[Federal Register Volume 78, Number 50 (Thursday, March 14, 2013)]
[Notices]
[Pages 16329-16331]
[FR Doc No: 2013-05882]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-69080; File No. SR-NYSEArca-2013-21]

Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change Amending Rules
Governing Order Format and System Entry Requirements

March 8, 2013.
    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 March 5, 2013, NYSE Arca, Inc. (the ``Exchange'' or
``NYSE Arca'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been prepared by the self-regulatory
organization. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 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 the
Substance of the Proposed Rule Change

    The Exchange proposes to amend rules governing Order Format and
System Entry Requirements. The text of the proposed rule change is
available on the Exchange's Web site 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 IV 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
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange proposes to amend Exchange Rule 6.67(c) by revising
the requirements for entering an order into the Electronic Order
Capture System (``EOC''). In addition, the Exchange proposes to delete
all references pertaining to the Electronic Tablet, a decommissioned
Exchange order entry mechanism.
Order Format and System Entry Requirements
    EOC is the Exchange's floor-based electronic audit trail and order
tracking system that provides an accurate time-sequenced record of all
orders and transactions entered and executed on the floor of the
Exchange. EOC records the receipt of an order and documents the life of
the order through the process of execution, partial execution, or
cancellation. This system includes the electronic communications
interface between booth terminals and the Floor Broker work stations
and hand held applications. The EOC was developed by the Exchange to
fulfill one of the undertakings contained in the Commission's Order
Instituting Public Administrative Proceedings Pursuant to Sections
19(h)(1) of the Securities Exchange Act of 1934, Making Findings and
Imposing Remedial Sanctions (``Order'').\4\ Specifically, the EOC is
intended to respond to Section IV.B.e.(v) of the Order, which requires,
among other things, that the Exchange incorporate into its audit trail
all non-electronic orders such that the audit trail provides an
accurate, time-sequenced record of electronic and other orders,
quotations and transactions, beginning with the receipt of the order
and documenting the life of the order through the process of execution,
partial execution, or cancellation.
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    \4\ See Securities Exchange Act Release No. 43268 (September 11,
2000) and Administrative Proceeding File No. 3-10282.
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    In order to comply with the terms of Rule 6.67(c)(1), and thus be
in compliance with the Order, Floor Brokers and employees of floor
brokerage firms (collectively ''Floor Brokers'') upon receiving an
order for execution on the Exchange must immediately, prior to
representation in the trading crowd, record the details of the order
into EOC. This process, commonly referred to the ``systemization'' of
an order, creates an accurate time-sequenced record of orders on the
Exchange.
    The Exchange has prescribed certain data elements that must be
entered into the EOC before an order may be represented in the Trading
Crowd. These data elements, as contained in Rule 6.68--Record of
Orders, include:

(1) CMTA Information and the name of the clearing OTP Holder or Firm;
\5\ (2) options symbol, expiration month, exercise price and type of
options; (3) side of the market and order type; \6\ (4) quantity of
options; (5) limit or stop price or special conditions; (6) opening or
closing transaction; (7) time in force; (8) account origin code; \7\
and (9) whether the order was solicited or unsolicited. The Exchange
may, from time to time, also require additional information if needed.
The remaining data elements prescribed in Rule 6.68 are to be recorded
as the events occur and/or during trade reporting procedures.
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    \5\ The CMTA process allows an OTP Holder to enter trade that is
subsequently settled into the account of a different Broker Dealer
at the Options Clearing Corporation.
    \6\ Order type is also referred to as the origin code (i.e.
Customer, Firm or Market Maker).
    \7\ Supra see note 6.
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    The Exchange now proposes to incorporate into the text of Rule
6.67(c) specific data elements required for the proper systemization of
an order. The Exchange proposes that in order to meet the requirements
for the proper systemization of an order Floor Brokers will be required
to enter into the EOC: (i) The option symbol; (ii) the expiration date
of the option; \8\ (iii) the exercise price; (iv) buy or sell with
applicable limit or stop price or special instructions; (v) call or
put; (vi) the quantity of contracts; (vii) the name of the clearing OTP
Holder or OTP Firm; and (viii) such other information as may be
required by the Exchange from time to time. Any additional information
with respect to the order including those data elements that [sic]
found in Rule 6.68 that pursuant to this proposal will no longer be
required at the time of systemization, shall be recorded
contemporaneously upon receipt which may occur after the representation
and execution of the order. The proposed order entry requirements for
the EOC are consistent with the order format requirements of Rule
6.67(b). Thus, adopting the order format requirements of Rule 6.67(b)
for the EOC and incorporating them into Rule 6.67(c) will serve to
align Exchange Rules on order entry requirements. In addition, the
Exchange notes that the proposed order entry requirements necessary for
the systemization of an order for the EOC are substantially similar to
those prescribed by the Chicago Board Options Exchange (``CBOE'')
pursuant to CBOE Rule 6.24(a)(2).\9\
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    \8\ In order to accommodate Quarterly Options Series and Short
Term Option Series, the Exchange proposes to require the actual
expiration date of an option, and not just the expiration month, as
presently required.
    \9\ See CBOE Rule 6.24(a)(2). See also Securities Exchange Act
Release No. 50996 (January 7, 2005), 70 FR 2436 (Jan 13, 2005) (SR-
CBOE-2004-77).
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    Pursuant to the proposed rule change, Floor Brokers will be
required to enter much of the same information when systematizing an
order as is presently required, with the exception of the Clearing
Member Trade Agreement (``CMTA'') \10\ information, opening/closing
designation, the order type or account origin code, the time in force,
and whether the order was solicited or unsolicited. Floor Brokers have
told the Exchange that generally these are the last bits of information
given to them when receiving an order and that waiting to receive this
information and enter it into EOC can delay the representation and
execution of an order. In today's trading environment of rapidly moving
markets and the need to execute an order and hedge a trade in real or
near real time, even a slight delay can prove to be detrimental to the
handling of an order. Because the CMTA information, the opening/closing
designation, the account origin code, the time if force and whether an
order was solicited or unsolicited are not contractual terms of a trade
itself nor are they required data elements pursuant to the Exchange's
order format requirements, the Exchange does not believe this
information needs to be entered into the EOC prior to an order being
represented in the Trading Crowd, but may be entered contemporaneously
upon the receipt of such information, even if that occurs after the
order had been represented and executed in the Trading Crowd.
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    \10\ The CMTA process allows an OTP Holder or OTP Firm to
execute a trade that is subsequently settled into the account of a
different broker dealer by the Options Clearing Corporation.
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    The Exchange notes that proposed rule changes contained in this
filing relate only to the system entry requirements for floor based
orders and do not amend or revise rules governing the record of orders
(Rule 6.68). Floor Brokers must continue to maintain proper order
records, including any order information that is presently required for
the proper systemization of an order that will no longer be required
for that purpose pursuant to this proposal. In addition, the Exchange
notes that this proposal does not amend or revise rules governing trade
reporting duties (Rule 6.69).
The Electronic Tablet
    The Electronic Tablet was an order entry system which would record
orders in a hand written format that in turn could be transmitted to a
Floor Broker's EOC workstation for representation in the Trading Crowd.
The Electronic Tablet provided an alternative to the order entry
functionality of the EOC while providing for an accurate time-sequenced
record of orders on the Exchange. Floor Brokers could hand write order
information into the Electronic Tablet upon receipt of an order, route
the order to EOC and then manually key into EOC additional order and
transaction information for reporting and clearing purposes.
    The Electronic Tablet was designed to expedite the entry of orders
into EOC. Due to ongoing enhancements to the functionality of the EOC
system since its introduction, the Electronic Tablet was used
increasingly less often and eventually became obsolete. The Electronic
Tablet was fully decommissioned by the Exchange in 2009. Because Floor
Brokers may satisfy all order entry requirements by entering an order
directly into EOC, the Exchange has no plans to utilize the Electronic
Tablet functionality going forward. Accordingly, the Exchange proposes
to delete references to the Electronic Tablet found in its Rules.
2. Statutory Basis
    The proposed rule change is consistent with Section 6(b) of the
Securities Exchange Act of 1934 (the ``Act''),\11\ in general, and
furthers the objectives of Section 6(b)(5),\12\ in particular, in that
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, and to remove impediments to and perfect
the mechanism of a free and open market and a national market system.
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    \11\ 15 U.S.C. 78f(b).
    \12\ 15 U.S.C. 78f(b)(5).
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    The proposed changes to order entry requirements for the EOC is
designed to promote just and equitable principles of trade, to foster
cooperation and coordination with persons engaged in facilitating
transactions in securities by ensuring that the terms of an order
continue to be properly systematized prior to the order being
represented in the Trading Crowd. The Exchange notes that changes are
consistent with the order systemization requirements in the Order which
requires, among other things, that the Exchange incorporate into its
audit trail all non-electronic orders such that the audit trail
provides an accurate, time-sequenced record of electronic and other
orders, quotations

