[Federal Register: November 3, 2009 (Volume 74, Number 211)]
[Notices]
[Page 56856-56857]
[DOCID:fr03no09-72]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0519]

Public Workshop: International Conference on Harmonisation S2
Genetic Toxicology Issues; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public
workshop entitled ``ICH S2 Genetic Toxicology Issues.'' The 1-day
public workshop is intended to seek constructive input from experts in
the field of genetic toxicology on proposed changes to the
International Conference on Harmonisation (ICH) guidance ``S2(R1)
Genotoxicity Testing and Data Interpretation for Pharmaceuticals
Intended for Human Use'' that was published in March 2008.

DATES: The public workshop will be held on January 25, 2010, from 8:30
a.m. to 5 p.m. Register by January 15, 2010, to make a presentation at
the workshop. See section II in the SUPPLEMENTARY INFORMATION section
for information on how to attend the workshop. We are opening a docket
to receive your written or electronic comments. Written or electronic
comments must be submitted to the docket by February 24, 2010, to
receive consideration.

ADDRESSES: The public workshop will be held at the Food and Drug
Administration, Center for Drug Evaluation and Research Advisory
Committee Conference Room, 5630 Fishers Lane, rm. 1066, Rockville, MD
20857. Submit written or electronic requests to make a presentation to
Adele Seifried (see FOR FURTHER INFORMATION CONTACT). Submit written
comments to the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Submit electronic comments to http://www.regulations.gov. All comments
should be identified with the docket number found in brackets in the
heading of this document.

FOR FURTHER INFORMATION CONTACT: Adele Seifried, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 6482, Silver Spring, MD 20993-0002, 301-
796-0535, FAX:<PHONE_NUMBER>, e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Objectives

    The objectives of this workshop are to provide a scientific forum
where experts in the field of genetic toxicology can provide their
views on proposed changes to ICH S2(R1). These proposed changes are
described in the following paragraphs.

A. The Genetox Battery and Followup Testing: Options 1 and 2

    The ICH steering committee agreed that revision of ICH S2 was
appropriate because the 2 guidances that comprise it, ICH S2A and ICH
S2B, were finalized nearly 15 years ago and much has been learned in
the interim. ICH S2(R1) is a draft version that discusses the
components of a basic genetic toxicology battery as well as in vivo
followup testing that should be conducted when in vitro tests are
positive. ICH S2(R1) offers two test options: Option 1 is similar to
the current ICH and CDER test battery with some modifications. Option 2
removes the in vitro mammalian cell test from the test battery and
instead includes two in vivo endpoints that can be assessed in a single
assay. The workshop will examine these options in addressing what
constitutes an adequate genetic toxicology battery, including which
tests are reasonable followups to a positive in vitro cytogenetic assay
or mouse lymphoma assay. The workshop will also examine the following:
(1) Whether an in vivo comet assay is a reasonable followup test to a
positive in vitro cytogenetic or mouse lymphoma assay, and if not, what
alternatives exist, and (2) whether the two-option system being
proposed would provide comparable or superior patient protection to the
current single-option test battery.

B. Top Concentration for Mammalian In Vitro Genotoxicity Assays

    The current ICH safety guidances specify that drug substances
should be tested up to a concentration of 10 millimolars (mM) in vitro
if no toxicity is seen at lower concentrations. The draft ICH S2(R1)
proposes to lower this top concentration for required testing to 1 mM.
This workshop will examine the scientific basis for this proposal and
its potential effect on patient safety.

II. Attendance and Registration to Speak

    There is no fee to attend the workshop, and attendees who do not
wish to make a formal presentation to the scientific panel do not need
to register. Seating will be on a first-come,

first-served basis. Opportunities to address the panel during the
meeting will occur during discussion of each topic, and speakers will
be required to register ahead of time. If you would like to make a
formal presentation during the open public sessions, you must register
and provide an abstract of your presentation by 5 p.m. e.s.t. on
January 15, 2010. To speak, submit your name, title, business
affiliation (if applicable), address, telephone and fax numbers, and e-
mail address to Adele Seifried (see FOR FURTHER INFORMATION CONTACT).
FDA has included issues for comment in section I of the SUPPLEMENTARY
INFORMATION section. You should also identify by letter each issue you
wish to address in your presentation and the approximate time requested
for your presentation.
    FDA will do its best to accommodate those who wish to speak.
Individuals and organizations with common interests are urged to
consolidate or coordinate their comments and to request time for a
joint presentation. FDA will determine the amount of time allotted to
each presenter. Persons registered to make a formal presentation should
check in before the workshop. In addition, we strongly encourage
written comments to the docket. Written or electronic comments will be
accepted until February 24, 2010.
    If you need special accommodations because of disability, contact
Adele Seifried (see FOR FURTHER INFORMATION CONTACT) at least 7 days
before the workshop.

III. Comments

    Regardless of attendance at the public workshop, interested persons
may submit written or electronic comments to the Division of Dockets
Management (see ADDRESSES). Submit a single copy of electronic comments
or two paper copies of any mailed comments, except that individuals may
submit one paper copy. Comments should be identified with the docket
number found in brackets in the heading of this document. To ensure
consideration, submit comments by (see DATES). Received comments may be
seen in the Division of Dockets Management between 9 a.m. and 4 p.m.,
Monday through Friday.

IV. Transcripts

    Please be advised that as soon as a transcript is available, it
will be accessible at http://www.regulations.gov. It may be viewed at
the Division of Dockets Management (see ADDRESSES). A transcript will
also be available in either hardcopy or on CD-ROM, after submission of
a Freedom of Information request. Written requests are to be sent to
the Division of Freedom of Information (HFI-35), Office of Management
Programs, Food and Drug Administration, 5600 Fishers Lane, rm. 6-30,
Rockville, MD 20857.

    Dated: October 27, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-26397 Filed 11-2-09; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register: July 1, 2010 (Volume 75, Number 126)]
[Notices]
[Page 38173-38175]
[DOCID:fr01jy10-137]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[U.S. DOT Docket Number NHTSA-2010-0086]

Reports, Forms, and Recordkeeping Requirements

AGENCY: National Highway Traffic Safety Administration (NHTSA), DOT.

ACTION: Request for public comment on extension of a currently approved
collection of information.

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SUMMARY: Before a Federal agency can collect certain information from
the public, it must receive approval from the Office of Management and
Budget (OMB). Under procedures established by the Paperwork Reduction
Act of 1995, before seeking OMB approval, Federal agencies must solicit
public comment on proposed collections of information, including
extensions and reinstatement of previously approved collections. This
document describes an existing collection of information for an
existing regulation for the aftermarket modification of vehicles to
accommodate people with disabilities, for which NHTSA intends to seek
renewed OMB approval.

DATES: Comments must be received on or before August 30, 2010.

ADDRESSES: Comments must refer to the docket number cited at the
beginning of this notice, and may be submitted by any of the following
methods:
     Federal eRulemaking Portal: Go to http://
www.regulations.gov. Follow the online instructions for submitting
comments.
     Mail: Docket Management Facility, M-30, U.S. Department of
Transportation, West Building, Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590.
     Hand Delivery or Courier: West Building, Ground Floor,
Room W12-140, 1200 New Jersey Avenue, SE., between 9 a.m. and 5 p.m.
e.t., Monday through Friday, except Federal holidays. Telephone: 1-800-
647-2251.
     Instructions: All submissions must include the docket
number for this document. Please identify the collection of information
for which a comment is provided by referencing the OMB Control Number,
2127-0635. Note that all comments received will be posted without
change to http://www.regulations.gov, including any personal
information provided. Please see the Privacy Act heading below.
    Privacy Act: Anyone is able to search the electronic form of all
comments received into any of our dockets by the name of the individual
submitting the comment (or signing the comment, if submitted on behalf
of an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (65 FR 19477-78) or you may visit http://
DocketsInfo.dot.gov.

FOR FURTHER INFORMATION CONTACT: Ms. Gayle Dalrymple, NHTSA, 1200 New
Jersey Avenue, SE., Room W45-333, NVS-123, Washington, DC 20590. Mrs.
Dalrymple's telephone number is<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995,
before an agency submits a proposed collection of information to OMB
for approval, it must first publish a document in the Federal Register
providing a 60-day comment period and otherwise consult with members of
the public and affected agencies concerning each proposed collection of
information. The OMB has promulgated regulations describing what must
be included in such a document. Under OMB's regulation (at 5 CFR
1320.8(d)), an agency must ask for public comment on the following:
    (1) Whether the proposed collection of information is necessary for
the proper performance of the functions of the agency, including
whether the information will have practical utility;
    (2) The accuracy of the agency's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used;
    (3) How to enhance the quality, utility, and clarity of the
information to be collected;
    (4) How to minimize the burden of the collection of information on
those who are to respond, including the use of appropriate automated,
electronic, mechanical, or other technological collection techniques or
other forms of information technology, e.g., permitting electronic
submission of responses.
    In compliance with these requirements, NHTSA asks for public
comments on the following collection of information:
    Title: Exemption for the Make Inoperative Prohibition.
    OMB Control Number: 2127-0635.
    Form Number: This collection of information uses no standard form.
    Type of Request: Extension of a currently approved collection of
information.
    Abstract: On February 27, 2001 NHTSA published a final rule (66 FR
12638) to facilitate the modification of motor vehicles so that persons
with disabilities can drive or ride in them as passengers. In that
final rule, the agency issued a limited exemption from a statutory
provision that prohibits specified types of commercial entities from
either removing safety equipment or features installed on motor
vehicles pursuant to the Federal motor vehicle safety standards or
altering the equipment or features so as to adversely affect their
performance. The exemption

