198; telephone and fax<PHONE_NUMBER>;
email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    The EASA, which is the Technical Agent for the Member States of the
European Union, has issued EASA AD 2020-0279, dated December 14, 2020
(EASA AD 2020-0279) (also referred to as the Mandatory Continuing
Airworthiness Information, or the MCAI), to correct an unsafe condition
for all Model A330-201, A330-202, A330-203, A330-223, A330-223F, A330-
243, A330-243F, A330-301, A330-302, A330-303, A330-321, A330-322, A330-
323, A330-341, A330-342, A330-343, A330-743L, A330-841, A330-941, A340-
211, A340-212, A340-213, A340-311, A340-312, A340-313, A340-541, A340-
542, A340-642, and A340-643 airplanes. Model A330-743L, A340-542, and
A340-643 airplanes are not certificated by the FAA and are not included
on the U.S. type certificate data sheet; this AD therefore does not
include those airplanes in the applicability.
    This AD was prompted by a report that an erroneous torque value for
the attachment nuts to install a pitot probe was included in the
affected AMM task. The FAA is issuing this AD to address

the erroneous torque value. If not addressed it could lead to erroneous
total pressure measurement being relayed to navigation systems,
possibly resulting in reduced control of the airplane. See the MCAI for
additional background information.

Related Service Information Under 1 CFR Part 51

    EASA AD 2020-0279 describes procedures for re-torqueing the
attachment nuts of each affected part and prohibits the use of the
affected AMM task. This material 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

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to the FAA's bilateral agreement with the State of Design Authority,
the FAA has been notified of the unsafe condition described in the MCAI
referenced above. The FAA is issuing this AD because the FAA 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.

Requirements of This AD

    This AD requires accomplishing the actions specified in EASA AD
2020-0279 described previously, as incorporated by reference, except
for any differences identified as exceptions in the regulatory text of
this AD.

Explanation of Required Compliance Information

    In the FAA's ongoing efforts to improve the efficiency of the AD
process, the FAA initially worked with Airbus and EASA to develop a
process to use certain EASA ADs as the primary source of information
for compliance with requirements for corresponding FAA ADs. The FAA has
since coordinated with other manufacturers and civil aviation
authorities (CAAs) to use this process. As a result, EASA AD 2020-0279
is incorporated by reference in this final rule. This AD, therefore,
requires compliance with EASA AD 2020-0279 in its entirety, through
that incorporation, except for any differences identified as exceptions
in the regulatory text of this AD. Using common terms that are the same
as the heading of a particular section in the EASA AD does not mean
that operators need comply only with that section. For example, where
the AD requirement refers to ``all required actions and compliance
times,'' compliance with this AD requirement is not limited to the
section titled ``Required Action(s) and Compliance Time(s)'' in the
EASA AD. Service information specified in EASA AD 2020-0279 that is
required for compliance with EASA AD 2020-0279 is available on the
internet at https://www.regulations.gov by searching for and locating
Docket No. FAA-2020-1172.

FAA's Justification and Determination of the Effective Date

    An unsafe condition exists that requires the immediate adoption of
this AD without providing an opportunity for public comments prior to
adoption. The FAA has found that the risk to the flying public
justifies waiving notice and comment prior to adoption of this rule
because an erroneous torque value for the attachment nuts to install a
pitot probe could lead to erroneous total pressure measurement being
relayed to navigation systems, possibly resulting in reduced control of
the airplane. In addition, the compliance time for the required action
is shorter than the time necessary for the public to comment and for
publication of the final rule. Therefore, the FAA finds good cause that
notice and opportunity for prior public comment are impracticable. In
addition, for the reasons stated above, the FAA finds that good cause
exists for making this amendment effective in less than 30 days.

Comments Invited

    The FAA invites you to send any written relevant data, views, or
arguments about this AD. Send your comments to an address listed under
ADDRESSES. Include ``Docket No. FAA-2020-1172; Project Identifier MCAI-
2020-01661-T'' at the beginning of your comments. The most helpful
comments reference a specific portion of the final rule, explain the
reason for any recommended change, and include supporting data. The FAA
will consider all comments received by the closing date and may amend
this final rule because of those comments.
    Except for Confidential Business Information (CBI) as described in
the following paragraph, and other information as described in 14 CFR
11.35, the FAA will post all comments received, without change, to
https://www.regulations.gov, including any personal information you
provide. The agency will also post a report summarizing each
substantive verbal contact received about this final rule.

Confidential Business Information

    CBI is commercial or financial information that is both customarily
and actually treated as private by its owner. Under the Freedom of
Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public
disclosure. If your comments responsive to this AD contain commercial
or financial information that is customarily treated as private, that
you actually treat as private, and that is relevant or responsive to
this AD, it is important that you clearly designate the submitted
comments as CBI. Please mark each page of your submission containing
CBI as ``PROPIN.'' The FAA will treat such marked submissions as
confidential under the FOIA, and they will not be placed in the public
docket of this AD. Submissions containing CBI should be sent to
Vladimir Ulyanov, Aerospace Engineer, Large Aircraft Section,
International Validation Branch, FAA, 2200 South 216th St., Des Moines,
WA 98198; telephone and fax<PHONE_NUMBER>; email
<EMAIL_ADDRESS>Any commentary that the FAA receives which is
not specifically designated as CBI will be placed in the public docket
for this rulemaking.

Regulatory Flexibility Act (RFA)

    The requirements of the RFA do not apply when an agency finds good
cause pursuant to 5 U.S.C. 553 to adopt a rule without prior notice and
comment. Because the FAA has determined that it has good cause to adopt
this rule without notice and comment, RFA analysis is not required.

Costs of Compliance

    The FAA estimates that this AD affects 112 airplanes of U.S.
registry. The FAA estimates the following costs to comply with this AD:

                                      Estimated Costs for Required Actions
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per       Cost on U.S.
                          Labor cost                              Parts cost        product         operators
----------------------------------------------------------------------------------------------------------------
1 work-hour x $85 per hour = $85.............................              $0              $85           $9,520
----------------------------------------------------------------------------------------------------------------

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.
    The FAA is 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

    The FAA determined that this AD will not have federalism
implications under Executive Order 13132. This AD will not have a
substantial direct effect on the States, on the relationship between
the national government and the States, or on the distribution of power
and responsibilities among the various levels of government.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866, and
    (2) Will not affect intrastate aviation in Alaska.

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:

2021-02-05 Airbus SAS: Amendment 39-21388; Docket No. FAA-2020-1172;
Project Identifier MCAI-2020-01661-T.

(a) Effective Date

    This airworthiness directive (AD) becomes effective January 29,
2021.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to all Airbus SAS airplanes, certificated in any
category, identified in paragraphs (c)(1) through (9) of this AD.
    (1) Model A330-201, A330-202, A330-203, A330-223, and A330-243
airplanes.
    (2) Model A330-223F and A330-243F airplanes.
    (3) Model A330-301, A330-302, A330-303, A330-321, A330-322,
A330-323, A330-341, A330-342, and A330-343 airplanes.
    (4) Model A330-841 airplanes.
    (5) Model A330-941 airplanes.
    (6) Model A340-211, A340-212, and A340-213 airplanes.
    (7) Model A340-311, A340-312, and A340-313 airplanes.
    (8) Model A340-541 airplanes.
    (9) Model A340-642 airplanes.

