[Federal Register Volume 81, Number 174 (Thursday, September 8, 2016)]
[Notices]
[Page 62122]
[FR Doc No: 2016-21415]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL00-95-291; EL00-98-263]

San Diego Gas & Electric Company v. Sellers of Energy and
Ancillary Services Into Markets Operated by the California Independent
System Operator Corporation and the California Power Exchange;
Investigation of Practices of the California Independent System
Operator and the California Power Exchange; Notice of Compliance Filing

    Take notice that on August 29, 2016, the California Power Exchange
Corporation submitted additional information related to May 5, 2016
Refund Rerun Compliance Filing pursuant to the Federal Energy
Regulatory Commission's (Commission) July 15, 2011 Order Accepting
Compliance Filings and Providing Guidance.\1\
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    \1\ San Diego Gas & Elec. Co. v. Sellers of Energy and Ancillary
Servs., 136 FERC ] 61,036 (2011).
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    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date. On or
before the comment date, it is not necessary to serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 5 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive email
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern Time on September 23, 2016.

    Dated: August 31, 2016.
Kimberly D. Bose,
Secretary.
[FR Doc. 2016-21415 Filed 9-7-16; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register: May 29, 2007 (Volume 72, Number 102)]
[Notices]
[Page 29491]
[DOCID:fr29my07-31]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP07-449-000]

Columbia Gas Transmission Corporation; Notice of Proposed Changes
in FERC Gas Tariff

May 21, 2007.
    Take notice that on May 15, 2007, Columbia Gas Transmission
Corporation (Columbia) tendered for filing as part of its FERC Gas
Tariff, Second Revised Volume No. 1, the following tariff sheets, with
a proposed effective date of June 14, 2007:

Thirteenth Revised Sheet No. 262,
First Revised Sheet No. 489,
Original Sheet No. 490.

    Columbia states that it is making this filing to provide tariff
authority addressing operational purchases and sales of natural gas by
Columbia.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed in accordance with the provisions of
Section 154.210 of the Commission's regulations (18 CFR 154.210).
Anyone filing an intervention or protest must serve a copy of that
document on the Applicant. Anyone filing an intervention or protest on
or before the intervention or protest date need not serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.

Kimberly D. Bose,
Secretary.
 [FR Doc. E7-10179 Filed 5-25-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 206 (Tuesday, October 25, 2016)]
[Proposed Rules]
[Pages 73360-73362]
[FR Doc No: 2016-25655]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2016-9317; Directorate Identifier 2016-CE-029-AD]
RIN 2120-AA64

Airworthiness Directives; Diamond Aircraft Industries GmbH
Airplanes

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

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to adopt a new airworthiness directive (AD) for
certain Diamond Aircraft Industries GmbH Model DA 42 airplanes. This
proposed AD results from mandatory continuing airworthiness information
(MCAI) originated by an aviation authority of another country to
identify and correct an unsafe condition on an aviation product. The
MCAI describes the unsafe condition as an uncommanded engine shutdown
during flight due to failure of the propeller regulating valve caused
by hot exhaust gases escaping from fractured engine exhaust pipes. We
are issuing this AD to correct the unsafe condition on these products.

DATES: We must receive comments on this proposed AD by December 9,
2016.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
    For service information identified in this proposed AD, contact
Diamond Aircraft Industries GmbH, N.A. Otto-Stra[szlig]e 5, A-2700
Wiener Neustadt, Austria, telephone: +43 2622 26700; fax: +43 2622
26780; email<EMAIL_ADDRESS>Internet: http://www.diamondaircraft.com. You may review this referenced service
information at the FAA, Small Airplane Directorate, 901 Locust, Kansas
City, Missouri 64106. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-
9317; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this proposed AD, the regulatory evaluation, any comments
received, and other information. The street address for the Docket
Office (telephone<PHONE_NUMBER>) is in the ADDRESSES section. Comments
will be available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Mike Kiesov, Aerospace Engineer, FAA,
Small Airplane Directorate, 901 Locust, Room 301, Kansas City, Missouri
64106; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2016-9317;
Directorate Identifier 2016-CE-029-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD because of those comments.
    We will post all comments we receive, without change, to http://regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Community, has issued AD
No. 2016-0156, dated August 2, 2016 (referred to after this as ``the
MCAI''), to correct an unsafe condition for the specified products. The
MCAI states:

    Two cases were reported of uncommanded engine in-flight shutdown
(IFSD) on DA 42 aeroplanes. Subsequent investigations identified
these occurrences were due to failure of the propeller regulating
valve, caused by hot exhaust gases coming from fractured engine
exhaust pipes. The initiating cracks on the exhaust pipes were not
detected during previous inspections, since those exhaust pipes are
equipped with non-removable heat shields that do not allow
inspection for certain sections of the exhaust pipe.
    This condition, if not corrected, could lead to further cases of
IFSD or overheat damage, possibly resulting in a forced landing,
with consequent damage to the aeroplane and injury to occupants.
    To address this potential unsafe condition, Diamond Aircraft
Industries (DAI) developed an exhaust pipe without a directly
attached integral heat shield that allows visual inspection over the
entire exhaust pipe length. DAI issued Mandatory Service Bulletin
(MSB) 42-120 and relevant Working Instruction (WI) WI-MSB 42-120,
providing instructions to install the modified exhaust pipes. As an
interim measure, an additional bracket was designed to hold the
exhaust pipe in place in case of a pipe fracture.
    For the reasons described above, this AD requires replacement of
the exhaust pipes with pipes having new design, and prohibits
(re)installation of the previous design pipes.

    You may examine the MCAI on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-
9317.

Related Service Information Under 1 CFR Part 51

    Diamond Aircraft Industries GmbH has issued Mandatory Service
Bulletin MSB 42-120, dated June 24, 2016, and Work Instruction WI-MSB
42-120, dated June 24, 2016. In combination, this service information
describes procedures for replacing the exhaust

pipes with exhaust pipes having a new design. This service information
is reasonably available because the interested parties have access to
it through their normal course of business or by the means identified
in the ADDRESSES section of this NPRM.

FAA's Determination and Requirements of the Proposed AD

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

Costs of Compliance

    We estimate that this proposed AD would affect 130 products of U.S.
registry. We also estimate that it would take the following to comply
with the requirements of this proposed AD:
    It would take about 1 work-hour per product to comply with the
installation of additional exhaust clamps required by this proposed AD.
The average labor rate is $85 per work-hour. Required parts would cost
about $125 per product.
    Based on these figures, we estimate the cost of this proposed AD on
U.S. operators for the installation of additional exhaust clamps to be
$27,300, or $210 per product.
    It would take about 4 work-hours per product to comply with the
exhaust pipe replacement required by this proposed AD. The average
labor rate is $85 per work-hour. Required parts would cost about $1,990
per product.
    Based on these figures, we estimate the cost of this proposed AD on
U.S. operators for the exhaust pipe replacement requirement to be
$302,900, or $2,330 per product.

Authority for This Rulemaking

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

Regulatory Findings

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

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new AD:

Diamond Aircraft Industries GmbH: Docket No. FAA-2016-9317;
Directorate Identifier 2016-CE-029-AD.

(a) Comments Due Date

    We must receive comments by December 9, 2016.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Diamond Aircraft Industries GmbH DA 42
airplanes, serial numbers 42.004 through 42.427 and 42.AC001 through
42.AC151, that have a TAE 125-02-99 or TAE 125-02-114 engine
installed, are equipped with an exhaust pipe, DAI part number (P/N)
D60-9078-06-01, or Technify P/Ns 52-7810-H0001 02, 52-7810-H0001 03,
or 52-7810-H0001 04, and are certificated in any category.

    Note to paragraph (c) of this AD: Airplanes equipped with an
exhaust pipe, DAI P/N D60-9078-06-01_01 or Technify P/N 52-7810-
H0014 01, are not affected by this AD.

(d) Subject

    Air Transport Association of America (ATA) Code 78: Engine
Exhaust.

(e) Reason

    This AD was prompted by mandatory continuing airworthiness
information (MCAI) originated by an aviation authority of another
country to identify and correct an unsafe condition on an aviation
product. The MCAI describes the unsafe condition as an uncommanded
engine shutdown during flight due to failure of the propeller
regulating valve caused by hot exhaust gases escaping from fractured
engine exhaust pipes. We are issuing this AD to prevent failure of
the propeller regulating valve, which could result in forced landing
with consequent damage to the airplane.