is limited in that it allows repair businesses to modify only certain
types of Federally-required safety equipment and features, under
specified circumstances. The regulation is found at 49 CFR Part 595
Subpart C--``Vehicle Modifications to Accommodate People with
Disabilities''.
    This final rule included two new ``collections of information,'' as
that term is defined in 5 CFR Part 1320 ``Controlling Paperwork Burdens
on the Public'': Modifier identification and a document to be provided
to the owner of the modified vehicle stating the exemptions used for
that vehicle and any reduction in load carrying capacity of the vehicle
of more than 100 kg (220 lbs).
    Modifiers who take advantage of the exemption created by this rule
are required to furnish NHTSA with a written document providing the
modifier's name, address, and telephone number, and a statement that
the modifier is availing itself of the exemption. The rule requires:
    ``S595.6 Modifier Identification.
    (a) Any motor vehicle repair business that modifies a motor vehicle
to enable a person with a disability to operate, or ride as a passenger
in, the motor vehicle and intends to avail itself of the exemption
provided in 49 CFR 595.7 shall furnish the information specified in
paragraphs (a)(1) through (3) of this section to: Administrator,
National Highway Traffic Safety Administration, 400 Seventh Street,
SW., Washington, DC 20590.
    (1) Full individual, partnership, or corporate name of the motor
vehicle repair business.
    (2) Residence address of the motor vehicle repair business and
State of incorporation if applicable.
    (3) A statement that the motor vehicle repair business modifies a
motor vehicle to enable a person with a disability to operate, or ride
as a passenger in, the motor vehicle and intends to avail itself of the
exemption provided in 49 CFR 595.7.
    (b) Each motor vehicle repair business required to submit
information under paragraph (a) of this section shall submit the
information not later than August 27, 2001. After that date, each motor
vehicle repair business that modifies a motor vehicle to enable a
person with a disability to operate, or ride as a passenger in, the
motor vehicle and intends to avail itself of the exemption provided in
49 CFR 595.7 shall submit the information required under paragraph (a)
not later than 30 days after it first modifies a motor vehicle to
enable a person with a disability to operate, or ride as a passenger
in, the motor vehicle. Each motor vehicle repair business who has
submitted required information shall keep its entry current, accurate
and compete by submitting revised information not later than 30 days
after the relevant changes in the business occur.''
    This requirement is a one-time submission unless changes are made
to the business as described in paragraph (b). NHTSA estimates that
there are currently 471 businesses making modifications to motor
vehicles to accommodate persons with disabilities. Of those 471, we
estimate 85 percent will need to use the exemptions provided by 49 CFR
595.7 (400 businesses). The initial registration of modifiers wishing
to use the exemptions occurred in 2001. Now, we assume that five
percent of the 400 businesses currently modifying vehicles will need to
change their information or new registrants will elect to use the
exemptions. We estimate registrations from 20 businesses each year of:
20 businesses x 10 minutes/business = 3.33 hours.
    We estimate the material cost associated with each submission to be
54 cents per responding business, or $10.80 nationwide annually.
    Burden means the total time, effort, or financial resources
expended by a person to generate, maintain, retain, disclose or provide
information to or for a Federal agency. This includes the time needed
to review instruction; develop, acquire, install, and utilize
technology and systems for the purposes of collecting, validating, and
verifying information, processing and maintaining information and
disclosing and providing information; adjust the existing ways to
comply with any previously applicable instructions and requirements;
train personnel to be able to respond to a collection of information;
and transmit or otherwise disclose the information.
    We seek comment on:
    1. Is our estimate of 471 businesses engaged in vehicle
modification to accommodate people with disabilities correct?
    2. Are we correct in assuming that a maximum of 85 percent of those
471 businesses, or 400 businesses, will need to use the exemptions
provided by 49 CFR 595.7?
    3. Are our estimates of the burden hours and material cost of
compliance with 49 CFR 595.6 reasonable?
    Modifiers who avail themselves of the exemptions in 49 CFR 595.7
are required to keep a record, for each applicable vehicle, listing
which standards, or portions thereof, no longer comply with the Federal
motor vehicle safety standards and to provide a copy to the owner of
the vehicle modified (see 49 CFR 595.7 (b) and (e) as published in the
final rule).
    We estimate that:
    1. There are approximately 2,700 vehicles modified for persons with
disabilities per year by 471 businesses;
    2. If 85 percent of the 471 businesses use the exemptions provided
by 49 CFR 595.7, those 400 businesses will modify 2300 vehicles
annually; and
    3. The burden for producing the record required by 49 CFR 595.7 in
accordance with paragraph (e) for those vehicles will be 767 hours per
year nationwide.
    In the final rule we anticipated that the least costly way for a
repair business to comply with this portion of the new rule would be to
annotate the vehicle modification invoice as to the exemption, if any,
involved with each item on the invoice. The cost of preparing the
invoice is not a portion of our burden calculation, as that preparation
would be done in the normal course of business. The time needed to
annotate the invoice, we estimate, is 20 minutes. Therefore, the burden
hours for a full year are calculated as:

2300 vehicles x 20 minutes/vehicle = 766.7 hours.

    This burden includes the calculation required by 49 CFR 595.7(e)5,
but not the gathering of the information required for the calculation.
That information would be gathered in the normal course of the vehicle
modification. The only extra burden required by the rule is the
calculation of the reduction in loading carrying capacity and conveying
this information to the vehicle owner. Again we are assuming that
annotation on the invoice is the least burdensome way to accomplish
this customer notification.
    There will be no additional material cost associated with
compliance with this requirement since no additional materials need be
used above those used to prepare the invoice in the normal course of
business. We are assuming it is normal and customary in the course of
vehicle modification business to prepare an invoice, to provide a copy
of the invoice to the vehicle owner, and to keep a copy of the invoice
for five years after the vehicle is delivered to the owner in finished
form.
    We seek comment on whether our assumptions about the following are
reasonable:
    1. The document required by 49 CFR 595.7(b) and specified in
paragraph (e) will need to be prepared for

approximately 2300 vehicles modified nationwide per year,
    2. Annotation of each vehicle modification invoice as to which
exemptions were used will take an average of 20 minutes, and
    3. It is normal in the course of vehicle modification business to
prepare an invoice, to provide a copy of the invoice to the vehicle
owner, and to keep a copy of the invoice for five years after the
vehicle is delivered to the owner in finished form.
    Affected Public: Business or other for profit.
    Estimated Annual Burden: 770 hours, and $10.80.
    Estimated Number of Respondents: 400.
    Comments are invited on: Whether the proposed collection of
information is necessary for the proper performance of the functions of
the Department, including whether the information will have practical
utility; the accuracy of the Department's estimate of the burden of the
proposed information collection; ways to enhance the quality, utility
and clarity of the information to be collected; and ways to minimize
the burden of the collection of information on respondents, including
the use of automated collection techniques or other forms of
information technology.

    Issued on: June 25, 2010.
Nathaniel M. Beuse,
Office of Crash Avoidance Standards, Director.
[FR Doc. 2010-16036 Filed 6-30-10; 8:45 am]
BILLING CODE 4910-59-P


[Federal Register Volume 87, Number 220 (Wednesday, November 16, 2022)]
[Notices]
[Pages 68771-68774]
[FR Doc No: 2022-24892]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-96289; File No. SR-NYSEArca-2022-72]

Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing
and Order Granting Accelerated Approval of a Proposed Rule Change To
Add Violations of Rule 2.1210 to the Exchange's Minor Rule Violation
Plan for the Equities and Options Markets

November 9, 2022.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (the ``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby
given that, on October 26, 2022, NYSE Arca, Inc. (``NYSE Arca'' or the
``Exchange'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I and II
below, which Items have been prepared by the Exchange. The Commission
is publishing this notice to solicit comments on the proposed rule
change from interested persons and approving the proposal on an
accelerated basis.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to (1) add Rule 2.1210 to the list of minor
rule violations in Rule 10.9217 for both the equities and options
markets, and (2) make certain non-substantive clarifying changes to
Rule 10.9217. The proposed change is available on the Exchange's
website at www.nyse.com, at the principal office of the Exchange, and
at the Commission's Public Reference Room.

