[Federal Register Volume 86, Number 110 (Thursday, June 10, 2021)]
[Rules and Regulations]
[Pages 30753-30756]
[FR Doc No: 2021-12301]

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Rules and Regulations
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of Documents.

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Federal Register / Vol. 86, No. 110 / Thursday, June 10, 2021 / Rules
and Regulations

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2021-0458; Project Identifier MCAI-2021-00595-T;
Amendment 39-21602; AD 2021-12-15]
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 A330-243, A330-243F, A330-341, A330-342, and A330-343
airplanes. This AD was prompted by a report of an in-flight turnback
due to loss of green and blue hydraulic systems in cruise. This AD
requires inspecting for discrepancies of the hydraulic pressure switch
harnesses of affected engines, and applicable corrective actions, 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 June 25, 2021.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of June 25,
2021.
    The FAA must receive comments on this AD by July 26, 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
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 at https://www.regulations.gov by searching for and locating
Docket No. FAA-2021-0458.

Examining the AD Docket

    You may examine the AD docket at https://www.regulations.gov by
searching for and locating Docket No. FAA-2021-0458; 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.

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:

Background

    EASA, which is the Technical Agent for the Member States of the
European Union, has issued EASA AD 2021-0128, dated May 17, 2021 (EASA
AD 2021-0128) (also referred to as the Mandatory Continuing
Airworthiness Information, or the MCAI), to correct an unsafe condition
for all Airbus SAS Model A330-243, A330-243F, A330-341, A330-342, and
A330-343 airplanes.
    This AD was prompted by a report of a Model A330 airplane equipped
with Rolls-Royce Trent 700 engines that experienced an in-flight
turnback due to loss of green and blue hydraulic systems in cruise. On
the green hydraulic system, electronic centralized aircraft monitoring
(ECAM) warnings HYD G ENG 2 PUMP LO PR and G SYS LO PR were triggered,
resulting in loss of the green hydraulic system. On the blue hydraulic
system, ECAM warning HYD B ENG 1 PUMP LO PR was triggered, and the
flightcrew selected the blue hydraulic system engine-driven pump (EDP)
OFF, per flightcrew operating manual procedures. Subsequent inspections
of engine #1 revealed that during a previous maintenance shop visit,
and following partial re-routing of hydraulic harnesses, the blue and
green EDP pressure switch electrical connectors (4001JG2-A and 4001JG1-
A) were inadvertently cross connected. As a result, the blue hydraulic
system was declared faulty (ECAM message) in flight, when actually the
green hydraulic system had failed with low pressure. The FAA is issuing
this AD to address the potential loss of two hydraulic systems (blue
and green) in flight, instead of only one (green), which could lead to
loss of all hydraulic circuits, possibly resulting in loss of control
of the airplane. See the MCAI for additional background information.

Related Service Information Under 1 CFR Part 51

    EASA AD 2021-0128 specifies procedures for a general visual
inspection for discrepancies (including incorrect harness routing and
pump pressure connections) of the hydraulic pressure switch harnesses
of affected engines. EASA AD 2021-0128 also describes corrective
actions including a visual inspection to identify the clip points where
harnesses are not installed correctly, harness re-routing, and
hydraulic system testing. 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
2021-0128 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 developed a process to use certain civil aviation
authority (CAA) ADs as the primary source of information for compliance
with requirements for corresponding FAA ADs. The FAA has been
coordinating this process with manufacturers and CAAs. As a result,
EASA AD 2021-0128 is incorporated by reference in this AD. This AD,
therefore, requires compliance with EASA AD 2021-0128 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 EASA AD 2021-
0128 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 EASA AD 2021-0128. Service information specified in EASA
AD 2021-0128 that is required for compliance with it is available at
https://www.regulations.gov by searching for and locating Docket No.
FAA-2021-0458.

Justification for Immediate Adoption and Determination of the Effective
Date

    Section 553(b)(3)(B) of the Administrative Procedure Act (APA) (5
U.S.C. 551 et seq.) authorizes agencies to dispense with notice and
comment procedures for rules when the agency, for ``good cause,'' finds
that those procedures are ``impracticable, unnecessary, or contrary to
the public interest.'' Under this section, an agency, upon finding good
cause, may issue a final rule without providing notice and seeking
comment prior to issuance. Further, section 553(d) of the APA
authorizes agencies to make rules effective in less than thirty days,
upon a finding of good cause.
    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 forgoing notice and comment prior to adoption of this rule
because the loss of the blue and green hydraulic systems in flight
could lead to loss of all hydraulic circuits, possibly resulting in
loss of control of the airplane. Accordingly, notice and opportunity
for prior public comment are impracticable and contrary to the public
interest pursuant to 5 U.S.C. 553(b)(3)(B).
    In addition, the FAA finds that good cause exists pursuant to 5
U.S.C. 553(d) for making this amendment effective in less than 30 days,
for the same reasons the FAA found good cause to forgo notice and
comment.

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-2021-0458; Project Identifier MCAI-
2021-00595-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 56 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
----------------------------------------------------------------------------------------------------------------
3 work-hours x $85 per hour = $255...........................              $0             $255          $14,280
----------------------------------------------------------------------------------------------------------------

    The FAA estimates the following costs to do any necessary on-
condition actions that would be required based on the results of any
required actions. The FAA has no way of determining the number of
aircraft that might need these on-condition actions:

                 Estimated Costs of On-Condition Actions
------------------------------------------------------------------------
                                                             Cost per
              Labor cost                   Parts cost        product
------------------------------------------------------------------------
8 work-hours x $85 per hour = $680....              $0             $680
------------------------------------------------------------------------

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:

2021-12-15 Airbus SAS: Amendment 39-21602; Docket No. FAA-2021-0458;
Project Identifier MCAI-2021-00595-T.

(a) Effective Date

    This airworthiness directive (AD) becomes effective June 25,
2021.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to all Airbus SAS Model A330-243, A330-243F,
A330-341, A330-342, and A330-343 airplanes, certificated in any
category.

(d) Subject

    Air Transport Association (ATA) of America Code 71, Powerplant.

(e) Reason

    This AD was prompted by a report of an in-flight turnback due to
loss of green and blue hydraulic systems in cruise. The FAA is
issuing this AD to address the potential loss of the blue and green
hydraulic systems in flight, which could lead to loss of all
hydraulic circuits, possibly resulting in loss of 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
2021-0128, dated May 17, 2021 (EASA AD 2021-0128).

(h) Exceptions to EASA AD 2021-0128

    (1) Where EASA AD 2021-0128 refers to its effective date, this
AD requires using the effective date of this AD.
    (2) Where paragraph (2) of EASA AD 2021-0128 specifies actions
if ``discrepancies are found,'' for this AD ``discrepancies''
include incorrect harness routing and pump pressure connections.
    (3) The ``Remarks'' section of EASA AD 2021-0128 does not apply
to this AD.

(i) No Reporting Requirement

    Although the service information referenced in EASA AD 2021-0128
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); or Rolls-Royce's EASA
DOA. If approved by a DOA, the approval must include the DOA-
authorized signature.
    (3) Required for Compliance (RC): If any service information
referenced in EASA AD 2021-0128 contains paragraphs that are labeled
as RC, the instructions in RC paragraphs, including subparagraphs
under an RC paragraph, must be done to comply with this AD; any
paragraphs, including subparagraphs under those paragraphs, that are
not identified as RC are recommended. The instructions in
paragraphs, including subparagraphs under those paragraphs, not
identified as RC may be deviated from using accepted methods in
accordance with the operator's maintenance or inspection program
without obtaining approval of an AMOC, provided the instructions
identified as RC can be done and the airplane can be put back in an
airworthy condition. Any substitutions or changes to instructions
identified as RC require approval of an AMOC.

