[Federal Register Volume 85, Number 105 (Monday, June 1, 2020)]
[Notices]
[Pages 33272-33274]
[FR Doc No: 2020-11740]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2020-0062]

Marking of Commercial Motor Vehicles; Application for an
Exemption--Adirondack Trailways, Pine Hill Trailways, and New York
Trailways

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of final disposition; grant of application for
exemption.

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SUMMARY: The Federal Motor Carrier Safety Administration (FMCSA)
announces its decision to grant Adirondack Transit Lines, Inc. (dba
Adirondack Trailways), Pine Hill-Kingston Bus Corp. (dba Pine Hill
Trailways), and Passenger Bus Corp. (dba New York Trailways) an
exemption from FMCSA's commercial motor vehicle (CMV) marking rules
under certain circumstances involving the exchange of equipment and/or
drivers. FMCSA has determined that the terms and conditions of the
exemption likely ensure a level of safety equivalent to, or greater
than, the level of safety achieved without the exemption.

DATES: This exemption is effective June 1, 2020 and expires May 28,
2025.

ADDRESSES: Docket: For access to the docket to read background
documents or comments, go to www.regulations.gov at any time or visit
Room W12-140 on the ground level of the West Building, 1200 New Jersey
Avenue SE, Washington, DC, between 9 a.m. and 5 p.m., ET, Monday
through Friday, except Federal holidays. To be sure someone is there to
help you, please call<PHONE_NUMBER> or<PHONE_NUMBER> before visiting
Docket Operations.
    The on-line Federal Docket Management System (FDMS) is available 24
hours each day, 365 days each year.
    Privacy Act: In accordance with 5 U.S.C. 553(c), DOT solicits
comments from the public to better inform its rulemaking process. DOT
posts these comments, without edit, including any personal information
the commenter provides, to www.regulations.gov, as described in the
system of records notice (DOT/ALL-14 FDMS), which can be reviewed at
www.dot.gov/privacy.

FOR FURTHER INFORMATION CONTACT: Ms. La Tonya Mimms, FMCSA Driver and
Carrier Operations Division; Office of Carrier, Driver and Vehicle
Safety Standards; Telephone:<PHONE_NUMBER>. Email<EMAIL_ADDRESS>If you
have questions on viewing or submitting material to the docket, contact
Docket Services, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Public Participation

Viewing Comments and Documents

    To view comments, as well as documents mentioned in this preamble
as being available in the docket, go to www.regulations.gov and insert
the docket number, ``FMCSA-2020-0062'' in the ``Keyword'' box and click
``Search.'' Next, click the ``Open Docket Folder'' button and choose
the document to review. If you do not have access to the internet, you
may view the docket by visiting the Docket Management Facility in Room
W12-140 on the ground floor of the DOT West Building, 1200 New Jersey
Avenue SE, Washington, DC 20590, between 9 a.m. and 5 p.m., E.T.,
Monday through Friday, except Federal holidays. To be sure someone is
there to help you, please call<PHONE_NUMBER> or<PHONE_NUMBER> before
visiting Docket Operations.

II. Legal Basis

    FMCSA has authority under 49 U.S.C. 31136(e) and 31315 to grant
exemptions from certain parts of the Federal Motor Carrier Safety
Regulations. FMCSA must publish a notice of each exemption request in
the Federal Register (49 CFR 381.315(a)). The Agency must provide the
public an opportunity to inspect the information relevant to the
application, including any safety analyses that have been conducted.
The Agency must provide an opportunity for public comment on the
request.
    The Agency reviews the safety analyses and the public comments and
determines whether granting the exemption would be likely to achieve a
level of safety equivalent to, or greater than, the level that would be
achieved by the current regulation (49 CFR 381.305). The decision of
the Agency must be published in the Federal Register (49 CFR
381.315(b)) with the reason for the granting or denial, and, if
granted, the specific person or class of persons receiving the
exemption and the regulatory provision or provisions from which
exemption is granted. The notice must specify the effective period of
the exemption (up to 5 years), and explain the terms and conditions of
the exemption. The exemption may be renewed (49 CFR 381.300(b)).

III. Request for Exemption

    Under 49 CFR 390.21, commercial motor vehicles must display the
legal name or single trade name of the motor carrier operating the
vehicle and the

USDOT identification number assigned to that motor carrier. For motor
carriers operating interchanged passenger carrying vehicles, the
requirements of section 390.21(b)(3) are satisfied if the vehicle is
marked with a single placard, sign, or other device affixed to the
right (curb) side of the vehicle on or near the front passenger door.
The placard, sign, or device must display the legal name or a single
trade name of the motor carrier operating the CMV and the motor
carrier's USDOT number, preceded by the words ``Operated by.''
    Adirondack Trailways, Pine Hill Trailways, and New York Trailways
combined operate approximately 130 motorcoaches using about 124 drivers
in intercity bus service. The three commonly owned passenger services
interchange buses and drivers frequently each year. Additionally,
Adirondack Trailways is party to longstanding agreements for through
service with various carriers and for revenue pooling with Greyhound
Lines, Inc. The applicants explained that the frequency with which
motorcoaches are involved in interchange arrangements with the three
Trailways carriers, Greyhound Lines, and other passenger carriers makes
it difficult to comply with section 390.21(b)(3). This is especially
the case when the interchanges happen on short notice and in remote
locations. Therefore, the companies are seeking an exemption from the
CMV marking requirements in 49 CFR 390.21(b)(3).

IV. Public Comments

    On January 14, 2020 (85 FR 2229), the Agency published a notice
requesting public comment on the exemption request from Adirondack
Trailways, Pine Hill Trailways, and New York Trailways. The Agency
received three responses to the notice, with comments from two
individuals who opposed the exemption application and comments from the
American Bus Association (ABA) writing in support of the request.
    Mr. Michael Millard said ``[b]ased on the legal issues of three
carriers sharing one insurance policy and issues regarding drivers
employed by multiple carriers I suggest the application [should be]
denied and the three carriers do what they already seem to have done.
Become one carrier.''
    An anonymous commenter stated: ``In a world where there is great
concern about chameleon carriers, these carriers are asking for an
exemption from the one tool that FMCSA has to track who is responsible
for the safety of the vehicle on the road.''
    The ABA believes ``This action, coupled with the [carriers'] long-
standing safety record and level of service to the passengers in the
region, persuades ABA to support the petition for exemption.''

V. FMCSA Decision and Safety Analysis

    FMCSA believes it is appropriate to grant the applicants an
exemption from 49 CFR 390.21 concerning the CMV marking requirements
for interchanged passenger-carrying equipment. The frequency with which
vehicles are interchanged between the commonly owned and controlled
motor carries of passengers, Greyhound Lines and other authorized motor
carriers of passengers creates significant challenges for achieving
compliance with 49 CFR 390.21(b)(3). The Agency has determined, as
required by 49 U.S.C. 31315(b) and the implementing regulations under
49 CFR part 381, that the exemption is likely to achieve a level of
safety that is equivalent to, or greater than, the level of safety that
would be obtained in the absence of the exemption.
    The Agency acknowledges the commenters' concerns. However, the
exemption does not provide relief from a rule that could impact the
safety performance of the commonly owned companies. The only question
is whether the agency should provide an exemption to address the
marking requirements when the interchanges between carriers happen
frequently, especially on short notice and in remote locations. These
carriers still bear full responsibility for compliance with the
applicable safety regulations. Furthermore, the granting of the
exemption does not leave Federal and State safety enforcement personnel
without a means of identifying the carrier responsible for the
operation of a vehicle on a given trip, or a means of conducting
compliance assurance activities.
    From a safety equivalency perspective, each of the passenger
carriers providing transportation services would continue to be subject
to all regulations concerning on-road safety performance (e.g., driver
licensing and qualifications, controlled substances and alcohol
testing, inspection, repair, and maintenance, hours of service, etc.).
Each passenger carrier would also continue to meet the financial
responsibility requirements and maintain operating authority. The
Agency's information technology system provides a means for immediate
notification by the insurance carrier if the insurance policy is
cancelled, or there is a change in operating authority status.
    In addition, each vehicle would display the name and USDOT number
assigned to the owner/lessee of the passenger-carrying vehicle, with
information about the responsible motor carrier readily available from
the driver.
    FMCSA does not believe the exemption will compromise safety because
the public can easily identify one of the FMCSA-authorized carriers
involved in the transportation, while Federal or State enforcement
personnel would have immediate access to the identity of the
responsible carrier, if the name and USDOT number displayed on the side
of the passenger-carrying vehicle is not the operating carrier for the
specific trip.

VI. Terms and Conditions of the Exemption

    This exemption from 49 CFR 390.21(b)(3) is issued to Adirondack
Transit Lines, Inc. (dba Adirondack Trailways), Pine Hill-Kingston Bus
Corp. (dba Pine Hill Trailways), and Passenger Bus Corp. (dba New York
Trailways). The conditions of this exemption are as follows:
    1. Passenger-carrying commercial vehicles display the name and
USDOT number of the owner/lessee;
    2. A document is signed by at least one of the authorized carriers
involved in the movement of the vehicle that provides (in electronic or
paper format):
    a. The registered name of each party to the agreement;
    b. The USDOT number for each party to the agreement;
    3. The passenger carrier named on the driver's record of duty
status is the responsible motor carrier;
    4. The owner/lessee and the responsible motor carrier cooperate
with all Federal, State and local enforcement officials to provide the
identity of the operators of the passenger carrying vehicle.
    The carrier and drivers must comply with all other requirements of
the Federal Motor Carrier Safety Regulations (49 CFR parts 350-399) and
Hazardous Materials Regulations (49 CFR parts 105-180).