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

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

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

1. Purpose
    The Exchange proposes to (1) add Rule 2.1210 (Registration
Requirements) to the list of minor rule violations in Rule 10.9217 for
both the equities and options markets, and (2) make certain non-
substantive clarifying changes to Rule 10.9217.
Addition of Rule 2.1210 to the List of Rules Eligible for a Minor Fine
    Rule 10.9217 sets forth the list of rules under which a ETP Holder,
OTP Holder or OTP Firm or covered person may be subject to a fine under
a minor rule violation plan as described in Rule 10.9216(b) for both
its equities and options markets.
    Rule 2.1210, which was adopted in 2018,\4\ sets forth the
requirements for persons engaged in the investment banking or
securities business of an ETP Holder, OTP Holder or OTP Firm to be
registered with the Exchange as a representative or principal in each
category of registration appropriate to his or her functions and
responsibilities as specified in Rule 2.1220.
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    \4\ See Securities Exchange Act Release No. 84389 (October 10,
2018), 83 FR 52272 (October 16, 2018) (SR-NYSEArca-2018-71) (Notice
of Filing and Immediate Effectiveness of Amendments to Rules
Regarding Qualification, Registration and Continuing Education
Applicable to Equity Trading Permit Holders, Options Trading Permit
Holders or OTP Firms).
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    The Exchange proposes to add Rule 2.1210 to the list of rules in
Rule 10.9217 eligible for disposition pursuant to a minor fine under
Rule 10.9216(b). Specifically, the Exchange proposes to add Rule 2.1210
to Rule 10.9217(g) as new item 13 applicable to both equities and
options permit holders. NYSE Arca Rule 2.1210 is substantially similar
to Rule 1210 adopted by the Exchange's affiliate New York Stock
Exchange LLC (``NYSE'') in 2018 \5\ which is currently eligible for
minor rule fines under the NYSE's version of Rule 10.9217.\6\ The
Exchange believes that having the ability to issue a minor rule fine
for failing to comply with the registration requirements of Rule 2.1210
would be consistent with and complement the Exchange's current ability
to issue minor rule fines for other registration violations (e.g., Rule
2.24 (Registration--Employees of ETP Holders)). The Exchange further
believes that the violations of the registration requirements are
particularly suited to minor rule fines because minor fines provide a
reasonable means of addressing violations that do not rise to the level
of requiring formal disciplinary proceedings, while providing greater
flexibility in handling certain violations.
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    \5\ See Securities Exchange Act Release No. 84336 (October 2,
2018), 83 FR 50727 (October 9, 2018) (SR-NYSE-2018-44) (Notice of
Filing and Immediate Effectiveness of Amendments To Rules Regarding
Qualification, Registration and Continuing Education Applicable to
Members and Member Organizations).
    \6\ See NYSE Rule 9217. See generally Securities Exchange Act
Release No. 87212 (October 3, 2019), 84 FR 54193 (October 9, 2019)
(SR-NYSE-2019-44) (Order Granting Approval of a Proposed Rule
Change, as Modified by Amendment No. 1, To Add Certain Rules to the
List of Minor Rule Violations in Rule 9217, Delete Obsolete Rules,
and Increase the Maximum Fine for Minor Rule Violations).
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    The Exchange further proposes to add fine levels for violations of
Rule 2.1210 to both the equities and the options fine schedules. First,
the Exchange would add proposed first, second and third level fines for
violations of Rule 2.1210 to the options fine schedule as proposed Rule
10.9217(h)(iii)(12) of $1,000 for the first violation, $2,500 for the
second violation and $3,500 for the third and subsequent violations.
The proposed fine levels would be the same as those in the Exchange's
current Rule 10.9217(h)(iii)(11) for violations of Rule 2.23. Second,
the Exchange would add proposed first, second and third level fines for
violations of Rule 2.1210 to the equities fine schedule as proposed
Rule 10.9217(i)(2)(12) of $1,000 for the first violation, $2,500 for
the second violation and $3,500 for the third and subsequent
violations. The proposed fine levels would be the same as those in the
Exchange's current Rule 10.9217(i)(2)(11) for violations of Rule 2.24.
    The Exchange believes that the proposed change would strengthen the

Exchange's ability to carry out its oversight and enforcement
responsibilities in cases where full disciplinary proceedings are
unwarranted in view of the minor nature of the particular violation.
Non-Substantive Clarifying Changes to Rule 10.9217
    The Exchange proposes the following non-substantive clarifying
changes to Rule 10.9217.
    First, the Exchange proposes to correct a typographical error in
Rule 10.9217(h)(i)(23). Rule 10.9217(h)(i)(23) sets forth the proposed
fine levels for violations of the rule governing reporting of options
positions. Rule 10.9217(h)(i)(23), however, refers to Rule 6.4-O(a)
(Series of Options Open for Trading) and not Rule 6.6-O(a), which
governs reporting of options positions, which is correctly referred to
in Rule 10.9217(e)(23). The Exchange accordingly proposes to correct
the error.
    Second, the Exchange proposes to add clarifying language regarding
the disposition of minor rule fines for violations of the CAT
Compliance Rules in the Rule 11.6800 Series based on language adopted
by the Exchange's affiliates. Specifically, the Exchange would add a
new footnote 4 to current Rule 10.9217(h)(iii)(13) and a new footnote 3
to current Rule 10.9217(i)(2)(14) (governing minor rule fine levels of
the options and equities markets, respectively) that would provide as
follows:

    For failures to comply with the Consolidated Audit Trail
Compliance Rule requirements of the Rule 11.6800 Series, the
Exchange may impose a minor rule violation fine of up to $2,500. For
more serious violations, other disciplinary action may be sought.

    The language is identical to that adopted by the Exchange's
affiliates NYSE and NYSE Chicago, Inc.\7\ In addition, ``Up to
$2,500.00'' would be deleted from current Rule 10.9217(i)(2)(14) and
10.9217(h)(iii)(13) as redundant of proposed footnote 3. The proposed
change is not intended to make a substantive change. Violations of the
CAT Compliance Rules are currently eligible for minor rule fines and
$2,500 is currently the maximum eligible fine.
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    \7\ See NYSE Rule 9217(d) (``For failures to comply with the
Consolidated Audit Trail Compliance Rule requirements of the Rule
6800 Series, the Exchange may impose a minor rule violation fine of
up to $2,500. For more serious violations, other disciplinary action
may be sought.''); NYSE Chicago Rule 10.9217(f), n. ** (same).
---------------------------------------------------------------------------

    Third, the Exchange would add a missing footnote number ``2'' to
the end of Rule 10.9217(i)(2)(11), governing failure to comply with the
employee registration or other requirements of Rule 2.24. The numbered
footnote text appears in the rule, but the footnote number was
inadvertently omitted from Rule 10.9217(i)(2)(11).
2. Statutory Basis
    The proposed rule change is consistent with Section 6(b) of the
Act,\8\ in general, and furthers the objectives of Section 6(b)(5),\9\
in particular, because it is designed to prevent fraudulent and
manipulative acts and practices, to promote just and equitable
principles of trade, to foster cooperation and coordination with
persons engaged in facilitating transactions in securities, to remove
impediments to, and perfect the mechanism of, a free and open market
and a national market system and, in general, to protect investors and
the public interest.
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    \8\ 15 U.S.C. 78f(b).
    \9\ 15 U.S.C. 78f(b)(5).
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    Minor rule fines provide a meaningful sanction for minor or
technical violations of rules when the conduct at issue does not
warrant stronger, immediately reportable disciplinary sanctions. The
inclusion of a rule in Rule 10.9217 does not minimize the importance of
compliance with the rule, nor does it preclude the Exchange from
choosing to pursue violations of eligible rules through formal
disciplinary action if the nature of the violations or prior
disciplinary history warrants more significant sanctions. Rather, the
Exchange believes that the proposed rule change will strengthen the
Exchange's ability to carry out its oversight and enforcement
responsibilities in cases where full disciplinary proceedings are
unwarranted in view of the minor nature of the particular violation.
The option to impose a minor rule sanction gives the Exchange
additional flexibility to administer its enforcement program in the
most effective and efficient manner while still fully meeting the
Exchange's remedial objectives in addressing violative conduct. The
proposed rule change is thus designed to prevent fraudulent and
manipulative acts and practices because it will provide the Exchange
the ability to issue a minor rule fine for violations of the
registration requirements set forth in Rule 2.1210 where a more formal
disciplinary action may not be warranted or appropriate. In addition,
the Exchange believes that adding rules based on the rules of its
affiliate to the Exchange's minor rule plan, and adding associated fine
levels based on current treatment of violations of its registration
rules, would promote fairness and consistency in the marketplace by
permitting the Exchange to issue a minor rule fine for violations of
substantially similar rules that are already eligible for minor rule
treatment, thereby harmonizing minor rule plan fines across affiliated
exchanges for the same conduct.
    The Exchange further believes that the proposed amendments to Rule
10.9217 are consistent with Section 6(b)(6) of the Act,\10\ which
provides that members and persons associated with members shall be
appropriately disciplined for violation of the provisions of the Act,
the rules and regulations thereunder and the rules of the exchange, by
expulsion, suspension, limitation of activities, functions, and
operations, fine, censure, being suspended or barred from being
associated with a member, or any other fitting sanction. As noted, the
proposed rule change would provide the Exchange ability to sanction
minor or technical violations of proposed Rule 2.1210 pursuant to the
Exchange's rules. Finally, the Exchange also believes that the proposed
changes are designed to provide a fair procedure for the disciplining
of members and persons associated with members, consistent with
Sections 6(b)(7) and 6(d) of the Act.\11\ Rule 10.9217 does not
preclude an ETP Holder, OTP Holder or OTP Firm or covered person from
contesting an alleged violation and receiving a hearing on the matter
with procedural rights through a litigated disciplinary proceeding.
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78f(b)(6).
    \11\ 15 U.S.C. 78f(b)(7) and 78f(d).
---------------------------------------------------------------------------

    In addition, the Exchange believes that the proposed non-
substantive clarifying changes described above to correct a
typographical error, add clarifying language regarding the disposition
of minor rule fines for violations of the CAT Compliance Rules in the
Rule 11.6800 Series based on language adopted by the Exchange's
affiliates, and to insert a missing footnote number would add clarity
and consistency to the Exchange's rules. The Exchange believes that
adding such clarity would also be consistent with the public interest
and the protection of investors because investors will not be harmed
and in fact would benefit from increased clarity, thereby reducing
potential confusion. In addition, the Exchange believes that
incorporating language relating to violations of the CAT Compliance
Rules adopted by the Exchange's affiliates would promote fairness and
consistency in the marketplace by eliminating differences and
harmonizing language related to

minor rule treatment of similar rule violations across affiliates. The
proposed change is not intended to make any substantive change to the
applicability of minor rule fines to violations of the CAT Compliance
Rules or the amount of those fines.