and transactions, beginning with the receipt of the order and
documenting the life of the order through the process of execution,
partial execution, or cancellation. The Exchange believes that aligning
the order entry requirements for the EOC with the Exchange's order
format requirements will further promote just and equitable principles
of trade, to foster cooperation and coordination with persons engaged
in facilitating transactions in securities on the Exchange. Reducing
the burden on Floor Brokers to enter order information prior to
representation will promote just and equitable principles of trade and
remove impediments to and perfect the mechanism of a free and open
market by reducing the delay in representation and execution of an
order on the Exchange. The proposal is also designed to prevent
fraudulent and manipulative acts and practices, by ensuring that the
Exchange is able to meet its obligation to create and maintain a time-
sequenced record of orders, quotations and transactions on the
Exchange. In addition, the deletion of rule references pertaining to a
decommissioned order entry system will help protect investors and the
public interest by reducing potential confusion that may result from
having obsolete or out-dated rules in the Exchange's rulebook.
Furthermore, the proposal removes impediments to and perfects the
mechanism of a free and open market and a national market system by
allowing for more timely executions of open-outcry orders.

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 rule change is
designed to enable NYSE Arca to align the order format requirements of
the Exchange with those of a competing options exchange. The proposal
would allow Floor Brokers on the Exchange to be afforded the ability to
transact business under the similar requirements as brokers on a
competing exchange. The Exchange believes that the proposal will reduce
the burden on Floor Brokers by coordinating different order entry
requirements on different exchanges. By reducing Floor Brokers burden
on order entry compliance, the Exchange believes the proposal will
improve the competitiveness of Exchange Floor Brokers and also promote
competition for orderflow among market participants and the options
exchanges.

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

    The Exchange has filed the proposed rule change pursuant to Section
19(b)(3)(A)(iii) of the Act \13\ and Rule 19b-4(f)(6) thereunder.\14\
Because the proposed rule change does not: (i) Significantly affect the
protection of investors or the public interest; (ii) impose any
significant burden on competition; and (iii) become operative prior to
30 days from the date on which it was filed, or such shorter time as
the Commission may designate, if consistent with the protection of
investors and the public interest, the proposed rule change has become
effective pursuant to Section 19(b)(3)(A) of the Act and Rule 19b-
4(f)(6)(iii) thereunder.
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    \13\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \14\ 17 CFR 240.19b-4(f)(6).
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    A proposed rule change filed under Rule 19b-4(f)(6) \15\ normally
does not become operative prior to 30 days after the date of the
filing. However, pursuant to Rule 19b-4(f)(6)(iii),\16\ the Commission
may designate a shorter time if such action is consistent with the
protection of investors and the public interest.
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    \15\ 17 CFR 240.19b-4(f)(6).
    \16\ 17 CFR 240.19b-4(f)(6)(iii).
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    At any time within 60 days of the filing of such proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings under
Section 19(b)(2)(B) \17\ of the Act to determine whether the proposed
rule change should be approved or disapproved.
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    \17\ 15 U.S.C. 78s(b)(2)(B).
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IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-NYSEArca-2013-21 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NYSEArca-2013-21. 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 Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549-1090, on official business days between the hours
of 10:00 a.m. and 3:00 p.m. Copies of such filing also will be
available for inspection and copying at the principal office of the
Exchange. All comments received will be posted without change; the
Commission does not edit personal identifying information from
submissions. You should submit only information that you wish to make
available publicly. All submissions should refer to File Number SR-
NYSEArca-2013-21, and should be submitted on or before April 4, 2013.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\18\
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    \18\ 17 CFR 200.30-3(a)(12).
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Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2013-05882 Filed 3-13-13; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 78, Number 141 (Tuesday, July 23, 2013)]
[Notices]
[Pages 44105-44106]
[FR Doc No: 2013-17590]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 14430-000]

Monroe Hydro, LLC; Notice of Intent to File License Application,
Filing of Pre-Application Document, and Approving Use of the
Traditional Licensing Process

    a. Type of Filing: Notice of Intent to File License Application and
Request to Use the Traditional Licensing Process.
    b. Project No.: 14430-000
    c. Date Filed: April 2, 2013
    d. Submitted By: Monroe Hydro, LLC
    e. Name of Project: Monroe Drop Hydroelectric Project
    f. Location: On the western side of the Bureau of Reclamation's
North Unit Irrigation District Main Canal, in Jefferson County, Oregon.
The project occupies 2.1 acres of United States lands administered by
USDA Forest Service.
    g. Filed Pursuant to: 18 CFR 5.3 of the Commission's regulations
    h. Potential Applicant Contact: Gia Schneider, Natel Energy, 2175
Monarch Street, Alameda, CA 94501;<PHONE_NUMBER>; email<EMAIL_ADDRESS>    i. FERC Contact: Adam Beeco at<PHONE_NUMBER>; or email at
<EMAIL_ADDRESS>    j. Monroe Hydro filed its request to use the Traditional Licensing
Process on April 2, 2013. Monroe Hydro provided public notice of its
request on June 5, 2013. In a letter dated July 16, 2013, the Director
of the Division of Hydropower Licensing approved Monroe Hydro's request
to use the Traditional Licensing Process.
    k. With this notice, we are initiating informal consultation with:
(a) the U.S. Fish and Wildlife Service and/or NOAA Fisheries under
section 7 of the Endangered Species Act and the joint agency
regulations thereunder at 50 CFR, Part 402; (b) NOAA Fisheries under
section 305(b) of the Magnuson-Stevens Fishery Conservation and
Management Act and implementing regulations at 50 CFR 600.920; and (c)
the Oregon State Historic Preservation Officer, as required by section
106, National Historical Preservation Act, and the implementing
regulations of the

Advisory Council on Historic Preservation at 36 CFR 800.2.
    l. With this notice, we are designating Monroe Hydro as the
Commission's non-federal representative for carrying out informal
consultation, pursuant to section 7 of the Endangered Species Act and
section 106 of the National Historic Preservation Act.
    m. Monroe Hydro filed a Pre-Application Document (PAD) and a
proposed process plan and schedule with the Commission, pursuant to 18
CFR 5.6 of the Commission's regulations.
    n. A copy of the PAD is available for review at the Commission in
the Public Reference Room or may be viewed on the Commission's Web site
(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. For assistance, contact FERC Online Support at
<EMAIL_ADDRESS>or toll free at 1-866-208-3676, or for TTY,
(202) 502-8659. A copy is also available for inspection and
reproduction at the address in paragraph h.
    o. Register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filing and issuances
related to this or other pending projects. For assistance, contact FERC
Online Support.

    Dated: July 16, 2013.
Kimberly D. Bose,
Secretary.
[FR Doc. 2013-17590 Filed 7-22-13; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 84, Number 54 (Wednesday, March 20, 2019)]
[Notices]
[Pages 10317-10318]
[FR Doc No: 2019-05231]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-1918]

Human Immunodeficiency Virus-1 Infection: Developing Systemic
Drug Products for Pre-Exposure Prophylaxis; Guidance for Industry;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry entitled ``Human
Immunodeficiency Virus-1 Infection: Developing Systemic Drug Products
for Pre-Exposure Prophylaxis.'' The purpose of this guidance is to
provide to sponsors nonclinical and clinical recommendations specific
to the development of systemic drug products, with a focus on long-
acting systemic drug products (including small molecules and monoclonal
antibodies). This guidance incorporates the comments received for and
finalizes the draft guidance of the same name issued in June 2018.