Preemption

    In accordance with 49 U.S.C. 31315(d), as implemented by 49 CFR
381.600, during the period this exemption is in effect, no State shall
enforce any law or regulation applicable to interstate commerce that
conflicts with or is inconsistent with this exemption with respect to a
firm or person operating under the exemption. States may adopt the same
exemption with respect to operations in intrastate commerce.

FMCSA Notification

    Adirondack Trailways, Pine Hill Trailways, and New York Trailways
must notify FMCSA within 5 business days of any accident (as defined by
49 CFR 390.5) involving the operation of any of their CMVs while under
this exemption. The notification must be emailed to [email protected] and
include the following information:
    a. Name of the Exemption: ``Adirondack Trailways, Pine Hill
Trailways, and New York Trailways'';
    b. The USDOT number of the operating carrier;
    c. Date of the accident;
    d. City or town, and State, in which the accident occurred, or
which is closest to the scene of the accident;
    e. Driver's name and driver's license State, number, and class;
    f. Co-Driver's name and driver's license State, number, and class;
    g. Vehicle company number and power unit license plate State and
number;
    h. Number of individuals suffering physical injury;
    i. Number of fatalities;
    j. The police-reported cause of the accident;
    k. Whether the driver was cited for violation of any traffic laws,
or motor carrier safety regulations; and
    l. The total driving time and the total on-duty time of the CMV
driver at the time of the accident.
    In addition, if there are any injuries or fatalities, the carrier
must forward the police accident report to [email protected] as soon as
available.

Termination

    The FMCSA does not believe the carriers covered by this exemption
will experience any deterioration of their safety record. However,
should this occur, FMCSA will take all steps necessary to protect the
public interest, including revoking the exemption. The FMCSA will
revoke the exemption immediately for failure to comply with its terms
and conditions.

James A. Mullen,
Deputy Administrator.
[FR Doc. 2020-11740 Filed 5-29-20; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register Volume 88, Number 136 (Tuesday, July 18, 2023)]
[Notices]
[Pages 45941-45943]
[FR Doc No: 2023-15126]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-97883; File No. SR-MIAX-2023-26]

Self-Regulatory Organizations; Miami International Securities
Exchange, LLC; Notice of Filing and Immediate Effectiveness of a
Proposed Rule Change To Amend Its Fee Schedule

July 12, 2023.
    Pursuant to the provisions of 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 June 28, 2023, Miami International Securities
Exchange, LLC (``MIAX'' or ``Exchange'') filed with the Securities and
Exchange Commission (``Commission'') a proposed rule change as
described in Items I, II, and III below, which Items have been prepared
by the Exchange. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange is filing a proposal to amend the MIAX Fee Schedule
(``Fee Schedule'') to extend the SPIKES Options Market Maker Incentive
Program (the ``Incentive Program'') until December 31, 2023.
    The text of the proposed rule change is available on the Exchange's
website at https://www.miaxglobal.com/markets/us-options/miax-options/rule-filings, at MIAX's principal office, and at the Commission's
Public Reference Room.

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

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
sections A, B, and C below, of the most significant 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 Fee Schedule to extend the
Incentive Program until December 31, 2023.
    On September 30, 2021, the Exchange filed its initial proposal to
implement a SPIKES Options Market Maker Incentive Program for SPIKES
options to incentivize Market Makers \3\ to improve liquidity,
available volume, and the quote spread width of SPIKES options
beginning October 1, 2021, and ending December 31, 2021.\4\ Technical
details regarding the Incentive Program were published in a Regulatory
Circular on September 30, 2021.\5\ On October 12, 2021, the Exchange
withdrew SR-MIAX-2021-45 and refiled its proposal to implement the
Incentive Program to provide additional details.\6\ In that filing, the
Exchange specifically noted that the Incentive Program would expire at
the end of the period (December 31, 2021) unless the Exchange filed
another 19b-4 Filing to amend the fees (or extend the Incentive
Program).\7\
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    \3\ The term ``Market Makers'' refers to ``Lead Market Makers'',
``Primary Lead Market Makers'' and ``Registered Market Makers''
collectively. See Exchange Rule 100.
    \4\ See SR-MIAX-2021-45.
    \5\ See MIAX Options Regulatory Circular 2021-56, SPIKES Options
Market Maker Incentive Program (September 30, 2021) available at
https://www.miaxglobal.com/sites/default/files/circular-files/MIAX_Options_RC_2021_56.pdf.
    \6\ See Securities Exchange Act Release No. 93424 (October 26,
2021), 86 FR 60322 (November 1, 2021) (SR-MIAX-2021-49).
    \7\ See id.
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    Between December 23, 2021 and March 22, 2023, the Exchange filed
several proposals to extend the Incentive Program, with the last
extension period ending June 30, 2023.\8\ In each of those filings, the
Exchange specifically noted that the Incentive Program would expire at
the end of the then-current period unless the Exchange filed another
19b-4 Filing to amend the fees (or extend the Incentive Program).\9\
The Exchange now proposes to extend the Incentive Program until
December 31, 2023.\10\
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    \8\ See Securities Exchange Act Release Nos. 93881 (December 30,
2021), 87 FR 517 (January 5, 2022) (SR-MIAX-2021-63); 94574 (April
1, 2022), 87 FR 20492 (April 7, 2022) (SR-MIAX-2022-12); 95259 (July
12, 2022), 87 FR 42754 (July 17, 2022) (SR-MIAX-2022-24); 96007
(October 7, 2022), 87 FR 62151 (October 13, 2022) (SR-MIAX-2022-32);
96007 (October 7, 2022), 87 FR 62151 (October 13, 2022) (SR-MIAX-
2022-32); 96588 (December 28, 2022), 88 FR 381 (January 4, 2023)
(SR-MIAX-2022-47); 97239 (April 3, 2023), 88 FR 20930 (April 7,
2023) (SR-MIAX-2023-13).
    \9\ See id.
    \10\ The Exchange notes that at the end of the extension period,
the Incentive Program will expire unless the Exchange files another
19b-4 Filing to amend the terms or extend the Incentive Program.
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    The Exchange proposes to extend the Incentive Program for SPIKES
options to continue to incentivize Market Makers to improve liquidity,
available volume, and the quote spread width of SPIKES options.
Currently, to be eligible to participate in the Incentive Program, a
Market Maker must meet certain minimum requirements related to quote
spread width in certain in-the-money (ITM) and out-of-the-money (OTM)
options as determined by the Exchange and communicated to Members via
Regulatory Circular.\11\ Market Makers must also satisfy a minimum time
in the market in the front 2 expiry months of 70%, and have an average
quote size of 25 contracts. The Exchange established two separate
incentive compensation pools that are used to compensate Market Makers
that satisfy the criteria pursuant to the Incentive Program.
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    \11\ See supra note 5.
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    The first pool (Incentive 1) has a total amount of $40,000 per
month, which is allocated to Market Makers that meet the minimum
requirements of the Incentive Program. Market Makers are required to
meet minimum spread