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 that is not necessary or appropriate
in furtherance of the purposes of the Act. The proposed change is not
designed to address any competitive issue but rather to update the
Exchange's rules to strengthen the Exchange's ability to carry out its
oversight and enforcement functions and deter potential violative
conduct.

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

    No written comments were solicited or received with respect to the
proposed rule change.

III. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
File Number SR-NYSEArca-2022-72 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-NYSEArca-2022-72. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549 on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-NYSEArca-2022-72 and should be submitted
on or before December 8, 2022.

IV. Commission's Findings and Order Granting Accelerated Approval of
Proposed Rule Change

    The Commission finds that the proposed rule change is consistent
with the requirements of the Act and the rules and regulations
thereunder applicable to a national securities exchange.\12\ In
particular, the Commission finds that the proposed rule change is
consistent with Section 6(b)(5) of the Act,\13\ which requires that the
rules of an exchange be designed to promote just and equitable
principles of trade, to remove impediments and to perfect the mechanism
of a free and open market and a national market system, and, in
general, to protect investors and the public interest. The Commission
also believes that the proposal is consistent with Sections 6(b)(1) and
6(b)(6) of the Act \14\ which require that the rules of an exchange
enforce compliance with, and provide appropriate discipline for,
violations of Commission and Exchange rules. Finally, the Commission
finds that the proposal is consistent with the public interest, the
protection of investors, or otherwise in furtherance of the purposes of
the Act, as required by Rule 19d-1(c)(2) under the Act,\15\ which
governs minor rule violation plans.
---------------------------------------------------------------------------

    \12\ In approving this proposed rule change, the Commission has
considered the proposed rule's impact on efficiency, competition,
and capital formation. See 15 U.S.C. 78c(f).
    \13\ 15 U.S.C. 78f(b)(5).
    \14\ 15 U.S.C. 78f(b)(1) and 78f(b)(6).
    \15\ 17 CFR 240.19d-1(c)(2).
---------------------------------------------------------------------------

    As stated above, the Exchange proposes to amend Rule 10.9217 by:
(1) adding Rule 2.1210 (Registration Requirements) to the list of minor
rule violations, including in the fine schedules, for both the equities
and options markets; and (2) making other clarifying and non-
substantive changes.
    The Commission believes that Rules 10.9216(b) and 10.9217 are an
effective way to discipline a member for a minor violation of a rule.
More specifically, the Commission believes that the proposed addition
of Rule 2.1210 (Registration Requirements) to the Exchange's list of
current minor rule violations provides a reasonable means of addressing
violations that do not rise to the level of requiring formal
disciplinary proceedings, while providing greater flexibility in
handling certain violations. The Commission also believes that amending
the associated fine schedule is consistent with the Act because it may
help the Exchange's ability to better carry out its oversight and
enforcement responsibilities by levying appropriate fines for minor
violations of the rules included in Rule 10.9217, including minor
violations of Rule 2.1210. Finally, the Commission believes that the
Exchange's proposal to make certain non-substantive changes to Rule
10.9217 are consistent with the Act because these changes will add
clarity to the Exchange's rules.
    In approving the proposed rule change, the Commission in no way
minimizes the importance of compliance with the Exchange's rules and
all other rules subject to fines under Rules 10.9216(b) and 10.9217.
The Commission believes that a violation of any self-regulatory
organization's rules, as well as Commission rules, is a serious matter.
However, Rules 10.9216(b) and 10.9217 provide a reasonable means of
addressing rule violations that may not rise to the level of requiring
formal disciplinary proceedings, while providing greater flexibility in
handling certain violations. The Commission expects that the Exchange
will continue to conduct surveillance with due diligence and make a
determination based on its findings, on a case-by-case basis, whether a
fine of more or less than the recommended amount is appropriate for a
violation under Rules 10.9216(b) and 10.9217 or whether a violation
requires formal disciplinary action.
    For the same reasons as discussed above, the Commission finds good
cause, pursuant to Section 19(b)(2) of the Act,\16\ for approving the
proposed rule change prior to the thirtieth day after the date of
publication of the notice of the filing thereof in the Federal
Register. The proposal will

assist the Exchange in preventing fraudulent and manipulative practices
by allowing the Exchange to adequately enforce compliance with, and
provide appropriate discipline for, violations of Exchange rules.
Moreover, the proposed changes raise no new or novel issues.
Accordingly, the Commission believes that a full notice-and-comment
period is not necessary before approving the proposal.
---------------------------------------------------------------------------

    \16\ 15 U.S.C. 78s(b)(2).
---------------------------------------------------------------------------

V. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the Act
\17\ and Rule 19d-1(c)(2) thereunder,\18\ that the proposed rule change
(SR-NYSEArca-2022-72) be, and hereby is, approved on an accelerated
basis.
---------------------------------------------------------------------------

    \17\ 15 U.S.C. 78s(b)(2).
    \18\ 17 CFR 240.19d-1(c)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\19\
---------------------------------------------------------------------------

    \19\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Sherry R. Haywood,
Assistant Secretary.
[FR Doc. 2022-24892 Filed 11-15-22; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 84, Number 4 (Monday, January 7, 2019)]
[Notices]
[Page 64]
[FR Doc No: 2018-28474]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER19-669-000]

Supplemental Notice That Initial Market-Based Rate Filing
Includes Request for Blanket Section 204 Authorization; Northfield
Mountain LLC

    This is a supplemental notice in the above-referenced proceeding of
Northfield Mountain LLC's application for market-based rate authority,
with an accompanying rate tariff, noting that such application includes
a request for blanket authorization, under 18 CFR part 34, of future
issuances of securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE, Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is January 15, 2019.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
5 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street NE, Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for electronic review in the
Commission's Public Reference Room in Washington, DC. There is an
eSubscription link on the website that enables subscribers to receive
email notification when a document is added to a subscribed docket(s).
For assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For TTY,
call<PHONE_NUMBER>.

    Dated: December 26, 2018.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2018-28474 Filed 1-4-19; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 72 (Tuesday, April 15, 2014)]
[Rules and Regulations]
[Pages 21146-21148]
[FR Doc No: 2014-08340]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 62

[EPA-R07-OAR-2013-0692; FRL-9909-45-Region 7]

Approval and Promulgation of State Plans for Designated
Facilities and Pollutants; Air Emissions From Existing Municipal Solid
Waste Landfills; State of Missouri

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is taking direct
final action to approve a revision to the state section 111 plan for
Municipal Solid Waste (MSW) Landfills submitted by the State of
Missouri Department of Natural Resources. This plan contains state
rules ``Municipal Solid Waste Landfills'' and ``Restriction of
Emissions from Municipal Solid Waste Landfills'' that were updated as a
result of amendments to the Federal Emission Guidelines (EG) published
April 10, 2000; October 17, 2000; and September 21, 2006. The plan also
corrects typographical and administrative changes in the Missouri
Rules. This approval means that EPA finds the State Plan meets
applicable Clean Air Act (CAA) requirements.

DATES: This direct final rule will be effective June 16, 2014, without
further notice, unless EPA receives adverse comments by May 15, 2014.
If EPA receives adverse comments, we will publish a timely withdrawal
of the direct final rule in the Federal Register informing the public
that the rule will not take effect.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R07-
OAR-2013-0692, by one of the following methods:
    1. www.regulations.gov. Follow the on-line instructions for
submitting comments.
    2. Email<EMAIL_ADDRESS>    3. Mail or Hand Delivery: Craig Bernstein, Environmental Protection
Agency, Air Planning and Development

Branch, 11201 Renner Boulevard, Lenexa, Kansas 66219.
    Instructions: Direct your comments to Docket ID No. EPA-R07-OAR-
2013-0692. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
www.regulations.gov, including any personal information provided,
unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit through www.regulations.gov or
email information that you consider to be CBI or otherwise protected.
The www.regulations.gov Web site is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an email
comment directly to EPA without going through www.regulations.gov, your
email address will be automatically captured and included as part of
the comment that is placed in the public docket and made available on
the Internet. If you submit an electronic comment, EPA recommends that
you include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, i.e., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, is not placed on the internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available either electronically in www.regulations.gov or
in hard copy at the Environmental Protection Agency, Air Planning and
Development Branch, 11201 Renner Boulevard, Lenexa, Kansas 66219. The
Regional Office's official hours of business are Monday through Friday,
8:00 to 4:30 excluding Federal holidays. The interested persons wanting
to examine these documents should make an appointment with the office
at least 24 hours in advance.

FOR FURTHER INFORMATION CONTACT: Craig Bernstein, Environmental
Protection Agency, Air Planning and Development Branch, 11201 Renner
Boulevard, Lenexa, Kansas 66219 at<PHONE_NUMBER>, or by email at
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document ``we,'' ``us,'' or
``our'' refer to EPA. This section provides additional information by
addressing the following:

I. Background
II. Have the requirements for approval of a section 111(d) plan
revision been met?
III. What action is EPA taking?