DATES: The announcement of the guidance is published in the Federal
Register on March 20, 2019.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2018-D-1918 for ``Human Immunodeficiency Virus-1 Infection:
Developing Systemic Drug Products for Pre-Exposure Prophylaxis.''
Received comments will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked

as ``confidential'' will not be disclosed except in accordance with 21
CFR 10.20 and other applicable disclosure law. For more information
about FDA's posting of comments to public dockets, see 80 FR 56469,
September 18, 2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Kimberly Struble, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6374, Silver Spring MD 20993-0002, 301-
796-1500.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``Human Immunodeficiency Virus-1 Infection: Developing
Systemic Drug Products for Pre-Exposure Prophylaxis.'' The purpose of
this guidance is to provide to sponsors nonclinical and clinical
recommendations specific to the development of systemic drug products,
with a focus on long-acting systemic drug products (including small
molecules and monoclonal antibodies) for the prevention of sexually
acquired human immunodeficiency virus-1 (HIV-1) infection.
Specifically, this guidance addresses FDA's current thinking regarding
the overall development program and clinical trial designs to support
the development of systemic drug products for the prevention of HIV-1
infection. FDA recognizes the challenges in evaluating systemic drug
products for the prevention of sexually acquired HIV-1 infection. FDA
continues to evaluate possible approaches for the development of new
therapies for HIV prevention and will update this guidance if new
information becomes available.
    This guidance finalizes the draft guidance of the same name issued
on June 14, 2018 (83 FR 27782). All public comments received on the
draft guidance have been considered and the guidance has been revised
as appropriate, along with a few editorial changes.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Human Immunodeficiency Virus-1 Infection:
Developing Systemic Drug Products for Pre-Exposure Prophylaxis.'' It
does not establish any rights for any person and is not binding on FDA
or the public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations. This guidance
is not subject to Executive Order 12866.

II. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information that are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collection of information submitted under 21 CFR part 312
has been approved under OMB control number 0910-0014. The collection of
information submitted under 21 CFR part 314 has been approved under OMB
control number 0910-0001.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at
either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or
https://www.regulations.gov.

    Dated: March 14, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-05231 Filed 3-19-19; 8:45 am]
 BILLING CODE 4164-01-P


As seen in the topographic map below, the natural advective air flow along the Kanawha River valley may also enhance the contribution of emissions from Mason County into the nonattainment area. 6 113 EPA intends, based on this review, to modify the West Virginia recommended nonattainment boundary and include Mason County with the Charleston MSA. A summary of the data that supports the addition of Mason County to the State's recommendation is provided below. 6 114 SUMMARY OF CHARLESTON, WV MSA EPA Reg ST COUNTY State Recommend PM2.5 Designation PM2.5 DESIGNATION Area  ' 99 C/ MSA 3 WV P utnam Nonattainment Nonattainment Charleston, WV 3 WV Kanawha Nonattainment Nonattainment Charleston, WV 3 WV Mason Attainment Nonattainment ( Huntington) 3 WV Fayette Attainment Attainment 3 WV Raleigh Attainment Attainment 3 WV Jackson Attainment Attainment 3 WV Nicholas Attainment Attainment 3 WV B oone Attainment Attainment 3 WV Lincoln Attainment Attainment 3 WV Roane Attainment Attainment 3 WV Clay Attainment Attainment 3 WV Logan Attainment Attainment 3 WV Wyoming Attainment Attainment 3 WV Mingo Attainment Attainment 3 WV Braxton Attainment Attainment 3 WV C alhoun Attainment Attainment 6 115 SUMMARY OF FACTOR 1: EMISSIONS CHARLESTON, WV MSA Counties sorted by Largest Weighted Emissions Contribution Total Emissions, 2001 ( tons) EPA Reg ST COUNTY PM SO2 NOx VOC Amm Carbon Crustal Weighted Emissions Factor 3 WV P utnam 4,395 80,150 39,795 3,752 97 1,165 2,604 20.3 3 WV K anawha 2,683 24,109 27,119 16,506 396 1,266 1,182 18.0 3 WV Cabell 2,365 5,155 27,903 7,080 181 1,318 774 17.7 3 WV Mason 3,610 70,053 31,327 2,831 264 899 2,162 16.2 3 WV Fayette 1,536 4,485 5,065 3,134 100 479 950 6.3 3 WV Raleigh 930 456 4,595 5,220 170 472 417 6.0 3 WV Jackson 1,780 3,464 3,947 2,394 158 451 1,128 5.9 3 WV Wayne 550 1,023 6,485 2,620 56 317 199 4.2 3 WV Logan 410 152 1,620 2,158 49 214 181 2.7 3 WV Nicholas 434 193 1,102 1,720 84 206 208 2.6 3 WV W yoming 470 430 3,981 1,807 142 197 238 2.6 3 WV Boone 412 118 1,571 1,298 30 197 190 2.5 3 WV Mingo 437 281 2,842 1,379 150 191 217 2.5 3 WV Braxton 312 138 2,265 1,597 91 185 109 2.4 3 WV Lincoln 259 67 1,314 1,128 37 143 108 1.8 3 WV Roane 213 106 1,083 1,108 99 119 87 1.5 3 WV Clay 155 41 533 542 28 94 57 1.2 3 WV Calhoun 114 43 937 512 35 68 42 0.9 SUMMARY OF FACTOR 2: AIR QUALITY CHARLESTON , WV MSA Design Values EPA Reg ST COUNTY ' 01' 03 ' 00' 02 ' 99' 01 3 WV P utnam NO MONITOR 3 WV K anawha 17.1 NA 17.8 NA 18.4 NA 3 WV Mason NO MONITOR 3 WV Fayette NO MONITOR 3 WV Raleigh 13.1 A 13.5 A 14.0 A 3 WV Jackson NO MONITOR 3 WV Nicholas NO MONITOR 3 WV B oone NO MONITOR 3 WV Lincoln NO MONITOR 3 WV R oane NO MONITOR 3 WV C lay NO MONITOR 6 116 SUMMARY OF FACTOR 3: POPULATION DENSITY AND DEGREE OF URBANIZATION CHARLESTON, WV MSA Counties Sorted by Population  Highest to Lowest Population & Area EPA Reg ST COUNTY 2002 Area ( sq miles) Density ' 02 3 WV K anawha 195,790 903 217 3 WV Raleigh 78,899 607 130 3 WV P utnam 52,230 346 151 3 WV Fayette 47,129 664 71 3 WV Jackson 28,204 466 61 3 WV Nicholas 26,404 649 41 3 WV Mason 26,004 432 60 3 WV Boone 25,554 503 51 3 WV Lincoln 22,256 438 51 3 WV Roane 15,267 484 32 3 WV Clay 10,357 342 30 SUMMARY FACTOR 4: COMMUTING PATTERNS CHARLESTON, WV MSA Counties sorted by VMT  Highest to Lowest VMT Commuting to Other Metro Counties EPA Reg ST COUNTY 2002 Percent Number 3 WV K anawha 2,600 4 3,500 3 WV Raleigh 1,028 2 643 3 WV Fayette 605 12 1,904 3 WV P utnam 578 48 11,367 3 WV Jackson 511 19 2,152 3 WV Nicholas 359 5 468 3 WV Boone 300 35 2,972 3 WV Mason 270 8 763 3 WV Roane 183 25 1,319 3 WV Lincoln 154 33 2,324 3 WV Clay 116 30 925 6 117 SUMMARY FACTOR 5: EXPECTED GROWTH CHARLESTON, WV MSA Counties sorted by Growth Rate  Highest to Lowest Population VMT EPA Reg ST COUNTY 2002 Growth ' 90' 00 Pct chng ' 90' 00 Growth ' 02' 10 Pct chng ' 02' 10 3 WV P utnam 52,230 8,754 20 53 9 3 WV Jackson 28,204 2,062 8  231  45 3 WV Mason 26,004 779 3 23 9 3 WV Raleigh 78,899 2,401 3  199  19 3 WV Lincoln 22,256 726 3 141 92 3 WV Clay 10,357 347 3 21 19 3 WV Roane 15,267 326 2 26 14 3 WV Fayette 47,129  373  1  18  3 3 WV Nicholas 26,404  213  1  50  14 3 WV Boone 25,554  335  1 24 8 3 WV K anawha 195,790  7,546  4 432 17 Factor 8: Jurisdictional Boundaries The 1999 MSA was expanded in 2003 to include Lincoln, Boone and Clay counties. The review of these counties, however, did not provide sufficient evidence to include these counties in the nonattainment area. The Charleston area has recently been designated nonattainment for the 8 hour ozone standard. Similar to the fine particulate monitoring, Kanawha monitored a violation of the 8 hour ozone standard. Kanawha and Putnam were included in the ozone nonattainment area.