(k) Related Information

    For more information about this AD, 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>
(l) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference

(IBR) of the service information listed in this paragraph under 5
U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless this AD specifies otherwise.
    (i) European Union Aviation Safety Agency (EASA) AD 2021-0128,
dated May 17, 2021.
    (ii) [Reserved]
    (3) For EASA AD 2021-0128, contact 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
EASA AD on the EASA website at https://ad.easa.europa.eu.
    (4) You may view this 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>. This material may be found in the AD
docket at https://www.regulations.gov by searching for and locating
Docket No. FAA-2021-0458.
    (5) You may view this material that is incorporated by reference
at the National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, email
<EMAIL_ADDRESS>or go to https://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on June 6, 2021.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2021-12301 Filed 6-8-21; 4:15 pm]
BILLING CODE 4910-13-P


[Federal Register Volume 80, Number 35 (Monday, February 23, 2015)]
[Notices]
[Pages 9457-9459]
[FR Doc No: 2015-03581]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2007-1196; FRL-9923-36-OAR]

Recent Postings of Broadly Applicable Alternative Test Methods

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of availability.

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SUMMARY: This notice announces the broadly applicable alternative test
method approval decisions the Environmental Protection Agency (EPA) has
made under and in support of New Source Performance Standards (NSPS),
the National Emission Standards for Hazardous Air Pollutants (NESHAP),

and the Consolidated Federal Air Rule under the Clean Air Act (CAA) in
2014.

FOR FURTHER INFORMATION CONTACT: An electronic copy of each alternative
test method approval document is available on the EPA's Web site at
www.epa.gov/ttn/emc/approalt.html. For questions about this notice,
contact Ms. Lula H. Melton, Air Quality Assessment Division, Office of
Air Quality Planning and Standards (E143-02), Environmental Protection
Agency, Research Triangle Park, NC 27711; telephone number: (919) 541-
2910; fax number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
For technical questions about individual alternative test method
decisions, refer to the contact person identified in the individual
approval documents.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this notice apply to me?

    This notice will be of interest to entities regulated under 40 Code
of Federal Regulations (CFR) parts 60 and 63, state, local, and tribal
agencies, and the EPA Regional Offices responsible for implementation
and enforcement of regulations under 40 CFR parts 60 and 63.

B. How can I get copies of this information?

    You may access copies of the broadly applicable alternative test
method approval documents from the EPA's Web site at www.epa.gov/ttn/emc/approalt.html.

II. Background

    Broadly applicable alternative test method approval decisions made
by the EPA in 2014 under the NSPS, 40 CFR part 60 and the NESHAP, 40
CFR part 63 are identified in this notice (see Table 1). Source owners
and operators may voluntarily use these broadly applicable alternative
test methods subject to their specific applicability. Use of these
broadly applicable alternative test methods does not change the
applicable emission standards.
    As explained in a previous Federal Register notice published at 72
FR 4257 (January 30, 2007) and found on the EPA's Web site at
www.epa.gov/ttn/emc/approalt.html, the EPA Administrator has the
authority to approve the use of alternative test methods to comply with
requirements under 40 CFR parts 60, 61, and 63. This authority is found
in sections 60.8(b)(3), 61.13(h)(1)(ii), and 63.7(e)(2)(ii). A similar
authority is granted in 40 CFR part 65 under section 65.158(a)(2). In
the past, we have performed thorough technical reviews of numerous
requests for alternatives and modifications to test methods and
procedures. Based on these reviews, we have often found that these
changes or alternatives would be equally valid and appropriate to apply
to other sources within a particular class, category, or subcategory.
Consequently, we have concluded that, where a method modification or an
alternative method is clearly broadly applicable to a class, category,
or subcategory of sources, it is both more equitable and efficient to
approve its use for all appropriate sources and situations at the same
time.
    It is important to clarify that alternative methods are not
mandatory but permissive. Sources are not required to employ such a
method but may choose to do so in appropriate cases. Source owners or
operators should review the specific broadly applicable alternative
method approval decision on the EPA's Web site at www.epa.gov/ttn/emc/approalt.html before electing to employ it. As per section 63.7(f)(5),
by electing to use an alternative method for 40 CFR part 63 standards,
the source owner or operator must continue to use the alternative
method until approved otherwise.
    The criteria for approval and procedures for submission and review
of broadly applicable alternative test methods are outlined at 72 FR
4257 (January 30, 2007). We will continue to announce approvals for
broadly applicable alternative test methods on the EPA's Web site at
www.epa.gov/ttn/emc/approalt.html and publish a notice annually that
summarizes approvals for broadly applicable alternative test methods.
    This notice comprises a summary of four such approval documents
posted to our Technology Transfer Network from January 1, 2014, through
December 31, 2014. The alternative method decision letter/memo number,
the reference method affected, sources allowed to use this alternative,
and the modification or alternative method allowed are summarized in
Table 1 of this notice. Please refer to the complete copies of these
approval documents available from the EPA's Web site at www.epa.gov/ttn/emc/approalt.html as Table 1 serves only as a brief summary of the
broadly applicable alternative test methods.
    This notice also acknowledges two broadly applicable test method
approvals that we retracted in 2014. Broadly applicable alternative
test method approvals referred to as ALT-061 and ALT-087 issued on
September 22, 2009, and July 27, 2011, respectively, were withdrawn. In
the Federal Register notices dated February 22, 2010, and February 15,
2012, we announced the approvals of the use of single-point sampling at
the centroid of the exhaust when sampling gaseous emissions and diluent
gases from federally regulated engines. However, based on comments that
we received (on the proposed rule titled, ``Revisions to Test Methods
and Testing Regulations,'' published in the Federal Register on January
9, 2012) from the Alaska Department of Environmental Conservation in a
letter dated March 9, 2012, we no longer believe that this alternative
is appropriate for broad applicability. Therefore, we have withdrawn
broadly applicable alternative approvals, ALT-061 and ALT-087. Please
refer to the withdrawal memo on EPA's Web site at http://www.epa.gov/ttn/emc/approalt.html for details regarding our decision to withdraw
ALT-061 and ALT-087.
    If you are aware of reasons why a particular alternative test
method approval that we issued should not be broadly applicable, we
request that you make us aware of the reasons in writing, and we will
revisit the broad approval. Any objection to a broadly applicable
alternative test method, as well as the resolution of that objection,
will be announced on the EPA's Web site at www.epa.gov/ttn/emc/approalt.html and in the subsequent Federal Register notice. If we
decide to retract a broadly applicable test method, we would continue
to grant case-by-case approvals, as appropriate, and would (as states,
local and tribal agencies and the EPA Regional Offices should) consider
the need for an appropriate transition period for users either to
request case-by-case approval or to transition to an approved method.

    Dated: February 8, 2015.
Stephen D. Page,
Director, Office of Air Quality Planning and Standards.