(f) Actions and Compliance

    Unless already done, do the following actions. For the purpose
of this AD, if the flight hours accumulated since first installation
of an affected exhaust pipe is not known, use the total hours time-
in-service (TIS) accumulated on the airplane.
    (1) At whichever of the following compliance times that occurs
later, install additional exhaust pipe clamps following the
INSTRUCTIONS section of Diamond Aircraft Industries GmbH Work
Instruction WI-MSB 42-120, dated June 24, 2016, as specified in the
Accomplishments/Instructions paragraph of Diamond Aircraft
Industries GmbH Mandatory Service Bulletin MSB 42-120, dated June
24, 2016. The replacement required in paragraph (f)(2) of this AD
may be done in lieu of installing additional exhaust pipe clamps.
    (i) Before or upon accumulating 1,300 hours TIS since the
affected exhaust pipe was first installed on an airplane; or
    (ii) Within the next 200 hours TIS after the effective date of
this AD or within the next 12 months after the effective date of
this AD, whichever occurs first.
    (2) At whichever of the following compliance times that occurs
later, replace the exhaust pipes listed in paragraph (c) of this AD
with an exhaust pipe DAI P/N D60-9078-06-01_01 or Technify P/N 52-
7810-H0014 01. Do the replacement following the INSTRUCTIONS section
of Diamond Aircraft Industries GmbH Work Instruction WI-MSB 42-120,
dated June 24, 2016, as specified in the Accomplishments/
Instructions paragraph of Diamond Aircraft Industries GmbH Mandatory
Service Bulletin MSB 42-120, dated June 24, 2016.

    (i) Before or upon accumulating 2,800 hours TIS since the
affected exhaust pipe was first installed on an airplane; or
    (ii) Within the next 200 hours TIS after the effective date of
this AD or within the next 12 months after the effective date of
this AD, whichever occurs first.
    (3) After installing an exhaust pipe DAI P/N D60-9078-06-01_01
or Technify P/N 52-7810-H0014 01, as required by this AD, do not
install an exhaust pipe listed in paragraph (c) of this AD.

(g) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
Standards Office, FAA, has the authority to approve AMOCs for this
AD, if requested using the procedures found in 14 CFR 39.19. Send
information to ATTN: Mike Kiesov, Aerospace Engineer, FAA, Small
Airplane Directorate, 901 Locust, Room 301, Kansas City, Missouri
64106; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>Before using any approved AMOC on any airplane
to which the AMOC applies, notify your appropriate principal
inspector (PI) in the FAA Flight Standards District Office (FSDO),
or lacking a PI, your local FSDO.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.
    (3) Reporting Requirements: For any reporting requirement in
this AD, a federal agency may not conduct or sponsor, and a person
is not required to respond to, nor shall a person be subject to a
penalty for failure to comply with a collection of information
subject to the requirements of the Paperwork Reduction Act unless
that collection of information displays a current valid OMB Control
Number. The OMB Control Number for this information collection is
2120-0056. Public reporting for this collection of information is
estimated to be approximately 5 minutes per response, including the
time for reviewing instructions, completing and reviewing the
collection of information. All responses to this collection of
information are mandatory. Comments concerning the accuracy of this
burden and suggestions for reducing the burden should be directed to
the FAA at: 800 Independence Ave. SW., Washington, DC 20591, Attn:
Information Collection Clearance Officer, AES-200.

(h) Related Information

    Refer to MCAI European Aviation Safety Agency (EASA) AD No.
2016-0156, dated August 2, 2016, for related information. You may
examine the MCAI on the Internet at http://www.regulations.gov by
searching for and locating Docket No. FAA-2016-9317. For service
information related to this AD, contact Diamond Aircraft Industries
GmbH, N.A. Otto-Stra[szlig]e 5, A-2700 Wiener Neustadt, Austria,
telephone: +43 2622 26700; fax: +43 2622 26780; email:
<EMAIL_ADDRESS>Internet: http://www.diamondaircraft.com. You
may review this referenced service information at the FAA, Small
Airplane Directorate, 901 Locust, Kansas City, Missouri 64106. For
information on the availability of this material at the FAA, call
(816) 329-4148.

    Issued in Kansas City, Missouri, on October 17, 2016.
Pat Mullen,
Acting Manager, Small Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2016-25655 Filed 10-24-16; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register: June 26, 2007 (Volume 72, Number 122)]
[Notices]
[Page 35043-35044]
[DOCID:fr26jn07-27]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP01-481-001]

ANR Storage Company; Notice of Negotiated Rate Filing

June 19, 2007.
    Take notice that on June 13, 2007, ANR Storage Company (ANR
Storage) tendered for filing and approval a negotiated rate agreement
between ANR Storage and Tenaska Gas Storage LLC. The service agreement
is being filed as a negotiated rate because the parties have agreed to
fixed rates for the term of the contract.
    ANR Storage requests that the Commission accept and approve the
subject filing to be effective April 1, 2008.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed in accordance with the provisions of
Sec.  154.210 of the Commission's regulations (18 CFR 154.210). Anyone
filing an intervention or protest must serve a copy of that document on
the Applicant. Anyone filing an intervention or protest on or before
the intervention or protest date need not serve motions to intervene or
protests on persons other than the Applicant.

    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.

Kimberly D. Bose,
Secretary.
 [FR Doc. E7-12302 Filed 6-25-07; 8:45 am]

BILLING CODE 6717-01-P


United States
Environmental Protection
Agency

Office of Chemical Safety and Pollution Prevention
(7503P)
	EPA XXX-X-XX-XXX
                                                                   	April 2015
	Product Performance Test Guidelines

		OCSPP 810.2100:

            Sterilants & Sporicides

            Recommendations for Efficacy Testing

                                    NOTICE

  	This guideline is one of a series of test guidelines established by the United States Environmental Protection Agency's Office of Chemical Safety and Pollution Prevention (OCSPP) for use in testing pesticides and chemical substances to develop data for submission to the Agency under the Toxic Substances Control Act (TSCA) (15 U.S.C. 2601, et seq.), the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) (7 U.S.C. 136, et seq.), and section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA) (21 U.S.C. 346a). Prior to April 22, 2010, OCSPP was known as the Office of Prevention, Pesticides and Toxic Substances (OPPTS). To distinguish these guidelines from guidelines issued by other organizations, the numbering convention adopted in 1994 specifically included OPPTS as part of the guideline's number. Any test guideline developed after April 22, 2010 will use the new acronym (OCSPP) in their title.

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

  	For additional information about these test guidelines and to access the guidelines electronically, please go to http://www.epa.gov/ocspp and select the topic entitled, "Test Methods and Guidelines." You may also access the guidelines in http://www.regulations.gov grouped by Series under Docket ID #s: EPA-HQ-OPPT-2009-0150 through EPA-HQ-OPPT-2009-0159, and EPA-HQ-OPPT-2009-0576.

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

OPPTS 810.2100: Sterilant/Sporicide -- Efficacy Data Recommendations for Public Health Uses

(a) Scope

      (1) Applicability. This guideline describes test methods that EPA believes will generally satisfy testing requirements of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) (7U.S.C. 136, et seq.) and the Federal Food, Drug, and Cosmetic Act (FFDCA) (21 U.S.C. 346a). It addresses testing to demonstrate the effectiveness of antimicrobial pesticides bearing claims for use as a sterilant/sporicide. Refer to OCSPP 810.2000: General Considerations for Testing Antimicrobial Agents for additional guidance.

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

(b) Purpose. This guideline addresses efficacy testing for antimicrobial pesticides intended to be used on hard, inanimate, environmental surfaces, and, which bear label claims as a sterilant and/or sporicide.

(c) General Considerations

      (1) Claims. This guideline provides guidance for developing data solely for the purpose of supporting a basic sterilant/sporicide claim with or without an additional sporicidal claim (e.g., Bacillus anthracis, Clostridium difficile). Furthermore, guidance is provided for applicants seeking only a sporicidal claim for specific spore-forming bacteria such as B. anthracis and C. difficile.

      (2) Verification Tests. Data submitted to support sterilant/sporicide claims are subject to independent verification testing in a second laboratory, or can be tested in the same laboratory with a new set of inoculated carriers, separate study director, Quality Assurance Unit and technical staff.

      (3) Alternate Materials. When an antimicrobial product is intended to be effective in treating a specific hard porous surface, a method modification may be necessary which specifies the use of the porous material (as a carrier) in the test protocol. In addition, control carrier count data (mean log10 spores per carrier), neutralization confirmation data, and sterility controls should be developed to assure the validity of the test results when these types of method modifications are employed. Method modifications should be submitted to the Agency in writing for approval prior to data generation and collection.

      (4) Entire Room or Large Chamber Application. A simulated use test is needed when an antimicrobial product is intended for treating an entire room or large chamber. For general guidance, see section (g)(2) of this document; however, a testing protocol specific to the product should be developed and submitted to the Agency for approval prior to data generation and collection.

(d) Sterilant/Sporicide Claim. This section provides testing guidance for products with sterilant/sporicide claims to inactivate spores of Bacillus subtilis and Clostridium sporogenes on hard inanimate surfaces.

      (1) Liquid Products (ready-to-use, dilutable concentrates and water soluble powder formulations) and Gases.