Factor 9: Level of Control EPA identified large sources greater than 1000 tons per year for any pollutant and evaluated its distance to a violating monitor for fine particulate. This screening identified the closest large source to be 37 miles from the Kanawha violating monitor. West Virginia has provided additional information on the level of control of the Mountaineer and Philip Sporn power plants. There was a reduction in NOx in 2002 due to installation of NOx controls on the Mountaineer plant ( 1300 MW). Additional SO2 controls are also planned in 2007 for this plant. The Philip Sporn plant ( 1050 MW) does not currently, nor has plans to install, state of the art controls. A review of the reductions from the controls added to Mountaineer does not substantially change the estimated emissions contribution to the nonattainment area.

Justifications for Changes to EPA Recommendations Contained in the June 29, 2004 Letters to States Mason County was an adjacent county proposed to be included with the nonattainment area largely because of the emissions from two power plants. The State of West Virginia has provided additional information and rationale for including a portion of the County containing the power plants to the adjacent Huntington Ashland nonattainment area. The 6 118 two power plants, Mountaineer and Philip Sporn, are located at the northern edge of Mason County. Apart from the emissions of the power plants the County is mostly rural and the parameters of the factors relating to population, vehicle miles traveled and commuting rank well below the factors for the two counties in the Charleston MSA. The partial county associated with the Huntington Ashland area is described in section <IP_ADDRESS>.

EPA is designating Putnam and Kanawha as the Charleston nonattainment area.

<IP_ADDRESS> Huntington Ashland ( KY WV OH) Area Discussion The Huntington Metropolitan Statistical Area ( MSA) is comprised of six counties including two counties in West Virginia. Two counties in this MSA have monitored violations of the fine particulate ( PM2.5) National Ambient Air Quality Standard ( NAAQS) of 15.0 µ g/ m3. Based on the monitored violations, the Huntington MSA is considered a presumptive nonattainment area. Cabell County, WV is part of the MSA and monitored 16.6 µ g/ m3 for the time period 2001 2003. This value is being considered the Design Value for the nonattainment area.

The State of West Virginia, in the Secretary Timmermeyer correspondence of February 13, 2004, recommended the two MSA counties to be included in the Huntington nonattainment area. EPA has reviewed the State's recommendations as well as additional data provided by West Virginia on June 3, EPA agrees with the recommendation to include Cabell and Wayne Counties. Additional counties in Kentucky and Ohio have been reviewed and designated by EPA Regions 4 and 5, respectively. A summary of the designations is found in the table below; however, data and analysis on those counties are found in separate documents generated by each respective region.

Summary of Evaluation Based on weighted emissions, EPA estimates that Mingo and Lincoln counties, adjacent to the Huntington MSA have relatively low emissions contribution to the metropolitan area. A review of the remaining factors provided additional evidence for the designation of attainment for these surrounding counties.

Data supporting EPA's intended designation for the West Virginia counties as part of the Huntington nonattainment area is provided below. 6 119 Summary Huntington Ashland, WV KY OH MSA EPA Reg ST COUNTY State Recommend PM2.5 Designation PM2.5 Designation Area  ' 99 C/ MSA 4 KY B oyd " Defer" Nonattainment Huntington Ashland, WV KY OH 3 WV Cabell Nonattainment Nonattainment Huntington Ashland, WV KY OH 4 KY Carter Attainment Attainment Huntington Ashland, WV KY OH 4 KY Greenup Attainment Attainment Huntington Ashland, WV KY OH 5 OH Lawrence Nonattainment Nonattainment Huntington Ashland, WV KY OH 3 WV Wayne Nonattainment Nonattainment Huntington Ashland, WV KY OH 5 OH Adams Attainment Nonattainment 4 KY Elliott Attainment Attainment 5 OH Gallia Attainment Nonattainment 5 OH Jackson Attainment Attainment 4 KY Lawrence Attainment Nonattainment 4 KY Lewis Attainment Attainment 3 WV Lincoln Attainment Attainment Adjacent County 4 KY Martin Attainment Attainment 3 WV Mingo Attainment Attainment Adjacent County 5 OH Pike Attainment Attainment 4 KY Rowan Attainment Attainment 5 OH Scioto Nonattainment Nonattainment Adjacent County with Violating Monitor 6 120 SUMMARY OF FACTOR 1: EMISSIONS Huntington Ashland, WV KY OH MSA ** Counties Listed by Percent Contribution to Harrisburg CMSA** Total Emissions, 2001 ( tons) EPA Reg ST COUNTY PM SO2 NOX VOC Amm Carbon Crustal Weighted Emissions Factor PM2.5 Designation 5 OH Gallia 10,010 164,984 61,079 1,839 300 2,171 6,238 141.4 Nonattainment 5 OH Adams 6,417 125,136 52,992 1,508 431 1,435 3,973 102.4 Nonattainment 5 KY Lawrence 2,903 56,066 21,265 919 56 745 1,718 48.3 Nonattainment 3 WV Cabell 2,365 5,155 27,903 7,080 181 1,318 774 40.3 Nonattainment 5 KY B oyd 2,314 11,740 13,478 8,620 467 689 1,242 25.2 Nonattainment 5 OH Scioto 1,053 2,790 5,566 4,703 350 400 559 12.5 Nonattainment 3 WV Wayne 550 1,023 6,485 2,620 56 317 199 9.6 Nonattainment 5 KY G reenup 477 2,519 4,336 1,795 156 295 160 9.5 Attainment 5 OH Lawrence 770 841 4,399 4,366 207 293 379 8.6 Nonattainment 5 KY Lewis 429 469 2,873 990 222 285 121 8.1 Attainment 5 KY Carter 506 237 2,615 1,996 223 242 249 6.8 Attainment 5 OH Pike 425 4,203 2,081 1,311 149 172 237 6.8 Attainment 5 KY Rowan 336 313 1,691 1,535 91 204 123 5.7 Attainment 3 WV Mingo 437 281 2,842 1,379 150 191 217 5.5 Attainment 5 OH Jackson 404 461 1,320 1,717 165 164 219 4.7 Attainment 5 KY Martin 281 661 1,236 706 762 136 131 4.0 Attainment 3 WV Lincoln 259 67 1,314 1,128 37 143 108 4.0 Attainment 5 KY Elliott 164 115 393 313 42 114 46 3.1 Attainment SUMMARY OF FACTOR 2: AIR QUALITY Huntington Ashland, WV KY OH MSA Design Values EPA Reg ST COUNTY ' 01' 03 ' 00' 02 ' 99' 01 4 KY B oyd 15.0 A 15.7 NA 15.5 NA 3 WV Cabell 16.6 NA 17.3 NA 17.8 NA 4 KY Carter 12.2 A 13.1 A 12.9 A 4 KY Greenup No Monitor 5 OH Lawrence 15.8 NA 16.7 NA 17.4 na 3 WV Wayne No Monitor 5 OH Scioto 17.2 NA 17.5 NA 20.0 NA Region III in agreement with West Virginia Recommendation for Huntington MSA 6 121 Justifications for Changes to EPA Recommendations Contained in the June 29, 2004 Letters to States In the June 2004 letters from EPA to the States responding to their designation recommendations, EPA expressed intent to designate a number of counties nonattainment primarily because of high pollutant emissions from power plants. Most of these plants were located in counties outside but near to the metropolitan area. EPA suggested that a State could provide a partial county boundary that would extend to the relevant power plant to include it in the nonattainment area.