width requirements in a select number of ITM and OTM SPIKES option
contracts as determined by the Exchange and communicated to Members via
Regulatory Circular.\12\ A complete description of how the Exchange
calculates the minimum spread width requirements in ITM and OTM SPIKES
options can be found in the published Regulatory Circular.\13\ Market
Makers are also required to maintain the minimum spread width,
described above, for at least 70% of the time in the front two (2)
SPIKES options contract expiry months and maintain an average quote
size of at least 25 SPIKES options contracts. The amount available to
each individual Market Maker is capped at $10,000 per month for
satisfying the minimum requirements of the Incentive Program. In the
event that more than four Market Makers meet the requirements of the
Incentive Program, each qualifying Market Maker is entitled to receive
a pro-rated share of the $40,000 monthly compensation pool dependent
upon the number of qualifying Market Makers in that particular month.
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    \12\ See id.
    \13\ See id.
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    The second pool (Incentive 2 Pool) is capped at a total amount of
$100,000 per month which is used during the Incentive Program to
further incentivize Market Makers who meet or exceed the requirements
of Incentive 1 (``qualifying Market Makers'') to provide tighter quote
width spreads. The Exchange ranks each qualifying Market Maker's quote
width spread relative to each other qualifying Market Maker's quote
width spread. Market Makers with tighter spreads in certain strikes, as
determined by the Exchange and communicated to Members via Regulatory
Circular,\14\ are eligible to receive a pro-rated share of the
compensation pool as calculated by the Exchange and communicated to
Members via Regulatory Circular,\15\ not to exceed $25,000 per Member
per month. Qualifying Market Makers are ranked relative to each other
based on the quality of their spread width (i.e., tighter spreads are
ranked higher than wider spreads) and the Market Maker with the best
quality spread width receives the highest rebate, while other eligible
qualifying Market Makers receive a rebate relative to their quality
spread width.
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    \14\ See id.
    \15\ See id.
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    The Exchange proposes to extend the Incentive Program until
December 31, 2023. The Exchange does not propose to make any amendments
to how it calculates any of the incentives provided for in Incentive
Pools 1 or 2. The details of the Incentive Program can continue to be
found in the Regulatory Circular that was published on September 30,
2021 to all Exchange Members.\16\ The purpose of this extension is to
continue to incentivize Market Makers to improve liquidity, available
volume, and the quote spread width of SPIKES options. The Exchange will
announce the extension of the Incentive Program to all Members via a
Regulatory Circular.
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    \16\ See id.
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2. Statutory Basis
    The Exchange believes that its proposal to amend its Fee Schedule
is consistent with Section 6(b) of the Act \17\ in general, and
furthers the objectives of Section 6(b)(4) of the Act \18\ in
particular, in that it is an equitable allocation of reasonable fees
and other charges among its members and issuers and other persons using
its facilities. The Exchange also believes the proposal furthers the
objectives of Section 6(b)(5) of the Act 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 and is not designed to permit unfair discrimination between
customers, issuers, brokers and dealers.
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    \17\ 15 U.S.C. 78f(b).
    \18\ 15 U.S.C. 78f(b)(4) and (5).
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    The Exchange believes that it is reasonable, equitable, and not
unfairly discriminatory to extend the Incentive Program for Market
Makers in SPIKES options until December 31, 2023. The Incentive Program
is reasonably designed because it will continue to incentivize Market
Makers to provide quotes and increased liquidity in select SPIKES
options contracts. The Incentive Program is reasonable, equitably
allocated and not unfairly discriminatory because all Market Makers in
SPIKES options may continue to qualify for Incentive 1 and Incentive 2,
dependent upon each Market Maker's quoting in SPIKES options in a
particular month. Additionally, if a SPIKES Market Maker does not
satisfy the requirements of Incentive Pool 1 or 2, then it simply will
not receive the rebate offered by the Incentive Program for that month.
    The Exchange believes that it is reasonable, equitable and not
unfairly discriminatory to continue to offer this financial incentive
to SPIKES Market Makers because it will continue to benefit all market
participants trading in SPIKES options. SPIKES options is a Proprietary
Product on the Exchange and the continuation of the Incentive Program
encourages SPIKES Market Makers to satisfy a heightened quoting
standard, average quote size, and time in market. A continued increase
in quoting activity and tighter quotes may yield a corresponding
increase in order flow from other market participants, which benefits
all investors by deepening the Exchange's liquidity pool, potentially
providing greater execution incentives and opportunities, while
promoting market transparency and improving investor protection.
    The Exchange believes that the Incentive Program is equitable and
not unfairly discriminatory because it will continue to promote an
increase in SPIKES options liquidity, which may facilitate tighter
spreads and an increase in trading opportunities to the benefit of all
market participants. The Exchange believes it is reasonable to operate
the Incentive Program for a continued limited period of time to
strengthen market quality for all market participants. The resulting
increased volume and liquidity will benefit those Members who are
eligible to participate in the Incentive Program and will also continue
to benefit those Members who are not eligible to participate in the
Incentive Program by providing more trading opportunities and tighter
spreads.

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act.
Intra-Market Competition
    The Exchange believes that the proposed extension of the Incentive
Program to December 31, 2023 would continue to increase intra-market
competition by incentivizing Market Makers to quote SPIKES options,
which will continue to enhance the quality of quoting and increase the
volume of contracts available to trade in SPIKES options. To the extent
that this purpose is achieved, all the Exchange's market participants
should benefit from the improved market liquidity for SPIKES options.
Enhanced market quality and increased transaction volume in SPIKES
options that results from the anticipated increase in Market Maker
activity on the Exchange will benefit all market participants and
improve competition on the Exchange.

Inter-Market Competition
    The Exchange does not believe that the proposed rule changes will
impose any burden on inter-market competition that is not necessary or
appropriate in furtherance of the purposes of the Act because the
proposed extension of the Incentive Program applies only to the Market
Makers in SPIKES Options, which are traded exclusively on the Exchange.

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

    Written comments were neither solicited nor received.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(ii) of the Act,\19\ and Rule 19b-4(f)(2) \20\ thereunder.
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.
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    \19\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \20\ 17 CFR 240.19b-4(f)(2).
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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 (https://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
file number SR-MIAX-2023-26 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-MIAX-2023-26. 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 (https://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
a.m. and 3 p.m. Copies of the filing also will be available for
inspection and copying at the principal office of the Exchange. Do not
include personal identifiable information in submissions; you should
submit only information that you wish to make available publicly. We
may redact in part or withhold entirely from publication submitted
material that is obscene or subject to copyright protection. All
submissions should refer to file number SR-MIAX-2023-26 and should be
submitted on or before August 8, 2023.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\21\
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    \21\ 17 CFR 200.30-3(a)(12).
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J. Matthew DeLesDernier,
Deputy Secretary.
[FR Doc. 2023-15126 Filed 7-17-23; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 88, Number 33 (Friday, February 17, 2023)]
[Notices]
[Pages 10370-10371]
[FR Doc No: 2023-03394]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2023-0002]

Final Flood Hazard Determinations; Correction

AGENCY: Federal Emergency Management Agency; Department of Homeland
Security.

ACTION: Notice; correction.

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SUMMARY: On November 28, 2022, FEMA published in the Federal Register a
final flood hazard determination notice that contained an erroneous
table. This notice provides corrections to that table to be used in
lieu of the erroneous information. The table provided here represents
the final flood hazard determinations and communities affected for
Gallatin County, Kentucky and Incorporated Areas.

DATES: The date of March 21, 2023 has been established for the Flood
Insurance Rate Map (FIRM), and where applicable, the supporting FIS
report showing the new or modified flood hazard information for each
community.

ADDRESSES: The FIRM, and if applicable, the FIS report containing the
final flood hazard information for each community is available for
inspection at the respective Community Map Repository address listed in
the tables below and will be available online through the FEMA Map
Service Center at https://msc.fema.gov by the date indicated above.

FOR FURTHER INFORMATION CONTACT: Rick Sacbibit, Chief, Engineering
Services Branch, Federal Insurance and Mitigation Administration, FEMA,
400 C Street SW, Washington, DC 20472,<PHONE_NUMBER>, or (email)
[email protected]; or visit the FEMA Mapping and Insurance
eXchange (FMIX) online at https://www.floodmaps.fema.gov/fhm/fmx_main.html.

SUPPLEMENTARY INFORMATION: The Federal Emergency Management Agency
(FEMA) makes the final determinations listed below for the new or
modified flood hazard information for each community listed.
Notification of these changes has been published in newspapers of local
circulation and 90 days have elapsed since that publication. The Deputy
Associate Administrator for Insurance and Mitigation has resolved any
appeals resulting from this notification.
    This final notice is issued in accordance with section 110 of the
Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR part
67. FEMA has developed criteria for floodplain management in floodprone
areas in accordance with 44 CFR part 60.
    Interested lessees and owners of real property are encouraged to
review the new or revised FIRM and FIS report available at the address
cited below for each community or online through the FEMA Map Service
Center at https://msc.fema.gov.
    The flood hazard determinations are made final in the watersheds
and/or communities listed in the table below.

(Catalog of Federal Domestic Assistance No. 97.022, ``Flood
Insurance.'')

Correction

    In the final flood hazard determination notice published at 87 FR
73021 in the November 28, 2022 issue of the Federal Register, FEMA
published a table titled Gallatin County, Kentucky and Incorporated
Areas. This table contained inaccurate information as to communities
affected by the final flood hazard determinations featured in the
table. In this document, FEMA is publishing a table containing the
accurate information. The information provided below should be used in
lieu of that previously published.

(Catalog of Federal Domestic Assistance No. 97.022, ``Flood
Insurance.'')

Michael M. Grimm,
Assistant Administrator for Risk Management, Federal Emergency
Management Agency, Department of Homeland Security.

------------------------------------------------------------------------
                                             Community map repository
               Community                             address
------------------------------------------------------------------------
            Gallatin County, Kentucky and Incorporated Areas
                         Docket No.: FEMA-B-2185
------------------------------------------------------------------------
City of Glencoe........................  Gallatin County Courthouse, 200
                                          Washington Street, Warsaw, KY
                                          41095.
City of Warsaw.........................  Gallatin County Courthouse, 200
                                          Washington Street, Warsaw, KY
                                          41095.
Unincorporated Areas of Gallatin County  Gallatin County Courthouse, 200
                                          Washington Street, Warsaw, KY
                                          41095.
------------------------------------------------------------------------

[FR Doc. 2023-03394 Filed 2-16-23; 8:45 am]
BILLING CODE 9110-12-P


MEMORANDUM

DATE:		September 18, 2014

TO:		Clean Power Plan for Existing Power Plants; Docket Id: OAR - 2013-0602

FROM:	EPA Region 1

SUBJECT:	September 16, 2014 Meeting with Vermont State Staff Regarding Proposed Clean Power Plan for Existing Power Plants
--------------------------------------------------------------------------------

SUMMARY

      A meeting was held between EPA and the attendees listed below on September 16, 2014 to discuss the proposed Clean Power Plan for Existing Power Plants. Discussion covered applicability definitions and thresholds, particularly for biomass and renewable energy sources.

ATTENDEES (all by phone)
Vermont:
Asa Hopkins
Brian Woods
Doug Elliott
Elaine O'Grady
Kevin Fink
Mary Jo Krolewski
Megan O'Toole

EPA:
Cynthia Greene
Dave Conroy
David Risley
Chris Sherry
Christian Fellner
Gabrielle Stevens
Jenny Noonan
John Moskal
Matt Clouse
Shutsu Wong

Questions from the state are attached.


February 6, 2009

The Honorable Elizabeth Craig

Acting Assistant Administrator for Air

U.S. Environmental Protection Agency

Ariel Rios Building

1200 Pennsylvania Avenue, N.W.

Washington, D.C. 20460

Re: EPA’s Proposed Ban on the Sale or Distribution of Pre-Charged
Appliances, Docket ID No. EPA-HQ-OAR-2007-0163, 73 Fed. Reg. 78705
(December 23, 2008).