I. Background

    Standards and guidelines for new and existing MSW landfills are
promulgated under the authority of section 111 of the CAA. These
standards can be found at 40 CFR part 60, subpart WWW, new source
performance standards (NSPS) for new MSW landfills, and subpart Cc,
emission guidelines (EG) for existing MSW landfills. The final NSPS and
EG were published in the Federal Register on March 12, 1996 (49 FR
9905). We first approved Missouri's section 111(d) plan for MSW
landfills on April 24, 1998 (63 FR 20320). The state's plan consists
primarily of two state rules which adopt the Federal landfill
requirements. These rules are 10 CSR 10-6.310 ``Restriction of
Emissions from Municipal Solid Waste Landfills'' (which covers all
areas of Missouri except St. Louis) and 10 CSR 10-5.490 ``Municipal
Solid Waste Landfills'' (which covers the St. Louis area).
    Since Missouri last amended both of these state rules, EPA has
published in the Federal Register three final rules that update the
requirements for municipal solid waste landfills. The dates and Federal
Register citations are: April 10, 2000 (65 FR 18906); October 17, 2000
(65 FR 61744), and September 21, 2006 (71 FR 55127). Missouri updated
rules 10 CSR 10-5.490 ``Municipal Solid Waste Landfills'' and 10 CSR
10-6.310 ``Restriction of Emissions from Municipal Solid Waste
Landfills'' to incorporate EPA's recent amendments, to correct
typographical errors, to include formatting changes, and to correct
inconsistencies. Missouri's request to move definitions from 10 CSR 10-
5.490 and 10 CSR 10-6.310 to rule 10 CSR 10-6.020 ``Definitions and
Common Reference Tables'' has been addressed in a separate rulemaking
action. In a separate action being published in today's Federal
Register, EPA is taking action to approve rule 10 CSR 10-5.490
``Municipal Solid Waste Landfills'' into Missouri's SIP as well.

II. Have the requirements for approval of a section 111(d) plan
revision been met?

    The Missouri Air Conservation Commission adopted rule amendments to
10 CSR 10-5.490 and 10 CSR 10-6.310 on February 2, 2012, after
considering comments received at a public hearing. The Missouri Air
Conservation Commission has full legal authority to develop rules
pursuant to section 643.050 of the Missouri Air Conservation Law. The
State followed all applicable administrative procedures in proposing
and adopting the rule actions. After publication by the Missouri
Secretary of State in the Code of State Regulations, the amendments
became effective May 30, 2012. The State of Missouri has incorporated
these rule amendments into its revised section 111(d) plan and
submitted the plan and rules to us for approval pursuant to section
111(d). We have evaluated the state plan revision against criteria in
the EG and against the plan approval criteria at 40 CFR 60.23 through
40 CFR 60.26, subpart B ``Adoption and Submittal of State Plans for
Designated Facilities.'' The state plan meets all of the applicable
requirements of 40 CFR part 60, subpart B and subpart Cc.

III. What action is EPA taking?

    EPA is approving the revisions to the Missouri section 111(d) plan
submitted by the State of Missouri for MSW landfills, which
incorporates the recent EPA updated rules. We are publishing this rule
without a prior proposed rule because we view this as a
noncontroversial action and anticipate no adverse comment because the
revisions are administrative and consistent with Federal regulations.
However, in the ``Proposed Rules'' section of today's Federal Register,
we are publishing a separate document that will serve as the proposed
rule to approve the section 111(d) revision. If EPA receives adverse
comments on this direct final rule, we will publish a timely withdrawal
in the Federal Register informing the public that this direct final
rule will not take effect. We would address all public comments in any
subsequent final rule based on the proposed rule.

Statutory and Executive Order Reviews

A. General Requirements
    Under Executive Order 12866 (58 FR 51735, October 4, 1993), this
action is not a ``significant regulatory action'' and therefore is not
subject to review by the Office of Management and Budget. For this
reason, this action is also not subject to Executive Order 13211,

``Actions Concerning Regulations That Significantly Affect Energy
Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001). This action
merely approves state law as meeting Federal requirements and imposes
no additional requirements beyond those imposed by state law.
Accordingly, the Administrator certifies that this rule will not have a
significant economic impact on a substantial number of small entities
under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.). Because
this rule approves pre-existing requirements under state law and does
not impose any additional enforceable duty beyond that required by
state law, it does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4). This rule also does not
have tribal implications because it will not have a substantial direct
effect on one or more Indian tribes, on the relationship between the
Federal Government and Indian tribes, or on the distribution of power
and responsibilities between the Federal Government and Indian tribes,
as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
This action also does not have Federalism implications because it does
not have substantial direct effects on the States, on the relationship
between the national government and the States, or on the distribution
of power and responsibilities among the various levels of government,
as specified in Executive Order 13132 (64 FR 43255, August 10, 1999).
This action merely approves a state rule implementing a Federal
requirement, and does not alter the relationship or the distribution of
power and responsibilities established in the Act. This rule also is
not subject to Executive Order 13045 (62 FR 19885, April 23, 1997),
because it approves a state rule implementing a Federal standard.
    In reviewing section 111(d) plan submissions, EPA's role is to
approve State choices, provided that they meet the criteria of the Act.
In this context, in the absence of a prior existing requirement for the
State to use voluntary consensus standards (VCS), EPA has no authority
to disapprove a section 111(d) plan submission for failure to use VCS.
It would thus be inconsistent with applicable law for EPA, when it
reviews a section 111(d) plan submission, to use VCS in place of a
section 111(d) plan submission that otherwise satisfies the provisions
of the Act. Thus, the requirements of section 12(d) of the National
Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do
not apply. This rule does not impose an information collection burden
under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C.
3501 et seq.).
B. Submission to Congress and the Comptroller General
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. This rule is not a
``major rule'' as defined by 5 U.S.C. 804(2).
C. Petitions for Judicial Review
    Under Section 307(b)(1) of the Act, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by August 12, 2013. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this rule for the purposes of judicial review nor does
it extend the time within which a petition for judicial review may be
filed, and shall not postpone the effectiveness of such rule or action.
This action approving Missouri's section 111(d) plan revision for SSI
sources may not be challenged later in proceedings to enforce its
requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 62

    Environmental protection, Air pollution control, Carbon monoxide,
Hydrocarbons, Incorporation by reference, Intergovernmental relations,
Ozone, Particulate matter, Reporting and recordkeeping requirements,
Sulfur oxides.

    Dated: April 3, 2014.
Karl Brooks,
Regional Administrator, Region 7.

    Chapter I, title 40 of the Code of Federal Regulations is amended
as follows:

PART 62--APPROVAL AND PROMULGATION OF STATE PLANS FOR DESIGNATED
FACILITIES AND POLLUTANTS

0
1. The authority citation for part 62 continues to read as follows:

    Authority: 42 U.S.C. 7401 et seq.

Subpart AA--Missouri

0
2. Section 62.6357 is amended by adding paragraph (e) to read as
follows:

Sec.  62.6357  Identification of plan.

* * * * *
    (e) Amended plan for the control of air emissions from Municipal
Solid Waste Landfills submitted by the Missouri Department of Natural
Resources on February 9, 2012. The effective date of the amended plan
is May 30, 2012.

[FR Doc. 2014-08340 Filed 4-14-14; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 77, Number 136 (Monday, July 16, 2012)]
[Notices]
[Pages 41777-41778]
[FR Doc No: 2012-17252]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. DI12-9-000]

Jacob Focht; Notice of Declaration of Intention and Soliciting
Comments, Protests, and/or Motions To Intervene

    Take notice that the following application has been filed with the
Commission and is available for public inspection:
    a. Application Type: Declaration of Intention.
    b. Docket No: DI12-9-000.
    c. Date Filed: June 27, 2012.
    d. Applicant: Jacob Focht.
    e. Name of Project: Jacobs Creek Hydroelectric Project.
    f. Location: The proposed Jacobs Creek Hydroelectric Project will
be located near the city of Valdez, Unorganized Borough, Alaska,
affecting T. 9 S., R. 4 W., sec. 30, Copper River Meridian.
    g. Filed Pursuant to: Section 23(b)(1) of the Federal Power Act, 16
U.S.C. 817(b).
    h. Applicant Contact: Troy Hardwick, H & K Energy Solutions LLC,
P.O. Box 90961, Anchorage, AK 99509; telephone:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>