A number of states responded to this suggestion with a series of connected townships or other unique boundaries. Some states also suggested an alternative approach in which partial county areas for power plants in some cases could be small " free standing" boundaries that are considered part of the nearby nonattainment area. In this way, it would not be necessary to include additional townships or other minor civil divisions comprising an odd shaped " land connector" extending from the main part of the nonattainment area to the power plant.

After considering these comments from the States, EPA agrees that such an approach is preferable in cases where a partial county nonattainment boundary has not already been established for that source ( e. g. partial county boundaries recently established for 8 hour ozone nonattainment areas), or where the source is not located close enough to where the partial county boundary could be contiguous to the rest of the nonattainment area. Such free standing portions of nonattainment areas should only be established based on a pre existing boundary for a minor civil division such as a township, tax district, or other defined boundary recognized for other governmental use. Accordingly, this kind of partial county boundary should not be defined simply as the boundary of the facility.

As noted in section <IP_ADDRESS> above, after consultation with the State of West Virginia EPA has added the portion of Mason County which contains the Mountaineer and Philip Sporn power plants to the Huntington Ashland area. Mason County has population, vehicle miles traveled and commuting factors which are lower than the factors for the six counties in the three state MSA. The primary reason for including the adjacent county of Mason is the contribution of emissions from two power plants. The state of West Virginia has submitted, as requested, an identification of a partial county to include the Mountaineer and Philip Sporn power plants. In Mason County the Tax District of Graham is nonattainment. The remainder of Mason County is attainment/ unclassifiable.

Tax District Boundaries were selected as the minor civil division to identify partial county areas. Tax district boundary lines were adopted by the West Virginia Legislature in 1978 as a general reference to delineate rural tax district boundaries. The boundaries were drawn from 1: 24,000 scale USGS topographic maps in 1978 and coincide with county magisterial districts as of July 1, 1973. Unlike magisterial districts that are realigned every ten years following the census, the tax district boundary does not follow equal representation requirements. 6 122 <IP_ADDRESS> Marion Area ( Fairmont CSA)

Discussion The Marion area is a county that is not part of a 1999 Metropolitan Statistical area. In 2003, however, the Office of Management and Budget ( OMB) delineated new boundaries using the 2000 Census Data. Marion was included in the Fairmont CBSA in 2003. Harrison and Preston Counties, part of the 2003 Clarksburg CBSA are included with Marion in the larger 2003 Combined Statistical Area ( CSA). Marion County has monitored violations of the fine particulate ( PM2.5) National Ambient Air Quality Standard ( NAAQS) of 15.0 µ g/ m ³ . Based on the monitored violations, the Fairmont CSA is considered a presumptive nonattainment area. Marion County has monitored 15.4 µ g/ m3 for the time period 2001 2003. This monitor is intended to be used as the Design Value monitor for the Marion nonattainment area.

The State of West Virginia, in the Secretary Timmermeyer correspondence of February 13, 2004, recommended the single county as a nonattainment area EPA has reviewed the State's recommendations as well as additional data provided by West Virginia on June 3, 2004. EPA agrees with the recommendation for Marion County, however, EPA intends to add two adjacent counties, Harrison and Monongalia, to the nonattainment area.

Summary of Evaluation Based on weighted emissions screening, EPA has identified Wetzel County and Taylor County to have relatively low emissions contribution to the metropolitan area. Review of the remaining factors, provides additional evidence for the designation of attainment for these surrounding counties.

Harrison, Preston and Monongalia counties, however, show higher contribution to the area, based on the weighted emissions factor. Population density and commuting patterns are relatively small in this rural area. Although both Harrison and Monongalia have monitored attainment, estimates show potential exceedances of the standard in other parts of Monongalia County. The actual emissions from Harrison and Monongalia counties, are estimated to substantially contribute to the monitored violations in Marion County when reviewed with topography and meteorology. EPA intends to modify the West Virginia recommended nonattainment boundary and include Harrison and Monongalia counties with the Marion MSA. A summary of the data that supports the modification of the State's recommendation is provided below. 6 123 SUMMARY OF MARION, WV AREA EPA Reg ST COUNTY State Recommend PM2.5 Designation PM2.5 Designation Area  ' 99 C/ MSA N/ A 2003 CBSA Area Listed 3 WV Marion Nonattainment Nonattainment Fairmount CBSA 3 WV Monongalia Attainment Nonattainment Morgantown, WV CBSA 3 WV Harrison Attainment Nonattainment Clarksburg, WV CBSA 3 WV Wetzel Attainment Attainment 3 WV Taylor Attainment Attainment Clarksburg, WV CBSA 6 124 SUMMARY OF FACTOR 1: EMISSIONS MARION, WV AREA ** Counties Listed by Percent Contribution to area** Total Emissions, 2001 ( tons) EPA Reg ST COUNTY PM SO2 NOX VOC Amm Carbon Crustal Weighted Emissions Factor 3 WV Monongalia 5,459 81,413 17,545 5,606 185 1,320 3,331 54.7 3 WV Harrison 2,781 7,671 35,477 4,641 240 657 1,748 28.1 3 WV Preston 1,715 21,864 6,528 1,874 271 465 1,021 17.4 3 WV M arion 777 7,953 6,069 3,075 102 295 413 10.0 3 WV Wetzel 260 698 4,323 1,720 45 160 79 4.8 3 WV Lewis 244 372 4,095 1,795 123 143 87 4.3 3 WV Upshur 342 141 1,583 1,676 90 178 150 4.0 3 WV Barbour 294 84 800 740 200 131 145 2.8 3 WV T yler 292 176 1,233 1,869 44 122 126 2.8 3 WV T aylor 253 416 2,595 721 67 73 128 2.5 3 WV Ritchie 166 118 713 636 75 97 63 2.1 3 WV G ilmer 122 24 1,088 640 47 73 44 1.8 3 WV Doddridge 123 30 798 434 39 73 46 1.7 SUMMARY OF FACTOR 2: AIR QUALITY MARION, WV AREA Design Values EPA Reg ST COUNTY ' 01' 03 ' 00' 02 ' 99' 01 3 WV M arion 15.4 NA 15.7 NA 15.9 na 3 WV Monongalia 14.9 A 15.0 A 15.0 A 3 WV Harrison 14.0 A 14.5 A 14.8 A SUMMARY OF FACTOR 3: POPULATION DENSITY AND DEGREE OF UBANIZATION MARION, WV AREA Population & Area EPA Reg ST COUNTY 2002 Area ( sq miles) Density ' 02 3 WV M arion 56,433 310 182 3 WV Monongalia 82,895 361 230 3 WV Harrison 67,856 416 163 6 125 SUMMARY FACTOR 4: COMMUTING PATTERNS MARION, WV AREA VMT Commuting to Other Metro Counties EPA Reg ST COUNTY 2002 Percent Number 3 WV M arion 475 3 WV Monongalia 810 3 1,234 3 WV Harrison 707 6 1,651 SUMMARY FACTOR 5: EXPECTED GROWTH MARION, WV AREA Population VMT EPA Reg ST COUNTY 2002 Growth ' 90' 00 Pct chng ' 90' 00 Growth ' 02' 10 Pct chng ' 02' 10 3 WV M arion 56,433  651  1 95 20 3 WV Monongalia 82,895 6,357 8  180  22 3 WV Harrison 67,856  719  1  47  7 Factor 8: Jurisdictional Boundaries The 1999 MSA was expanded in 2003 to include Harrison, Taylor and Doddridge Counties. The review of Taylor and Doddridge Counties, however, did not provide sufficient evidence to include these counties in the nonattainment area.