EPA’s Proposed Adjustments to the Allowance System for Controlling
HCFC Production, Import, and Export, Docket ID No. EPA-HQ-OAR-2008-0496,
73 Fed. Reg. 78680 (December 23, 2008).

Dear Ms. Craig:

The U.S. Small Business Administration’s (SBA) Office of Advocacy
(Advocacy) submits the following comment on the Environmental Protection
Agency’s (EPA) proposed rule, Protection of Stratospheric Ozone: Ban
on the Sale or Distribution of Pre-Charged Appliances (“pre-charged
ban”). Beginning on January 1, 2010 (“deadline”), the proposed
rule would ban the sale or distribution of air-conditioning and
refrigeration appliances containing HCFC-22, HCFC-142b, or blends
containing one or both of these substances.  The rule would also extend
to air-conditioning and refrigeration appliances that are suitable only
for use with newly produced HCFC-22, HCFC-142b, or blends containing one
or both of these controlled substances (“restricted refrigerants”).

Advocacy applauds EPA for issuing prompt clarifications about the
pre-charged ban in response to concerns raised by stakeholders about
servicing equipment that use restricted refrigerants.  Advocacy
encourages EPA to incorporate those provisions in the final rule,
clarifying: (1) that uncharged components manufactured after 2010 that
can be field charged with recycled refrigerant can continue to be
manufactured after the deadline, and (2) that the rule will allow
charged component parts manufactured prior to the deadline to be used in
servicing existing equipment.  However, as discussed below, additional
rule revisions are also warranted to address some remaining small
business issues.

This comment letter also discusses EPA’s related proposed allocation
rule, Protection of Stratospheric Ozone: Adjustments to the Allowance
System for Controlling HCFC Production, Import, and Export, published on
the same day as the pre-charged ban proposed rule.  Advocacy believes it
is necessary to address both proposed rules in this letter because a
proper interpretation of the pre-charged ban proposal requires use of
certain definitions and interpretive language contained in the preamble
of the proposed allocation rule.

We and many others were surprised by EPA’s certification in the
pre-charged ban proposal that this rule would have no effect on small
entities.  However, as explained below, we now understand that EPA meant
that there would be no adverse effect on small entities based on the
assumption that EPA’s proposal would leave no stranded inventory.  In
fact, many small manufacturers, distributors and retailers could incur
significant financial losses unless the EPA revises the proposed rule
and related interpretations of the scope of the ban.  Advocacy agrees
with EPA regarding the need for restrictions on refrigerants in order to
protect stratospheric ozone, and believes the proposals below will offer
adequate flexibility for small entities, while still achieving the goal
of protecting stratospheric ozone.

Office of Advocacy

Advocacy was established by Congress under to Pub. L. 94-305 to
represent the views of small entities before federal agencies and
Congress.  Advocacy is an independent office within SBA, so the views
expressed by Advocacy do not necessarily reflect the views of SBA or the
Administration.

The Regulatory Flexibility Act (RFA), as amended by the Small Business
Regulatory Enforcement Fairness Act, gives small entities a voice in the
rulemaking process.  For all rules that are expected to have a
significant economic impact on a substantial number of small entities,
federal agencies are required by the RFA to assess the impact of the
proposed rule on small businesses and to consider less burdensome
alternatives.

Moreover, Executive Order 13272 requires federal agencies to notify
Advocacy of any proposed rules that are expected to have a significant
economic impact on a substantial number of small entities and to give
every appropriate consideration to any comments on a proposed or final
rule submitted by Advocacy.  Further, the agency must include, in any
explanation or discussion accompanying publication in the Federal
Register of a final rule, the agency's response to any written comments
submitted by Advocacy on the proposed rule.

Advocacy Comments

The Factual Basis for the Proposal’s Certification Is Incorrect; A
Revised Final Rule Can Provide a Proper Foundation for A New
Certification of No Significant Economic Effect

EPA certified that the pre-charged ban “will not have a significant
economic impact on a substantial number of small entities.”  EPA
identified the following categories of businesses affected by the
proposed rule: chlorofluorocarbon gas manufacturers, importers, and
exporters (NACIS Code 325120) and manufacturers and importers of air
conditioners and refrigerators (NACIS Code 333415).  EPA further
explained that, “[t]his proposed rule will not impose any requirements
on small entities.  None of the entities affected by this rule are
considered small as defined by the NACIS Codes listed above.”

Advocacy disagrees with the EPA’s factual basis for the certification:
approximately 90% of businesses that manufacture and import air
conditioners and refrigerators (NAICS codes 333415) have fewer than 500
employees.  The relevant small business size standard is 750 employees,
and therefore, over 90% of the businesses in these two sectors are
considered small businesses.  The proposed rule states there is no
impact, but even if the costs associated with purchasing alternative
refrigerant and manufacturing component costs are only slightly higher
than status quo, the rule will have some economic impact on the
manufacturers, although we agree that this cost would not cause a
significant economic impact.

However, there was no discussion of the potential economic impact of
stranded inventory on retailers and distributors of air conditioners,
refrigerators, and other appliances subject to the pre-charged ban.  The
adverse economic impact to those small entities, as well as
manufacturers, could be quite high due to stranded inventory that could
not be sold to the ultimate consumer by the deadline.  Either retailers
and distributors would have to absorb the inventory costs, or
manufacturers would be left with equipment they can no longer sell.

Advocacy now understands that EPA’s intent was to prevent any
significant stranded inventory problem, and thus assumed there were no
inventory related costs, and no adverse impacts on retailers and
distributors.  Indeed, EPA stated in the preamble that the January 2010
date was chosen “to provide adequate planning time for the various
stakeholders to take actions to permit for a smooth transition.”  If
the final rule achieves EPA’s intent of eliminating inventory related
costs, then EPA could properly certify the rule as having no significant
cost on affected small businesses of all types.  EPA should revise its
factual foundation for the certification in the final rule.  In
conclusion, while the agency failed to provide a factual foundation for
the proposal, Advocacy agrees that, with a solution to the stranded
inventory problem, the final rule can be properly certified.

EPA should allow sale and distribution of air conditioning and
refrigeration units that were placed into initial inventory prior to
January 1, 2010.

Advocacy endorses exemptions to the “interstate commerce” ban that
would allow the continued sale of products subject to the pre-charged
ban beyond the deadline if the items were manufactured prior to January
1, 2010.  Otherwise, the pre-charged ban could have adverse effects
reaching beyond the air-conditioning and refrigeration industry to
retailers, distributors, and manufacturers of products that incorporate
such products (e.g. boat manufacturers).

The air-conditioning business is seasonal, and many purchasing and
manufacturing decisions for summer 2009 have already been finalized.  We
have been informed by small entity representatives that manufacturers,
distributors and retailers virtually all understood that products could
be manufactured through December 31, 2009.  Retailers and manufacturers
with leftover inventory should be allowed to sell their inventory to
mitigate any harmful effects on the industry, as EPA apparently
intended.  Advocacy encourages EPA to adopt a grandfathering provision
for air-conditioning and refrigeration appliances and components
containing restricted refrigerants manufactured prior to January 1,
2010, that are placed in initial inventory prior to the deadline.

Definition of manufactured

Advocacy disagrees with EPA’s new proposed interpretation of when
air-conditioning and refrigeration appliances and components are
considered “manufactured.”  EPA puts forward a narrow definition of
“manufactured” in the allocation proposed rule: an appliance is
considered to be “manufactured” at the point it becomes “a
stand-alone piece of equipment,” ready to function for its purpose.
As a result, EPA considers some appliances, such as those used in
commercial and industrial process refrigeration, to be
“manufactured” at the installation site: at the point when all the
components are installed, the refrigerant loop is completed, and the
devices are fully charged with refrigerant.

Advocacy believes that for split systems (e.g., an air handler and a
compressor unit), the completion of a refrigerant loop, or the on-site
adjustment of equipment to its proper charge should not be considered
the date of manufacture of the appliance.  Advocacy would argue that
these actions should be considered service or installation activities,
rather than manufacturing.  Even though installation of these component
appliances may be a more complex process, the actual manufacture of each
component appliance should be the date when the appliance component left
the manufacturer and entered initial inventory, regardless of the
complexity of installation.  This comports with the conventional
understanding of the word “manufacturing.”

Advocacy asks EPA to use the same language adopted in the 2001
Reconsideration of the 610 Nonessential Products Ban for class I
refrigerants so that the items are considered “manufactured” once
they enter the initial inventory at the manufacturing site.  The 2001
rule gives a definition of initial inventory that is compatible with
common industry usage: the date “that the original product has
completed all its processes and is ready for sale by the
manufacturer.”  EPA has used shipping forms, lot numbers, manufacturer
date stamps or codes, invoices, or the like to determine proof of the
date of manufacture, and Advocacy would urge a similar objective
approach for all appliances subject to the pre-charged ban.  EPA’s new
definition would conflict with the conventional understanding of
“manufacturing” and contribute to unnecessary confusion.

Exemptions from the pre-charged ban

Manufacture of component parts containing very small initial charge for
servicing equipment

Advocacy understands that EPA is open to considering an exemption to
allow some small pre-charged units (TXV valves and other equipment as
industry may suggest) to continue to be manufactured beyond 2010 if the
industry can show that it is not cost-effective or practical to
manufacture such item as an uncharged component.  Advocacy asks that EPA
allow exemptions for these units in order to ensure an adequate
inventory of component parts available to service equipment manufactured
prior to January 1, 2010.