         (i) Test Method. The Agency recommends use of the AOAC International (AOAC) Official Method 966.04 Sporicidal Activity of Disinfectants test (revised 2013, see Ref. 1). To demonstrate efficacy of a product, testing against spores of Bacillus subtilis [American Type Culture Collection (ATCC) 19659] and Clostridium sporogenes (ATCC 3584), each inoculated on two types of carriers (porcelain  penicylinders and silk suture loops), should be conducted. Furthermore, neutralizer confirmation should be demonstrated using AOAC 966.04, method II, section h using growth media and incubation conditions suitable for each microbe.

         (ii) Batches. Three batches of the product at or below the lower certified limit(s) (LCL) listed on the confidential statement of formula (CSF) of the product should be tested.

         (iii) Number of Carriers and Related Requirements. Sixty carriers of each type should be tested against spores of both B. subtilis and C. sporogenes (240 carriers per batch, or a total of 720 carriers for all three batches). For a valid test, a mean control count of 1 x 10[5]  -  1 x 10[6] spores per carrier should be attained for both microbes on both carrier types. The inoculated carriers should meet the level of acid resistance outlined in the AOAC 966.04 method.

         (iv) Spore Production. Use AOAC 966.04 (Method I) for testing spores of C. sporogenes. For C. sporogenes, use cooked meat medium amended with MnSO4 for spore generation and inoculation of porcelain penicylinders and silk suture loops. Follow AOAC 966.04 (Method II) for testing spores of B. subtilis on porcelain penicylinders and silk suture loops. For B. subtilis, use nutrient agar amended with MnSO4 for spore generation.

         (v) Claims with Use of a Device. Any sterilant which is a vapor or gas and is recommended for use in a specific device should be tested using the AOAC Method 966.04 in that specific device and according to the directions for use of that specific device. To address this situation, modifications to the AOAC Method 966.04 may be necessary; method modifications should be submitted to the Agency for review and approval prior to conducting the tests.

         (vi) Dacron Loops. Method 966.04 also provides for the use of Dacron loops (also termed braided polyester), instead of silk suture loops, for testing peracetic acid containing products.

         (vii) Evaluation of Success. The product should kill the test spores on all of the 720 carriers without any positives (i.e., no growth of test organism in the subculture medium). No contamination of the culture tubes is allowed.

         (viii) Verification Testing. For verification tests, follow the above testing guidance except thirty carriers representing each of the two types of surfaces (porcelain penicylinders and silk suture loops) should be tested against the spores of both B. subtilis and C. sporogenes on one sample of the product at the lower certified limit(s) (LCL). In addition, the inoculated carriers should meet the method-recommended levels of acid resistance, control carrier counts and confirmation of neutralization should be conducted. For verification testing, the product should kill the test spores on all 120 carriers without any positives (i.e., no growth of test organism in the subculture medium). No contamination of the culture tubes is allowed.

      (2) Sprays, mists and foams. A liquid product applied as a spray using a pump or trigger sprayer should be tested as a liquid as described above. For all other spray formulations types (aerosols) and other formulations such as mists, foams and gels, the applicant should submit a testing protocol consistent with the anticipated application and use pattern of the product for Agency review and approval prior to testing. Use AOAC method 966.04 for spore production, control counts, and neutralization testing.

(e)	Sporicidal products with Clostridium difficile claims.  Refer to the "Guidance for Efficacy Evaluation of Products with Sporicidal Claims Against Clostridium difficile" issued June 2014 (http://www.epa.gov/oppad001/cdif-guidance.html). A collaborative study is underway  to evaluate  the recommended test methods and issue revised guidance.

(f) Sporicidal products with Bacillus anthracis (B. anthracis) claims. This section addresses efficacy tests for all products with claims to inactivate B. anthracis spores on inanimate surfaces. The Agency recommends three possible approaches as described in paragraphs (f)(1)(i) through (f)(1)(iii) of this guideline.

      (1) Liquids (ready to use, dilutable concentrates and water soluble powder formulations), gases and vapors.

      (i)                Test Procedure for Sterilant/Sporicide plus a B. anthracis Claim. The Agency recommends use of the AOAC Method 966.04 (Method II) to demonstrate the sterilant/sporicidal efficacy of products as described in (d)(1)(i)-Test Procedure. In addition, conduct a confirmatory test using virulent B. anthracis spores (or a surrogate species acceptable to EPA) inoculated on thirty carriers representing each of two types of surfaces (porcelain penicylinders and silk suture loops) on two product samples, representing two different batches of the product (a total of 120 carriers). Control carrier counts should be 1 x 105 to 1 x 106 spores per carrier.

                    (A)                     Evaluation of Success. The product should kill all of the test spores on all of the initial and confirmatory carriers (840 carriers) without any positives (i.e., no growth of test organism in the subculture medium). No contamination of the culture tubes is allowed.

      (ii)                Test Procedure for Sporicidal Decontaminants--qualitative testing. The Agency recommends use of the AOAC International Official Method 966.04 Sporicidal Activity of Disinfectants test (Method II, revised 2013, see Ref. 1) using virulent B. anthracis spores (or a surrogate acceptable to EPA). Sixty carriers representing either or both of two types of surfaces (porcelain penicylinders and/or silk suture loops) should be tested on three samples representing three different batches of product, tested at or below certified limits (LCL) of the product. The inoculum employed should provide a target count of 1 x 10[5]  - 1 x 10[6] spores per carrier. If one surface type is tested, then there are 60 carriers per sample, or a total of 180 carriers; if both surfaces types are tested, then the total number of carriers is 360. Media sterility controls and system controls (check for aseptic technique during carrier transfer process) are recommended per the method.

                  (A)  Evaluation of Success. The product should kill all of the test spores on all of the 180 (or 360) carriers without any positives (i.e., no growth of test organism in the subculture medium). No contamination of the culture tubes is allowed.

      (iii)                Test Procedure for Sporicidal Decontaminants--quantitative testing. The Agency recommends the use of a well-developed, quantitative sporicidal test method acceptable to EPA such as AOAC Method 2008.05 or ASTM method E2197-11 using virulent B. anthracis spores (or a surrogate acceptable to EPA) on porous and/or nonporous surfaces acceptable to EPA. The inoculum employed should provide a target count of 1 x 10[7] spores per carrier. The product should be tested on three samples representing three different batches of product, one batch tested at or below certified limits (LCL). The number of carriers will vary depending on the test method. The coupon material(s) should be representative of those found at the site(s) that appear on the product's labeling, and be acceptable to EPA.

                  (A) Evaluation of Success. The product should achieve a mean log reduction of >=6 logs per lot tested based on the number of viable spores recovered.

      (g)    Simulated Use Testing for Gas and Vapor Products

      (1) Test procedure. In addition to conducting one of the three laboratory studies in section (f) of this guideline, simulated-use testing should also be conducted for vapor and gas products. Protocols for the simulated-use test should be submitted to the Agency for review and approval prior to conducting the test. The testing should be conducted under conditions that are representative of the uses specified on the product's labeling, and in a setting that is representative of the label use site(s). For example, a product intended for use in a room or a large warehouse should be tested in an empty room or large chamber. The purpose of the test would be to assure that key parameters for efficacy (chemical concentration, temperature, relative humidity and contact time) are accurately monitored and maintained throughout the enclosed space, and establish product generation rate (lbs/hr) and rate/volume (lbs/hr/ft3).

      (2) Additional Considerations. Important issues to consider in developing the protocol for this test include:

         (i) The test should be conducted in a sealed enclosure at least the size of a typical office or other room that simulates the intended use pattern and designed to measure the distribution of the product and conditions needed to meet the measure of success in the laboratory efficacy test. Items that might be treated (e.g., dressers, upholstered furniture, carpet, etc.) during an actual fumigation, should be included in this test.

         (ii) The protocol should specify the dimensions of the enclosure, number and location of monitoring devices (e.g., for gas or vapor concentration, total mass of gas or vapor injected into the enclosure, temperature, relative humidity), product application equipment, heaters and fans, contact time, etc. The equipment used to monitor and maintain these test parameters should be described.

         (iii) All recorded test results pertaining to the test conditions/parameters should	 be submitted to the Agency. The maximum volume of space that can be treated with a particular unit should be reported to the Agency. The minimum total mass of gas or vapor required to maintain the required concentration and contact time per cubic foot of space to be decontaminated should be reported.

         (iv) Appropriate controls should be employed to assess both the sterility of the test system and viability of the spore inoculum. Uninoculated carriers and/or uninoculated biological indicators should be placed in the test chamber to assess sterility of the test environment. Unexposed inoculated carriers and/or biological indicators should be used to determine the suitability of the growth medium designed for the recovery of viable spores.

         (v) This test must be conducted either in accordance with Good Laboratory Practices (GLP) per 40 CFR Part 160 or in a federal laboratory with an appropriate Quality Assurance Project Plan (QAPP).