Factor 9: Level of Control EPA identified large sources greater than 1000 tons per year for any pollutant and evaluated its distance to a violating monitor for fine particulate. There are large uncontrolled sources in Monongalia and Harrison counties.

Justifications for Changes to EPA Recommendations Contained in the June 29, 2004 Letters to States In the June 2004 letters from EPA to the States responding to their designation recommendations, EPA expressed intent to designate a number of counties nonattainment primarily because of high pollutant emissions from power plants. Most of these plants were located in counties outside but near to the metropolitan area. EPA suggested that a State could provide a partial county boundary that would extend to the relevant power plant to include it in the nonattainment area.

A number of states responded to this suggestion with a series of connected townships or other unique boundaries. Some states also suggested an alternative approach in which partial county areas for power plants in some cases could be small " free standing" boundaries that are considered part of the nearby nonattainment area. In this way, it would not be necessary to include additional townships or other minor civil divisions comprising an odd shaped " land connector" extending from the main part of the nonattainment area to the power plant. 6 126 After considering these comments from the States, EPA agrees that such an approach is preferable in cases where a partial county nonattainment boundary has not already been established for that source ( e. g. partial county boundaries recently established for 8 hour ozone nonattainment areas), or where the source is not located close enough to where the partial county boundary could be contiguous to the rest of the nonattainment area. Such free standing portions of nonattainment areas should only be established based on a pre existing boundary for a minor civil division such as a township, tax district, or other defined boundary recognized for other governmental use. Accordingly, this kind of partial county boundary should not be defined simply as the boundary of the facility.

All of the counties in the proposed Marion County ( AKA Fairmont CBSA) nonattainment area are predominantly rural in nature. The primary reason for including the adjacent counties of Monongalia and Harrison is the contribution of emissions from power plants. The state of West Virginia has submitted, as requested, an identification of partial counties to include the Fort Martin and Harrison power plants. In Monongalia County the Tax District of Cass is nonattainment. The remainder of Monongalia County is attainment/ unclassifiable. In Harrison County the Tax District of Clay and Eagle is nonattainment. The remainder of Harrison County is attainment/ unclassifiable.

Tax District Boundaries were selected as the minor civil division to identify partial county areas. Tax district boundary lines were adopted by the West Virginia Legislature in 1978 as a general reference to delineate rural tax district boundaries. The boundaries were drawn from 1: 24,000 scale USGS topographic maps in 1978 and coincide with county magisterial districts as of July 1, 1973. Unlike magisterial districts that are realigned every ten years following the census, the tax district boundary does not follow equal representation requirements.

<IP_ADDRESS> Parkersburg Area Discussion The Parkersburg Metropolitan Statistical Area ( MSA) is comprised of two counties: Wood County, WV and Washington County, OH. Wood County, part of the MSA has monitored violations of the fine particulate ( PM2.5) National Ambient Air Quality Standard ( NAAQS) of 15.0 µ g/ m ³ . Based on the monitored violations, the Parkersburg MSA is considered a presumptive nonattainment area. Wood County has monitored 16.0 µ g/ m3 for the time period 2001 2003. This monitor is intended to be used as the Design Value monitor for the Parkersburg nonattainment area. Review of the Ohio counties has been done by EPA Region 5 and is specified in documentation generated by that Region. The EPA intended designation for Ohio counties is provided in the table below.

The State of West Virginia, in the Secretary Timmermeyer correspondence of February 13, 2004, recommended Wood County to be included in the Parkersburg nonattainment area. EPA has reviewed the State's recommendations as well as additional data provided by West Virginia on June 3, 2004 and agrees with the recommendation for Wood County, however, EPA intends to add an adjacent county, Pleasants County, WV, to the nonattainment area. 6 127 Summary of Evaluation Based on weighted emissions screening, EPA has identified Tyler, Ritchie, and Roane and Calhoun counties in West Virginia to have relatively low emissions contribution to the metropolitan area. Review of the remaining factors provided additional evidence for the designation of attainment for these surrounding counties.

Pleasants and Wirt counties were added to the Parkersburg metropolitan area in the revised 2003 OMB metropolitan definition. Closer examination highlights the emissions contribution by Pleasants County to the area. Wirt County, in contrast, has low estimated emissions contribution to the area.

Wood County, part of the MSA, and Pleasants County, an adjacent county, show comparable emissions and similar air quality estimates. The population density and commuting patterns of Pleasants when compared to the core MSA counties in this area are not, however, substantial. The geography, however, does provide supporting information for designation of nonattainment as a contributing county. A small portion of Pleasants County juts into the metropolitan area. This portion of the county contains a major emitting source. EPA intends, based on this review, to modify the West Virginia recommended nonattainment boundary and include Pleasants County with the Parkersburg MSA. A summary of the data that supports the addition of Pleasants County to the State's recommendation is provided below.

Parkersburg WV OH MSA EPA Reg ST COUNTY State Recommend PM2.5 Designation PM2.5 Designation Area  ' 99 C/ MSA 5 OH Washington Attainment Nonattainment Parkersburg Marietta, WV OH 3 WV W ood Nonattainment Nonattainment Parkersburg Marietta, WV OH 5 OH Athens Attainment Attainment 3 WV C alhoun Attainment Attainment 3 WV Jackson Attainment Attainment 5 OH Meigs Attainment Attainment 5 OH Monroe Attainment Attainment 5 OH Morgan Attainment Attainment 5 OH Noble Attainment Attainment 3 WV Pleasants Attainment Nonattainment Parkersburg 2003 CBSA 3 WV R itchie Attainment Attainment 3 WV Roane Attainment Attainment 3 WV Tyler Attainment Attainment 3 WV Wirt Attainment Attainment Parkersburg 2003 CBSA 6 128 SUMMARY OF FACTOR 1: EMISSIONS PARKERSBURG WV OH MSA ** Counties Listed by Percent Contribution to area** Total Emissions, 2001 ( tons) EPA Reg ST COUNTY PM SO2 NOX VOC Amm Carbon Crustal Weighted Emissions Factor 5 OH Washington 10,743 173,312 37,020 5,274 565 2,415 6,711 48.4 3 WV Pleasants 2,602 68,264 23,398 1,337 29 823 1,411 17.7 3 WV Wood 1,144 6,514 6,943 7,148 243 591 482 10.3 3 WV Jackson 1,780 3,464 3,947 2,394 158 451 1,128 7.7 5 OH Athens 417 733 3,166 2,400 204 176 222 3.1 5 OH Monroe 715 4,532 2,809 1,166 230 162 504 3.0 5 OH Meigs 309 375 2,244 1,051 164 147 145 2.5 3 WV T yler 292 176 1,233 1,869 44 122 126 2.1 3 WV Ritchie 166 118 713 636 75 97 63 1.6 5 OH Morgan 217 81 558 921 228 88 122 1.5 5 OH Noble 219 144 1,622 1,377 197 87 127 1.5 3 WV Wirt 84 19 206 406 45 46 36 0.8 3 WV Roane 213 106 1,083 1,108 99 119 87 2.0 3 WV Calhoun 114 43 937 512 35 68 42 1.2 SUMMARY OF FACTOR 2: AIR QUALITY PARKERSBURG WV OH MSA Design Values EPA Reg ST COUNTY ' 01' 03 ' 00' 02 ' 99' 01 5 OH Washington No monitor 3 WV Wood 16.0 NA 17.0 NA 17.6 NA 3 WV Pleasants No monitor 3 WV Wirt No monitor SUMMARY OF FACTOR 3: POPULATION DENSITY AND DEGREE OF UBANIZATION PARKERSBURG WV OH MSA Population & Area EPA Reg ST COUNTY 2002 Area ( sq miles) Density ' 02 5 OH Washington 62,561 635 99 3 WV Wood 87,306 367 238 3 WV Pleasants 7,579 131 58 3 WV Wirt 5,935 233 25 6 129 SUMMARY FACTOR 4: COMMUTING PATTERNS PARKERSBURG WV OH MSA VMT Commuting to Other Metro Counties EPA Reg ST COUNTY 2002 Percent Number 5 OH Washington 737 21 5,927 3 WV Wood 911 9 3,316 3 WV Pleasants 78 35 1,026 3 WV Wirt 44 54 1,215 SUMMARY FACTOR 5: EXPECTED GROWTH PARKERSBURG WV OH MSA Population VMT EPA Reg ST COUNTY 2002 Growth ' 90 ' 00 Pct chng ' 90' 00 Growth ' 02' 10 Pct chng ' 02' 10 5 OH Washington 62,561 997 2 19 3 3 WV Wood 87,306 1,071 1 108 12 3 WV Pleasants 7,579  32  0 26 33 3 WV Wirt 5,935 681 13 28 64 Factor 8: Jurisdictional Boundaries The 1999 MSA was expanded in 2003 to include Pleasants and Wirt counties. The review of Wirt County, however, did not provide sufficient evidence to include these counties in the nonattainment area.