  Table 1--Approved Alternative Test Methods and Modifications to Test Methods Referenced in or Published Under
               Appendices in 40 CFR Parts 60 and 63 Posted Between January 2014 and December 2014
----------------------------------------------------------------------------------------------------------------
   Alternative method decision        As an alternative or
        letter/memo number           modification  to . . .           For . . .               You may . . .
----------------------------------------------------------------------------------------------------------------
ALT-105..........................  Method 25A--Determination  Sources subject to 40     Produce and use vendor
                                    of Total Gaseous Organic   CFR part 63, subpart      certified calibration
                                    Concentration Using a      BBBBBB; 40 CFR part 63,   gases that meet the
                                    Flame Ionization           subpart R, and 40 CFR     following requirements:
                                    Analyzer or Method 25B--   part 60, subpart XX.      prepared in accordance
                                    Determination of Total                               with ISO 6142; analyzed
                                    Gaseous Organic                                      in accordance with ISO
                                    Concentration Using a                                6143; filled at ISO
                                    Nondispersive Infrared                               17025 accredited
                                    Analyzer.                                            laboratories; and have
                                                                                a total expanded
                                                                                uncertainty of less
                                                                                than 1% (relative) with
                                                                                caveats stipulated in
                                                                                the agency's approval
                                                                                letter dated May 12,
                                                                                2014.
ALT-106..........................  Method 18--Measurement of  Spark ignition internal   Use an alternative
                                    Gaseous Organic Compound   combustion engines        testing approach using
                                    Emissions by Gas           subject to 40 CFR part    GC to separate and
                                    Chromatography or Method   60, subpart JJJJ.         measure methane and
                                    25A--Determination of                                ethane, followed by GC
                                    Total Gaseous Organic                                back-flush procedures
                                    Concentration Using a                                to measure NMEOC in
                                    Flame Ionization                                     post-combustion
                                    Analyzer.                                            emissions with caveats
                                                                                stipulated in the
                                                                                agency's approval
                                                                                letter dated June 6,
                                                                                2014.
ALT-107..........................  Test methods to            Stationary reciprocating  Use a certified and
                                    demonstrate initial and    internal combustion       quality assured CO and
                                    annual compliance with     engines subject to 40     O2 CEMS that meet the
                                    CO testing requirements    CFR part 63, subpart      criteria specified in
                                    prescribed in paragraph    ZZZZ--National            the agency's approval
                                    63.6630(e) of 40 CFR       Emissions Standards for   letter dated November
                                    part 63, subpart ZZZZ.     Hazardous Air             20, 2013.
                                                               Pollutants for
                                                               Stationary
                                                               Reciprocating Internal
                                                               Combustion Engines.
ALT-108..........................  The minimum sample volume  Sources subject to 40     Use a 2-hour minimum
                                    requirement of 30 dscf     CFR part 63, subpart      sampling time in lieu
                                    when using Method 29--     EEEEEEE, National         of a 30 dscf minimum
                                    Determination of Metals    Emission Standards for    sample volume when
                                    Emissions from             Hazardous Air             Method 29 is applied.
                                    Stationary Sources.        Pollutants: Gold Mine
                                                               Ore Processing and
                                                               Production Area Source
                                                               Category.
----------------------------------------------------------------------------------------------------------------
Source owners or operators should review the specific broadly applicable alternative method approval letter on
  the EPA's Web site at www.epa.gov/ttn/emc/approalt.html before electing to employ it.

[FR Doc. 2015-03581 Filed 2-20-15; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 80, Number 241 (Wednesday, December 16, 2015)]
[Rules and Regulations]
[Pages 78146-78149]
[FR Doc No: 2015-31464]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2015-0023; FRL-9935-81]

Choline Chloride; Exemption From the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of the Choline Chloride (Acetyl Choline) in
or on all food commodities when applied/used pre-harvest and used in
accordance with label directions and good agricultural practices. CP
Bio, Inc., submitted a petition to EPA under the Federal Food, Drug,
and Cosmetic Act (FFDCA), requesting an exemption from the requirement
of a tolerance. This regulation eliminates the need to establish a
maximum permissible level for residues of Choline Chloride.

DATES: This regulation is effective December 16, 2015. Objections and
requests for hearings must be received on or before February 16, 2016,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2015-0023, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Robert McNally, Biopesticides and
Pollution Prevention Division (7511P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460-0001; main telephone number:<PHONE_NUMBER>; email
address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR
part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2015-0023 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
February 16, 2016. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2015-0023, by one of
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html. Additional
instructions on commenting or visiting the docket, along with more
information about dockets generally, is available at http://www.epa.gov/dockets.

II. Background and Statutory Findings

    In the Federal Register of March 4, 2015 (80 FR 11611) (FRL-9922-
68), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance
petition (PP 4F8287) by CP Bio, Inc., 4802 Murrieta Street, Chino, CA
91710. The petition requested that 40 CFR part 180 be amended by
establishing an exemption from the requirement of a tolerance for
residues of Choline Chloride in or on all food commodities (when
applied pre-harvest). That document referenced a summary of the
petition prepared by the petitioner CP Bio, Inc., which is available in
the docket, http://www.regulations.gov. There were no substantive
comments received in response to the notice of filing.
    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the exemption is ``safe.'' Section 408(c)(2)(A)(ii) of FFDCA defines
``safe'' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.'' This includes exposure through
drinking water and in residential settings, but does not include
occupational exposure. Pursuant to FFDCA section 408(c)(2)(B), in
establishing or maintaining in effect an exemption from the requirement
of a tolerance, EPA must take into account the factors set forth in
FFDCA section 408(b)(2)(C), which require EPA to give special
consideration to exposure of

infants and children to the pesticide chemical residue in establishing
a tolerance and to ``ensure that there is a reasonable certainty that
no harm will result to infants and children from aggregate exposure to
the pesticide chemical residue.-. . . '' Additionally, FFDCA section
408(b)(2)(D) requires that the Agency consider ``available information
concerning the cumulative effects of a particular pesticide's
residues'' and ``other substances that have a common mechanism of
toxicity.''
    EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. First, EPA determines the
toxicity of pesticides. Second, EPA examines exposure to the pesticide
through food, drinking water, and through other exposures that occur as
a result of pesticide use in residential settings.

III. Toxicological Profile

    Consistent with FFDCA section 408(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
this action and considered its validity, completeness and reliability,
and the relationship of this information to human risk. EPA has also
considered available information concerning the variability of the
sensitivities of major identifiable subgroups of consumers, including
infants and children.

A. Overview of Choline Chloride

    Choline Chloride is an ammonium salt that readily dissociates into
two constituents--Choline and Chloride. It presents as a white
crystalline solid that is odorless. Each constituent is ubiquitous in
the environment, constitutes a regular part of the human diet, and
serves many critical functions in the human body. Choline is found in
such foods as egg yolk, vegetables and animal fat. It is a precursor of
a vital neurotransmitter; and it is critical for the structural
integrity of cell membranes and various metabolic functions. Chloride
is also a regular part of the human diet, particularly as a constituent
of edible salt, and serves many functions in human biology. Chiefly,
Chloride is an essential electrolyte responsible for maintaining acid/
base balance, transmitting nerve impulses and regulating fluid in and
out of cells.
    Choline Chloride is already approved for use by EPA as an inert
ingredient in pesticide products without numerical limitation for pre-
harvest use (40 CFR 180.920). Additionally, Choline Chloride is
designated as GRAS (Generally Recognized as Safe) and is approved by
the Food and Drug Administration (FDA) as a human nutrient under 21 CFR
182.8252 and as a nutrient in animal feeds under 21 CFR 582.5252.
    As a biopesticide, Choline Chloride is considered a plant growth
regulator (PGR) intended for use to increase growth and decrease stress
in growing crops. It has a non-toxic mode of action; and as with most
PGRs, it is applied at low concentrations because use at high
concentrations result in detrimental effects to the plant.