	Prior existing contracts or plans for equipment subject to the
pre-charged ban

In order to minimize the adverse economic effects of the pre-charged
ban, Advocacy also suggests that the  EPA: (1) make exemptions for
binding contracts for the purchase of equipment made prior to the
deadline but for economic or other reasons cannot be delivered until
after 2010, and (2) provide an exemption for construction projects that
have received building code approval of plans that include equipment
subject to the pre-charged ban but will not be completed until the
pre-charged ban is in effect.  In this current economic climate, we
expect that this would be a significant problem.  These exemptions are
necessary to achieve EPA’s expressed goal of avoiding stranded
inventory.  Without these exemptions, EPA would jeopardize the RFA
certification of no significant economic impacts on small entities.

Conclusion

Advocacy believes that EPA’s current certification is improper because
its stated factual basis is incorrect.  However, a revised final rule
incorporating Advocacy’s suggested changes may be properly certified
as posing no significant economic impact on small entities.

Advocacy recommends that EPA address the following issues:

interpret “manufactured” as “the date in which the appliance is
placed in initial inventory, where the original product has completed
all of its manufacturing processes and is ready for sale by the
manufacturer,” a definition consistent with both industry practice and
prior EPA and DOE rulemakings;

allow continued production of certain small units containing de minimis
levels of restricted refrigerant after the deadline if it is not
practical or cost-effective to manufacture these items with no charge;
and

provide exemptions from the pre-charged ban where plans to use
restricted refrigerants were in place before the ban.

Thank you for the opportunity to comment on this proposed rule. Please
feel free to contact me or Kevin Bromberg at<PHONE_NUMBER> (or
HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>) if
you have any questions or require any additional information.

Sincerely,

Shawne C. McGibbon

Acting Chief Counsel for Advocacy

Kevin Bromberg

Assistant Chief Counsel for Advocacy

Anna S. Rittgers

Mercatus Fellow, Office of Advocacy

cc: Kevin Neyland, Acting Administrator

Office of Information and Regulatory Affairs

Office of Management and Budget

ENDNOTES

Page   PAGE  2  of   NUMPAGES  7

 73 Fed. Reg. 78705 (Dec. 23, 2008).

 Ibid.

 Ibid.

 73 Fed. Reg. 78680 (Dec. 23, 2008).

 5 U.S.C. § 601 et seq.

 Pub. L. 104-121, Title II, 110 Stat. 857 (1996) (codified in various
sections of 5 U.S.C. § 601 et seq.).

 Executive Order No. 13,272, 67 Fed. Reg. 53,461 (Aug. 13, 2002).

 73 Fed. Reg. 78714 (Dec. 23, 2008).

 Ibid.

 Ibid.

 Ibid.

 Out of 720 total firms, 633 have fewer than 500 employees.  Employer
Firms, & Employment by Employment Size of Firm by NAICS Codes, 2006.
HYPERLINK "http://www.sba.gov/advo/research/us06_n6.pdf"
http://www.sba.gov/advo/research/us06_n6.pdf

 73 Fed. Reg. 78710 (Dec. 23, 2008).

 73 Fed. Reg. 78714 (Dec. 23, 2008).

 Advocacy asks EPA to use an approach similar to that found in 40 CFR
Part 82, subpart C.

 73 Fed. Reg. 78699 (Dec. 23, 2008).

 66 Fed. Reg. 57520 (Nov. 15, 2001).


Twentieth Annual EPA Conference May 1997 8  27 MR. TELLIARD: Our next speaker is Henry Kahn. Henry is Chief of the Statistical Branch Group with the Office of Science and Technology. Henry is my counterpart in statistics. Henry is going to talk to you today about alternative estimates of detection and quantitation.

ALTERNATIVE ESTIMATES OF DETECTION Henry D. Kahn and Charles E. White U. S. Environmental Protection Agency Kathleen Stralka and Raphael Kuznetsovski Science Applications International Corporation ABSTRACT This paper considers alternative procedures for estimation of detection levels based on some modifications of procedures contained in the EPA Method Detection Limit ( MDL) described in 40 CFR, Part 136, Appendix B. Also discussed is measurement precision and its central role in determining detection levels. Difficulties associated with precision estimates based on a calibration relationship are illustrated. The MDL procedure uses estimates of measurement precision determined by replicate measurements in the low concentration range. The modifications of the MDL procedure considered here are specified in the procedure as optional steps and result in enhanced estimates of measurement precision used in determining detection levels. These optional steps are rarely, if ever, used in current practice. The procedures are illustrated using data generated by EPA Method 1638 for the determination of trace elements by inductively coupled plasma mass spectrometry. These data demonstrate the pattern typical of much chemical analytical data where the error structure has approximately constant variance in the low concentration range and proportional variance ( i. e., variance increasing with concentration) at higher concentrations. The Rocke Lorenzato model for this relationship will be used in evaluating the results of implementing the MDL optional steps which demonstrate that the procedures yield MDL values in the low concentration range where error variance is effectively constant.

___________________________________________________________________________________ Presented at the 20th Annual Conference on Analysis of Pollutants in the Environment, May 7 8, 1997, Norfolk, Virginia Twentieth Annual EPA Conference 8  28 May 1997 ALTERNATIVE ESTIMATES OF DETECTION Henry D. Kahn and Charles E. White U. S. Environmental Protection Agency Kathleen Stralka and Raphael Kuznetsovski Science Applications International Corporation INTRODUCTION A number of different procedures are available for determining detection levels for chemical analytical measurements. The US Environmental Protection Agency ( EPA) has promulgated a procedure for determining detection limits, referred to as a Method Detection Limit ( MDL) and described in 40 CFR, Part 136, Appendix B, that has become widely used. The key to determining detection level values is the precision of measurement ( defined as the standard deviation of replicate measurements at a given concentration) in the low concentration range, i. e., near and at zero. One of the advantages of the EPA procedure is that it provides step by step process for determining precision. In this paper, we will address the following: measurement precision as an important characteristic of an analytical method; statistical models of precision; the relationship between precision and alternative methods for determining detection levels; illustration of the estimation of detection levels with some inductively coupled plasma mass spectrometric ( ICPMS) metals data using the EPA MDL procedure and the Rocke Lorenzato model.

MEASUREMENT PRECISION Measurement precision is defined as the degree of agreement among replicate analyses of a sample. This degree of agreement is expressed as the standard deviation of the replicates. An understanding of the precision associated with an analytical procedure is fundamental to the evaluation of the capabilities of the procedure. This is especially true with regard to establishing detection levels. The manner in which precision varies with concentration being measured is sometimes referred to as " error structure" of the test method. This is discussed by Caulcutt and Boddy ( 1983) who distinguish between a constant precision method where the standard deviation of measurement is constant throughout the range of measurement and an decreasing precision method where the standard deviation is directly proportional to the concentration being measured and thus increases or decreases as the concentration increases or decreases, respectively.

Unfortunately, the description of error structure by Caulcutt and Boddy ( 1983) does not consider what has become recognized as a common type of error structure, i. e., one in which precision is effectively constant in the low concentration region near zero and then becomes proportional to concentration ( i. e., measurement variability increases) as concentration increases. Most EPA chemical analysis methods are expected to exhibit such a combined error structure. Therefore, the estimated precision in the range near zero is critical to establishing detection and quantification levels. The adoption of the proportional error model without proper consideration of the behavior near zero implies, incorrectly, that error decreases to zero as concentration decreases. Failure to recognize the combined error structure can lead to difficulties as the following example from Gibbons ( 1994), and repeated in Gibbons ( 1995), illustrates. Twentieth Annual EPA Conference May 1997 8  29 Figure 1: Standard Deviations of Replicates Versus Benzene Spike Concentrations, Observed Standard Deviations and Estimated Standard Deviations from Weighted Regression by Gibbons ( 1994, 1995). Gibbons used a weighted regression analysis to estimate a calibration relationship for benzene. He then used the residual variance from the regression relationship to estimate the error variance over the calibration range, extrapolated the variance to the low concentration range [ more than two orders of magnitude below the range of the observed data] and took the square root to estimate the standard deviation. The results of this are shown in Figure 1 which displays the observed standard deviations and the estimated standard deviation relationship as reported by Gibbons. In the Figure, circles indicate standard deviations modeled ( i. e., not observed) while the dots indicate standard deviations estimated from actual replicate sample measurements made at spike concentrations. The Figure is rather striking; it shows clearly that the observed data and the values determined by the model do not match. The observed data suggest a concave curve, bending toward an intersection with the vertical axis at a positive value at zero concentration, which is consistent with the combined error structure model. The modeled data, in contrast, have a convex shape with the extrapolated values curving down to zero. Indeed, the curvature becomes quite extreme in the low concentration region where the values were extrapolated outside the range of the observed data.

Since the MDL is determined as the product of the standard deviation and a constant that depends only on the number of replicates, the modeled results shown in Figure 1 were used as the basis for criticism of EPA's MDL procedure. The criticism alleges that the MDL facilitates the development of arbitrarily low detection levels. Noting the decrease in the standard deviations extrapolated to low concentrations, Gibbons ( 1994) states that " low published MDLs can be achieved only by spiking at lower and lower concentrations, regardless of their relationship to the true MDL.". The same data and estimated relationship were used to support similar assertions in Gibbons ( 1995). Inspection of Figure 1, however, demonstrates that the data, unlike the extrapolated model, do not support these assertions. Twentieth Annual EPA Conference 8  30 May 1997 We emphasize that the data shown in Figure 1 were obtained directly from tables in the two sources cited; i. e., the reported values were not manipulated or adjusted to obtain the results shown in the plot. An appropriate model for precision of measurement might have avoided the difficulty demonstrated by the modeled results shown in the plot. This is discussed in the next section.