(d) Subject

    Air Transport Association (ATA) of America Code 34, Navigation.

(e) Reason

    This AD was prompted by a report that an erroneous torque value
for the attachment nuts to install a pitot probe was included in the
affected Aircraft Maintenance Manual (AMM) task. The FAA is issuing
this AD to address the erroneous torque value. If not addressed it
could lead to erroneous total pressure measurement being relayed to
navigation systems, possibly resulting in reduced control of the
airplane.

(f) Compliance

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

(g) Requirements

    Except as specified in paragraph (h) of this AD: Comply with all
required actions and compliance times specified in, and in
accordance with, European Union Aviation Safety Agency (EASA) AD
2020-0279, dated December 14, 2020 (EASA AD 2020-0279).

(h) Exceptions to EASA AD 2020-0279

    (1) Where EASA AD 2020-0279 refers to its effective date, this
AD requires using the effective date of this AD.
    (2) The ``Remarks'' section of EASA AD 2020-0279 does not apply
to this AD.

(i) No Reporting Requirement

    Although the service information referenced in EASA AD 2020-0279
specifies to submit certain information to the manufacturer, this AD
does not include that requirement.

(j) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
Large Aircraft Section, International Validation Branch, 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 responsible Flight
Standards Office, as appropriate. If sending information directly to
the Large Aircraft Section, International Validation Branch, send it
to the attention of the person identified in paragraph (k) of this
AD. 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
responsible Flight Standards Office.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain instructions from a manufacturer, the instructions must be
accomplished using a method approved by the Manager, Large Aircraft
Section, International Validation Branch, FAA; or EASA; or Airbus
SAS's EASA Design Organization Approval (DOA). If approved by the
DOA, the approval must include the DOA-authorized signature.
    (3) Required for Compliance (RC): Except as required by
paragraph (j)(2) of this AD, if any service information referenced
in EASA AD 2020-0279 that contains paragraphs that are labeled as
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Branch, FAA, 2200 South 216th St., Des Moines, WA 98198; telephone
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    (i) European Union Aviation Safety Agency (EASA) AD 2020-0279,
dated December 14, 2020.
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    Issued on January 7, 2021.
Gaetano A. Sciortino,
Deputy Director for Strategic Initiatives, Compliance & Airworthiness
Division, Aircraft Certification Service.
[FR Doc. 2021-00807 Filed 1-12-21; 11:15 am]
BILLING CODE 4910-13-P


PHENOLS OCCUPATIONAL/ RESIDENTIAL EXPOSURE ASSESSMENT ( OPPTS 248.4000) September 9, 2004 Office of Pesticide Programs Antimicrobials Division U. S. Environmental Protection Agency 1801 South Bell Street Arlington, VA 22202 September 7, 2004 Page 2 of 20 EXECUTIVE SUMMARY This document is the Occupational and Residential Exposure Chapter of the Reregistration Eligibility Decision Document ( RED) for Phenol & Salts and addresses potential exposure and risks to humans from use of these chemicals in occupational and residential settings.

Phenols and salts are active ingredients in disinfectant and deodorizer formulations used as a material preservative, and in commercial, institutional, industrial and medical premises as well as in homes and food handling establishments. Phenols and salts are formulated as soluble concentrate, towelette, ready to use solution and aerosol spray. Based on product labels, all formulations are liquid. Application methods include applying the liquid onto surfaces, spraying surfaces and rooms and wiping surfaces with impregnated towelettes.

The endpoints used in this document to assess the risks of phenol and salts are the short and intermediate term developmental NOAEL to estimate oral and dermal risks and the inhalation LOAEL for inhalation risks. An uncertainty factor or " target" margin of exposure ( MOE) of 100 was selected for the incidental oral and dermal risk assessments, based on 10x for differences among humans ( intra species variability) and 10x for differences between the test animals and humans ( inter species extrapolation). For the inhalation risk assessment, an uncertainty factor of 300 is applied for short and intermediate term risk assessments ( 10x interspecies extrapolation, 10x intraspecies variation, 3x for use of a LOAEL). For long term inhalation risk assessments, an uncertainty factor of 1000 would be applied to the risk assessment ( 10x interspecies extrapolation, 10x intraspecies variation, 3x for use of a LOAEL, 3x for lack of a long term study), but no long term uses were identified.

In summary, the residential uses of phenol that are of concern include: the dermal route of exposure for painting with an airless sprayer ( dermal MOE = 12, target MOE 100 and inhalation MOE = 290, target MOE 300) and the dermal route of exposure for painting with a paintbrush/ roller ( dermal MOE = 31). All of the other residential uses did not indicate a risk of concern. The short and intermediate term duration occupational uses of phenol that are of concern include the airless painting and wiping scenario. The dermal MOE for airless sprayers for workers wearing chemical resistant gloves is 21 ( target MOE is 100) and the inhalation route ( MOE = 88 with a target of 300). The wiping scenarios indicates a dermal MOE of 70 ( target MOE of 100). All of the other occupational uses of phenol are not of concern.

1.0 Background Purpose This document presents the results of the Agency's review of the potential human health effects of occupational and residential exposure to phenol and phenol salts. This document is for use in the Agency's development of Reregistration Eligibility Decision Document ( RED) for Phenol and Salts. Page 3 of 20 Criteria for Conducting Exposure Assessments An occupational and/ or residential exposure risk assessment is required for an active ingredient if ( 1) certain toxicological criteria are triggered and ( 2) there is potential exposure to handlers ( mixers, loaders, applicators, etc.) during use or to persons entering treated sites after application.

1.1 Summary of Toxicity Concerns Relating to Exposures.

Acute Toxicology According to the toxicity memorandum dated March 20, 2004 ( USEPA, 2004), information on the acute toxicity of phenol is available in the open scientific literature and studies submitted to the Office of Toxic Substances.

The acute oral toxicity of phenol has been described in IRIS as varying widely, from doses of 14 mg/ kg to 930 mg/ kg ( USEPA, 2002). Data assembled by the Antimicrobials Division shows oral LD50 values in the range of 297 1120 mg/ kg, which corroborates to some extent the results reported in IRIS.

Acute dermal toxicity of phenol as reported in IRIS showed a dermal LD50 of 669.4 mg/ kg from application of undiluted phenol for 24 hours to the skin of rats ( Conning and Hayes, 1970). Decreasing the concentration of phenol appears to result in higher dermal LD50 values; for example, application of a 50% aqueous solution showed an LD50 value of 2350 mg/ kg ( OTS # 0515564/ 86 070001402).

Data on acute inhalation toxicity of phenol are limited. In a study submitted to OTS ( OTS# 0515567/ 86 870001405), rats were exposed for 8 hours to 2.5 L/ min of 100% phenol, with no mortality reported. In a two week inhalation toxicity study, neurotoxicity was observed at a concentration of 0.1 mg/ L but no mortality was observed.