The Parkersburg area has recently been designated nonattainment for the 8 hour ozone standard. Wood County, WV and Washington County, OH both monitored violations of the ozone standard.

Factor 9: Level of Control EPA identified large sources greater than 1000 tons per year for any pollutant and evaluated its distance to a violating monitor for fine particulate. This screening identified the Pleasants Power Plant 13 miles from the violating monitor. West Virginia has provided additional information on the level of control of the Pleasants plant. Additional NOX controls have recently been added to the power plant. The 1200 MW plant is now well controlled. There is a 15% scrubber bypass currently operating on the plant, however. The much smaller Willow Island power plant ( 228 MW) is located in Pleasants County and is not well controlled.

Justifications for Changes to EPA Recommendations Contained in the June 29, 2004 Letters to States In the June 2004 letters from EPA to the States responding to their designation recommendations, EPA expressed intent to designate a number of counties nonattainment primarily because of high pollutant emissions from power plants. Most of these plants were 6 130 located in counties outside but near to the metropolitan area. EPA suggested that a State could provide a partial county boundary that would extend to the relevant power plant to include it in the nonattainment area.

A number of states responded to this suggestion with a series of connected townships or other unique boundaries. Some states also suggested an alternative approach in which partial county areas for power plants in some cases could be small " free standing" boundaries that are considered part of the nearby nonattainment area. In this way, it would not be necessary to include additional townships or other minor civil divisions comprising an odd shaped " land connector" extending from the main part of the nonattainment area to the power plant.

After considering these comments from the States, EPA agrees that such an approach is preferable in cases where a partial county nonattainment boundary has not already been established for that source ( e. g. partial county boundaries recently established for 8 hour ozone nonattainment areas), or where the source is not located close enough to where the partial county boundary could be contiguous to the rest of the nonattainment area. Such free standing portions of nonattainment areas should only be established based on a pre existing boundary for a minor civil division such as a township, tax district, or other defined boundary recognized for other governmental use. Accordingly, this kind of partial county boundary should not be defined simply as the boundary of the facility.

All of the counties in the proposed Parkersburg nonattainment area are predominantly rural in nature. The primary reason for including the adjacent county of Pleasants is the contribution of emissions from the Pleasants power plant The state of West Virginia has submitted, as requested, an identification of partial counties to include the power plant. In Pleasants County the Tax District of Grant is nonattainment. The remainder of Pleasants County is attainment/ unclassifiable.

Tax District Boundaries were selected as the minor civil division to identify partial county areas. Tax district boundary lines were adopted by the West Virginia Legislature in 1978 as a general reference to delineate rural tax district boundaries. The boundaries were drawn from 1: 24,000 scale USGS topographic maps in 1978 and coincide with county magisterial districts as of July 1, 1973. Unlike magisterial districts that are realigned every ten years following the census, the tax district boundary does not follow equal representation requirements.

EPA is designating Wood and part of Pleasants counties as the West Virginia portion of the Parkersburg nonattainment area.

<IP_ADDRESS> Steubenville OH WV Area Discussion The Steubenville Weirton MSA includes three counties. Two counties in West Virginia, Brooke and Hancock, as well as Jefferson County, OH. The surrounding counties have been evaluated and designated as part of the Pittsburgh and Wheeling nonattainment areas. Hancock and Brooke counties both monitored violations of the fine particulate ( PM2.5) National Ambient Air 6 131 Quality Standard ( NAAQS) of 15.0 µ g/ m ³ . Based on the monitored violations, the Steubenville MSA is considered a presumptive nonattainment area. Jefferson County, OH has monitored 17.8 µ g/ m3 for the time period 2001 2003. This monitor is intended to be used as the Design Value monitor for the Steubenville nonattainment area.

The State of West Virginia, in the Secretary Timmermeyer correspondence of February 13, 2004, recommended Hancock and Brooke counties as part of the Steubenville nonattainment area. EPA has reviewed the State's recommendations as well as additional data provided by West Virginia on June 3, 2004. EPA agrees with the recommendation.

Summary of Evaluation Both counties recommended by the State have monitored violations of the standard. Adjacent counties are for the most part have been analyzed under other metropolitan areas. Data supporting EPA's intended nonattainment boundaries and West Virginia's recommendation is provided below.

STATUS OF STEUBENVILLE MSA AND SURROUNDING AREA EPA Reg ST COUNTY State Recommend PM2.5 Designation PM2.5 Designation Area  ' 99 C/ MSA eparegion stpostal county_ name state_ rec msa_ name C/ MSA Total ( excluding surrounding) = 3 counties 3 WV B rooke Nonattainment Nonattainment Steubenville Weirton, OH WV 3 WV Hancock Nonattainment Nonattainment Steubenville Weirton, OH WV 5 OH Jefferson Nonattainment Nonattainment Steubenville Weirton, OH WV 3 PA Beaver Nonattainment Nonattainment Pittsburgh, PA 5 OH Belmont Attainment Nonattainment Wheeling, WV OH 5 OH Columbiana Attainment Nonattainment Youngstown Warren, OH 3 WV Ohio Nonattainment Nonattainment Wheeling, WV OH 3 PA Washington Nonattainment Nonattainment Pittsburgh, PA 5 OH Carroll Attainment Attainment Canton Massillon, OH 5 OH Harrison Attainment Attainment 6 132 SUMMARY OF FACTOR 1: EMISSIONS STEUBENVILLE MSA ** Counties Listed by Percent Contribution to area** Total Emissions, 2001 ( tons) EPA Reg ST COUNTY PM SO2 NOX VOC Amm Carbon Crustal Weighted Emissions Factor 5 OH Jefferson 12,247 217,794 61,402 4,082 287 2,723 7,529 39.9 3 PA Beaver 4,948 40,380 39,564 8,738 543 1,368 2,900 18.8 3 PA Washington 3,011 8,221 22,097 9,392 813 1,190 1,505 12.5 5 OH Belmont 2,797 51,374 13,036 4,211 464 734 1,667 9.6 3 WV H ancock 4,335 1,982 4,961 3,585 571 1,243 1,747 9.4 5 OH Columbiana 1,187 1,291 5,825 5,881 1,250 442 696 4.2 3 WV Ohio 351 514 3,609 2,779 123 192 135 1.9 3 WV Brooke 527 1,663 2,500 4,358 439 191 277 1.8 5 OH Carroll 363 386 1,886 1,422 375 120 234 1.2 5 OH Harrison 191 258 712 786 254 70 116 0.6 SUMMARY OF FACTOR 2: AIR QUALITY STEUBENVILLE MSA Design Values EPA Reg ST COUNTY ' 01' 03 ' 00' 02 ' 99' 01 3 WV Brooke 16.8 NA 16.8 NA 17.4 NA 3 WV H ancock 17.4 NA 17.5 NA 17.4 NA 5 OH Jefferson 17.8 NA 18.2 NA 18.9 NA The two Region 3 counties to be evaluated as part of the Steubenville MSA have monitored violations of the PM2.5 Standard. Evaluation of the remaining factors is not necessary.