Statistical Models of Precision Statistical models of precision of measurement must represent a range of observed behavior. Traditional, uncomplicated models of precision, such as the constant precision model throughout the range of measurement or precision as a simple linear relationship with concentration are rarely, if ever, realized empirically over a wide range of concentration. This is illustrated by the problems cited in Gibbons ( 1994 and 1995) A new approach proposed by Rocke and Lorenzato ( 1995) models precision of measurement as comprised of two error components, one additive and one multiplicative. The Rocke Lorenzato ( R L) model has a number of appealing features: 1) it allows data near zero to determine the estimated standard deviation near zero and the data at large concentrations determine the standard deviation at large concentrations; 2) it allows for data at large concentrations to be lognormal which is often observed; and 3) it has a credible physical interpretation. The R L model is y = x exp0 + ,

where: y = measured concentration x = true concentration 0 = multiplicative error ~ N( 0, F 0 2) , = additive error ~ N ( 0, F, 2 ).

The standard deviation of the model is given by S( x) = [ F, 2 + x2exp( F 0 2) { exp( F 0 2)  1}] ½ .

The standard deviation is easier to work with if we define A0 = F, 2 and A1 = exp( F 0 2) { exp( F 0 2)  1}

so that S( x) = [ A0 + A1 x2 ] ½ .

The use of this model to illustrate the determination of detection levels will be described below. Twentieth Annual EPA Conference May 1997 8  31 Methods for Determination of Detection This section will present a brief summary of four alternative methods for determining detection levels. All are similar functionally and all require estimates of precision at zero or low, near zero concentrations.

Currie ( 1995) IUPAC Pure and Applied Chemistry:

" The decision ` detected' or ` not detected' is made by comparison of the estimated quantity with the Critical Value LC of the respective distribution, such that the probability of exceeding LC is no greater than " if the analyte is absent ( L= 0, null hypothesis)"

LC = t1",< s0 In this definition, t1",< is the value of a t statistic with < degrees of freedom and s0 is an estimate of the standard deviation of measurement at zero concentration.

Rocke Lorenzato ( 1995) Technometrics:

" 3.1 Detection Limits: ... observations at true concentration .. zero are normally distributed with standard deviation F,. If r replicates are used, then any average of measured values greater than D is unlikely to have come from a zero concentration sample."

D = 3 F, / or American Chemical Society [ ACS] ( 1983) Analytical Chemistry:

" The limit of detection ( LOD) is defined as the lowest concentration level that can be determined to be statistically different from a blank." The recommended value of LOD is 3 F where F is the standard deviation of blank measurements.

US EPA ( 1984):

The US EPA method detection limit ( MDL), described in 40 CFR Part 136, Appendix B, was first promulgated as an EPA procedure in the Federal Register in 1984. The MDL is based on the procedure described in Glaser et al ( 1981) which defines the MDL as MDL = t0.99,< s where t0.99,< is the 99th percentile point of the t distribution with < degrees of freedom and s is an estimate of the standard deviation of measurement at a low concentration level. The MDL procedure provides a step by step procedure for selecting concentration levels at which replicate measurements are made that are the basis for the estimated standard deviation and the number of degrees of freedom for the t statistic. For the recommended 7 replicates, < = 6 and t0.99,6 = 3.14. Twentieth Annual EPA Conference 8  32 May 1997 These four methods for determining detection levels are similar. Operationally, the objective is to provide some level above background at which it is possible to decide that an analyte is present in a sample. This is implemented by specifying a multiple of the standard deviation of measurement at or near zero concentration and determining an estimate of that level using chemical measurements generated for that purpose. The Currie, R L, and ACS estimators require estimates of the standard deviation at zero while the EPA procedure allows for the use of a standard deviation estimated at a level that is usually greater than zero.

The EPA procedure, in fact, has a number of advantages over the other procedures that include the following: the EPA procedure is stated in a straight forward, step by step manner that many chemists find easy to follow; objective procedures are provided for selecting initial spike concentrations at which standard deviation estimates are generated and optional iterative steps are provided that result in improved estimates of standard deviations and detection levels. The advantages associated with the EPA procedure can be quite significant especially in cases where it is not feasible to obtain measurements directly on blank or zero concentration samples. Under the assumption that the R L model, or a similar model, is an appropriate representation of measurement error, the EPA procedure provides a conservative estimate of detection capabilities. That is, if measurement error increases with concentration, the EPA procedure should tend to result in somewhat larger estimates of detection levels in comparison with procedures that utilize an estimate of the standard deviation at zero.

MEASUREMENT VARIATION FOR METHOD 1638 The MDL procedures will be illustrated using replicate measurement data at low spike concentrations using draft EPA Method 1638: Inductively coupled plasma mass spectrometry for metals. Method 1638 was used to generate replicate measurements for a number of metals at low spike concentrations. For each metal, seven replicate measurements were made at 12 concentrations, from zero to 25,000 parts per trillion. As shown in Figure 2, the variation among replicate measurements does not increase in a linear relationship to the spike concentration. The use of the semi log scale in Figure 2 provides a plot of the relationship that allows for a clear picture of the relationship between standard deviation and concentration. As hypothesized by Glaser et al. ( 1981) in the development of the MDL, measurement variation appears to be approximately constant for spike concentrations in a neighborhood near zero. This apparent relationship between measurement and variation is consistent conceptually with the Rocke and Lorenzato ( 1995) two component model described above.

MDL PROCEDURE Key features of the EPA MDL procedure, of direct relevance to the discussion in this paper, are described in summary form in this section. Complete descriptions of the procedure are given in EPA ( 1995) and Glaser et al. ( 1981).

Selection of Concentrations Selection of analyte concentrations at which to determine initial estimates of the detection level are critically important. The initial estimate of the detection level is used as the concentration at which samples are spiked and replicate measurements made to estimate the precision used in the determination of the MDL. The rules in the MDL Procedure for selecting initial spiking concentration are as follows: Twentieth Annual EPA Conference May 1997 8  33 a. The concentration value that corresponds to an instrument signal/ noise in the range of 2.5 to 5.

b. The concentration equivalent of three times the standard deviation of replicate instrumental measurements of the analyte in reagent water.

c. The region of the standard curve where there is a significant change in sensitivity, i. e., a break in the slope of the standard curve.

d. Instrument limitations.

In our opinion, the most objective of these is Rule b. ( which corresponds to 1. b. in EPA [ 1995]). Replicate measures at zero concentration were available for the ICPMS data so the standard deviation of these measurements was used as the basis for the initial estimates of the MDL. Subsequent estimates of the standard deviation required by the MDL procedure were determined by the Rocke Lorenzato model for standard deviation as a function of concentration fit to the ICPMS data. The procedure is described briefly below.

MDL Iteration Procedure The MDL procedure uses an iteration routine to proceed to a final value for the MDL. The iterative steps are summarized below in order:

1. S0 = standard deviation of replicates at 0 ( rule b., above);

2. MDL0 = 3 S0 = initial MDL estimate;

3. S1 = estimate of standard deviation based on 7 replicates at MDL0 ;

4. MDL1 = 3.14 S1 = MDL, where 3.14 is the 99th percentile value of the t distribution with 6 degrees of freedom;

5. If 1< MDL1 / MDL0 < 5, then go to step 6. If this inequality is not satisfied, then repeat initial MDL concentration selection process, i. e., assess S0 and other rules for concentration selection described above and obtain new replicate measurements;

6. S2 = estimate of standard deviation based on 7 replicates at MDL1;

7. If S2 2 / S1 2 < 3.05 ( i. e., an F statistic comparison of S2 2 and S1 2 ), then S = /{[ S1 2 + S2 2 ]/ 2} and MDL2 = 2.68 S , where 2.68 is the 99th percentile value of the t distribution with 12 degrees of freedom; and MDL = MDL2.

8. If S2 2/ S1 2 $ 3.05 then MDL1 = 3.14 S2 . Twentieth Annual EPA Conference 8  34 May 1997 9. S2 2 is redesignated as S1 2 and reiterate steps beginning at Step 6.