Phenol has also been shown to be a significant eye and skin irritant. Strong sensitization has also been observed in a dermal sensitization study ( USEPA, 2004).

Other Endpoints of Concern Phenol  Report of the Antimicrobials Division Toxicology Endpoint Selection Committee ( May 20, 2004) indicates that there are toxicological endpoints of concern for phenol. The endpoints and associated uncertainty factors used in assessing risks for phenol are presented in Table 2.

The endpoint used for the short and intermediate term incidental oral risk assessment is the developmental NOAEL is 60 mg/ kg/ day ( UF = 100), based on reduced fetal body weight. An uncertainty factor or " target" margin of exposure ( MOE) of 100 was selected for the incidental Page 4 of 20 oral risk assessment, based on 10x for differences among humans ( intra species variability) and 10x for differences between the test animals and humans ( inter species extrapolation).

The short and intermediate term developmental NOAEL is 60 mg/ kg/ day ( UF = 100), based on reduced fetal body weight. A dermal absorption factor of 50% is used since an oral endpoint was selected. An uncertainty factor or " target" margin of exposure ( MOE) of 100 was selected for the dermal risk assessment, based on 10x for differences among humans ( intra species variability) and 10x for differences between the test animals and humans ( inter species extrapolation).

The endpoint used for inhalation risk assessment is an LOAEL of 0.1 mg/ L, based on alterations in sliding angle from tilting plane test, and significant increases in liver enzymes. An uncertainty factor of 300 is applied to this risk assessment for short and intermediate term risk assessments ( 10x interspecies extrapolation, 10x intraspecies variation, 3x for use of a LOAEL). For longterm risk assessments, an uncertainty factor of 1000 is applied to the risk assessment ( 10x interspecies extrapolation, 10x intraspecies variation, 3x for use of a LOAEL, 3x for lack of a long term study).

Table 2. Toxicological Endpoints for Phenol Exposure Scenario Dose ( mg/ kg/ day) used in risk assessment UF / MOE Uncertainty Factors Study and Toxicological Effects Incidental Oral Short and intermediateterm NOAEL = 60 mg/ kg/ day MOE = 100 Developmental toxicity study in rats ( NTP, 1983). Based on significant reductions from the control in mean fetal body weight/ litter at 120 mg/ kg/ day.

Dermal1 Short and intermediateterm NOAEL = 60 mg/ kg/ day MOE = 100 Developmental toxicity study in rats ( NTP, 1983). Based on significant reductions from the control in mean fetal body weight/ litter at 120 mg/ kg/ day. Page 5 of 20 Table 2. Toxicological Endpoints for Phenol Exposure Scenario Dose ( mg/ kg/ day) used in risk assessment UF / MOE Uncertainty Factors Study and Toxicological Effects Inhalation All durations LOAEL = 0.1 mg/ L ( equivalent to 26.08 mg/ kg/ day) MOE = 300 ( ST, IT)

MOE = 1000 ( LT) Dalin and Kristofferson: Physiological Effects of a Sub lethal Concentration of Inhaled Phenol on the Rat. Ann. Zool. Fennici 11: 193 199, 1974 LOAEL of 0.1 mg/ L, based on alterations in sliding angle from tilting plane test, and significant increases in liver enzymes 1A dermal absorption factor of 50% should be used since an oral endpoint was selected. 2 Using the " Route to Route Extrapolation" Memo from John Whalen dated October 9, 1998, the LOAEL of 0.1 mg/ L is equivalent to 26.08 mg/ kg/ day based on the following equation: 0.1 mg/ L x 100% absorption x 10.26 L/ hr/ kg ( rat respiratory volume) x 6 hr/ day ( rat exposure duration) / 0.236 kg ( rat body weight) Page 6 of 20 1.2 Summary of Use Patterns and Formulations Table 3 lists the active EPA registration numbers of the products containing phenol and phenol salts evaluated in this document. The scenarios considered in the risk assessment are shown in Table 4. These scenarios were selected based on examination of product labels describing uses for the product. Most of the scenarios fall under the " Medical premises and equipment" category.

Table 3. EPA Registration Numbers for Phenol Products Use Category Formulation EPA Registration Numbers Disinfectant/ Deodorizer Aerosol Spray 8383 4, 69658 3, 75480 1, 8383 3 Concentrate 8383 6 Towelette 8383 7 Material Preservative Ready to Use 8383 1 Table 4. Use scenarios for phenol and phenol salts.

Use Site Category Scenario Commercial, institutional and industrial premises and equipment ° Applying liquid on hard, non porous surfaces in commercial establishments. ° Spraying disinfectant on non porous surfaces ( aerosol spray) ° Spraying disinfectant on carpets.

Medical premises and equipment ° Applying liquid on non porous surfaces in medical treatment and patient rooms, operating rooms, emergency rooms, recovery rooms and bathrooms, and on medical and dental equipment. ° Spraying disinfectant on medical devices prior to sterilization and on surfaces in hospitals and nursing homes. ° Wiping chemical laden towelette on non porous surfaces in medical treatment and patient rooms, operating rooms, emergency rooms, recovery rooms and bathrooms, and on medical and dental equipment. ° Spraying disinfectant on non porous surfaces in medical treatment and patient rooms, operating rooms, emergency rooms, recovery rooms and bathrooms.( aerosol spray) ° Spraying disinfectant on medical equipment, toilet seats, shower stalls, etc.( aerosol spray) ° Spraying deodorizer in rooms ( aerosol spray) ° Pouring liquid into hemodialysis machines ° Spraying disinfectant on carpets. Page 7 of 20 Use Site Category Scenario Food handling/ storage establishments premises and equipment ° Spraying disinfectant on sinks, drain boards, cabinets, garbage cans, under sinks and faucets Residential and Public Access premises ° Spraying disinfectant on non food contact areas ( spray for 3 4 seconds Noviguard) ° Spraying/ applying disinfectant on carpets. ° Applying liquid on surfaces in hotels, airplanes, trains, boats, etc. ° Spraying disinfectant on surfaces in day care centers, health clubs, schools, etc. ° Spraying disinfectant on non porous surfaces ( aerosol spray) ° Wiping chemical laden towelette on non porous surfaces. ° Toddler exposure to residues of disinfectant on carpets Material Preservative ° Adding ( pouring) liquid to polishes, cleansers, paints and protectants.

Phenol and phenol salts are active ingredients in disinfectant, deodorizer and cleaner formulations. At least one product reviewed is also an industrial additive used as a preservative for polishes, cleansers, paints and protectants. These formulations have bactericidal, virucidal, fungicidal and tuberculocidal properties, kill mold and mildew and eliminate odors.

Use site categories for these formulations include material preservatives, commercial, institutional and industrial premises and equipment, medical premises and equipment, food handling establishments and residential and public access premises. A review of product labels indicate that most of these formulations are intended for use in hospitals, clinics, medical and veterinary offices, nursing homes, laboratories, industrial clean rooms, ambulances, hotels, restaurants, schools, transportation facilities, health spas and toilets.