    i. FERC Contact: Any questions on this notice should be addressed
to Henry Ecton,<PHONE_NUMBER>, or Email address<EMAIL_ADDRESS>    j. Deadline for filing comments, protests, and/or motions: August
13, 2012.
    Comments, Motions to Intervene, and Protests may be filed
electronically via the Internet. See 18 CFR 385.2001(a)(l)(iii) and the
instructions on the Commission's Web site under the ``eFiling'' link.
If unable to be filed electronically, documents may be paper-filed. To
paper-file, an original and eight copies should be mailed to: Kimberly
D. Bose, Secretary, Federal Energy Regulatory Commission, 888 First
Street NE., Washington, DC 20426. For more information on how to submit
these types of filings, please go to the Commission's Web site located
at http://www.ferc.gov/filing-comments.asp.
    Please include the docket number (DI12-9-000) on any comments,
protests, and/or motions filed.
    k. Description of Project: The proposed Jacobs Creek Hydroelectric
Project will be located on Jacobs Creek, tributary to Lowe River, near
Valdez, AK. The proposed project will consist of: (1) A small reservoir
created by an existing large log that traverses Jacobs Creek; (2) a 6-
inch-diameter, 600-foot-long penstock; (3) a powerhouse that will
contain a 24-kW Turgo Runner on a 3-phase generator; (4) a 422-foot-
long tailrace returning water to Jacobs Creek; (5) a 166-foot-long
underground transmission line transmitting power to the Copper River
Electric Association, Inc.; and (6) appurtenant facilities.
    When a Declaration of Intention is filed with the Federal Energy
Regulatory Commission, the Federal Power Act requires the Commission to
investigate and determine if the interests of interstate or foreign
commerce would be affected by the project. The Commission also
determines whether or not the project: (1) Would be located on a
navigable waterway; (2) would occupy or affect public lands or
reservations of the United States; (3) would utilize surplus water or
water power from a government dam; or (4) if applicable, has involved
or would involve any construction subsequent to 1935 that may have
increased or would increase the project's head or generating capacity,
or have otherwise significantly modified the project's pre-1935 design
or operation.
    l. Locations of the Application: Copies of this filing are on file
with the Commission and are available for public inspection. This
filing may be viewed on the Web at http://www.ferc.gov using the
``eLibrary'' link. Enter the Docket number excluding the last three
digits in the docket number field to access the document. You may also
register online at http://www.ferc.gov/docs-filing/esubscription.asp to
be notified via email of new filings and issuances related to this or
other pending projects. For assistance, call 1-866-208-3676 or email
<EMAIL_ADDRESS>for TTY, call<PHONE_NUMBER>. A copy is also
available for inspection and reproduction at the address in item (h)
above.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Comments, Protests, or Motions to Intervene--Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214. In determining the appropriate action to take, the Commission
will consider all protests or other comments filed, but only those who
file a motion to intervene in accordance with the Commission's Rules
may become a party to the proceeding. Any comments, protests, or
motions to intervene must be received on or before the specified
comment date for the particular application.
    o. Filing and Service of Responsive Documents--All filings must
bear in all capital letters the title ``COMMENTS'', ``PROTESTS'', and/
or ``MOTIONS TO INTERVENE'', as applicable, and the Docket Number of
the particular application to which the filing refers. A copy of any
Motion to Intervene must also be served upon each representative of the
Applicant specified in the particular application.
    p. Agency Comments--Federal, state, and local agencies are invited
to file comments on the described application. A copy of the
application may be obtained by agencies directly from the Applicant. If
an agency does not file comments within the time specified for filing
comments, it will be presumed to have no comments. One copy of an
agency's comments must also be sent to the Applicant's representatives.

    Dated: July 10, 2012.
Kimberly D. Bose,
Secretary.
[FR Doc. 2012-17252 Filed 7-13-12; 8:45 am]
BILLING CODE 6717-01-P


  SEQ CHAPTER \h \r 1 APPENDIX J__

ADDITIONAL SENSITIVITY ANALYSES RELATED TO THE BENEFITS ANALYSIS  TC \l1
"

The analysis presented in Chapter 5 __ is based on our current
interpretation of the scientific and economic literature.  That
interpretation requires judgments regarding the best available data,
models, and modeling methodologies and the assumptions that are most
appropriate to adopt in the face of important uncertainties.  The
majority of the analytical assumptions used to develop the primary
estimates of benefits have been reviewed and approved by EPA’s SAB.
Both EPA and the SAB recognize that data and modeling limitations as
well as simplifying assumptions can introduce significant uncertainty
into the benefit results and that alternative choices exist for some
inputs to the analysis, such as the mortality C-R functions.

This appendix supplements our primary analysis of benefits with three
additional sensitivity calculations.  These supplemental estimates
examine sensitivity to both valuation issues (e.g., the appropriate
income elasticity) and for physical effects issues (e.g., the structure
of the cessation lag and the sensitivity of the premature mortality
estimate to the presence of a presumed threshold).  These supplemental
estimates are not meant to be comprehensive.  Rather, they reflect some
of the key issues identified by EPA or commentors as likely to have a
significant impact on total benefits.  The individual adjustments in the
tables should not simply be added together because 1) there may be
overlap among the alternative assumptions and 2) the joint probability
among certain sets of alternative assumptions may be low.

J.1	Premature Mortality Cessation Lag Structure

Over the last ten years, there has been a continuing discussion and
evolving advice regarding the timing of changes in health effects
following changes in ambient air pollution.  It has been hypothesized
that some reductions in premature mortality from exposure to ambient
PM2.5 will occur over short periods of time in individuals with
compromised health status, but other effects are likely to occur among
individuals who, at baseline, have reasonably good health that will
deteriorate because of continued exposure.  No animal models have yet
been developed to quantify these cumulative effects, nor are there
epidemiologic studies bearing on this question.  The SAB-HES has
recognized this lack of direct evidence.  However, in early advice, they
also note that “although there is substantial evidence that a portion
of the mortality effect of PM is manifest within a short period of time,
i.e., less than one year, it can be argued that, if no lag assumption is
made, the entire mortality excess observed in the cohort studies will be
analyzed as immediate effects, and this will result in an overestimate
of the health benefits of improved air quality.  Thus some time lag is
appropriate for distributing the cumulative mortality effect of PM in
the population” (EPA-SAB-COUNCIL-ADV-00-001, 1999, p. 9).  In recent
advice, the SAB-HES suggests that appropriate lag structures may be
developed based on the distribution of cause-specific deaths within the
overall all-cause estimate (  XE "EPA-SAB-COUNCIL-ADV-04-002, 2004"
EPA-SAB-COUNCIL-ADV-04-002, 2004).  They suggest that diseases with
longer progressions should be characterized by longer-term lag
structures, while air pollution impacts occurring in populations with
existing disease may be characterized by shorter-term lags.

A key question is the distribution of causes of death within the
relatively broad categories analyzed in the long-term cohort studies.
Although it may be reasonable to assume the cessation lag for lung
cancer deaths mirrors the long latency of the disease, it is not at all
clear what the appropriate lag structure should be for cardiopulmonary
deaths, which include both respiratory and cardiovascular causes.  Some
respiratory diseases may have a long period of progression, while
others, such as pneumonia, have a very short duration.  In the case of
cardiovascular disease, there is an important question of whether air
pollution is causing the disease, which would imply a relatively long
cessation lag, or whether air pollution is causing premature death in
individuals with preexisting heart disease, which would imply very short
cessation lags.  The SAB-HES provides several recommendations for future
research that could support the development of defensible lag
structures, including using disease-specific lag models and constructing
a segmented lag distribution to combine differential lags across causes
of death (  XE "EPA-SAB-COUNCIL-ADV-04-002, 2004"
EPA-SAB-COUNCIL-ADV-04-002, 2004).  The SAB-HES indicated support for
using “a Weibull distribution or a simpler distributional form made up
of several segments to cover the response mechanisms outlined above,
given our lack of knowledge on the specific form of the distributions”
(  XE "EPA-SAB-COUNCIL-ADV-04-002, 2004"  EPA-SAB-COUNCIL-ADV-04-002,
2004, p. 24).  However, they noted that “an important question to be
resolved is what the relative magnitudes of these segments should be,
and how many of the acute effects are assumed to be included in the
cohort effect estimate” (  XE "EPA-SAB-COUNCIL-ADV-04-002, 2004"
EPA-SAB-COUNCIL-ADV-04-002, 2004, p. 24-25).  Since the publication of
that report in March 2004, EPA has sought additional clarification from
this committee.  In its followup advice provided in December 2004, this
SAB suggested that until additional research has been completed, EPA
should assume a segmented lag structure characterized by 30 percent of
mortality reductions occurring in the first year, 50 percent occurring
evenly over years 2 to 5 after the reduction in PM2.5, and 20 percent
occurring evenly over the years 6 to 20 after the reduction in PM2.5
(EPA-COUNCIL-LTR-05-001, 2004).  The distribution of deaths over the
latency period is intended to reflect the contribution of short-term
exposures in the first year, cardiopulmonary deaths in the 2- to 5-year
period, and long-term lung disease and lung cancer in the 6- to 20-year
period.  Furthermore, in their advisory letter, the SAB-HES recommended
that EPA include sensitivity analyses on other possible lag structures.
In this appendix, we investigate the sensitivity of premature
mortality-reduction related benefits to alternative cessation lag
structures, noting that ongoing and future research may result in
changes to the lag structure used for the primary analysis.

In previous advice from the SAB-HES, they recommended an analysis of 0-,
8-, and 15-year lags, as well as variations on the proportions of
mortality allocated to each segment in the segmented lag structure (  XE
"EPA-SAB-COUNCIL-ADV-00-001, 1999"  EPA-SAB-COUNCIL-ADV-00-001, 1999,
(EPA-COUNCIL-LTR-05-001, 2004).  The 0-year lag is representative of
EPA’s assumption in previous RIAs.  The 8- and 15-year lags are based
on the study periods from the   XE "Pope et al. (1995"  Pope et al.
(1995) and   XE "Dockery et al. (1993"  Dockery et al. (1993) studies,
respectively.  However, neither the Pope et al. nor Dockery et al.
studies assumed any lag structure when estimating the relative risks
from PM exposure.  In fact, the Pope et al. and Dockery et al. analyses
do not supporting or refute the existence of a lag.  Therefore, any lag
structure applied to the avoided incidences estimated from either of
these studies will be an assumed structure.  The 8- and 15-year lags
implicitly assume that all premature mortalities occur at the end of the
study periods (i.e., at 8 and 15 years).