         (vi) Evaluation of sporicidal success. Measurements should show that the same concentration, temperature, and relative humidity, can be maintained for the required contact time needed to achieve 100% kill (i.e., no growth of the test organism on any of the carriers) in the qualitative laboratory test, or a >=6 log10 reduction in the quantitative test is demonstrated in the simulated-use test. In addition, measurements of the fumigant mass injection/generation rate (e.g., pounds/hour), divided by the volume of the simulated use test bed, that was used to arrive at the required generation rate/volume (e.g., pounds per hour/cubic foot) for the fumigation, should be included with the data, and listed on the product label.

(h)	Water-soluble powders and non-volatile liquid products for Commercial Sterilants for Aseptic Packaging of Low Acid Food. This section addresses efficacy tests for products with claims to inactivate spores on hard, non-porous, inanimate surfaces for aseptic packaging.

         (1)          Test procedure. The Agency recommends modifications of the AOAC International Official Method 966.04 as described above to demonstrate the sterilant efficacy of commercial sterilants for aseptic packaging of low acid foods. However, sixty carriers representing one type of surface (stainless steel penicylinders) should be tested against spores on three samples representing three different batches of the product (180 carriers per organism). Products should demonstrate effectiveness in 20 seconds or less at temperatures less than 80˚C. If a longer contact time or a different temperature is required for the product, the applicant should contact the Agency prior to testing. The inoculum employed should provide a count of 1 x 10[5]  -  1 x 10[6] spore forming units per carrier. Other modifications to the AOAC Method 966.04 to address this use should be submitted to the Agency for review and approval prior to conducting the tests. The type of spore former to be used is dependent on the type of chemical sterilant as follows:

            (i)                Hydrogen peroxide based sterilants should be tested against B. subtilis (ATCC 19659), C. sporogenes (ATCC 3584), and B. cereus (ATCC 14579).

            (ii)                Peroxyacid based sterilants should be tested against B. subtilis (ATCC 19659), C. sporogenes (ATCC 3584) and B. cereus (ATCC 14579).

            (iii)                For sterilant classes other than those listed above, consultation with EPA and FDA is recommended prior to generation of product data to identify the organisms for supporting aseptic packaging label claims.

         (2)          Evaluation of sterilant success. The product should kill the test spores on all of the carriers without any failures. No contamination of the culture tubes is allowed.

(i) References: The references in this paragraph may be consulted for addi - tional background information.

      (1) Official Methods of Analysis of the AOAC International, Chapter 6, Disinfectants, Official Method 966.04 Sporicidal Activity of Disinfectants, 2013. AOAC International, Suite 500, 481 North Frederick Avenue, Gaithersburg, MD 20877-2417.

      (2) Official Methods of Analysis of the AOAC International, Chapter 6, Disinfectants, Official Method 2008.05 Quantitative Three Step Method (Efficacy of Liquid Sporicides Against Spores of Bacillus subtilis on a Hard Nonporous Surface), 2013. AOAC International, Suite 500, 481 North Frederick Avenue, Gaithersburg, MD 20877-2417.

      (3) Annual Book of ASTM Standards, Standard Quantitative Disk Carrier Test Method for Determining Bactericidal, Virucidal, Fungicidal, Mycobactericidal, and Sporicidal Activities of Chemicals, Designation E 2197-11. ASTM International, 100 Barr Harbor Drive, West Conshohocken, PA 19428-2959.

      (4) Annual Book of ASTM Standards, Standard Test Method for Production of Clostridium difficile Spores for Use in Efficacy Evaluation of Antimicrobial Agents, Designation E2839-11. ASTM International, 100 Barr Harbor Drive, West Conshohocken, PA 19428-2959.


SF 83 SUPPORTING STATEMENT ENVIRONMENTAL PROTECTION AGENCY NESHAP for Primary Aluminum Reduction Plants ( 40 CFR part 63, subpart LL) ( Renewal)

1. Identification of the Information Collection 1( a) Title of the Information Collection NESHAP for Primary Aluminum Reduction Plants ( 40 CFR part 63, subpart LL) ( Renewal)

1( b) Short Characterization/ Abstract The National Emission Standards for Hazardous Air Pollutants ( NESHAP) standards for this rule were proposed on September 26, 1996, and were promulgated on October 7, 1997. These standards apply to the owner or operator of the affected facilities which include new or existing potlines, paste production plants, or anode bake furnaces associated with primary aluminum production and located at a major source, and for each new pitch storage tank associated with a primary aluminum reduction plant.

In general, all the NESHAP standards implement Section 12( b) of the Clean Air Act, as amended, and are based on the Administrator's determination that primary aluminum reduction plants emit or have the potential to emit hazardous air pollutants ( HAPs). The standards ensure that all major sources of air toxic emissions achieve the level of control already being achieved by the better controlled and lower emitting sources in each category, and involves the installation, operation and maintenance of particulate control devices such as electrostatic precipitators or scrubbers. The major HAPs emitted by these facilities include hydrogen fluoride ( HF) measured as total fluorides ( TF) and polycyclic organic matter ( POM). In addition to HAPs, this standard addresses particulate matter smaller than 10 microns in diameter ( PM 10), which are controlled under the National Ambient Air Quality Standards ( NAAQS).

All the NESHAP standards require initial notifications, performance tests, and periodic reports according to the general provisions specified in 40 CFR part 63, subpart A. Owners or operators are also required to maintain records of the occurrence and duration of any startup, shutdown, or malfunction in the operation of an affected facility, or any period during which the monitoring system is inoperative. Section 63.850 of the final standard includes these provisions, except that the existing performance specifications for continuous emission monitors ( CEMs) are not applicable to HF CEMs because such specifications have not yet been developed for that device. These notifications, reports, and records are essential in determining compliance, and are required of all sources subject to the NESHAP standards.

Any owner or operator subject to the provisions of this part will maintain a file of these measurements, and retain the file for at least five years following the date of such occurrence, 2 measurement, maintenance, corrective action, report or record. All reports are sent to the delegated state or local authority. In the event that there is no such delegated authority, the reports are sent directly to the EPA regional office. Approximately 23 major sources are currently subject to the standard, and it is estimated that there will be no new growth in the industry over the next three years, with the exception of one additional source per year that will become subject to the standard over the next three years due to the reconstruction of an existing affected facility. The average annual cost to industry over the next three years of this Information Collection Request ( ICR) is estimated to be $ 7,756,195 ( rounded).

The Office of Management and Budget ( OMB) approved the currently active ICR without any " Terms of Clearance."

2. Need for and Use of the Collection 2( a) Need/ Authority for the Collection The EPA is charged under Section 112 of the Clean Air Act, as amended, to establish standards of performance for each category or subcategory of major sources and area sources of hazardous air pollutants. These standards are applicable to new or existing sources of hazardous air pollutants and shall require the maximum degree of emission reduction. In addition, Section 114( a) states that the Administrator may require any owner or operator subject to any requirement of this Act to:

( A) Establish and maintain such records; ( B) make such reports; ( C) install, use, and maintain such monitoring equipment, and use such audit procedures, or methods; ( D) sample such emissions ( in accordance with such procedures or methods, at such locations, at such intervals, during such periods, and in such manner as the Administrator shall prescribe); ( E) keep records on control equipment parameters, production variables or other indirect data when direct monitoring of emissions is impractical; ( F) submit compliance certifications in accordance with Section 114( a)( 3); and ( G) provide such other information as the Administrator may reasonably require.

In the Administrator's judgment, HAPs emissions from hydrogen fluoride ( HF), polycyclic organic matter ( POM), and particulate matter smaller than 10 microns in diameter ( PM 10) from primary aluminum reduction plants cause or contribute to air pollution that may reasonably be anticipated to endanger public health or welfare. Therefore, the NESHAP were promulgated for this source category at 40 CFR part 63, subpart LL.

2( b) Practical Utility/ Users of the Data 3 The control of emissions of hydrogen fluoride ( HF), polycyclic organic matter ( POM) which includes hazardous air pollutants ( HAPs), particulate matter smaller than 10 microns in diameter ( PM 10), and HAPs from primary aluminum reduction plants requires not only the installation of properly designed equipment, but also the operation and maintenance of that equipment. Emissions of hydrogen fluoride ( HF), polycyclic organic matter ( POM) which includes HAPs and particulate matter smaller than 10 microns in diameter ( PM 10) from primary aluminum reduction plants are the result of operation of potlines, paste production plants, pitch storage tanks and anode bake furnaces. The subject standards are achieved by the capture of particulate matter smaller than 10 microns in diameter from paste production plants.