Formulation Types and Percent Active Ingredient Concentrations of phenol and phenol salts in products range from 1.6 % to 8.2% ( 1.6% being the most common concentration). All formulations are in liquid form and include ready to use solutions, pressurized liquids and impregnated materials ( towelettes).

1.3 Methods Used for Mixing/ Loading/ Applying Based on the review of product labels, the use patterns specific to phenol and phenol salts are associated with the following application methods:

Commercial uses ° Applying liquid on hard, non porous surfaces in commercial establishments with wipes and sprays. ° Spraying disinfectant on non porous surfaces. ° Spraying disinfectant on carpets. Page 8 of 20 Medical uses ° Applying liquids with wipes and sprays on non porous surfaces in medical treatment and patient rooms, operating rooms, emergency rooms, recovery rooms and bathrooms, and on medical and dental equipment. ° Spraying disinfectant on medical devices prior to sterilization and on surfaces in hospitals and nursing homes. ° Wiping chemical laden towelette on non porous surfaces in medical treatment and patient rooms, operating rooms, emergency rooms, recovery rooms and bathrooms, and on medical and dental equipment. ° Spraying disinfectant on non porous surfaces in medical treatment and patient rooms, operating. rooms, emergency rooms, recovery rooms and bathrooms. ° Spraying disinfectant on medical equipment, toilet seats, shower stalls, etc. ° Spraying deodorizer in rooms. ° Pouring liquid into hemodialysis machines. ° Spraying disinfectant on carpets.

Food handling uses ° Spraying disinfectant on sinks, drain boards, cabinets, garbage cans, under sinks and faucets Residential uses ° Spraying disinfectant on non food contact areas . ° Spraying disinfectant on carpets. ° Applying liquids with wipes and sprays on surfaces in hotels, airplanes, trains, boats, etc. ° Spraying disinfectant on surfaces in day care centers, health clubs, schools, etc. ° Spraying disinfectant on non porous surfaces.

Material Preservative uses ° Adding ( pouring) liquid during the manufacturing of polishes, cleansers, paints and protectants.

2.0 MATERIAL PRESERVATIVES / COMMERCIAL, INSTITUTIONAL, INDUSTRIAL / MEDICAL PREMISES AND EQUIPMENT Six short and intermediate term exposure scenarios have been considered in this assessment:

° Material preservatives ( pouring) in the manufacturing of paint, ° Use of disinfectant solutions in hemodialysis machines, ° Application of paint treated with a material preservative using airless sprayer, ° Application of paint treated with a material preservative using paintbrush/ roller, ° Use of disinfectant/ deodorizing spray on hard non porous surfaces, and ° Use of disinfectant towelette on hard non porous surfaces Page 9 of 20 Occupational Handlers Inhalation and dermal exposures were addressed for occupational populations using surrogate data from the Chemical Manufacturers Association ( CMA, 1992) and the Pesticide Handlers Exposure Database ( PHED). Using surrogate unit exposure data, application rates from labels, and EPA estimates of daily amount handled, exposure and risks to handlers were assessed. At this time, EPA has not identified postapplication scnearios for commercial uses that are not addressed by the residential postapplication exposure assessment ( e. g., the contacting treated surfaces are represented by children's incidental oral and dermal exposures while crawling on treated surfaces such as carpets).

For hemodialysis machines, the label indicates that the product can be used in single patient and multiplepatient delivery systems. The use of this product in multi patient delivery systems was chosen for evaluation since it involves a greater volume of product ( 1.0 L vs. 0.150 mL) than the single patient delivery system. It was assumed that the machines are disinfected daily and on average, a worker handles 3 machines per day. The " gloved liquid pour disinfectant" unit exposure data from the CMA study were used in the dermal and inhalation exposure assessment.

One phenol product is listed for use as an industrial additive, and lists paint as a possible use. The label recommends that between 2% 5% by active ingredients be added. As a conservative measure, it is assumed that the treated paint is comprised of 5% active ingredient, by weight. Assuming that paint has a density of 10 lbs per gallon, the concentration of phenols in paint is 0.5 lbs a. i./ gallon. For the material preservative use of phenol, primary handlers adding the product during the manufacturing of paint has been selected to represent the high end of exposure for the primary handlers. It is assumed that paint is produced in 1,000 gallon batches ( i. e., 10,000 lbs). In addition, painting has been selected to represent the high end of the exposures for the secondary handlers. Two painting scenarios were considered in this assessment: use of an airless sprayer and use of a paintbrush/ roller to paint the exterior of a house. The PHED unit exposure data were used in the dermal ( gloved) and inhalation exposure assessment. In a commercial/ industrial setting, it was assumed that worker using an airless sprayer would handle 50 gal/ day while, a worker using a paintbrush/ roller would handle 5 gal/ day.

The sprays and the solution used to treat the towelette contain 1.62 percent phenol/ sodium phenate. It was assumed that the density of this solution is the same as the density of water. The gloved CMA unit exposure data for wiping were used in the dermal and inhalation exposure assessment. The label for the towelette product did not describe the quantity of product to be used; rather, the directions state that the towelette is to be used to wipe the surface, and then the surface should be wiped dry. In the absence of more specific use information, it was assumed that 1 liter ( which is equivalent to two 16oz cans) of the solution used to wet the towelette is used by the exposed individual per day. Similarly, the aerosol spray directions state that the product can be sprayed 2 4 seconds to deodorize a room, but no data were available describing the quantity of product that is emitted by spraying for this time. Therefore, 1 liter of solution was also assumed for use of the aerosol spray. The PHED unit exposure data were used to calculate the dermal ( gloved) and inhalation exposures in the aerosol spray assessment.

The results of the short and intermediate term MOE analysis for these scenarios are presented in Table 4. The estimated short and intermediate term dermal MOEs for the following scenarios were below the target MOE of 100, and are therefore of concern:

° Painting using an airless sprayer ( MOE = 21) Page 10 of 20 ° Wiping hard surfaces using a towelette ( MOE = 70)

The estimated short and intermediate term inhalation MOEs for the following scenarios were below the target MOE of 300, and are therefore of concern:

° Painting using an airless sprayer ( MOE = 88)