In addition to the simple 8- and 15-year lags, we have added three
additional sensitivity analyses examining the impact of assuming
different allocations of mortality to the segmented lag of the type
suggested by the SAB-HES.  The first sensitivity analysis assumes that
more of the mortality impact is associated with chronic lung diseases or
lung cancer and less with acute cardiopulmonary causes.  This
illustrative lag structure is characterized by 20 percent of mortality
reductions occurring in the first year, 50 percent occurring evenly over
years 2 to 5 after the reduction in PM2.5, and 30 percent occurring
evenly over the years 6 to 20 after the reduction in PM2.5.  The second
sensitivity analysis assumes the 5-year distributed lag structure used
in previous analyses, which is equivalent to a three-segment lag
structure with 50 percent in the first 2-year segment, 50 percent in the
second 3-year segment, and 0 percent in the 6- to 20-year segment.  The
third sensitivity analysis assumes a negative exponential relationship
between reduction in exposure and reduction in mortality risk.  This
structure is based on an analysis by   XE "Röösli et al. (2004"
Röösli et al. (2004), which estimates the percentage of total
mortality impact in each period t as

		(C.1)

The   XE "Röösli et al. (2004"  Röösli et al. (2004) analysis
derives the lag structure by calculating the rate constant

(–0.5) for the exponential lag structure that is consistent with both
the relative risk from the cohort studies and the change in mortality
observed in intervention type studies (e.g.,   XE "Pope et al., 1992"
Pope et al. [1992] and   XE "Clancy et al., 2002"  Clancy et al.
[2002]).  This is the only lag structure examined that is based on
empirical data on the relationship between changes in exposure and
changes in mortality.

The estimated impacts of alternative lag structures on the monetary
benefits associated with reductions in PM-related premature mortality
(estimated with the Pope et al. ACS impact function) are presented in
Table J-1.  These estimates are based on the value of statistical lives
saved approach (i.e., $5.5 million per incidence) and are presented for
both a 3 and 7 percent discount rate over the lag period.

Table J_-1.  Sensitivity of Benefits of Premature Mortality Reductions
to Alternative Cessation Lag Structures, Using Pope et al (2002) Effect
Estimate

Alternative Lag Structures for PM-Related Premature Mortality 	15/35

Alternative Lag Structures for PM-Related Premature Mortality	Value

(billion 1999$)a.b	Percent Difference from Base Estimate

None	Incidences all occur in the first year

		3% discount rate	$16.53.5	10.4%

		7% discount rate	$$3.516.5	31.2%

8-year	Incidences all occur in the 8th year

		3% discount rate	$2.913.4	-10.3%

		7% discount rate	$2.210.3	-18.3%

15-year	Incidences all occur in the 15th year

		3% discount rate	$2.310.9	-27.0%

		7% discount rate	$6.41.4	-49.1%

Alternative Segmented	20 percent of incidences occur in 1st year, 50
percent in years 2 to 5, and 30 percent in years 6 to 20

		3% discount rate	$14.53.1	-3.2%

		7% discount rate	$11.52.5	-8.7%

5-Year Distributed	50 percent of incidences occur in years 1 and 2 and
50 percent in years 2 to 5

		3% discount rate	$15.73.4	4.9%

		7% discount rate	$14.73.1	17.1%

Exponential	Incidences occur at an exponentially declining rate
following year of change in exposure

		3% discount rate	$15.83.4	5.6%

		7% discount rate	$14.43.1	14.8%

a	Dollar values rounded to two significant digits.

   TC \l1 "

The results of this sensitivity analyses demonstrate that because of
discounting of delayed benefits, the lag structure may also have a large
impact on monetized benefits, reducing benefits by 30 percent if an
extreme assumption that no effects occur until after 15 years is
applied.  However, for most reasonable distributed lag structures,
differences in the specific shape of the lag function have relatively
small impacts on overall benefits.  For example, the overall impact of
moving from the previous 5-year distributed lag to the segmented lag
recommended by the SAB-HES in 2004 in the primary estimate is relatively
modest, reducing benefits by approximately 5 percent when a 3 percent
discount rate is used and 15 percent when a 7 percent discount rate is
used.  If no lag is assumed, benefits are increased by around 10 percent
relative to the segmented lag with a 3 percent discount rate and 30
percent with a 7 percent discount rate.

X. 2	Threshold Sensitivity Analysis

Chapter __ presents the results of the PM2.5 premature mortality
benefits analysis based on an assumed cutpoint in the long-term
mortality concentration-response function at 10 µg/m3, and an assumed
cutpoint in the short-term morbidity concentration-response functions at
10 µg/m3. There is ongoing debate as to whether there exists a
threshold below which there would be no benefit to further reductions in
PM2.5.  Some researchers have hypothesized the presence of a threshold
relationship.  The nature of the hypothesized relationship is the
possibility that there exists a PM concentration level below which
further reductions no longer yield premature mortality reduction
benefits.  EPA’s most recent PM2.5 Criteria Document concludes that
“the available evidence does not either support or refute the
existence of thresholds for the effects of PM on mortality across the
range of concentrations in the studies” (U.S. EPA, 2004b  XE "U.S.
EPA, 2004"  , p. 9-44).  EPA’s Science Advisory Board (SAB) that
provides advice on benefits analysis methods has been to model premature
mortality associated with PM exposure as a non-threshold effect, that
is, with harmful effects to exposed populations regardless of the
absolute level of ambient PM concentrations.

For these reasons we provide the results of a sensitivity analysis in
which we estimate the change in reduction in incidence of PM2.5-related
premature mortality resulting from changes in the presumed threshold. We
also provide a corresponding estimate of the valuation of these changes
in incidence.

Table _-2:  Mortality Threshold Sensitivity Analysis for 0.070 ppm Ozone
Scenario (Using Pope et al., 2002 Effect Estimate with Slope Adjustment
for Thresholds Above 7.5 ug) 90th Percentile Confidence Intervals
Provided in Parentheses a

East	Western U.S. Excluding CA	California	Total

Less Certainty That Benefits Are at Least as Large	No Threshold	570

(230—920)	30

(11—45)	53

(21—85)	650

	Threshold at 7.5 µg	580

(230—930)	15

(6—24)	51

(20—85)	650

(250—1,000)

	Threshold at 10 µg	510

(200—810)	0.2

(0.07—0.3)	47

(18—75)	550

(220—890)

	Threshold at 12 µg	100

(40—160)	0.03

(0.01—0.04)	42

(16—67)	140

(56—230)

More Certainty That Benefits are at Least as Large	Threshold at 14 µg
---	---	36

(14—59)	36

(14—59)

a  All estimates are rounded to 2 significant digits.  All rounding
occurs after final summing of unrounded estimates.  As such, totals will
not sum across columns.

Table __-3:  Sensitivity of Monetized Benefits of Reductions in
Mortality Risk to Assumed Thresholds for 15/35 Scenario (Using Pope et
al., 2002 Effect Estimate with Slope Adjustment for Thresholds Above 7.5
ug) 90th Percentile Confidence Intervals Provided in Parentheses a

Less Certain that Benefits Are at Least as Large	No Threshold	3%	$3,300

($830--$6,900)	$160

($41--$340)	$310

($77--$630)	$3,800

($950--$7,900)

7%	$2,800

($700--$5,800)	$140

($34--$280)	$260

($64--$530)	$3,200

($800--$6,200)

 	Threshold at 7.5 ug	3%	$3,400

($840--$7,000)	$86

($22--$$180)	$300

($74--$620)	$3,700

($940--$7,800)

7%	$2,800

($710--$5,900)	$72

($18--$150)	$250

($63--$520)	$3,200

($790--$6,600)

 	Threshold at 10 ug	3%	$2,900

($730--$6,100)	$1

($0.2--$2)	$270

($67--$560)	$3,200

($800--$6,600)

7%	$2,500

($620--$5,100)	$0.8

($0.2--$1.7)	$230

($57--$470)	$2,700

($670--$5,600)

 	Threshold at 12 ug	3%	$590

($150--$1,200)	$0.2

($0.04--$0.3)	$240

($61--$500)	$830

($210--$1,700)

7%	$490

($120--$1,000)	$0.1

($0.03--$0.3)	$200

($51--$420)	$700

($180--$1,500)

	Threshold at 14 ug	3%	--	--	$210

($53--$440)	$210

($53--$440)

More Certain that Benefits Are at Least as Large

7%	--	--	$180

($44--$370)	$180

($44--$370)

a  All estimates are rounded to 2 significant digits.  All rounding
occurs after final summing of unrounded estimates.  As such, totals will
not sum across columns.

J.2	Visibility Benefits in Additional Class I Areas  TC \l1 "

The Chestnut and Rowe (1990a) study from which the primary valuation
estimates are derived only examined WTP for visibility changes in Class
I areas (national parks and wilderness areas) in the southeast,
southwest, and California.  To obtain estimates of WTP for visibility
changes at national parks and wilderness areas in the northeast,
northwest, and central regions of the U.S., we have to transfer WTP
values from the studied regions.  This introduces additional uncertainty
into the estimates.  However, we have taken steps to adjust the WTP
values to account for the possibility that a visibility improvement in
parks in one region is not necessarily the same environmental quality
good as the same visibility improvement at parks in a different region.
This may be due to differences in the scenic vistas at different parks,
uniqueness of the parks, or other factors, such as public familiarity
with the park resource.  To take this potential difference into account,
we adjusted the WTP being transferred by the ratio of visitor days in
the two regions.