B. Biochemical Pesticide Toxicology Data Requirements

    All applicable mammalian toxicology data requirements supporting
the petition to establish an exemption from the requirement of a
tolerance for the use of Choline Chloride as an active ingredient for
use as a PGR on food crops have been fulfilled. All acute toxicology
data requirements were fulfilled through guideline studies. The Acute
Oral Toxicity Category is III; all other categories are IV.
Additionally, the information submitted in support of the application
indicate that Choline Chloride is non-mutagenic and that it is not
subchronically or developmentally toxic. Subchronic oral toxicity,
mutagenicity and developmental toxicity data requirements were
satisfied through scientific literature. Subchronic dermal and
inhalation requirements were waived for lack of exposure. (A complete
assessment of the toxicology submission for Choline Chloride can be
found in the docket.)

C. EPA's Safety Determination

    EPA evaluated the available toxicity and exposure data on Choline
Chloride and considered its validity, completeness, and reliability, as
well as the relationship of this information to human risk. A full
explanation of the data upon which EPA relied and its risk assessment
based on that data can be found within the August 11, 2015, document
entitled ``Federal Food, Drug, and Cosmetic Act (FFDCA) Considerations
for Choline Chloride.'' This document, as well as other relevant
information, is available in the docket for this action as described
under ADDRESSES. Based upon its evaluation, EPA concludes that there is
a reasonable certainty that no harm will result to the U.S. population,
including infants and children, from aggregate exposure to residues of
Choline Chloride. Therefore, an exemption from the requirement of a
tolerance is established for residues of Choline Chloride in or on all
food commodities when applied pre-harvest and used in accordance with
label directions and good agricultural practices.

IV. Aggregate Exposures

    In examining aggregate exposure, FFDCA section 408 directs EPA to
consider available information concerning exposures from the pesticide
residue in food and all other non-occupational exposures, including
drinking water from ground water or surface water and exposure through
pesticide use in gardens, lawns, or buildings (residential and other
indoor uses).

A. Dietary Exposure

    Food Exposure. Dietary exposure to the pesticidal residues of
Choline Chloride is expected to be negligible. (1) Choline Chloride is
a PGR and is necessarily applied at low concentrations. (High
concentrations result in detrimental effects to the plant). (2) Choline
Chloride biodegrades rapidly. A MITI-I test demonstrated that Choline
Chloride is 93% degraded within 14 days. (3) As a salt, Choline
Chloride dissociates readily when in contact with water, making its
persistence as a residue even more unlikely.
    Should exposure occur, however, minimal to no risk is expected for
the general population, including infants and children. Notably, humans
are already dietarily exposed to Choline Chloride. It is produced
endogenously, and is found naturally in foods in the human diet.
Indeed, it is considered an essential human dietary component, serving
critical functions in nerve transmission, cell membrane integrity and
lipid metabolism.
    Drinking Water Exposure. No significant residues of Choline
Chloride are expected in drinking water when products are used
according to label instructions. The active ingredient is applied
terrestrially at low concentrations; it is very soluble in water; and
it biodegrades rapidly, once applied. As such, any residues of Choline
Chloride in drinking water are anticipated to be negligible.
    It should be additionally noted that both Choline and Chloride, the
constituents of Choline Chloride, are ubiquitous in the environment;
and there is a long history of incidental, but minor, exposure through
drinking water.

B. Other Non-Occupational Exposure

    Non-occupational exposure to Choline Chloride residues are not
expected. Choline Chloride is not intended for use in residential
settings; it is intended for agricultural use only.

Nonetheless, even in the event of incidental exposure, minimal to no
risk is expected due to the low toxicity of the chemical as explained
in the risk assessment found in the docket.

V. Cumulative Effects From Substances With a Common Mechanism of
Toxicity

    Section 408(b)(2)(D)(v) of FFDCA requires that, when considering
whether to establish, modify, or revoke a tolerance, the Agency
consider ``available information'' concerning the cumulative effects of
a particular pesticide's residues and ``other substances that have a
common mechanism of toxicity.''
    EPA has not found Choline Chloride to share a common mechanism of
toxicity with any other substances, and Choline Chloride does not
appear to produce a toxic metabolite produced by other substances. For
the purposes of this tolerance action, therefore, EPA has assumed that
Choline Chloride does not have a common mechanism of toxicity with
other substances. For information regarding EPA's efforts to determine
which chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

VI. Determination of Safety for U.S. Population, Infants and Children

    FFDCA section 408(b)(2)(C) provides that, in considering the
establishment of a tolerance or tolerance exemption for a pesticide
chemical residue, the EPA shall assess the available information about
consumption patterns among infants and children, special susceptibility
of infants and children to pesticide chemical residues, and the
cumulative effects on infants and children of the residues and other
substances with a common mechanism of toxicity. In addition, FFDCA
section 408(b)(2)(C) provides that the EPA shall apply an additional
tenfold (10X) margin of safety for infants and children in the case of
threshold effects to account for prenatal and postnatal toxicity and
the completeness of the database on toxicity and exposure, unless the
EPA determines that a different margin of safety will be safe for
infants and children. This additional margin of safety is commonly
referred to as the Food Quality Protection Act Safety Factor. In
applying this provision, the EPA either retains the default value of
10X, or uses a different additional or no safety factor when reliable
data are available to support a different additional or no safety
factor.
    Because there are no threshold effects associated with this
biochemical, an additional margin of safety for infants and children is
not necessary.
    EPA has determined that there are no foreseeable dietary risks to
the U.S. population, including infants and children, from the
pesticidal use of Choline Chloride. Exposure to the residues of Choline
Chloride is expected to be negligible due to the low concentrations
associated with its use as a PGR, its high solubility and its rapid
biodegradability. Moreover, any exposure to Choline Chloride residues
are not expected to pose a risk. No toxic endpoints have been
identified for Choline Chloride. There has been a long history of
significant human dietary and endogenous exposure without documented
incident. And the constituents of Choline Chloride are known to be
readily metabolized.

VII. Other Considerations

A. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes since
the Agency is establishing an exemption from the requirement of a
tolerance without any numerical limitation.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
    The Codex has not established a MRL for Choline Chloride.

VIII. Conclusions

    Based on its assessment of Choline Chloride, EPA concludes that
there is a reasonable certainty that no harm will result to the general
population, or to infants and children, from aggregate exposure to
Choline Chloride. EPA is therefore establishing an exemption from the
requirement of a tolerance for residues of Choline Chloride in or on
all food commodities when applied pre-harvest in accordance with label
directions and good agricultural practices.

 IX. Statutory and Executive Order Reviews

    This action establishes a tolerance under FFDCA section 408(d) in
response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
    This action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply

to this action. In addition, this action does not impose any
enforceable duty or contain any unfunded mandate as described under
Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et
seq.).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).

X. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: December 1, 2015.
Jack E. Housenger,
Director, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority:  21 U.S.C. 321(q), 346a and 371.

0
2. Add Sec.  180.1334 to subpart D to read as follows:

Sec.  180.1334  Choline Chloride; Exemption from the Requirement of a
Tolerance.

    An exemption from the requirement of a tolerance is established for
residues of Choline Chloride in or on all food commodities when Choline
Chloride is applied pre-harvest and used in accordance with label
directions and good agricultural practices.

[FR Doc. 2015-31464 Filed 12-15-15; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 76, Number 247 (Friday, December 23, 2011)]
[Notices]
[Pages 80408-80409]
[FR Doc No: 2011-32857]

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 DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2011-0180]

Addendum to the Memorandum of Understanding with the Department
of Energy (August 28, 1992); Oak Ridge, Tennessee Facilities

AGENCY: The Department of Labor, Occupational Safety and Health
Administration (OSHA).