The aerosol inhalation exposure and risk estimates from CMA and PHED discussed above do not account for the potential vapor inhalation exposure to phenol ( phenol has a relatively high vapor pressure). Therefore, the potential vapor inhalation exposure to handlers are addressed by modeling of the air concentrations. Because the occupational handlers for cleaning products use the same weight fraction of phenol as the residential handlers, the same type of application techniques ( i. e., wipes, sprays), and will clean in various rooms to accommodate the additional amount handled ( e. g., moving room to room in a hotel or painting various town homes), the air concentrations and vapor inhalation risk estimates will be similar to those experienced by the residents as presented below in the residential section ( i. e., EFAST assessment). Based on these assumptions, the short and intermediate term vapor derived inhalation risks are not of concern ( i. e., MOEs greater than the target MOE of 300 for the average daily dose). For commercial painters, WPEM ( see below for model description) estimated a peak instantaneous concentration of 23 mg/ m3. WEPM also estimates an average daily dose for professional painters of 0.36 mg/ kg/ day which corresponds to a MOE of 72 ( i. e., LOAEL 26 mg/ kg/ day / 0.36 mg/ kg/ day). This inhalation risk estimate is of concern ( ST/ IT target MOE is 300 and long term MOE is 1,000) Page 11 of 20 Table 4. Calculation of Short and Intermediate term Dermal and Inhalation MOE for Occupational Usesa Exposure Scenario Method of Applicat ion Dermal Unit Exposur e ( mg/ lb ai) b Inhalati on Unit Exposur e ( mg/ lb ai) c Appl. Rate d ( lb a. i./ gal) Amount Treated Absorbed Dermal Dose ( mg/ kg/ da y) f Dermal MOE g Inhalation Dose ( mg/ kg/ day ) h Inhalatio n MOE i Material Preservative ( Paint) Liquid Pour 0.135 ( CMA gloves) 0.00361 ( CMA) 5% by weight 10,000 lbs of paint 0.56 110 0.030 870 Hemodialysis Liquid Pour 36.5 ( CMA gloves) 1.89 ( CMA) 0.187 lbs a. i./ delivery system 3 delivery systems/ d ay 0.171 350 0.015 1700 Painting Airless Sprayer 14 ( PHED gloves) 0.83 ( PHED) 0.5 50 gal/ day 2.9 21 0.296 88 Paintbru sh/ Roller 24 ( PHED gloves) 0.28 ( PHED) 0.5 5 gal/ day 0.50 120 0.010 2600 Hard Surface Disinfection Towelett e 2870 ( CMA no gloves) 67.3 ( CMA) 0.0357 lbs a. i./ liter used 1 liter of product 0.854 70 0.0343 760 Aerosol Spray 81 ( PHED gloves) 1.3 ( PHED) 0.0357 lbs a. i./ liter used 1 liter of product 0.024 290 0.00066 39,000 a MOEs rounded to 2 significant figures. b Dermal unit exposures are from CMA and PHED, gloves worn as indicated. c Inhalation unit exposures are from CMA and PHED. d Application rates are based on the phenol labels. It is assumed that both the phenol and sodium phenate present in products are active ingredients. f Abs. dermal dose ( mg/ kg/ day) = [ unit exposure ( mg/ lb ai) * Dermal Absorption Factor ( 0.5) * Appl. rate ( lb ai/ gallon) * gallons handled / Body weight ( 60 kg). g MOE = NOAEL ( mg/ kg/ day) / Daily Dose [ Where short and intermediate term dermal NOAEL = 60 mg/ kg/ day]. Target MOE is 100. h Inhalation dose ( mg/ kg/ day) = [ unit exposure (

g/ lb ai) * 0.001 mg/

g unit conversion * max appl rate ( lb ai/ gal) * gallons handled * 1 inhalation absorption] / Body weight ( 70 kg). i MOE = LOAEL ( mg/ kg/ day) / Daily Dose [ LOAEL for all durations = 0.1 mg/ L ( which equals 0.1 mg/ L * 10.26 L/ hr/ kg * 6 hrs/ day / 0.236 kg = 26.08 mg/ kg/ day]. Target MOE is 300 for short and intermediate term.

Occupational Postapplication The potential occupational postapplication exposure to phenol is based on the relatively high vapor pressure. Postapplication inhalation exposure is expected for workers remaining in areas of treatment ( e. g., medical personnel, janitors, etc). At this time, air concentration measurements taken after phenol treatments are not available. In addition, modeled results for inhalation exposure are not specific for occupational uses. Therefore, the air concentration for the 1.62% product in the EFAST model estimate listed in the residential section below was used. The average daily air concentration for the 1.62% products is 0.352 mg/ m3. Using an 8 hour Page 12 of 20 workday, the dose is estimated to be 0.050 mg/ kg/ day ( i. e., 0.352 mg/ m3 x 1.25 m3/ hr breathing rate x 8 hr/ day x ( 1/ 70 kg BW)). The short and intermediate term inhalation MOE is 520, and therefore, not of concern. ( i. e., LOAEL of 26 mg/ kg/ day / 0.05 mg/ kg/ day).

2.1 RESIDENTIAL AND PUBLIC ACCESS PREMISES Residential Handlers The following scenarios were considered for residential handlers of phenol containing products:

° Application of paint treated with a material preservative using an airless sprayer and a paintbrush/ roller, ° Use of disinfectant/ deodorizing spray on hard non porous surfaces, and ° Use of disinfectant towelette on hard non porous surfaces.

Inhalation and dermal exposures were addressed for residential handlers using surrogate data from the Chemical Manufacturers Association ( CMA, 1992) and the Pesticide Handlers Exposure Database ( PHED). Using surrogate unit exposure data, application rates from labels, EPA estimates of daily amount handled, and two exposure models, exposure and risks to residential handlers were assessed.

As previously discussed, one phenol product is listed for use as an industrial additive, and lists paint as a possible use. The concentration of phenols in paint is 0.5 lbs a. i./ gallon. Two painting scenarios were considered in this assessment: use of an airless sprayer and use of a paintbrush/ roller to paint the exterior of a house. The PHED unit exposure data as cited in the Residential Exposure SOPs were used in the dermal and inhalation exposure assessment. These data are based on the clothing scenario of short pants and short sleeves. In a residential setting, it was assumed that homeowner using an airless sprayer would handle 15 gal/ day while, a resident using a paintbrush/ roller would handle 2 gal/ day.

The sprays and the solution used to treat the towelette contain 1.62 percent phenol/ sodium phenate. The no gloved CMA unit exposure data for wiping were used in the dermal and inhalation exposure assessment for the towelette product. The PHED unit exposure data as cited in the Residential Exposure SOPs were used in the dermal exposure assessment for the aerosol product. These data are based on the clothing scenario of short pants and short sleeves. The PHED unit exposure data were used in the inhalation exposure assessment for the aerosol product. For both the towelette and aerosol products, it was assumed that 0.5 liter ( which is equivalent to one 16oz can) is used by the exposed individual per day. The 0.5 liter assumption for the wipes is a screening level estimate ( indicating no risk of concern). However, additional refinements should be determined to refine the aggregate risks.

Because phenol has a relatively high vapor pressure ( 0.341 mmHg @ 25 C), there is also the concern for potential vapor inhalation exposure. To determine the potential inhalation exposure resulting from the vapor of phenol as a general purpose cleaner, the model EFAST ( Exposure and Fate Assessment Screening Tool) was used to estimate the air concentration. OPPT/ EETD has developed the model, EFAST, to estimate air concentrations. More information and access to the EFAST model is available at http:// www. epa. gov/ opptintr/ exposure/. In summary, EFAST Version 1.0 bases its air concentration Page 13 of 20 estimates on physical/ chemical properties. The air concentration estimates for the phenols are based on the model's standard input parameters. The following information is presented in the EFAST model:

".... it is assumed to contact the target surface, and to subsequently volatilize at a rate that depends upon the chemical's molecular weight and vapor pressure."