The notifications required in the applicable regulations are used to inform the Agency or delegated authority when a source becomes subject to the requirements of the regulations. The reviewing authority may then inspect the source to check if the pollution control devices are properly installed and operated and the regulations are being met. Performance test reports are needed as these are the Agency's record of a source's initial capability to comply with the emission standards, and serve as a record of the operating conditions under which compliance was achieved. The excess emissions reports are used for problem identification, as a check on source operation and maintenance, and for compliance determinations.

The information generated by the monitoring, recordkeeping and reporting requirements described in this ICR is used by the Agency to ensure that facilities affected by the NESHAP continue to operate the control equipment and achieve continuous compliance with the regulation. The semiannual reports are used for problem identification, as a check on source operation and maintenance, and for compliance determinations. Adequate monitoring, recordkeeping, and reporting are necessary to ensure compliance with the applicable regulations, as required by the Clean Air Act. The information collected from recordkeeping and reporting requirements is also used for targeting inspections, and is of sufficient quality to be used as evidence in court.

3. Nonduplication, Consultations, and Other Collection Criteria The requested recordkeeping and reporting are required under 40 CFR part 63, subpart LL.

3( a) Nonduplication If the subject standards have not been delegated, the information is sent directly to the appropriate EPA regional office. Otherwise, the information is sent directly to the delegated state or local agency. If a state or local agency has adopted their own similar standards to implement the Federal standards, a copy of the report submitted to the state or local agency can be sent to the Administrator in lieu of the report required by the Federal standards. Therefore, no duplication exists.

3( b) Public Notice Required Prior to ICR Submission to OMB 4 An announcement of a public comment period for the renewal of this ICR was published in the Federal Register 68 FR 62289 on November 3, 2003. No comments were received on the burden published in the Federal Register.

3( c) Consultations For this information collection, we referenced the most recent ICR, the preparer of the active ICR, and accessed the most recent data ( March 8, 2004) available on the Air Facility System ( AFS) database. We reviewed information available from the Office of Compliance Sector Notebook " Profile of the Nonferrous Metals Industry," the United States Census Bureau via the internet, and other websites covering primary aluminum production. We consulted with EPA's Office of Air Quality Planning and Standards, Information Transfer and Program Integration Division, and Mr. Richard Thomas, Century Aluminum of West Virginia, ( 304) 273 6280.

3( d) Effects of Less Frequent Collection Less frequent information collection would decrease the margin of assurance that facilities are continuing to meet the standards. Requirements for information gathering and recordkeeping are useful techniques to ensure that good operation and maintenance practices are applied and emission limitations are met. If the information required by these standards was collected less frequently, the likelihood of detecting poor operation and maintenance of control equipment and noncompliance would decrease.

3( e) General Guidelines None of these reporting or recordkeeping requirements violate any of the regulations established by OMB at 5 CFR part 1320, section 1320.5.

These standards require affected facilities to maintain all records, including reports and notifications for at least five years. This is consistent with the General Provisions as applied to the standards. EPA believes that the five year records retention requirement is consistent with the Part 70 permit program and the five year statute of limitations on which the permit program is based. Also, the retention of records for five years would allow EPA to establish the compliance history of a source and any pattern of compliance for purposes of determining the appropriate level of enforcement action. Historically, EPA has found that the most flagrant violators frequently have violations extending beyond the five years. EPA would be prevented from pursuing the worst violators due to the destruction or nonexistence of records if records were retained for less than five years.

3( f) Confidentiality Any information submitted to the Agency for which a claim of confidentiality is made will 5 be safeguarded according to the Agency policies set forth in Title 40, chapter 1, part 2, subpart B  Confidentiality of Business Information ( see 40 CFR 2; 41 FR 36902, September 1, 1976; amended by 43 FR 40000, September 8, 1978; 43 FR 42251, September 20, 1978; 44 FR 17674, March 23, 1979).

3( g) Sensitive Questions None of the reporting or recordkeeping requirements contain sensitive questions.

4. The Respondents and the Information Requested 4( a) Respondents/ SIC Codes The respondents to the recordkeeping and reporting requirements are primary aluminum reduction facilities. The United States Standard Industrial Classification ( SIC) code for the respondents affected by the standards is SIC 3334 which corresponds to the North American Industry Classification System ( NAICS) 331312 for Primary Production of Aluminum.

4( b) Information Requested None of these reporting or recordkeeping requirements violate any of the regulations established by OMB at 5 CFR part 1320, section 1320.5.

( i) Data Items All data in this ICR that are recorded and/ or reported are required by National Emission Standards for Hazardous Air Pollutants for Primary Aluminum Reduction Plants ( 40 CFR part 63, subpart LL).

A source must make the following reports:

Notification Reports Standard Citation by Section Notification and application of construction/ reconstruction. 63.05 Notification of initial compliance status. 63.850( a)( 6)

Notification of compliance approach. 63.850( a)( 8)

Initial notification when source becomes subject to standard. 63.9( b) and 63.850( a)

One time notification for each affected source of the intent to use an HF continuous emission monitor. 63.850( a)( 7) 6 Performance test results/ reports. 63.10( d)( 2), 63.850( a)( 5) and 63.850( b)

Initial performance test. 63.07( b) and 63.09( e)

Rescheduled initial performance test. 63.07( b)( 2)

Demonstration of continuous monitoring system, if applicable. 63.09( g)

Compliance status including excess emissions report. 63.09( h)

Reports Opacity or visible emissions. 63.10( d)( 3), 63.845( h), and 63.845( i)

Periodic startup, shutdown, malfunction reports and, if applicable, implementation plan. 63.10( d)( 5)( I) and 63.850( c)

Semiannual reports are required for periods of operation during which measured emissions exceed an applicable limit. If control device operating parameters are outside of the established ranges, quarterly reports are required as a result of excess emissions. 63.859( d)

A source must keep the following records:

Recordkeeping Startup, shutdown, malfunction periods where the continuous monitoring system is inoperative. 63.10( b)( 2)

Emission test results and other data needed to determine emissions. 61.13( g)

All reports and notifications. 63.10( b)

A copy of the startup, shutdown, and malfunction plan and if applicable, of the implementation plan for emissions averaging. 63.850( e)( 4)

Record of applicability. 63.10( b)( 3)

Records for sources with continuous monitoring systems ( CEMS) if it were used. 63.10( b)( 3)

Records are required to be retained for five years. The most recent two years of records must be retained at the facility. 63.850( e)( 1 2) 7 Recordkeeping Aluminum production rate and anode production. 63.850( e)( 4)

Records associated with an owner or operator request to monitor similar potlines, to perform reduced sampling, or to establish and alternative limit for a HF CEM system. 63.850( e)( 4)

Design information for paste production plant capture systems and alternative control devices. 63.850( e)( 4)

Emissions values from process and control devices. 63.859( e)( 4)

Documentation that daily inspections of process and control devices were performed and corrective action( s) taken as required. 63.859( e)( 4)

Electronic Reporting Currently, sources are using monitoring equipment that provides parameter data in an automated way, e. g., hydrogen fluoride and polycyclic organic matter emit HAPs from these facilities. Although personnel at the source still need to evaluate the data, this type of monitoring equipment has significantly reduced the burden associated with monitoring and recordkeeping. In addition, some regulatory agencies are setting up electronic reporting systems to allow sources to report electronically, which is reducing the reporting burden. It is estimated that approximately 50 percent of the respondents use electronic recordkeeping.

( ii) Respondent Activities Respondent Activities Read instructions.

If approved by the appropriate regulatory agency, a respondent may install, calibrate, maintain, and operate an HF CMS for the monitoring of TF secondary emissions as an alternative method.

Install, calibrate, maintain, and operate a continuous parameter monitor for each emission control device including dry alumina scrubbers, dry coke scrubbers, wet scrubbers, electrostatic precipitators and wet roof scrubbers.

Perform performance test using reference methods specified in Appendix A of 40 CFR part 60 including initial performance test. An alternative test method for TF and POM emissions may be used provided the owner or operator has demonstrated the equivalency of the alternative method to a specific plant and has received previous approval from the applicable regulatory authority for its use, or it meets the criteria specified in sections 63.848( d)( 1) and ( d)( 3) through ( d)( 6). 8 Respondent Activities Comply with emission monitoring requirements to measure TF, POM and opacity as required.

Write the notification and reports listed above.

Enter information required to be recorded above.

Develop, acquire, install, and utilize technology and systems for the purpose of disclosing and providing information.

Adjust the existing ways to comply with any previously applicable instructions and requirements.

Train personnel to be able to respond to a collection of information.

Transmit, or otherwise disclose the information.

Currently, sources are using automated monitoring equipment that provides parameter data. Although personnel at the source still need to evaluate the data, this type of monitoring equipment has significantly reduced the burden associated with monitoring and recordkeeping.

5. The Information Collected: Agency Activities, Collection Methodology, and Information Management 5( a) Agency Activities EPA conducts the following activities in connection with the acquisition, analysis, storage, and distribution of the required information.