ACTION: Addendum to Memorandum of Understanding between the Department
of Labor and the Department of Energy: the transfer of two existing
building complexes and three other parcels of land located at the East
Tennessee Technology Park in Oak Ridge, Tennessee; transfer of employee
safety and health authority from the Department of Energy (DOE) to the
Tennessee Occupational Safety and Health Administration (TOSHA).

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SUMMARY: This document is a notice of an addendum to the 1992
interagency Memorandum of Understanding (MOU) between the U.S.
Department of Labor and the U.S. Department of Energy. That MOU states
that DOE has exclusive authority over the occupational safety and
health of contractor employees at DOE Government-Owned and Contractor-
Operated facilities (GOCOs). In addition, the MOU between the
departments dated July 25, 2000, on safety and health enforcement at
privatized facilities and operations, provides that OSHA has regulatory
authority over occupational safety and health at certain privatized
facilities and operations on land formerly under the control of DOE.
This action is taken in accordance with the July 25, 2000 MOU, which
establishes specific interagency procedures for the transfer of
occupational safety and health coverage for such privatized facilities
and operations from DOE to OSHA and state agencies acting under state
plans approved by OSHA pursuant to section 18 of the Occupational
Safety and Health Act of 1970 (OSH Act), 29 U.S.C. 667. The MOUs may be
found on the internet via the OSHA Web page http://www.osha.gov under
the ``D'' for Department of Energy Transition Activities.

DATES: Effective Date: The effective date of the Addendum to the
Memorandum of Understanding is December 23, 2011.

FOR FURTHER INFORMATION CONTACT: Stefan Weisz, Safety and Occupational
Health Specialist, Office of Technical Programs and Coordination
Activities, Directorate of Technical Support and Emergency Management,
U.S. Department of Labor, Occupational Safety and Health
Administration, Room N-3655, 200 Constitution Avenue NW., Washington,
DC 20210; telephone<PHONE_NUMBER>. Access electronic copies of this
notice at OSHA's Web site: http://www.osha.gov.

SUPPLEMENTARY INFORMATION: The U.S. Department of Energy (DOE) and the
Occupational Safety and Health Administration (OSHA) of the U.S.
Department of Labor entered into a MOU on August 10, 1992, delineating
regulatory authority over the occupational safety and health of
contractor employees at DOE government-owned or leased, contractor-
operated (GOCO) facilities. In general, the MOU recognizes that DOE
exercises statutory authority under section 161(f) of the Atomic Energy
Act of 1954, as amended, [42 U.S.C. 2201(f)], relating to the
occupational safety and health of private-sector employees at these
facilities.
    Section 4(b)(1) of the OSH Act of 1970, 29 U.S.C. 653(b)(1),
exempts from OSHA authority working conditions with respect to which
other federal agencies have exercised statutory authority to prescribe
or enforce standards or regulations affecting occupational safety or
health. The 1992 MOU acknowledges DOE's extensive program for the
regulation of contractor health and safety, which requires contractor
compliance with all OSHA standards as well as additional requirements
prescribed by DOE, and concludes with an agreement by the agencies that
the provisions of the OSH Act will not apply to GOCO sites for which
DOE has exercised its authority to regulate occupational safety and
health under the Atomic Energy Act.
    In light of DOE's policy emphasis on privatization activities, OSHA
and DOE entered into a second MOU on July 25, 2000 that establishes
interagency procedures to address regulatory authority for occupational
safety and health at specified privatized facilities and operations on
sites formerly controlled by DOE. The 2000 MOU covers facilities and
operations on lands no longer controlled by DOE, which are not
conducting activities for or on behalf of DOE and where there is no
likelihood that any employee exposure to radiation from DOE sources
would be 25 millirems per year (mrem/yr) or more.
    In a letter dated January 5, 2011, DOE requested that OSHA or, as
appropriate, TOSHA accept occupational safety and health regulatory
authority over employees at the East Tennessee Technology Park in Oak
Ridge, Tennessee at two existing building complexes and three other
parcels of land pursuant to the MOU on Safety and Health Enforcement at
Privatized Facilities and Operations dated July 25, 2000. (Other
facilities and properties at the East Tennessee Technology Park were
transferred to TOSHA jurisdiction under this MOU by Federal Register
notices at 74 FR 120 (January 2, 2009) and 74 FR 39977 (August 10,
2009).
    The buildings and parcels of land transferred to the city of Oak
Ridge, the Community Reuse Organization of East Tennessee (CROET), and
the Heritage Center, LLC, are described as follows:

     The K-1000 complex consists of two separate buildings:
the upper building, which was formerly a visitor center, and the
lower building, which was formerly an access center. Building K-
1501-H&L is a two-story building located inside of the property
protection fence. It is currently used for maintenance and support
by CROET, the site's utility operator. Building K-1008-F is also
inside of the property protection fence and consists of offices,
meeting rooms, and rest rooms.
     The K-792 switchyard complex (transferred to the
Heritage Center, LLC, a subsidiary of CROET) includes the following
land parcels and buildings: 19.91 acres of land; K-791-B, which is
used for storage and office space; Building K-796-A, which is used
as a conference room; and, the K-792 northern expansion area, which
is 5 acres of undeveloped land, and a railroad spur. The area also
contains a privately owned building (K-1310-MP), and two privately
owned trailers (K-1310-MQ and K-1310-MS).

These privately owned properties, which are not being transferred,
have never been under DOE authority.
     Parcel ED-4 is 18 acres of woodland located in Roane
County.
     Parcel ED-5 West is 26.25 acres of grassland located
within the City of Oak Ridge. Parcel ED-5 includes a concrete slab,
which was formerly a base for a sampling tower.
     Parcel ED-8 is 84 acres located within the City of Oak
Ridge. The Heritage Center, LLC, will receive 78 acres of land, and
the 6 acres of roadway on Parcel ED-8 have been transferred to the
City of Oak Ridge.

    OSHA's Regional Office in Atlanta, Georgia, working with the OSHA
Nashville Area Office and TOSHA, determined that TOSHA is willing to
accept authority over the occupational safety and health of public-
sector and private-sector employees at the two existing building
complexes and the three other parcels of land at the East Tennessee
Technology Park in Oak Ridge, Tennessee that were transferred by deed
to the City of Oak Ridge and CROET, and the Heritage Center, LLC,
respectively. In a letter from OSHA to DOE dated October 7, 2011, OSHA
stated that TOSHA is satisfied with DOE assurances that (1) there is no
likelihood that any employee at these facilities will be exposed to
radiation levels that will be 25 millirems per year (mrem/yr) or more,
and (2) transfer of authority to TOSHA is free from regulatory gaps,
and does not diminish the safety and health protection of the
employees. According to this letter, TOSHA therefore accepted and
maintains health and safety regulatory authority over employees at
building complexes K-1000, K-1501--H & L, K-1008--F, and K-79.

Authority and Signature

    David Michaels, Ph.D., MPH, Assistant Secretary of Labor for
Occupational Safety and Health, U.S. Department of Labor, 200
Constitution Ave. NW., Washington, DC, directed the preparation of this
notice. This Federal Register notice provides public notice and serves
as an addendum to the 1992 OSHA/DOE MOU. OSHA is issuing this notice
under the authority specified by Section 8(g)(2) of the Occupational
Safety and Health Act of 1970 (29 U.S.C. 657(g)(2)) and Secretary of
Labor's Order No. 4-2010 (75 FR 55355).