Based on this benefits transfer methodology (implemented within the
preference calibration framework discussed in Chapter 5 and Appendix I),
estimated additional visibility benefits in the northwest, central, and
northeastern U.S. are provided in Table J-2.

Table J-2:  Monetary Benefits Associated with Improvements in Visibility
in Additional Federal Class I Areas in 2020 Incremental to 15/65
Attainment Strategy (in millions of 1999$)a

Suite of Standards	Northwestb	Centralc	Northeastd	Total

15/35	$96	$130	$6	$240

14/35	$67	$140	$44	$250

	a  	All estimates are rounded to 2 significant digits.  All rounding
occurs after final summing of unrounded estimates.  As such, totals will
not sum across columns

	b	Northwest Class I areas include Crater Lake, Mount Rainier, North
Cascades, and Olympic national parks, and Alpine Lakes, Diamond Peak,
Eagle Cap, Gearhart Mountain, Glacier Peak, Goat Rocks, Hells Canyon,
Kalmiopsis, Mount Adams, Mount Hood, Mount Jefferson, Mount Washington,
Mountain Lakes, Pasayten, Strawberry Mountain, and Three Sisters
wilderness areas.

	c	Central Class I areas include Craters of the Moon, Glacier, Grand
Teton, Theodore Roosevelt, Badlands, Wind Cave, and Yellowstone national
parks, and Anaconda-Pintlar, Bob Marshall, Bridger, Cabinet Mountains,
Fitzpatrick, Gates of the Mountain, Lostwood, Medicine Lake, Mission
Mountain, North Absaroka, Red Rock Lakes, Sawtooth, Scapegoat,
Selway-Bitterroot, Teton, U.L. Bend, and Washakie wilderness areas.

	d 	Northeast Class I areas include Acadia, Big Bend, Guadalupe
Mountains, Isle Royale, Voyageurs, and Boundary Waters Canoe national
parks, and Brigantine, Caney Creek, Great Gulf, Hercules-Glades, Lye
Brook, Mingo, Moosehorn, Presidential Range-Dry Roosevelt Campobello,
Seney, Upper Buffalo, and Wichita Mountains wilderness areas.

J.3	Income Elasticity of Willingness to Pay  TC \l1 "

As discussed in Chapter 5, our estimates of monetized benefits account
for growth in real GDP per capita by adjusting the WTP for individual
endpoints based on the central estimate of the adjustment factor for
each of the categories (minor health effects, severe and chronic health
effects, premature mortality, and visibility).  We examined how
sensitive the estimate of total benefits is to alternative estimates of
the income elasticities.  Table J-3 lists the ranges of elasticity
values used to calculate the income adjustment factors, while Table J-4
lists the ranges of corresponding adjustment factors.  The results of
this sensitivity analysis, giving the monetized benefit subtotals for
the four benefit categories, are presented in Table J-5.

Table J_-34.  Ranges of Elasticity Values Used to Account for Projected
Real Income Growtha  TC \l2 "

Benefit Category	Lower Sensitivity Bound	Upper Sensitivity Bound

Minor Health Effect	0.04	0.30

Severe and Chronic Health Effects	0.25	0.60

Premature Mortality	0.08	1.00

Visibilityb	—	—

a	Derivation of these ranges can be found in   XE "Kleckner and Neumann
(1999"  Kleckner and Neumann (1999) and   XE "Chestnut (1997"  Chestnut
(1997).  COI estimates are assigned an adjustment factor of 1.0.

b	No range was applied for visibility because no ranges were available
in the current published literature.

Table J_-45.  Ranges of Adjustment Factors Used to Account for Projected
Real Income Growtha  TC \l2 "

Benefit Category	Lower Sensitivity Bound	Upper Sensitivity Bound

Minor Health Effect	1.018	1.147

Severe and Chronic Health Effects	1.121	1.317

Premature Mortality	1.037	1.591

Visibilityb	—	—

a	Based on elasticity values reported in Table C-4, U.S. Census
population projections, and projections of real GDP per capita.

b	No range was applied for visibility because no ranges were available
in the current published literature.

Table J_-6.  Sensitivity of Monetized Benefits to Alternative Income
Elasticitiesa  TC \l2 "

Severe and Chronic Health Effects	--$1,400	$1,600--	$160$2,500
$190$2,700

Premature Mortalityb 	$2,000$13,000	$3,000$20,000	$2,800$23,000
$3,600$34,000

Visibility and Other Welfare Effectsc	$530	$530	$1,200	$1,200

Total Benefitsb	$2,000$15,000	$3,100$22,000	$2,900$26,000	$3,800$37,000

a	All estimates rounded to two significant digits.

b	Using mortality effect estimate from Pope et al (2002) to estimate
PM2.5 mortality and a 3 percent discount rate and mortality effect
estimate from Bell (2004)and 3 percent discount rate.

c	No range was applied for visibility because no ranges were available
in the current published literature.

	Consistent with the impact of mortality on total benefits, the
adjustment factor for mortality has the largest impact on total
benefits.  The value of mortality in 2020 ranges from 90 percent to 130
percent of the primary estimate based on the lower and upper sensitivity
bounds on the income adjustment factor.  The effect on the value of
minor and chronic health effects is much less pronounced, ranging from
98 percent to 105 percent of the primary estimate for minor effects and
from 93 percent to 106 percent for chronic effects.

C_.4	References  TC \l1 "

Chestnut, L.G.  1997.  “Draft Memorandum:  Methodology for Estimating
Values for Changes in Visibility at National Parks.”  April 15.

Chestnut, L.G., and R.D. Rowe.  1990a.  Preservation Values for
Visibility Protection at the National Parks:  Draft Final Report.
Prepared for Office of Air Quality Planning and Standards, U.S.
Environmental Protection Agency, Research Triangle Park, NC and Air
Quality Management Division, National Park Service, Denver, CO.

Chestnut, L.G., and R.D. Rowe.  1990b.  “A New National Park
Visibility Value Estimates.”  In Visibility and Fine Particles,
Transactions of an AWMA/EPA International Specialty Conference, C.V.
Mathai, ed. Air and Waste Management Association, Pittsburgh.

Clancy, L., P. Goodman, H. Sinclair, and D.W. Dockery.  2002.  “Effect
of Air-pollution Control on Death Rates in Dublin, Ireland:  An
Intervention Study.”  Lancet Oct 19;360(9341):1210-4.

Desvousges, W.H., F.R. Johnson, and H.S. Banzhaf.  1998.  Environmental
Policy Analysis With Limited Information: Principles and Applications of
the Transfer Method (New Horizons in Environmental Economics.)  Edward
Elgar Pub:  London.

EPA-SAB-COUNCIL-ADV-00-001.  October 1999.  The Clean Air Act Amendments
(CAAA) Section 812 Prospective Study of Costs and Benefits (1999):
Advisory by the Health and Ecological Effects Subcommittee on Initial
Assessments of Health and Ecological Effects.  Part 2.

EPA-SAB-COUNCIL-ADV-99-012.  July 1999.  The Clean Air Act Amendments
(CAAA) Section 812 Prospective Study of Costs and Benefits (1999):
Advisory by the Health and Ecological Effects Subcommittee on Initial
Assessments of Health and Ecological Effects.  Part 1.

EPA-SAB-COUNCIL-ADV-01-004.  September 2001.  Review of the Draft
Analytical Plan for EPA’s Second Prospective Analysis—Benefits and
Costs of the Clean Air Act 1990-2020:  An Advisory by a Special Panel of
the Advisory Council on Clean Air Compliance Analysis.

EPA-SAB-COUNCIL-ADV-04-002.  March 2004.  Advisory on Plans for Health
Effects Analysis in the Analytical Plan for EPA’s Second Prospective
Analysis—Benefits and Costs of the Clean Air Act, 1990-2020:  Advisory
by the Health Effects Subcommittee of the Advisory Council on Clean Air
Compliance Analysis.

Kleckner, N., and J. Neumann.  June 3, 1999.  “Recommended Approach to
Adjusting WTP Estimates to Reflect Changes in Real Income.”
Memorandum to Jim Democker, US EPA/OPAR.

Roosli M, Kunzli N, Braun-Fahrlander C, Egger M. 2005. “Years of life
lost attributable to air pollution in Switzerland: dynamic
exposure-response model.” International Journal of Epidemiology
34(5):1029-35.

U.S. Environmental Protection Agency (EPA).  2004.  Air Quality Criteria
for Particulate Matter, Volume II.  Office of Research and Development.
EPA/600/P-99/002bF, October 2004.

Although these studies were conducted for 8 and 15 years, respectively,
the choice of the duration of the study by the authors was not likely
due to observations of a lag in effects but is more likely due to the
expense of conducting long-term exposure studies or the amount of
satisfactory data that could be collected during this time period.

 The advice from the 2004 SAB-HES (U.S. EPA-SAB, 2004b) is characterized
by the following: “For the studies of long-term exposure, the HES
notes that Krewski et al. (2000  XE "Krewski et al. (2000"  ) have
conducted the most careful work on this issue.  They report that the
associations between PM2.5 and both all-cause and cardiopulmonary
mortality were near linear within the relevant ranges, with no apparent
threshold.  Graphical analyses of these studies (Dockery et al., 1993
XE "Dockery et al., 1993"  , Figure 3, and Krewski et al., 2000  XE
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