Agency Activities Observe initial performance tests and repeat performance tests if necessary.

Review notifications and reports, including performance test reports, and excess emissions reports, required to be submitted by industry.

Audit facility records.

Input, analyze, and maintain data in the Air Facility System ( AFS).

5( b) Collection Methodology and Management Following notification of startup, the reviewing authority might inspect the source to determine whether the pollution control devices are properly installed and operated. Performance test reports conducted for anode bake furnaces and potlines, as well as for primary and secondary 9 control systems, are used to discern the source's initial capability to comply with the standards and note the operating conditions under which compliance will be achieved. The regulatory authority will use performance tests' reports or design evaluation findings for pitch storage tanks to determine initial compliance with the standard. The semiannual emission reports, unless quarterly reports are required as a result of excess emissions, are used by the regulatory authority for problem identification, as a check on source operation and maintenance, and for compliance determinations.

Information contained in the reports is entered into the AFS which is operated and maintained by EPA's Office of Compliance. AFS is EPA's database for the collection, maintenance, and retrieval of compliance and annual emission inventory data for more than 100,000 industrial and government owned facilities. EPA uses the AFS for tracking air pollution compliance and enforcement by local and state regulatory agencies, EPA regional offices and EPA headquarters. EPA and its delegated Authorities can edit, store, retrieve and analyze the data.

The records required by this regulation must be retained by the owner or operator for five years.

5( c) Small Entity Flexibility A majority of the affected facilities are large entities ( e. g., large businesses). However, the impact on small entities ( i. e., small businesses) was taken into consideration during the development of the regulation. Due to technical considerations involving the process operations and the types of control equipment employed, the recordkeeping and reporting requirements are the same for both small and large entities. The Agency considers these requirements the minimum needed to ensure compliance and, therefore, cannot reduce them further for small entities. To the extent that larger businesses can use economies of scale to reduce their burden, the overall burden will be reduced.

5( d) Collection Schedule The specific frequency for each information collection activity within this request is shown in Table 1: Annual Respondent Burden  NESHAP for Primary Aluminum Reduction Plants ( 40 CFR part 63, subpart LL).

6. Estimating the Burden and Cost of the Collection Table 1 documents the computation of individual burdens for the recordkeeping and reporting requirements applicable to the industry for the subpart included in this ICR. The individual burdens are expressed under standardized headings believed to be consistent with the concept of burden under the Paperwork Reduction Act. Where appropriate, specific tasks and 10 major assumptions have been identified. Responses to this information collection are mandatory.

The Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB Control Number.

6( a) Estimating Respondent Burden The average annual burden to industry over the next three years from these recordkeeping and reporting requirements is estimated to be 122,607 ( Total Labor Hours from Table 1). These hours are based on Agency studies and background documents from the development of the regulation, Agency knowledge and experience with the NESHAP program, the previously approved ICR, and any comments received.

6( b) Estimating Respondent Costs ( i) Estimating Labor Costs This ICR uses the following labor rates:

Managerial $ 93.09 ($ 44.33 + 110%) Technical $ 64.13 ($ 30.54 + 110%) Clerical $ 39.65 ($ 18.88 + 110%)

These rates are from the United States Department of Labor, Bureau of Labor Statistics, June 2003, " Table 10. Private industry, by occupational and industry group." The rates are from column 1, " Total compensation." The rates have been increased by 110 percent to account for the benefit packages available to those employed by private industry.

( ii) Estimating Capital/ Startup and Operation and Maintenance Costs The type of industry costs associated with the information collection activities in the subject standards are labor costs which are addressed elsewhere in the ICR and the costs associated with continuous monitoring. The capital/ startup costs are one time costs when a facility becomes subject to the regulation. The annual operation and maintenance costs are the ongoing costs to maintain the monitors and other costs such as photocopying and postage.

( iii) Capital/ Startup vs. Operation and Maintenance ( O& M) Costs 11 Capital/ Startup vs. Operation and Maintenance ( O& M) Costs ( A) Continuous Monitoring Device ( B) Capital/ Startu p Cost for One Respondent ( C) Number of New Respondents ( D) Total Capital/ Startup Cost ( B X C) ( E) Annual O& M Costs for One Respondent ( F) Number of Respondents with O& M ( G) Total O& M, ( E X F)

HF CEMs ( similar potlines) 0 0 0 $ 1,669 23 $ 38,387 Method 14 ( manifolds at potlines) 0 0 0 $ 3,339 12 $ 40,068 Method 14A ( alcan cassettes) 0 0 0 $ 1,536 23 $ 35,328 $ 113,783 The total capital/ startup costs for this ICR are zero. This is the total of column D in the above table. These costs are shown on the OMB 83 I form in block 14( a), Total annualized capital/ startup costs.

The total operation and maintenance ( O& M) costs for this ICR are $ 114,000 ( rounded). This is the total of column G. These costs are shown on the OMB 83 I form in block 14( b), Total annual costs ( O& M).

The total respondent costs in block 14 have been calculated as the addition of the capital/ startup costs, and the annual operation and maintenance costs. The average annual cost for capital/ startup and operation and maintenance costs to industry over the next three years of the ICR is estimated to be $ 114,000. This cost is shown on the OMB 83 I form in block 14( c), Total annualized cost requested. The numbers in block 14 of the OMB 83 I form are rounded to show the cost in thousands of dollars.

6( c) Estimating Agency Burden and Cost The only costs to the Agency are those costs associated with analysis of the reported information. EPA's overall compliance and enforcement program includes activities such as the examination of records maintained by the respondents, periodic inspection of sources of emissions, and the publication and distribution of collected information.

The average annual Agency cost during the three years of the ICR is estimated to be $ 40,391. This cost is based on the average hourly labor rate as follows:

Managerial $ 54.02 ( GS 13, Step 5, $ 33.76 x 1.6) 12 Technical $ 40.08 ( GS 12, Step 1, $ 25.05 x 1.6) Clerical $ 21.70 ( GS 6, Step 3, $ 13.56 x 1.6)

These rates are from the Office of Personnel Management ( OPM) " 2004 General Schedule" which excludes locality rates of pay. Details upon which this estimate is based appear in Table 2: Average Annual EPA Burden  NESHAP for Primary Aluminum Reduction Plants ( 40 CFR part 63, subpart LL).

6( d) Estimating the Respondent Universe and Total Burden and Costs Based on our research for this ICR, approximately 23 existing sources are currently subject to the standard. It is estimated that no expected additional sources per year will become subject to the standard in the next three years.

Number of respondents is calculated using the following table which addresses the three years covered by this ICR.

Number of Respondents Respondents That Submit Reports Respondents That Do Not Submit Any Reports Year ( A) Number of New Respondents 1 ( B) Number of Existing Respondents ( C) Number of Existing Respondents That Keep Records but Do Not Submit Reports ( D) Number of Existing Respondents That Are Also New Respondents ( E) Number of Respondents ( E= A+ B+ C D)

1 1 23 0 1 23 2 1 23 0 1 23 3 1 23 0 1 23 Average 1 23 0 1 23 1 New respondents include sources with constructed, reconstructed and modified affected facilities. In this standard, existing respondents submit initial notifications.

To avoid double counting respondents column D is subtracted. As shown above, the average Number of Respondents over the three year period of this ICR is 23. This number appears on the OMB 83 I form in block 13( a), Number of respondents.

The total number of annual responses per year is calculated using the following table: 13 Total Annual Responses ( A) Information Collection Activity ( B) Number of Respondents ( C) Number of Responses ( D) Number of Existing Respondents That Keep Records But Do Not Submit Reports ( E) Total Annual Responses E=( BxC)+ D Notification of applicability 1 1 N/ A 1 Notification of construction// reconstruction 1 1 N/ A 1 Notification of actual startup 1 1 N/ A 1 Notification of performance test 1 1 N/ A 1 Notification of compliance status/ approach 1 1 N/ A 1 Report of monitoring exceedances 2.3 2 N/ A 4.6 Report of no excess emissions 20.7 2 N/ A 41.4 Startup, shutdown, malfunction report 2.3 2 N/ A 4.6 Total 56 ( rounded)

The number of Total Annual Responses is 56. This number is shown on the OMB 83 I form in block 13( b), Total annual responses.

The Total Hours Requested is shown on the OMB 83 I form in block 13( c). The total annual labor costs are $ 7,756,195. The annual labor costs are not shown on the OMB 83 I form. Details regarding these estimates may be found in Table 1. Annual Respondent Burden and Cost   NESHAP for Primary Aluminum Reduction Plants ( 40 CFR part 63, subpart LL).

Note that the total annual capital and O& M costs to the regulated entity are $ 114,000. This number is shown on the OMB 83 I form in block 14( c), Total annualized cost requested. These costs are detailed in Section 6( b)( iii), Capital/ Startup vs. Operation and Maintenance ( O& M) Costs.