    Signed at Washington, DC, on December 19, 2011.
David Michaels,
Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. 2011-32857 Filed 12-22-11; 8:45 am]
BILLING CODE 4510-26-P


[Federal Register Volume 76, Number 203 (Thursday, October 20, 2011)]
[Notices]
[Pages 65305-65306]
[FR Doc No: 2011-27137]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-65573; File No. SR-NYSEArca-2011-59]

Self-Regulatory Organizations; NYSE Arca, Inc.; Order Granting
Approval of Proposed Rule Change Adding Commentary .01 to Rule 6.37B
Concerning Market Maker Continuous Quoting Obligations and Adjusted
Option Series

October 14, 2011.

I. Introduction

    On August 16, 2011, NYSE Amex LLC (``Exchange'' or ``NYSE Arca'')
filed with the Securities and Exchange Commission (``Commission''),
pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ a proposed rule change to
add Commentary .01 to Rule 6.37B to indicate that market makers will
not be obligated to quote in adjusted option series and to reference an
existing exception to the quoting obligations. The proposed rule change
was published for comment in the Federal Register on September 1,
2011.\3\ The Commission received no comment letters on the proposed
rule change. This order approves the proposed rule change.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 65210 (August 26,
2011), 76 FR 54516 (``Notice'').
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II. Description of the Proposed Rule Change

    The Exchange proposes to add Commentary .01 to Rule 6.37B (i) To
add an exception to relieve market makers from the obligation to
continuously quote in adjusted option series, and (ii) to reflect in
Rule 6.37B an exception from the continuous quote requirements for
Long-Term Equity Option Series (``LEAPS'') that is currently provided
for in Rule 6.4(e)(i).
    Rule 6.37B, relating to market maker quotations, requires a Lead
Market Maker to provide continuous two-sided quotations throughout the
trading day in its appointed issues for 90% of the time the Exchange is
open for trading in each such issue. Rule 6.37B also requires non-lead
market makers to provide continuous two-sided quotations throughout the
trading day in their appointed issues for 60% of the time the Exchange
is open for trading in each such issue.
    Rule 6.4(e)(i), relating to LEAPS open for trading, currently
provides that Exchange Rules regarding continuous quoting obligations
do not apply to index option series until the time to expiration is
less than 12 months and do not apply to equity options or option on
Exchange Traded Fund Shares until the time to expiration is less than
nine months.\4\
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    \4\ In addition, Rule 6.4(e)(1) provides that trading in such
LEAPS will commence either when there is buying or selling interest,
or forty minutes prior to the close of trading for the day,
whichever occurs first. Further, the rule provides that quotations
will not be posted for extended far term option series until trading
in such series is commenced on the day.
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    The Exchange now proposes to add Commentary .01 to Rule 6.37B (the
rule applicable to market maker quotations) to reflect the exception
for LEAPS that is currently provided for in Rule 6.4(e)(i) to the
continuous quoting obligations contained in Rule 6.37B. In other words,
without altering the substance of the exception, the Exchange is
proposing to include text that already appears in Rule 6.4(e)(i) into
Rule 6.37B in order to reference that exception in the rule that
addresses market maker quoting obligations.
    In addition, the Exchange proposes to extend the exception from the
continuous quoting obligations to certain ``adjusted series.'' The
Exchange proposes to define an ``adjusted series'' for purposes of Rule
6.37B as ``an option series wherein, as a result of a corporate action
by the issuer of the underlying security, one option contract in the
series represents the delivery of other than 100 shares of underlying
stock or Exchange-Traded Fund Shares.'' \5\
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    \5\ The Exchange provided additional background regarding
adjusted series options in its Notice. See Notice, supra note 3, at
54517.
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    In its filing, the Exchange notes that adjusted series are
generally active for a short period of time following adjustment and
thereafter become inactive as new orders to open options positions in
the underlying are almost exclusively placed in the new standard
contracts.\6\ The Exchange noted that adjusted series may not meet the
standards to be considered ``active'' and thereby, under Commentary .03
to NYSE Arca Rule 6.86, the Exchange may no longer disseminate quotes
in such series.\7\ Consequently, market makers are currently required
to submit quotes in adjusted series that may not be published to OPRA
unless otherwise requested.\8\
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    \6\ See id.
    \7\ See id.
    \8\ Commentary .03 to Rule 6.86 states, in part, ``The Exchange
may determine that a series has become active intraday if (i) the
series trades at any options exchange; (ii) NYSE Arca receives an
order in the series; or (iii) NYSE Arca receives a request for quote
from a customer in that series. If a series becomes active intraday,
the Exchange will immediately disseminate quotes in the series to
OPRA, and continue to disseminate quotes for the balance of the
trading day.''
---------------------------------------------------------------------------

    In its filing, the Exchange states that market makers, including
Lead Market Makers, that have recently withdrawn from assignments in
classes have informed the Exchange that the withdrawals were based in
part on the obligation to continuously quote adjusted options series
whereby the quoting obligations on such less frequently traded option
series impacted the risk parameters acceptable to the market makers.\9\
The Exchange noted that market makers have also expressed concern that
the adjusted nature of these series complicates the calculation of an
appropriate quote.\10\ As a result of withdrawals from such assignments
by market makers, the Exchange states that liquidity, as well as
volume, has been negatively impacted in the affected options classes
listed on the Exchange.\11\ The Exchange now proposes to add an
exception to Rule 6.37B to relieve market makers from the obligation to
continuously quote in adjusted option series in order to encourage
market makers, including Lead Market Makers, to continue their
appointments in option classes that include adjusted series.
---------------------------------------------------------------------------

    \9\ See Notice, supra note 3, at 54517. See also Rule 6.35
(providing for market maker appointments by class).
    \10\ See Notice, supra note 3, at 54517.
    \11\ See id.
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III. Discussion and Commission's Findings

    After careful review, the Commission finds that the proposed rule
change is consistent with the requirements of Section 6 of the Act \12\
and the rules and regulations thereunder applicable to a national
securities exchange.\13\ In particular, the Commission finds that the
proposed rule change is consistent with Section 6(b)(5) of the Act,\14\
which requires, among other things, that the Exchange's rules be
designed to prevent fraudulent and manipulative acts and practices, to
promote just and equitable principles of trade, to foster cooperation

and coordination with persons engaged in facilitating transactions in
securities, to remove impediments to and perfect the mechanism of a
free and open market and a national market system, and, in general, to
protect investors and the public interest.
---------------------------------------------------------------------------

    \12\ 15 U.S.C. 78f.
    \13\ In approving this proposed rule change, the Commission has
considered the proposed rule's impact on efficiency, competition,
and capital formation. See 15 U.S.C. 78c(f).
    \14\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The Exchange's proposal to relieve market makers from the
obligation to continuously quote in adjusted series would not affect
market makers' other obligations. For example, the Commission notes
that the proposal does not excuse a market maker from the obligations
to respond with a two-sided, legal width market to a call for a market
by a floor broker.\15\ The Commission also notes that the proposal does
not excuse a market maker from the obligation to submit a single quote
or maintain continuous quotes in one or more series of an option issue
within the market maker's appointment whenever, in the judgment of such
Trading Official, it is necessary to do so in the interest of
maintaining fair and orderly markets.\16\ Accordingly, the Exchange's
proposal concerning adjusted series is narrowly tailored to, among
other things, remove impediments to and perfect the mechanism of a free
and open market and a national market system, and, in general, to
protect investors and the public interest. To the extent such series,
shortly after the adjustment, become inactive as a result of a lack of
interest in the series by market participants who have instead focused
their trading in the new standard contracts, the Exchange's proposal
would reduce the burden on market makers to submit continuous quotes
that the Exchange may not submit to OPRA. In so doing, the proposal may
incentivize market makers to continue appointments in classes that have
adjusted option series, and thereby should help maintain liquidity in
these classes to the benefit of the Exchange, its OTP Holders, and
investors. In addition, the obligation to continuously quote in such
illiquid series, for which there may be little or no trading interest,
is a minor part of a market maker's overall obligations and thus
requiring a continuous quote may not justify the system resources
necessary to accommodate them.
---------------------------------------------------------------------------