Currently, steps 6, 7, 8 and 9, are designated in the MDL procedure as optional steps and are rarely implemented. Typically, the MDL is determined by Step 4 if the condition in Step 5 is satisfied. In actual practice, implementation of the MDL procedure would require generation of replicate measurements at concentrations determined by MDL0 and MDL1 in order to generate estimates S1 and S2, respectively. In this study, the required estimates, S1 and S2, were determined by a Rocke Lorenzato model fit to the ICPMS data. That is, the parameters of the Rocke Lorenzato model ( A0 and A1 , defined above) for standard deviation of measurement as a function of concentration were estimated from the ICPMS data and the estimates S1 and S2 required for the MDL procedure were calculated from the estimated model and the concentrations generated in Steps 2 and 4. This requires that the Rocke Lorenzato model provides an adequate fit to the observed data. For the ICPMS data, we were able to obtain satisfactory fits to the data using weighted least squares to estimate the parameters. In general, the fit of the estimated models was satisfactory, especially in the critical low concentration range. This is illustrated in Figure 3 which shows the estimated parameters and plots of the fits for weighted least squares, non linear least squares and maximum likelihood estimates of the parameters for Pb206. The use of the MDL procedure with standard deviations estimated from the model is illustrated in Figure 4 for the Pb206 data and the model parameters estimated with weighted least squares. A summary of similar results for all the ICPMS data and plots for all the metals are contained in SAIC ( 1997) " Summary of statistical evaluations of data on the measurement of selected metals by inductively coupled plasma mass spectroscopy using EPA Method 1638". Twentieth Annual EPA Conference May 1997 8  35 Figure 2: Standard Deviations of Replicate Measurements at Low Concentrations, EPA's ICP/ MS Data. Twentieth Annual EPA Conference 8  36 May 1997 Measurement Precision at the MDL Components of measurement precision at a given concentration may be evaluated using the estimated Rocke Lorenzato model. That is, assuming the model provides a satisfactory fit to data on precision as a function of concentration, the fitted model can be used to evaluate the relative contributions of the constant error term and the proportional error term to the overall error at any given concentration. Of particular interest are the components of error at the MDL.. Any value selected as a detection criterion should be in a concentration range where error is effectively constant. The MDL procedure is intended to result in such a value. This is implied as a property of the MDL in the discussion in Glaser et al. ( 1981). Also, this corresponds to the discussion of detection in Rocke Lorenzato ( 1995) in which a detection level is defined only in terms of , the precision of measurement at zero. Using the estimated Rocke Lorenzato model, it is possible to evaluate the components of the error at the MDL values obtained through application of the EPA procedure. This may be done as follows:

Let a0 and a1 denote estimated values of A0 and A1, respectively, and let denote the estimated standard deviation of the Rocke Lorenzato model for a given spike concentration . Then, for x = MDL, define and which measure the relative proportions of the contribution of and through their representations as functions of and , respectively, at the MDL. In effect, T 0 = percent of s( MDL) due to proportional error and T, = percent of s( MDL) due to constant error.

DISCUSSION The statistics and were evaluated for each of the metals in the ICPMS data for each method of estimating and , i. e., weighted least squares ( WLS), nonlinear least squares ( NLS) and maximum likelihood estimates ( MLE). The results are summarized in the following table. In general, for all of the ICPMS metals, weighted least squares estimates provided the best fit of the data to the R L model in comparison to nonlinear least squares and maximum likelihood. Weighted least squares was also the least complicated to implement computationally. Maximum likelihood did not perform well generally due to numerical problems with the computer routines used to solve for the maximum likelihood estimates in some cases. These results are discussed in SAIC ( 1997). As discussed by Rocke and Lorenzato ( 1995), computation of the maximum likelihood estimates requires nonlinear minimization over several parameters for each calculation of the integrand in the product of n improper integrals. As a consequence, it is not surprising that the maximum likelihood estimates would be more sensitive to computational difficulties. This does not detract from the theoretical validity and importance of the maximum likelihood approach. In fact, this indicates that additional investigation of maximum likelihood estimation for this problem should be pursued. Twentieth Annual EPA Conference May 1997 8  37 The results in the Table provide an indication of the degree to which measurement precision at the MDL is determined by the constant and proportional error components. For the WLS and NLS estimates, the results show a consistent pattern of dominance of the constant error term at the MDL. That is, on average, roughly 97% of the precision at the MDL is determined by the constant term. This is expected because the MDL procedure is intended to result in a detection level at a low concentration where precision is effectively constant. This is an important property for a detection criterion to possess to be useful as an indicator of the presence of an analyte. The fact that this is the case for these data provides support for the use of the MDL procedure. The method described here, using and , is just one approach for evaluating components of measurement precision. There may be other criteria for evaluation of measurement precision that would lead to a different numerical representation of the results. Nevertheless, we believe that, in general, any evaluation based on an appropriate mathematical criterion would lead to similar conclusions. We base this judgment on the observed pattern of the data on precision as a function of concentration and the performance of the MDL procedure which is illustrated in Figure 4.

The results presented here demonstrate the implementation of the MDL procedure with the additional optional steps. The procedure was illustrated using the Rocke Lorenzato model to determine S1 and S2 and pooling the results to determine the final MDL. The use of the Rocke Lorenzato model and the requirement that the ratio of successive MDL values be between 1 and 5, insures that the final MDL value is between MDL0 and MDL1 because of the strictly increasing nature of the model. The strictly increasing property is due to the multiplicative component of the model which is additive with a coefficient, a1, which is always positive. In actual practice, however, S1 and S2, would be estimated using the seven replicate measurements at the concentrations determined at each step. This, of course, would yield less predictable results than those presented here. However, replicate measurements at an additional concentration, selected according to the rules provided in the procedure and pooling the results, will add statistical precision to the estimate of the standard deviation and a check on the initial MDL determination. In spite of the strictly increasing nature of the standard deviation estimated by the Rocke Lorenzato model, the degree of increase in the low concentration range is expected to be small so that there is a range where the standard deviation is effectively constant. As long as the MDL is based on a standard deviation in this concentration range, the procedure should provide a satisfactory result. The results obtained here suggest that this is the case for the ICPMS data considered. Twentieth Annual EPA Conference 8  38 May 1997 WLS NLS MLE Analyte Ag 107 2.87 97.13 2.93 97.07 10.06 89.94 Cd 111 2.11 97.89 2.27 97.73 9.82 90.18 Cu 63 1.63 98.37 1.83 98.17 10.92 89.08 Ni 60 3.04 96.96 3.10 96.90 86.23 13.77 Pb 206 2.63 97.37 2.74 97.26 12.64 87.36 Pb 207 2.35 97.65 2.48 97.52 12.06 87.94 Pb 208 3.18 96.82 3.30 96.70 8.09 91.91 Sb 123 2.11 97.89 2.21 97.79 7.56 92.44 Se 82 6.43 93.57 6.41 93.59 70.29 29.71 Tl 205 3.41 96.59 3.59 96.41 14.53 85.47 Zn 66 3.13 96.87 3.14 96.86 NA NA Average 2.99 97.01 3.09 96.91 24.22 75.78 TABLE: Percent of estimated measurement precision due to constant and proportional error at estimated analyte specific MDL T, (%) = percent of s( MDL) due to constant error T 0 (%) = percent of s( MDL) due to proportional error WLS = weighted least squares estimates NLS = nonlinear least squares estimates MLE = maximum likelihood estimates Twentieth Annual EPA Conference May 1997 8  39 REFERENCES American Chemical Society Committee on Environmental Improvement. ( 1983) Principles of Environmental Analysis, Analytical Chemistry, V. 55, 2210 2218.

Caulcutt, R. and Boddy, R. ( 1983) Statistics for Analytical Chemists. Chapman and Hall, New York.

Currie, L. A. ( 1995) Nomenclature in evaluation of analytical methods including detection and quantification capabilities, Pure & Applied Chemistry, V. 67, 1699 1723.

EPA ( 1995) Appendix B to Part 136  Definition and Procedure for the Determination of the Method Detection Limit  Revision 1.11, 40 Combined Federal Register, U. S. Government Printing Office, Washington.

EPA ( 1996) Method 1638: Determination of Trace Elements in Ambient Waters by Inductively Coupled Plasma   Mass Spectrometry, Engineering and Analysis Division ( 4303), Washington.

Gibbons, R. D. ( 1994) Statistical Methods for Groundwater Monitoring. Wiley, New York.

Gibbons, R. D. ( 1995) Some statistical and conceptual issues in the detection of low level environmental pollutants, Environmental and Ecological Statistics, Vol. 2, Num. 2.

Glaser, J. A., Foerst, D. L., McKee, G. D., Quane, S. A. and Budde, W. L. ( 1981) Trace Analyses for wastewaters. Environmental Science and Technology, Vol. 15, 1426 35.

Rocke, D. and Lorenzato, S. ( 1995) A Two Component Model for Measurement Error in Analytical Chemistry, Technometrics, Vol. 37, No. 2. Twentieth Annual EPA Conference 8  40 May 1997 R L Model a0: 1.06706321 a1: 0.00009617 s( eps): 1.03298752 s( nu): 0.00980581 F Test: 18.35938648 p value: 0.00159929 log RSS: 7.44184892 Weighted Least Squares Spike Concentration ( log scaled) Fitted Curve 0 10 100 1000 25000 1 108 214 ° °° ° ° ° ° ° ° ° ° °

°°° ° ° ° ° °

°

° °

Fitted Values ( log scaled) Residuals 1 5 10 50  30  10 0 10 20 °°° ° ° ° ° °

°

° °

° ° ° ° ° ° ° ° °

°

° °

Quantiles of Standard Normal Residuals  1 0 1  30  10 0 10 20 ° ° ° ° ° ° ° ° ° ° ° ° a0: 6.40406438 a1: 0.00010445 s( eps): 2.53062529 s( nu): 0.01021944 error: 12.51783357 log RSS: 7.35689372 Nonlinear Least Squares Spike Concentration ( log scaled) 0 10 100 1000 25000 1 108 214 ° °° ° ° ° ° ° ° ° ° °

°°°° ° ° ° °

°

° °

Fitted Values ( log scaled) 5 10 50  30  20  10 0 10 °°°° ° ° ° °

°

° °

° ° ° ° ° ° ° ° °

°

° °

Quantiles of Standard Normal  1 0 1  30  20  10 0 10 ° ° ° ° ° ° ° ° ° ° ° ° a0: 28.53929844 a1: 0.00223586 s( eps): 5.34221849 s( nu): 0.04720596 iter: 32.00000000 log RSS: 13.85397717 Maximum Likelihood Spike Concentration ( log scaled) 0 10 100 1000 25000 1 473 946 ° °° ° ° ° ° ° ° ° ° °