EFAST presents a peak air concentration as well as a daily air concentration. The peak air concentration estimate "... is the highest instantaneous air concentration that is modeled during the exposure event." This peak air concentration is not expected for any appreciable length of time.

EFAST was used to model the air concentration from general purpose cleaners using a weight fraction of 0.0162. EFAST indicates a peak concentration of 7.29 mg/ m3 from this activity. Because the peak concentration does not represent a daily inhalation exposure, the daily dose rather than the peak estimate from EFAST is used to compare to the short term inhalation toxicological endpoint. If a shortterm toxicological endpoint of less than one day were to be generated it should be compared to the peak air concentration estimate. However, because the toxicological endpoint of concern is based on greater than one day of exposure, the daily dose rate of 0.065 mg/ kg/ day from EFAST is used in this assessment. The daily dose rate is based on the average daily concentration of 0.35 mg/ m3.

The results of the MOE analysis using the CMA data for the general purpose cleaners are presented in Table 5. The calculated short term dermal MOEs are not of concern for the general purpose cleaners ( MOE = 140 and 1,800, for wiping and mopping, respectively). The calculated short term inhalation MOEs from the CMA data for the wiping and mopping are not of concern ( MOE = 1,500 and 79,000, respectively). The results of the EFAST model for general purpose cleaners indicate a short term inhalation MOE from the vapor of phenol to be 400. Therefore, the short term vapor inhalation portion of phenol is also not of concern for the general purpose cleaners ( i. e., above the target MOE of 300).

The results of the painting assessment using the PHED are also presented in Table 5. As indicated in Table 5, the dermal risks are of concern for homeowners painting with either a brush and/ or airless sprayer ( shortterm dermal MOEs = 31 and 12 for the brush and sprayer, respectively). The target MOE for the dermal route is 100. The inhalation estimates for the aerosol portion of the inhalation exposure do not pose a risk of concern ( i. e., short term inhalation MOEs = 6,500 and 290, respectively, target MOE = 300).

In addition to the aerosol inhalation risks presented in Table 5 for painters, phenol has a relatively high vapor pressure ( 0.341 mmHg @ 25 C), and therefore, EPA is also the concern for potential vapor inhalation exposure. To determine the potential inhalation exposure resulting from the vapor of phenol, the WPEM ( Wall Paint Exposure Assessment Model) was used to estimate the air concentration. OPPT/ EETD has developed the model, WPEM, to estimate air concentrations from painting. More information and access to WPEM is available at http:// epa. gov/ opptintr/ exposure/ docs/ wpem. htm. In summary, WPEM bases its air concentration estimates on models developed from small chamber data on paints.

WPEM is a user friendly, flexible software product that uses mathematical models developed from small chamber data to estimate the emissions of chemicals from oil based ( alkyd) and latex wall paint. This is then combined with detailed use, workload and occupancy data ( e. g., amount of time spent in the painted room, etc,) to estimate exposure. The output of WPEM was evaluated in a home used by EPA for testing Page 14 of 20 purposes and, in general, the results were within a factor of 2. The WPEM provides exposure estimates such as Lifetime and Average Daily Doses, Lifetime and Average Daily Concentrations, and peak concentrations. Specific input parameters include: the type of paint ( latex or alkyd) being assessed, density of the paint ( default values available), and the chemical weight fraction, molecular weight, and vapor pressure. ( WPEM website).

Phenol was assessed using WPEM for latex paints indoors. The following were used in estimating the short term vapor inhalation exposure from phenol in paints using the WPEM: a vapor pressure of 0.341 mmHg @ 25C, a mw of 94.11, a paint weight fraction of 0.05, and default model parameters. WPEM estimated a peak instantaneous concentration of 22.2 mg/ m3 and a acute potential dose rate ( representing the highest 24 hour exposure) of 0.98 mg/ kg/ day. Although the peak instantaneous concentration is available, it is not representative of the shortterm inhalation toxicological endpoint. The highest 24 hour inhalation dose estimate of 0.98 mg/ kg/ day corresponds to a short term inhalation MOE of 27 ( i. e., LOAEL 26 mg/ kg/ day / 0.98 mg/ kg/ day). Page 15 of 20 Table 5. Calculation of Short term Dermal and Inhalation MOE Using CMA and PHED Data for Residential Handlers a Exposure Scenario Method of Applicati on Dermal Unit Exposure ( mg/ lb ai) b Inhalatio n Unit Exposure ( mg/ lb ai) c Appl. Rate d ( lb a. i./ gal) Amount Treated Absorbed Dermal Dose ( mg/ kg/ day) f Dermal MOE g Inhalation Dose ( mg/ kg/ day) h Inhalatio n MOE i Painting Airless Sprayer 79 ( Res SOP PHED) 0.83 ( Res SOP PHED) 0.5 15 gal/ day 4.94 12 0.089 290 Paintbrus h/ Roller 230 ( Res SOP PHED) 0.28 ( Res SOP PHED) 0.5 2 gal/ day 1.92 31 0.0040 6500 Hard Surface Disinfection Towelette 2870 ( CMA no glove) 67.3 ( CMA) 0.0357 lbs a. i./ liter used 0.5 liter of product 0.427 140 0.017 1500 Aerosol Spray 220 ( Res SOP PHED) 1.3 ( PHED) 0.0357 lbs a. i./ liter used 0.5 liter of product 0.033 1800 0.00033 79,000 a MOEs rounded to 2 significant figures. b Dermal unit exposures are from CMA and PHED ( short pants and short sleeves for residential uses   Residential SOPs). c Inhalation unit exposures are from CMA and PHED study. d Application rates are based on the phenol labels. It is assumed that both the phenol and sodium phenate present in products are active ingredients f Abs. dermal dose ( mg/ kg/ day) = [ unit exposure ( mg/ lb ai) * Dermal Absorption Factor ( 0.5) * Appl. rate ( lb ai/ gallon) * gallons handled / Body weight ( 60 kg). g Dermal MOE = NOAEL ( mg/ kg/ day) / Daily Dose [ Where short term dermal NOAEL = 60 mg/ kg/ day]. Target MOE is 100. h Inhalation dose ( mg/ kg/ day) = [ unit exposure (

g/ lb ai) * 0.001 mg/

g unit conversion * max appl rate ( lb ai/ gal) * gallons handled * 1 inhalation absorption] / Body weight ( 70 kg). i Inhalation MOE = LOAEL ( mg/ kg/ day) / Daily Dose [ LOAEL for all durations = 0.1 mg/ L ( which equals 0.1 mg/ L * 10.26 L/ hr/ kg * 6 hrs/ day / 0.236 kg = 26.08 mg/ kg/ day]. Target MOE is 300 for short term Residential Post application Exposure The residential post application scenario considered in this assessment is exposure to residue from carpets that have been machine cleaned with a product containing phenol ( and phenol salts). It is believed that the carpet shampoo represents the high end of the exposures to toddlers from use of phenol. The carpets have been assessed rather than hard surface floors because the products appear not to be used to mop floors. Residential carpets are believed to be machine washed on an intermittent basis ( perhaps a few times per year), facilities such as day care centers may clean the carpets more often but are still believed to be of a short term duration ( i. e., carpets machine washed no more than weekly). Therefore, only the short term risks have been presented. The Page 16 of 20 potential for inhalation exposure to vapors of phenol after carpet cleaning are also of potential concern as are the potential inhalation exposure to vapors after painting indoors.