6( e) Bottom Line Burden Hours Burden Hours and Cost Tables The bottom line burden hours and cost tables for both the Agency and the respondents are attached. The annual public reporting and recordkeeping burden for this collection of information is estimated to average 2,189 ( rounded) hours per response.

6( f) Reasons for Change in Burden An increase in burden over the next three years of this ICR resulted from an increase in 14 the estimated number of responses. The increase in labor cost from the most recently approved ICR is due to a revised hourly labor rate from the United States Department of Labor.

6( g) Burden Statement The annual public reporting and recordkeeping burden for this collection of information is estimated to average 2,189 hours per response. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; to develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; to adjust the existing ways to comply with any previously applicable instructions and requirements; to train personnel to be able to respond to a collection of information; to search data sources; complete and review the collection of information; and to transmit or otherwise disclose the information.

An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a valid OMB Control Number. The OMB Control Numbers for EPA's regulations are listed at 40 CFR part 9 and 48 CFR chapter 15.

To comment on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including the use of automated collection techniques, EPA has established a public docket for this ICR under Docket ID Number OECA 2003 0139, which is available for public viewing at the Enforcement and Compliance Docket and Information Center in the EPA Docket Center ( EPA/ DC), EPA West, Room B102, 1301 Constitution Ave., NW, Washington, DC. The EPA Docket Center 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 Reading Room is ( 202) 566 1744, and the telephone number for the Enforcement and Compliance Docket and Information Center Docket is ( 202) 566 1752. An electronic version of the public docket is available through EPA Dockets ( EDOCKET) at http:// www. epa. gov/ edocket. Use EDOCKET to submit or view public comments, access the index listing of the contents of the public docket, and to access those documents in the public docket that are available electronically. When in the system, select " search," then key in the Docket ID Number identified above. Also, you can send comments to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street, NW, Washington, DC 20503, Attention: Desk Officer for EPA. Please include the EPA Docket ID Number OECA 2003 0139 and OMB Control Number 2060 0360 in any correspondence.

Part B of the Supporting Statement This part is not applicable because no statistical methods were used in collecting this information. 15 Table 1: Annual Respondent Burden and Cost  NESHAP for Primary Aluminum Reduction Plants ( 40 CFR part 63, subpart LL)

Burden item ( A)

Personhours per occurrence ( B)

No. of occurrences per respondent per year ( C)

Personhours per respondent per year ( C= AxB) ( D) Respondents per year b ( E) Technical personhours per year ( E= CxD) ( F) Managemen t personhours per year ( Ex0.05) ( G) Clerical personhours per year ( Ex0.1) ( H)

Total Cost Per Year a 1. Applications N/ A 2. Survey and Studies N/ A 3. Acquisition, installation,

and utilization of technology and systems 80 1 80 1 b 80 4 8 $ 5,819.96 4. Reporting Requirements A. Read instructions 4 1 4 1b 4 0.2 0.4 $ 291.00 B. Required Activities Initial performance test 120c 1 120 1b 120 6 12 $ 8,729.94 Annual performance test 100d 6.7e 670 23 f 15,410 770.5 1,541 $ 1,121,069.79 Monthly performance test ( Method 13/ 14) 200g 12 2,400 12h 28,800 1,440 2,880 $ 2,095,185.60 Monthly performance test ( CEM or Alcan cassette) 40i 25j 1,000 23 23,000 1,150 2,300 $ 1,673,238.50 Quarterly performance test 200k 15.3l 3,060 6m 18,360 918 1,836 $ 1,335,680.80 Daily monitoring 2n 365 730 23 16,790 839.5 1,679 $ 1,221,464.10 C. Create information Included in 4B 16 Burden item ( A)

Personhours per occurrence ( B)

No. of occurrences per respondent per year ( C)

Personhours per respondent per year ( C= AxB) ( D) Respondents per year b ( E) Technical personhours per year ( E= CxD) ( F) Managemen t personhours per year ( Ex0.05) ( G) Clerical personhours per year ( Ex0.1) ( H)

Total Cost Per Year a D. Gather existing information Included in 4B E. Write Report Notification of applicability 2 1 2 1b 2 0.1 0.2 $ 145.50 Notification of construction/ reconstruction 2 1 2 1 b 2 0.1 0.2 $ 145.50 Notification of actual startup 2 1 2 1b 2 0.1 0.2 $ 145.50 Notification of performance test Included in 4B Notification of special Compliance requirements N/ A Notification of compliance status/ approach ( intent to use HF CEM) 4 1 4 1 b 4 0.2 0.4 $ 291.00 NESHAP waiver application N/ A Report of performance test Included in 4B Report of monitoring exceedances 16 2o 32 2.3p 73.6 3.68 7.36 $ 5,354.36 Report of no excess emissions 8 2o 16 20.7q 331.2 16.56 33.12 $ 24,094.64 Startup, shutdown,

malfunction report 8 2 16 2.3 r 36.8 1.84 3.68 $ 2,677.17 17 Burden item ( A)

Personhours per occurrence ( B)

No. of occurrences per respondent per year ( C)

Personhours per respondent per year ( C= AxB) ( D) Respondents per year b ( E) Technical personhours per year ( E= CxD) ( F) Managemen t personhours per year ( Ex0.05) ( G) Clerical personhours per year ( Ex0.1) ( H)

Total Cost Per Year a 5. Recordkeeping Requirements A. Read instructions Included in 4B B. Plan activities N/ A C. Implement activities N/ A D. Develop record system N/ A E. Time to enter information Records of all information required by standards 3s 52 156 24 3,588 179.4 358.8 $ 261,025.21 F. Time to train personnel N/ A G. Time to adjust existing ways to comply with previously applicable requirements N/ A H. Time to transmit or disclose information 0.25t 2o 0.5 24 11.5 0.575 1.15 $ 836.63 I. Time for audits N/ A Subtotal Labor Burden 106,615 5,330.755 10,661.51 $ 7,756,195.20 TOTAL LABOR BURDEN AND COST ( rounded) 122,607 $ 7,756,195 Assumptions:

a This ICR uses the following labor rates: $ 93.09 per hour for Executive, Administrative, and Managerial labor; $ 64.13 per hour for Technical labor, and $ 39.65 per hour for Clerical labor. These rates are from the United States Department of Labor, Bureau of Labor Statistics, June 2003, " Table 10. Private industry, by 18 occupational and industry group."

b Assume one plant per year over the next three years will install a new or reconstructed pitch storage tank.

c We have assumed that it will take 120 hours to perform initial performance test.

d It will take 100 hours each for Method 13 and Method 315 for primary emission controls of [ total fluoride ( TF) and polycyclic organic matter ( POM)] systems at potlines and anode bake furnaces.

e Estimate 96 Method 13 tests and 58 Method 315 tests each year for primary control systems for a total of 154 tests for 23 respondents ( 154/ 23= 6.7 tests per respondent).

f All 23 primary aluminum reduction plants will conduct TF and POM monitoring at anode bake furnaces.

g It will take 200 hours for Method 13/ 14 for secondary emissions from potlines.

h Assume that 12 potlines have to install a Method 14 manifold and will perform manual sampling.

i It is estimated to take 40 hours for testing similar potlines ( CEM or Alcan cassette).

Assumptions contd:

j Assume that 48 potlines will be monitored under the alternative monitoring provisions for similar potlines, with 25 potlines per respondent ( 12* 48/ 23= 25).

k It is estimated to take 200 hours for a Method 315 test for secondary emissions.

l Assume a total of 23 Soderberg potlines and six plants, this will occur 15.3 per respondent ( 23* 4/ 6= 15.3).

m Assume all of the six Soderberg plants are tested each year for an average of six respondents per year.

n Assume it takes two hours per day for monitoring of operating parameters and visible emissions.

o Semiannual reports are required ( 2/ yr), unless quarterly reports are required as a result of excess emissions.

p Assume that 10 percent will fail to meet the standard.

q Assume that 90 percent will meet the standard.

r Assume that 10 percent must file startup, shutdown, malfunction reports.

s Assume that it will take three hours per week per plant to enter records.

t Assume it will take 15 minutes to transmit recorded information. 19 Table 2: Average Annual EPA Burden  NESHAP for Primary Aluminum Reduction Plants ( 40 CFR part 63, subpart LL)

Burden Item ( A) Person Hours Per Occurrenc e ( B) Number of Occurrence s Per Plant Per Year ( C) Person Hours Per Plant Per Year ( C= AxB) ( D)

Plants Per Year ( E) Technical Hours Per Year ( E= CxD) ( F) Management Hours Per Year ( F= 0.05xE) ( G) Clerical Hours Per Year ( G= 0.1xE) ( H) Total a Costs,