°° ° ° ° ° °

°

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Fitted Values ( log scaled) 5 10 50 500  800  400 0 °° ° ° ° ° ° °

°

°

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Quantiles of Standard Normal  1 0 1  800  400 0 ° ° ° ° ° ° ° ° ° ° ° ° Rocke Lorenzato Model for Standard Deviation vs Concentration Comparison of WLS, NLS, and MLE Fits ICPMS Metals Data Pb 206 with Spike Concentration <= 25000 Figure 3 Estimation results using Weighted Least Squares ( WLS), Non Linear Least Squares ( NLS) and Maximum Likelihood Estimation ( MLE) to fit the Rocke Lorenzato Model for standard deviation vs. concentration using data on Pb206 via ICPMS. Twentieth Annual EPA Conference May 1997 8  41 Standard Deviation MDL * S0 ( 0,0.58) ° ° ° ° ° ° ° ° ° ° °

* S1 ( 1.74, 1.03)

MDL0 * S2 ( 3.24, 1.03)

MDL1 0 1 10 20 50 100 200 500 1000 2000 5000 10000 25000 Spike Concentration ( parts per trillion) 0.1 1 10 100 The R L Parameters: a0= 1.067063 a1= 0.000096 MDL= 2.7693 Procedure for the Determination of the Method Detection Limit adjusted with respect to the Rocke Lorenzato Model Method of Estimation: Weighted Least Squares Analyte: Pb 206 ( Note: Both axes are on a log10 scale.)

AIC ( 1997) " Summary of statistical evaluations of data on the measurement of selected metals by Inductively coupled plasma mass spectroscopy using EPA Method 1638". Figure 4: Illustration of the MDL procedure including optional iterative step with data on Pb206 via ICPMS, standard deviation determined by Rocke Lorenzato model fit using Weighted Least Squares, final MDL value ( at vertical solid line) calculated with S determined by pooling S1 2 and S2 2.

QUESTION AND ANSWER SESSION MR. TELLIARD: Questions?

MR. PHILLIPS: John Phillips, Ford Motor Company. Can you tell me what are the criteria you use for MDL acceptance? Is it a one to five times, the spike concentration must be one to five times the MDL or one to 10? I see a lot of difference from lab to lab.

MR. KAHN: It's one to five. It's not necessarily acceptance, it's part of the procedure, it's in that slide on the iterative steps.

MR. TELLIARD: If the results aren't in the right range, you repeat. Twentieth Annual EPA Conference 8  42 May 1997 MR. PHILLIPS: So, if it's not in one to five range, you have to repeat it?

MR. TELLIARD: Yes.

MR. PHILLIPS: Correct?

MR. KAHN: Yes.

MR. TELLIARD: Right.

MR. PHILLIPS: Can you tell me, you did 12 different concentrations in the study that you did at the ICPMS?

MR. KAHN: Right.

MR. PHILLIPS: Did you try and compute MDLs at each of those different concentrations, and if so, can you tell me what the range of MDLs was?

MR. KAHN: No, we didn't do that. But actually, if you can get the slides up that have the data with the plots of the standard deviations versus concentration, either the small multiples or the thallium example. What you see there is a fairly large range of where the standard deviation is constant, or effectively constant.

MR. PHILLIPS: Yes.

MR. KAHN: No, not that one.

MR. TELLIARD: The one with all the little graphs on it.

MR. KAHN: All the little plots there. So, what that means is, if you're in this range, in that low concentration range, the range where measurement variability is effectively constant, you're going to get roughly the same MDL.

MR. PHILLIPS: Now, this works for metals, but how about chromatographic data, where you don't have random positive and negative noise?

MR. TELLIARD: We didn't...

MR. KAHN: We haven't done that, although that's something that we should do, it's something I want to do.

MR. TELLIARD: He keeps telling me we're going to do more.

MR. KAHN: I keep telling Bill we've got to generate more data. But seriously, this is a very serious point. If you want to know what the error structure is like, and that's the term often used to characterize these kinds of data, error structure. If you want to know what it's like, you've got to take data in that range. You don't extrapolate models out of that range. Spend the money, go through the effort... Twentieth Annual EPA Conference May 1997 8  43 MR. PHILLIPS: Yes, I'd probably generated over 1,000 of these types of curves in the last year. Much of it looking at metals data. I would say that it usually follows the Rocke Lorenzato or exponential fit to the data. But if you determine MDLs at each of those points, you get widely varying results, many of which are acceptable for the MDL protocol. As a matter of fact, it's sometimes many orders of magnitude difference in an MDL determination, at each of those different points, with the seven replicates. That's, I think, why it was referenced as an unanchored statistic, because you can get almost any number you want, depending on which data point you choose there.

MR. TELLIARD: Not if you follow the spiking level that you're supposed to start with.

MR. PHILLIPS: I'm saying that's all within the spiking level that's in the protocol.

MR. KAHN: Yes, but you're supposed to use, I mean that's the point of specifying, those initial spike level determinations. I'm not saying that there's no variation, that you're not going to get any variation, you will get some variation and it's also possible that that should be accounted for, as we consider modifications to the MDL procedure. The point of what we were doing here was to evaluate the current MDL procedure and the optional iteration scheme that's in the current method with an objective measure of the intial spike level.

MR. TELLIARD: Andy?

MR. EATON: Henry, Andy Eaton, Montgomery Watson Labs. Two comments pertaining to the data that's up there. If you look at that data and the fact that you do have a relatively flat standard deviation, the whole argument for iterative and going down until you get to two to five times the expected signal to noise ratio, maybe irrelevant because you've got cases there where presumably you're already flat at well above the two to five times, and therefore it calculates out fine, although I concur that you should keep going to look. Second thing, the one thing that's not in the EPA MDL protocol, and was something that we did build into the requirements for the information collection rule, is to gather that data at multiple concentration... or at multiple runs over multiple days. So, you're really looking at your overall precision and not the precision that you get when you do seven replicates right in a row.

MR. TELLIARD: It hasn't been the function to do that. You know, we're going to put this thing back out there in the late summer and we'll make some changes, but I don't think that will be one of them. It doesn't prohibit it, is one of our answers on that. I don't think it buys a lot for you at the bench, when you're trying to do this thing, to do it that way.

MR. KAHN: I mean, if you have control over, if you have good control over your measurement process, the fact that you do it at different days, shouldn't make that much of a difference. If it does, I would say somehow you've lost control of the process.

MR. TELLIARD: We're losing control of the time. One quick question.

MR. MADDALONE: Could we... this is Ray Maddalone, TRW. Would you move that slide up a little bit? I didn't see it from the back. What's the scale on the standard deviation there? It's zero to 100 to 200. I wondered, if you'd move that up a bit and saw what the standard of deviation really looks like at those low levels, what sort of variability we would actually be seeing and what would be the numbers for the MDL. Also, I'd like to see that first chart that was referenced to Gibbons, where they showed the real data versus the Gibbons model. Twentieth Annual EPA Conference 8  44 May 1997 MR. TELLIARD: Can we do this later? We're running out of time.

MR. MADDALONE: I just wanted to make, just ask Henry a question about that. Did you actually calculate with the real data, not with the Gibbons model data, which you objected to. Did you take those data points that were the real data points and calculate the range of MDLs from them?

MR. KAHN: No, we did not.

MR. MADDALONE: Thank you.

MR. KAHN: The question there was whether the data fit the model. Clearly the data do not fit the model Gibbons was using. If the data don't fit the model, conclusions based on the model are suspect.

MR. TELLIARD: Harry?

MR. MCCARTY: Real briefly, Bill, I'll amplify what Andy Eaton said. I'm the person who looked at the MDL studies from over 300 ICR labs for up to 17 analytes. Three days makes a difference. The other comment I didn't make, Bill Draper's presentation yesterday, most of the labs submitting data can't calculate an MDL, because they're using a spread sheet that uses the wrong sigma value. The sigma sub N, not sigma sub N 1. If you take that variation out, you're accounting for not the orders of magnitude, that Bill was talking about, but you're talking, you know, in some cases, 20 to 25 percent, just in the variability you'll see across the lab.

But Henry, I would suggest you get in touch with the ICR brethren you have there at the agency. All that data is available, much of it is in fact in electronic format and you could pull together a fair number of MDL studies in a limited range of concentrations, because the ICR did say spike somewhere in this range. There are good data, if you will, done over three days, the way it was requested. There are bad data done on a single day or two days, you may be able to make some of those comparisons. But for all the effort that was put into looking at this, there's a hell of a lot of data out there and it would be nice to be able to use it.

MR. TELLIARD: Thank you, Henry.


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

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[Federal Register: August 18, 2006 (Volume 71, Number 160)]
[Notices]
[Page 47796]
[DOCID:fr18au06-68]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. EL04-134-005; EL05-15-007]

Entergy Texas Arkansas; Notice of Filing

August 14, 2006.
    On June 27, 2006, East Texas Electric Cooperative, Inc. and Entergy
Arkansas, Inc. (EAI) filed a settlement agreement in the above
proceeding, resolving issues in dispute relating to EAI's Refund Report
originally filed on January 23, 2006. By this notice, comments on the
settlement agreement should be filed on or before August 28, 2006.

Magalie R. Salas,
Secretary.
[FR Doc. E6-13628 Filed 8-17-06; 8:45 am]

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