    \15\ See NYSE Arca Rule 6.37B.
    \16\ See NYSE Arca Rule 6.37(b)(5) and Commentary .05.
---------------------------------------------------------------------------

    Further, the proposed new Commentary .01 to Rule 6.37B (the rule
applicable to market maker quotations) to reflect the exception for
LEAPS provided for in Rule 6.4(e)(i) to the continuous quoting
obligations contained in Rule 6.37B, is not a new substantive
provision, but rather references the exception currently provided for
in Rule 6.4(e)(i). In so doing, the proposed change clarifies the
exception by referencing it in the rule applicable to market maker
quoting obligations generally.

IV. Conclusion

    It Is Therefore Ordered, pursuant to Section 19(b)(2) of the
Act,\17\ that the proposed rule change (SR-NYSEArca-2011-59) be, and
hereby is, approved.
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    \17\ 15 U.S.C. 78s(b)(2).

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

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

Elizabeth M. Murphy,
Secretary.
[FR Doc. 2011-27137 Filed 10-19-11; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 76, Number 133 (Tuesday, July 12, 2011)]
[Rules and Regulations]
[Pages 40820-40822]
[FR Doc No: 2011-17231]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

49 CFR Part 190

[Docket No. PHMSA-2011-0161]

Pipeline Safety; Enforcement Proceedings Involving an Informal
Hearing

AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA);
DOT.

ACTION: General policy statement; informal hearing process.

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

SUMMARY: PHMSA is issuing this document to notify operators of natural
gas and hazardous liquid pipeline facilities of the creation of a
dedicated ``Presiding Official'' for informal pipeline enforcement
hearings and the process operators can expect when requesting an
informal hearing. Hearings in pipeline safety enforcement cases are
conducted by a hearing officer in accordance with certain procedures
designed to ensure a fair and impartial decision on the merits. This
document explains those procedures and includes a description of the
dedicated hearing officer's roles and responsibilities, the process for
requesting a hearing, and the manner in which a case will proceed once
a hearing has been requested.

FOR FURTHER INFORMATION CONTACT: Sherri Pappas, Deputy Chief Counsel,
at<PHONE_NUMBER>. Information about PHMSA may be found at http://phmsa.dot.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    The Federal safety statute and regulations for natural gas and
hazardous liquid pipeline facilities provide a description of the
enforcement authority and sanctions exercised by the Associate
Administrator for achieving and maintaining pipeline safety. Pursuant
to chapter 601 of Title 49, United States Code, after notice and an
opportunity for a hearing, the Associate Administrator may order an
operator of a pipeline facility to take necessary corrective action,
including revisions to

its procedures, and may assess a civil penalty for a violation of a
pipeline safety regulation or order (49 U.S.C. 60108(a), 60112,
60117(l), 60118(b), and 60122). The regulations also prescribe the
procedures governing the exercise of that authority and the imposition
of those sanctions. In general, subpart B of 49 CFR part 190 (190.201-
190.239) provides an opportunity for a pipeline operator to submit a
written answer and/or request a hearing prior to the issuance of any
order that makes a finding of violation, assesses a civil penalty, or
requires corrective measures to be taken.
    Effective immediately, and to the extent practical, all timely
requested hearings will be held before the designated hearing officer
or ``Presiding Official'' within PHMSA.

II. Hearing Officer

    The person within PHMSA who conducts hearings relating to civil
penalty assessments, compliance orders, or safety orders is the
designated hearing officer. The person is a senior attorney within the
Office of Chief Counsel, on the staff of the Deputy Chief Counsel. To
ensure the fairness and impartiality of the proceeding, the hearing
officer is outside the line of authority of the Associate Administrator
as well as any staff involved in the investigation and prosecution of
the enforcement case. The dedicated hearing officer is not engaged
personally in any investigative or prosecutorial functions with regard
to enforcement matters, such as preparation of notices of probable
violation relating to civil penalty assessments and compliance orders,
and notices relating to corrective action orders and safety orders.
    The roles and responsibilities of the hearing officer are
consistent with current statutory and regulatory authority. They
include scheduling the hearing, holding pre-hearing conferences as
necessary, disposing of procedural requests or similar matters,
regulating the course of the hearing, ensuring an opportunity for a
full and complete record to be established, making a recommended
decision in the matter, and taking any other authorized action where
appropriate.

III. Separation of Functions

    Formerly, hearings were held before several different attorneys
from the Office of Chief Counsel and were assigned to an attorney who
had no role in the investigation and prosecution of the case being
heard. Now, all hearings will be held, to the extent practical, before
the designated hearing officer, who will have no role in the
investigation and prosecution of any enforcement cases.
    To ensure the impartiality and fairness of the decision-making
process, a hearing officer is (and has been) held to certain standards
regarding ``ex parte'' communications. An ex parte communication is any
informal communication between a party in a pending case and the
hearing officer regarding an issue in that case, occurring outside the
presence of the other parties and without notice and opportunity for
all parties to provide comment or rebuttal. If an enforcement case is
pending before a hearing officer, ex parte communications with the
hearing officer are not permitted by the operator, its counsel, or
agency staff involved in the investigation and prosecution of the case.
This applies to communications regarding information, facts, and
arguments regarding an issue in the case, but not routine
administrative matters, such as scheduling the hearing or providing
clarification about the enforcement process. This restriction also does
not apply to communications between the parties themselves.
    In addition, an individual engaged in the performance of
investigative or prosecuting functions for the agency in a case may
not, in that or a factually related case, participate in the attorney's
recommended decision, but may participate at the hearing as a witness
or counsel and submit a recommendation pursuant to Sec.  190.213(b)(4).

IV. Requesting a Hearing

    Section 190.209 provides that upon receipt of a notice of probable
violation, proposed civil penalty, or proposed compliance order, an
operator may respond within 30 days by paying the proposed penalty,
agreeing to the proposed compliance order, submitting written
information in answer to the notice, or requesting a hearing. Sections
190.233 and 190.239 also provide for responding to a notice of proposed
corrective action order or notice of proposed safety order, including
the option of requesting a hearing.
    Pursuant to Sec.  190.211, any request for a hearing must be
accompanied by a statement of the issues that the respondent intends to
raise at the hearing. The issues may relate to the allegations in the
notice, proposed corrective actions, or the proposed civil penalty
amount. The request should also indicate whether or not the operator
will be represented by counsel at the hearing.
    The right to a hearing is waived if not requested within 30 days of
receipt of the notice. An operator that submits a written response
without specifically requesting a hearing will be deemed to have waived
the right to a hearing, but the written material timely submitted will
be fully considered in the rendering of a decision in the matter. An
operator that requests only to ``reserve its right to a hearing'' will
be subject to the scheduling of a hearing unless the hearing request is
withdrawn.