Per Year Initial Performance Test 120 1 120 1b 120 6 12 $ 6,983.28 Excess Emissions Enforcement Activities 120 1 120 2.3c 276 13.8 27.6 $ 19,115.76 Report Review Notification of applicability 2 1 2 1b 2 0.1 0.2 $ 116.38 Notification of construction and reconstruction 2 1 2 1 b 2 0.1 0.2 $ 116.38 Notification of actual startup 2 1 2 1b 2 0.1 0.2 $ 116.38 Notification of special compliance requirements N/ A Notification of initial performance test 2 1 2 1 b 2 0.1 0.2 $ 116.38 Notification of compliance status 8 1 8 1 b 8 0.4 0.8 $ 465.55 Existing Plants Review of performance test report 8 1 8 23 d 184 9.2 18.4 $ 8,270.98 Review of excess emissions report 8 1 8 2.3 c 18.4 0.92 1.84 $ 827.10 20 Burden Item ( A) Person Hours Per Occurrenc e ( B) Number of Occurrence s Per Plant Per Year ( C) Person Hours Per Plant Per Year ( C= AxB) ( D)

Plants Per Year ( E) Technical Hours Per Year ( E= CxD) ( F) Management Hours Per Year ( F= 0.05xE) ( G) Clerical Hours Per Year ( G= 0.1xE) ( H) Total a Costs,

Per Year Review of no excess emissions report 2 2 4 20.7e 82.8 4.14 8.28 $ 3,721.93 Review of NESHAP waiver application N/ A Review of startup, shutdown,

malfunction report 2 1 2 2.3 f 4.6 0.23 0.46 $ 206.77 Subtotal 701.8 35.09 70.18 $ 39,940.51 Travel Expenses ( 1 person x 1 plant/ yr x 1 day/ plant x $ 50 per diem) + ($ 400/ round trip x 1 round trips/ yr) =

$ 450.00 TOTAL LABOR BURDEN and COST ( rounded) 807 $ 40,391 Assumptions:

a This cost is based on the following hourly labor rates times a 1.6 benefits multiplication factor to account for government overhead expenses: $ 54.02 for Managerial ( GS 13, Step 5, $ 33.76 x 1.6), $ 40.08 for Technical ( GS 12, Step 1, $ 25.05 x 1.6) and $ 21.70 Clerical ( GS 6, Step 3, $ 13.56 x 1.6). These rates are from the Office of Personnel Management ( OPM) " 2003 General Schedule" which excludes locality rates of pay.

b Assume that one plant per year over the next three years will install a new or reconstructed pitch storage tank.

c We assume that 10 percent of the 23 plants ( 2.3) have excess emissions.

d Assume that EPA/ State personnel will review summary of performance tests requirements to be submitted by all 23 plants on an annual basis.

e Assume that the remaining 90 percent of the 23 plants ( 20.7) do not have excess.

f Assume that 10 percent of plants per year ( 2.3) will report a startup, shutdown, malfunction incident.

g Travel expenses are incurred for one employee to attend testing. 21


[Federal Register Volume 87, Number 63 (Friday, April 1, 2022)]
[Notices]
[Pages 19144-19146]
[FR Doc No: 2022-06853]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-94533; File No. SR-Phlx-2022-13]

Self-Regulatory Organizations; Nasdaq PHLX LLC; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change To Amend the
Implementation Date Related to the Launch of Options on the Nasdaq-100
Volatility Index

March 28, 2022.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on March 15, 2022, Nasdaq PHLX LLC (``Phlx'' or ``Exchange'') filed
with the Securities and Exchange Commission (``Commission'') the
proposed rule change as described in Items I and II below, which Items
have been prepared by the Exchange. The Commission is publishing this
notice to solicit comments on the proposed rule change from interested
persons.
---------------------------------------------------------------------------

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

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

    The Exchange proposes to amend the implementation date related to
the launch of options on the Nasdaq-100[supreg] Volatility Index.

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

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

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

1. Purpose
    The Exchange proposes to amend the implementation date related to
the launch of options on the Nasdaq-100[supreg] Volatility Index
(``VOLQ''). In 2021, Phlx received approval \3\ to list and trade
options on VOLQ. Phlx subsequently received approval \4\ in 2021 to
amend the calculation of its final settlement price for options on
VOLQ. When Phlx amended the calculation of its final settlement price
for options on VOLQ, it also amended its implementation date to ``on or
before March 31, 2022.'' At this time the Exchange proposes to delay
the launch of VOLQ to ``on or before June 30, 2022.'' The Exchange
proposes the additional time to ensure market readiness and to allow a
third-party vendor additional time to test before launch. The Exchange
will issue an Options Trader Alert announcing the day it will list
options on VOLQ on Phlx at least thirty days prior to the launch date.
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    \3\ See Securities Exchange Act Release No. 91781 (May 5, 2021),
86 FR 25918 (May 11, 2021) (SR-Phlx-2020-41) (Notice of Filing of
Amendment Nos. 1 and 2 and Order Granting Accelerated Approval of a
Proposed Rule Change, as Modified by Amendment Nos. 1 and 2, To List
and Trade Options on a Nasdaq-100 Volatility Index).
    \4\ See Securities Exchange Act Release No. 93628 (November 19,
2021), 86 FR 67555 (November 26, 2021) (SR-Phlx-2021-56) (Order
Approving a Proposed Rule Change To Amend Options 4A, Section 12
Regarding the Calculation of the Closing Volume Weighted Average
Price for Options on the Nasdaq-100 Volatility Index in Certain
Circumstances).
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Background
    VOLQ is a new options index product that would enable retail and
institutional investors to manage volatility versus price risk. This
index will measure ``at-the-money'' volatility, a precise measure of
volatility used by investors. Unlike other indexes, this proposed novel
product isolates at-the-money volatility for precise trading and
hedging strategies. This product will provide investors information on
volatility index returns by allowing them to observe increases and
decreases of the Volatility Index. Specifically, VOLQ options will
measure changes in 30-day implied volatility of the Nasdaq-100 Index
(commonly known as and referred to by its ticker symbol, NDX). Options
on the Volatility Index will be cash-settled and will have European-
style exercise provisions.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\5\ in general, and furthers the objectives of Section
6(b)(5) of the Act,\6\ in particular, in that it is designed to promote
just and equitable principles of trade, 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,
by delaying the launch of options on VOLQ from ``on or before March 31,
2022'' to ``on or before June 30, 2022.'' This delay will provide
additional time to ensure market readiness and to allow a third-party
vendor additional time to test before launch, thereby ensuring a
successful launch of this new product.
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    \5\ 15 U.S.C. 78f(b).
    \6\ 15 U.S.C. 78f(b)(5).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    This proposed rule change does not impose any burden on competition
that is not necessary or appropriate in furtherance of the purposes of
the Act. The Exchange's proposal to delay the launch of options on VOLQ
does not impose an undue burden on competition. Delaying the launch
from ``on or before March 31, 2022'' to ``on or before June 30, 2022''
will provide Phlx additional time to ensure market readiness as well as
allow a third-party vendor additional time to test before launch. The
Exchange will issue an Options Trader Alert announcing the day it will
list options on VOLQ on Phlx at least thirty days prior to the launch
date.

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

    No written comments were either solicited or received.

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

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A)(iii) of the Act \7\ and
subparagraph (f)(6) of Rule 19b-4 thereunder.\8\
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    \7\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \8\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change at
least five business days prior to the date of filing of the proposed
rule change, or such shorter time as designated by the Commission.
The Exchange has satisfied this requirement.
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    A proposed rule change filed under Rule 19b-4(f)(6) \9\ normally
does not become operative prior to 30 days after the date of the
filing. However, pursuant to Rule 19b-4(f)(6)(iii),\10\ the Commission
may designate a shorter time if such action is consistent with the
protection of investors and the public interest. The Exchange has asked
the Commission to waive the 30-day operative delay. Waiver of the
operative delay would allow the Exchange to immediately delay the
launch of options on VOLQ, which would provide additional time to
ensure market readiness and allow a third-party vendor additional time
to test before launch. The Commission believes that waiver of the 30-
day operative delay is consistent with the protection of investors and
the public interest. Accordingly, the Commission hereby waives the
operative delay and designates the proposed rule change operative upon
filing.\11\
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    \9\ 17 CFR 240.19b-4(f)(6).
    \10\ 17 CFR 240.19b-4(f)(6)(iii).
    \11\ For purposes only of waiving the 30-day operative delay,
the Commission has also considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
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    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such

action is necessary or appropriate in the public interest, for the
protection of investors, or otherwise in furtherance of the purposes of
the Act. If the Commission takes such action, the Commission shall
institute proceedings to determine whether the proposed rule should be
approved or disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
File Number SR-Phlx-2022-13 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-Phlx-2022-13. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549 on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-Phlx-2022-13 and should be submitted on
or before April 22, 2022.
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    \12\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\12\
J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2022-06853 Filed 3-31-22; 8:45 am]
BILLING CODE 8011-01-P