Dermal Exposure There is the potential for dermal exposure to undressed toddlers crawling on the carpets. To determine toddler exposure to residues in treated carpet, the following equation was used:

PDD FR x SA BW =

where PDD = Potential daily dose FR = Flux rate of chemical from material ( mg/ m2/ day) SA = Surface area of the body which is in contact with carpet ( m2) BW = Body weight ( kg)

The following conservative assumptions were made in calculating the exposures/ risks due to limited data:

$ Toddlers ( 3 years old) are used to represent the 1 to 6 year old age group and are assumed to weigh 15 kg, the median for male and female toddlers ( USEPA, 2000b). A body surface area of 0.657 m2 has been assumed, which is the median value.

$ The label did not provide information on the volume of disinfectant to be used for carpet cleaning. Based on information about other carpet sanitizing solutions, it was assumed that 2 ounces of disinfectant are mixed with a gallon of water ( for rotary floor machines), and that the resulting solution is applied at a rate of 1000 sq. ft. per gallon. ° No data could be found regarding the quantity of solution residue left in the carpet after treatment. As a conservative measure, it has been assumed that 25% of the shampoo remains after the final vacuuming process. ° No leaching data were available that could be used to estimate a flux rate of the chemical from the carpet. Therefore, Residential SOPs estimate of 5% of the amount on the carpet is available for dermal transfer.

The calculation of the short term dermal dose and the dermal MOE are shown in Table 6. The dermal MOEs calculated is above the target MOE of 100 and therefore not of concern. Page 17 of 20 Table 6. Short term Risks Associated with Postapplication Dermal Exposure to Disinfectant on Carpets.

Parameter Value Rationale Application Rate 1000 ft2/ gallon of solution USEPA Assumption % a. i. in Formulated Product 1.62% Maximum rate listed on label (# 8383 3)

Formulated Product in solution 2 oz/ gallon Assumption Density of cleaning solution 1.0 g/ mL Assumed to be similar to density of water Flux Rate of Chemical from Carpet 0.13 mg/ m2/ day ( Density) * (% a. i.) * ( Formulated Product in Sol.) * ( 25% remaining)* ( 5% transfer) / ( App. Rate) * ( Conversion Factors)

Surface Area of Body in Contact with Carpet 0.657 m2 Median surface area of toddler Dermal Absorption 50%

Body Weight 15 kg Median body weight of toddler Potential Dermal Exposure 0.0028 mg/ kg/ day FR * SA * DA/ BW Dermal NOAEL 60 mg/ kg/ day Dermal MOE 21,000 ( Derm. NOAEL) / ( Daily Derm. Dose). Target MOE = 100.

Incidental Ingestion In addition to dermal exposure, infants crawling on treated carpets will also be exposed to phenold via incidental oral exposure. To calculate incidental ingestion exposure to phenols due to hand to mouth transfer, the scenarios established in the Standard Operating Procedures ( SOPs) for Residential Exposure Assessments were used. These scenarios use assumptions that are similar to those used in calculating exposures due to dermal contact of phenols from toddlers crawling on treated carpets. The assumptions above in the dermal assessment ( Table 6) estimates the transferable residues as 0.013 µ g/ cm2 . The estimated potential ingestion dose rate immediately after application would be calculated as follows:

PDR norm= ISR t x SA x FQ x SE x ET x 0.001 mg/ µ g BW where:

PDR norm = Potential dose rate ( mg/ kg/ day); ISR t = Indoor Surface Residue ( µ g/ cm2) at time 0; SA = Surface area of the hands that contact both the treated area, and the Page 18 of 20 individuals mouth ( cm2/ event); FQ = Frequency of hand to mouth events ( events/ hr); SE = Saliva extraction efficiency; and ET = Exposure Time ( 4 hrs/ day) BW = Body weight ( 15 kg)

The surface area used for each hand to mouth event is 20 cm2. It is assumed that there are 20 hand to mouth exposure events per hour ( 90th percentile). The short term incidental oral NOAEL of 60 mg/ kg/ day should be used as the toxicity endpoint for this scenario because of the intermittent nature of carpet shampoos. The potential dose rate ( PDR) using this equation is 0.0007 mg/ kg/ day resulting in a hand to mouth MOE for toddlers of 86,000.

Inhalation Exposure Carpet Treatments: Post application inhalation exposure to adults and toddlers after phenol use ( as a carpet cleaner) is concern because of the relatively high vapor pressure of phenol ( i. e., 0.341 mm Hg @ 25C). No postapplication air concentration data have been submitted to determine potential inhalation risk to the vapor phase. Therefore, EFAST was used to present a screening level estimate of the potential short term inhalation risk. The post application estimates are based on the EFAST results for the air concentration and inhalation dose from the adult handlers. The toddler risk estimates are corrected for the lower body weight ( i. e., 15 kg).

EFAST was used to model the air concentration from carpet cleaning using the general purpose cleaner portion of the model ( i. e., specific assessment of carpet cleaners are not available). The weight fraction is 0.002 ( 1.62% ai x 2 fl oz/ 128 oz per gallon conc x 8 lb per gallon density of carpet wash/ water = weight fraction of 0.002 or 0.2 percent). EFAST indicates a peak concentration of 0.90 mg/ m3. Because the peak concentration does not represent a daily inhalation exposure, the daily dose rather than the peak estimate from EFAST is used to compare to the short term inhalation toxicological endpoint. If a short term toxicological endpoint of less than one day were to be generated it should be compared to the peak air concentration estimate. However, because the toxicological endpoint of concern is based on greater than one day of exposure, the daily dose rate of 0.008 mg/ kg/ day from EFAST is used in this assessment for adults based on an average daily air concentration of 0.044 mg/ m3. The toddler's dose is extrapolated from the adult value presented in EFAST and is estimated as 0.038 mg/ kg/ day for toddlers ( i. e., 0.008 mg/ kg/ day x 71.8 kg adult BW x ( 1/ 15 kg toddler BW)). The inhalation MOE for adults is not of concern ( i. e., MOE = LOAEL of 26 mg/ kg/ day / 0.008 mg/ kg/ day = 3,300, target MOE of 300). Based on the same scenario, the toddler inhalation risk, scaled to the weight of the toddler is not of concern ( i. e., MOE = LOAEL of 26 mg/ kg/ day / 0.038 mg/ kg/ day = 680, target MOE of 100). The risks for the toddlers were scaled by body weight but not breathing rate. The breathing rate of a toddler is lower than that of an adult and there for the MOEs would be slightly higher. Page 19 of 20 Painting:

In addition to the estimates provided above for post application inhalation exposure, estimates are provided for post application inhalation exposure to paints because of the high vapor pressure of phenol. The WPEM used in the painting scenario above was also used for the postapplication assessment. The toddler post application assessment from WPEM uses a body weight of 20.3 kg, a slight deviation from EPA's estimate of 15 kg. WPEM estimated a peak instantaneous concentration of 5.28 mg/ m3 after painting and a acute potential dose rate ( representing the highest 24 hour exposure) of 1.3 mg/ kg/ day. Although the peak instantaneous concentration is available, it is not representative of the short term inhalation toxicological endpoint. WPEM also estimates an average daily dose over a 5 day period with a daily air concentration of 0.022 mg/ m3 and a dose of 0.011 mg/ kg/ day which corresponds to a MOE of 2,400 ( i. e., LOAEL 26 mg/ kg/ day / 0.011 mg/ kg/ day). The short term target MOE is 300, and therefore, the inhalation risk is not of concern.

3.0 Limitations and Uncertainties There are a number of uncertainties associated with this assessment. In general, conservative values were used in cases where data were lacking. Assessments for these scenarios should be considered as screening assessments, if data are presented/ developed they could be used to refine the risks. Examples of the uncertainties include:

° Surrogate dermal and inhalation data from Chemical Manufacturers Association ( CMA) database were used to assess handler exposure. Note that CMA surrogate data have the following deficiencies:

The inhalation concentrations were typically below the detection limits, so the unit exposures for the inhalation exposure route could not be accurately calculated.

The quality of the CMA data were assessed using the same grading criteria as PHED and the grades were all at C, D, E lower than PHED standards ( e. g., most of PHED is at grades A, B, C).

Grade C, D, E data frequently may have QA/ QC problems including lack of either/ or field fortification, laboratory recoveries, and storage stability information.

Grade C, D, E data have an insufficient amount of replicates.

Grade C, D, E data may have higher variabilities ( e. g., high CVs).

° The estimates used for the amount of product applied is based on best professional judgement ( e. g., production of paints, number of gallons of paint applied by airless sprayers and brush/ roller, number of wipes used, etc). Page 20 of 20 4.0 REFERENCES Conning, D. M. and M. J. Hayes. 1970. The dermal toxicity of phenol: an investigation of the most effective first aid measures. Br J Ind Med. 27: 155 159. As cited in ATSDR, 1998 USEPA. 2004. Phenol  Report of the Antimicrobials Division Toxicology Endpoint Selection Committee. Dated May 20, 2004. Memorandum from Timothy F. McMahon, Chair, ADTC, Antimicrobials Division.

USEPA. 2002. Toxicological Review of Phenol. Integrated Risk Information Sytem ( IRIS). September 2002. EPA/ 635/ R 02/ 006.

USEPA. 2000. Residential SOPs. EPA Office of Pesticide Programs   Human Health Division. Dated April 5, 2000.

USEPA. 1999. Evaluation of Chemical Manufacturers Association Antimicrobial Exposure Assessment Study. Memorandum from Siroos Mostaghimi, Ph. D., USEPA, to Julie Fairfax, USEPA> Dated November 4, 1999. DP Barcode D247642.


[Federal Register: February 27, 2006 (Volume 71, Number 38)]
[Proposed Rules]
[Page 9749-9750]
[DOCID:fr27fe06-20]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 52 and 69

[EPA-R09-OAR-2005-0506; FRL-8030-4]

State Implementation Plan Revision and Alternate Permit Program;
Territory of Guam

AGENCY:  Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing to grant full approval for the Guam operating
permit program regulations and an associated State Implementation Plan
(SIP) revision submitted by the Territory of Guam (Guam). These
submittals correct deficiencies identified in EPA's direct final
interim approval rulemaking of January 9, 2003 (68 FR 1162). Full
approval of Guam's alternate permit program and associated SIP revision
will allow sources to be permitted under Guam's approved alternate
operating permit program.

DATES: Any comments on this proposal must arrive by March 29, 2006.

ADDRESSES: Submit comments, identified by docket number EPA-R09-OAR-
2005-0506, by one of the following methods:
    1. Federal eRulemaking Portal: http://www.regulations.gov. Follow

the on-line instructions.
    2. Agency Web site: http://docket.epa.gov/rmepub/. EPA prefers

receiving comments through this electronic public docket and comment
system. Follow the on-line instructions to submit comments.
    3. E-mail<EMAIL_ADDRESS>    4. Mail or deliver: Gerardo Rios (Air-3), U.S. Environmental
Protection Agency Region IX, 75 Hawthorne Street, San Francisco, CA
94105-3901.
    Instructions: All comments will be included in the public docket
without change and may be made available online at http://www.regulations.gov
 including any personal information provided, unless

the comment includes Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Information that
you consider CBI or otherwise protected should be clearly identified as
such and should not be submitted through the agency Web site,
eRulemaking portal or e-mail. The agency Web site and eRulemaking
portal are ``anonymous access'' systems, and EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send e-mail directly to EPA, your e-mail address
will be automatically captured and included as part of the public
comment. If EPA cannot read your comment due to technical difficulties
and cannot contact you for clarification, EPA may not be able to
consider your comment.
    Docket: The index to the docket for this action is available
electronically at http://www.regulations.gov and in hard copy at EPA

Region IX, 75 Hawthorne Street, San Francisco, California. While all
documents in the docket are listed in the index, some information may
be publicly available only at the hard copy location (e.g., copyrighted
material), and some may not be publicly available in either location
(e.g., CBI). To inspect the hard copy materials, please schedule an
appointment during normal business hours with the contact listed in the
FOR FURTHER INFORMATION CONTACT section.

FOR FURTHER INFORMATION CONTACT: Ben Machol, EPA Region IX, at (415)
972-3770, (Machol.Ben@epa.gov), Pacific Islands Office, or Ed Pike, at
(415) 972-3970, (Pike.Ed@epa.gov), Permits Office, Air Division, at the
EPA--Region IX address listed above.

SUPPLEMENTARY INFORMATION: In the Rules and Regulations section of this
Federal Register, we are granting full approval of these local rules as
Guam's alternate permit program in a direct final action without prior
proposal because we believe this action is not controversial and do not
anticipate adverse comment. A detailed rationale for this approval is
set forth in the direct final rule. If we do not receive adverse
comments, no further activity is planned. If EPA receives adverse
comments, however, we will publish a timely withdrawal of the direct
final action and address the comments in a subsequent final action
based on this proposed rule. We will not open a second comment period,
so anyone interested in commenting should do so at this time. For more
information on this action, please see the information provided in the
direct final rule of the same title located under the Rules and
Regulations section of this Federal Register.

    Dated: January 20, 2006.
Laura Yoshii,
Acting Regional Administrator, Region IX.
[FR Doc. 06-1741 Filed 2-24-06; 8:45 am]

BILLING CODE 6560-50-P