V. Pre-Hearing Matters

    Within a reasonable time after the request for a hearing, the
hearing officer will ensure that the respondent has an opportunity to
review all materials in the enforcement record pertinent to the issues
to be determined. The enforcement record includes the notice and the
violation report with exhibits that are comprised of documents gathered
during the inspection and any other information included by the
inspector that is relevant to the allegations.
    The hearing officer will schedule the hearing, provide written
confirmation to the parties of the date, time and location, and request
a list of anticipated attendees. The hearing officer will also instruct
parties that all documents, evidence, or exhibits in support of the
case should be exchanged by furnishing a copy to all parties and
submitted at least ten days prior to the hearing. Any party intending
to introduce documents, evidence, or exhibits during the hearing will
also be directed to furnish copies to all parties.
    The hearing officer will address all procedural matters, including
but not limited to, motions for extensions of time, stipulations in
lieu of a hearing on particular issues, or withdrawal of a hearing
request. The hearing officer may direct that a request contain
sufficient detail, be specific as to the reason(s) for the request, and
be served on the appropriate PHMSA regional office.

VI. Hearing

    All hearings are held in accordance with Sec.  190.211 and are
conducted in an informal manner. The informal nature of the hearing
alleviates the need for the parties to strictly comply with formal
rules of evidence and rules of procedures. While the hearings are not
``formal,'' the hearing officer will take appropriate actions to
maintain an appropriate level of fairness and efficiency during the
proceeding. In addition, and with the assistance of the parties, the
hearing officer will ensure the hearing is conducted cordially and that
the parties maintain proper decorum at all times.
    Hearings are currently held either telephonically or in person.
They may

also be held by video teleconference in the future. During the hearing,
the operator can expect the region issuing the notice to introduce the
allegations and provide an explanation as to the evidence gathered in
support. The operator will then have the opportunity to present its own
information, facts, evidence, explanations, and arguments in response.
The operator may submit any material relevant to the issues under
consideration, and may call witnesses on its behalf and examine the
evidence and witnesses presented by the region. At the close of the
operator's presentation, the hearing officer may allow the presentation
of any rebuttal information by the region, and respondents may then
respond to that information.
    The hearing officer ensures that all parties have an ample
opportunity to present their position and supporting evidence, and will
end discussion on a topic only once it is clear that all the issues
have been fully examined. Questions may be asked by the hearing officer
during either party's presentations. In addition, the informal nature
of the proceeding allows the parties to ask questions of one another,
although parameters may be established to ensure the parties have
sufficient uninterrupted time to make their presentations. The hearing
officer ensures that discussion stays focused on the relevant and
determinative matters in the case and avoids allowing tangential issues
to become a distraction. The hearing will last as long as necessary to
ensure the parties have ample opportunity to present their case,
although the hearing officer will attempt to accommodate the parties'
schedules to the extent practicable.
    Written materials and evidence presented at the hearing will be
collected by the hearing officer for insertion into the record.
Hearings are not recorded and are not transcribed, but if requested in
advance of the hearing, the respondent may make arrangements for the
hearing to be transcribed at its own expense, provided that a copy of
the final transcript is submitted for the record. The hearing officer
may take notes, including electronic notes and recordings during the
hearing, but such personal notes are not part of the official record or
maintained by the agency.
    At the close of the hearing, the respondent may request an
opportunity to submit further written material for inclusion in the
record. The hearing officer will allow a reasonable time for the
submission of the material, but if the material is not submitted within
the time prescribed, the case will proceed to final action without the
material.

VII. After the Hearing

    If post-hearing documents contain new evidence or new arguments,
the hearing officer will provide written notification to all parties
and direct the parties to respond within a certain amount of time. The
hearing officer may also request that additional documents be submitted
after the hearing, if necessary, to fully develop the record.
    The hearing officer will ensure that all material submitted before
and during the hearing is placed in the record. At this stage, the
record will include the notice, violation report, written statements by
the parties, evidence submitted, list of hearing attendees, any hearing
transcript, and any other pre-hearing or post-hearing documents
submitted by the parties.
    Upon the close of a hearing and receipt of all post-hearing
submissions, the hearing officer will prepare a recommended decision to
be issued by the Associate Administrator. The restriction on ex parte
communications discussed above is especially applicable at this stage
of the proceeding, and the hearing officer will not engage in such
discussions or communications regarding the case with anyone involved
in the prosecution or defense of the notice. The hearing officer's
recommended decision may be reviewed by the Deputy Chief Counsel and
staff of the Associate Administrator prior to issuance by the Associate
Administrator.
    Upon signature of the decision by the Associate Administrator,
PHMSA will serve the decision upon the respondent and the applicable
region in accordance with Sec.  190.5. Decisions by the Associate
Administrator are also made publicly available on the PHMSA Enforcement
Transparency Web site.

    Issued in Washington, DC, on July 1, 2011.
Bizunesh Scott,
Chief Counsel.
Jeffrey D. Wiese,
Associate Administrator for Pipeline Safety.
[FR Doc. 2011-17231 Filed 7-11-11; 8:45 am]
BILLING CODE 4910-60-P


November 12, 2007

Karl Simon

Acting Division Director

Compliance and Innovative Strategies Division

1200 Pennsylvania Avenue, N. W.

Mail Code: 6406J

Washington, DC 20460

RE:	CAA Section 211(b) Fuels and Fuel Additives Health Effects Testing
Regulation:  Second Draft Final Report Gasoline Ethanol Vapor Condensate
- A 13-Week Whole-Body Inhalation Study in Rats with Neurotoxicity
Assessment and 4-Week In Vivo Genotoxicity and Immunotoxicity
Assessments (Study No. 00-6127)

Dear Mr. Karl Simon:

The American Petroleum Institute (API), on behalf of the Section 211(b)
Research Group (RG), is submitting the following information for EPA
review and approval as partial fulfillment of the CAA Section 211(b)
Alternative Tier 2 requirements of the testing regulation:

Second Draft Final Report: Gasoline Ethanol Vapor Condensate A 13-Week
Whole-Body Inhalation Study in Rats with Neurotoxicity Assessment and
4-Week In Vivo Genotoxicity and Immunotoxicity  Assessments (Study No.
00-6127)

 Reviewer Checklist

The Second Draft Final Report addresses all EPA and independent reviewer
comments as indicated, with page citation, in the Reviewer Checklist.

When the RG receives EPA’s approval of the second draft report, the
final study report will be submitted to you at the EPA Office of
Transportation and Air Quality, Transportation and Regional Programs
Division, as part of the requirements of Clean Air Act Section 211(b)(2)
and 211(e) (Docket No. A-90-07). If you require further information,
please contact Tom Gray by mail at this address.

Regards,

Thomas M. Gray

Encl (2):

Second Draft Final Report: Gasoline Ethanol Vapor Condensate A 13-Week
Whole-Body Inhalation Study in Rats with Neurotoxicity Assessment and
4-Week In Vivo Genotoxicity and Immunotoxicity  Assessments (Study No.
00-6127)

	Reviewer Checklist

Cc:	Gary Hoffman, HLS Study Director (via email)

	211b RG Oversight and Technical Committees

	Joe Sopata, EPA (via email)

	Monica Alvarez, EPA (via email)

	Amanda Evans, EPA (via email)

	Dave Kortum, EPA (via email)

  FILENAME  \* MERGEFORMAT  2007_march20_ETHANOL_1gen_ cvrletter 		An
equal opportunity employer

Thomas M. Gray

211(b) Technical Manager

1220 L Street, Northwest

Washington, DC  20005-4070

Tel<PHONE_NUMBER>

Fax<PHONE_NUMBER>

E-mail<EMAIL_ADDRESS>