Justifications for Changes to EPA Recommendations Contained in the June 29, 2004 Letters to States After consideration of all information provided, EPA has determined that the recommendation of June 29, 2004 as described above is still valid. Therefore, EPA is designating Brooke and Hancock counties as the West Virginia portion of the Steubenville nonattainment area.

<IP_ADDRESS> Hagerstown Martinsville Area Discussion Berkeley County, WV has monitored violations of the fine particulate ( PM2.5) National Ambient Air Quality Standard ( NAAQS) of 15.0 µ g/ m ³ . Based on the monitored violations, this county is considered a presumptive nonattainment area. Berkeley County has monitored 16.3 µ g/ m3 for the time period 2001 2003. This monitor is intended to be used as the Design Value monitor for the Hagerstown nonattainment area. 6 133 Berkeley County is actually part of the large Washington Baltimore CMSA. For planning purposes and consistency with existing ozone boundaries, EPA intends to separate Berkeley from the CMSA. The existing ozone nonattainment boundary includes Berkeley and Jefferson counties as an independent area, referred to as the Eastern WV panhandle. Berkeley County was defined by OMB in 2003 as part of the Hagerstown Martinsville CBSA with Washington County, MD.

West Virginia recommended both Jefferson and Berkeley counties as nonattainment in the February 13, 2004 recommendation letter. On June 1, 2004, the state revised its recommendation to exclude Jefferson County. Washington County, MD has also been recommended attainment by the state of Maryland. Berkeley County has monitored violations, EPA agrees with the West Virginia recommendation of nonattainment for Berkeley County; however, EPA intends to designate Berkeley County with the Hagerstown Martinsville CBSA following EPA April 1, 2003 guidance suggesting that single counties be included with the nearest metropolitan area.

Justifications for Changes to EPA Recommendations Contained in the June 29, 2004 Letters to States Please see tables in Section <IP_ADDRESS> ( Washington, DC area) for specific data on Berkeley and Washington County. After consideration of all information provided, EPA has determined that the recommendation of June 29, 2004 as described above is still valid. EPA is designating Washington County, MD and Berkeley County, WV as the Hagerstown Martinsville nonattainment area.

<IP_ADDRESS> Wheeling, WV OH Area Discussion The Wheeling Metropolitan Statistical Area ( MSA) is comprised of three counties including two counties in West Virginia. The table below lists the counties in the MSA. Two counties in this MSA, Marshall and Ohio counties in West Virginia have monitored violations of the fine particulate ( PM2.5) National Ambient Air Quality Standard ( NAAQS) of 15.0 µ g/ m ³ . Based on the monitored violations, the Wheeling MSA is considered a presumptive nonattainment area. Marshall County, WV is part of the MSA and monitored 15.7 µ g/ m3 for the time period 2001 2003. This value is being considered the Design Value for the nonattainment area.

The State of West Virginia, in the Secretary Timmermeyer correspondence of February 13, 2004, recommended the two MSA counties to be included in the Wheeling nonattainment area. EPA has reviewed the State's recommendations as well as additional data provided by West Virginia on June 3, EPA agrees with the State recommendation to include Marshall and Ohio Counties in the Wheeling nonattainment area. Belmont, Ohio has been reviewed and designated nonattainment by EPA Region 5. 6 134 SUMMARY OF FACTOR 1: EMISSIONS WHEELING, WV AREA ** Counties Listed by Percent Contribution to area** Total Emissions, 2001 ( tons) EPA Reg ST COUNTY PM SO2 NOX VOC Amm Carbon Crustal Weighted Emissions Factor 5 OH Jefferson 12,247 217,794 61,402 4,082 287 2,723 7,529 119.6 3 PA Greene 11,626 186,481 31,832 2,756 256 2,548 7,223 99.2 3 WV M arshall 5,596 113,921 44,521 4,125 122 1,319 3,417 65.0 3 PA Washington 3,011 8,221 22,097 9,392 813 1,190 1,505 35.4 5 OH Belmont 2,797 51,374 13,036 4,211 464 734 1,667 29.5 5 OH Guernsey 503 1,164 5,643 3,602 367 229 261 7.3 5 OH Monroe 715 4,532 2,809 1,166 230 162 504 5.5 3 WV O hio 351 514 3,609 2,779 123 192 135 5.5 3 WV Brooke 527 1,663 2,500 4,358 439 191 277 5.3 3 WV Wetzel 260 698 4,323 1,720 45 160 79 5.2 5 OH Noble 219 144 1,622 1,377 197 87 127 2.5 5 OH Harrison 191 258 712 786 254 70 116 1.8 SUMMARY OF FACTOR 2: AIR QUALITY WHEELING, WV AREA Design Values EPA Reg ST COUNTY ' 01' 03 ' 00' 02 ' 99' 01 5 OH Jefferson 17.8 NA 18.2 NA 18.9 NA 3 WV Brooke 16.8 NA 16.8 NA 17.4 NA 3 WV M arshall 15.7 NA 16.0 NA 16.5 NA 3 PA Washington 15.5 NA 15.7 NA 15.5 NA 5 WV O hio 15.2 NA 15.3 NA 15.7 NA 5 OH Harrison No Monitor 5 OH Belmont No Monitor 3 PA G reene No Monitor 3 OH Monroe No Monitor 3 WV Wetzel No Monitor 5 OH Guernsey No Monitor 5 OH Noble No Monitor 6 135 SUMMARY OF FACTOR 3: POPULATION DENSITY AND DEGREE OF UBANIZATION WHEELING, WV AREA Population & Area EPA Reg ST COUNTY 2002 Area ( sq miles) Density ' 02 3 PA Washington 204,110 857 238 5 OH Jefferson 72,402 410 177 5 OH Belmont 69,448 537 129 3 WV O hio 46,126 106 435 5 OH Guernsey 40,987 522 79 3 PA Greene 40,520 576 70 3 WV M arshall 34,898 307 114 3 WV Brooke 25,179 89 283 3 WV Wetzel 17,363 359 48 5 OH Harrison 15,890 404 39 5 OH Monroe 14,973 456 33 5 OH Noble 14,088 399 35 SUMMARY FACTOR 4: COMMUTING PATTERNS WHEELING, WV AREA VMT Commuting to Other Metro Counties EPA Reg ST COUNTY 2002 Percent Number 3 PA Washington 2,057 0 386 5 OH Belmont 1,066 20 5,667 5 OH Guernsey 1,026 2 365 5 OH Jefferson 741 7 2,045 3 PA Greene 560 1 101 3 WV O hio 437 15 2,964 5 OH Noble 362 2 103 3 WV Brooke 313 9 962 3 WV M arshall 233 37 5,233 5 OH Harrison 143 7 473 5 OH Monroe 142 15 852 3 WV Wetzel 111 8 519 6 136 SUMMARY FACTOR 5: EXPECTED GROWTH WHEELING, WV AREA Population VMT EPA Reg ST COUNTY 2002 Growth ' 90' 00 Pct chng ' 90' 00 Growth ' 02' 10 Pct chng ' 02' 10 5 OH Noble 14,088 2,722 24 229 172 5 OH Guernsey 40,987 1,768 5 636 163 3 PA Greene 40,520 1,122 3 161 40 5 OH Harrison 15,890  229  1 3 2 5 OH Monroe 14,973  317  2 2 1 5 OH Belmont 69,448  848  1 290 37 3 WV Brooke 25,179  1,545  6 94 43 3 WV Wetzel 17,363  1,565  8 4 4 3 PA Washington 204,110  1,687  1 168 9 3 WV Marshall 34,898  1,837  5  57  20 3 WV Ohio 46,126  3,444  7  83  16 5 OH Jefferson 72,402  6,404  8  48  6 Justifications for Changes to EPA Recommendations Contained in the June 29, 2004 Letters to States After consideration of all information provided, EPA has determined that the recommendation of June 29, 2004 as described above is still valid. Therefore, EPA is designating Marshall and Ohio counties as the West Virginia portion of the Wheeling nonattainment area.


Memo To: Memo to Docket No. OAR 2002 0076 From: Thomas E. Rosendahl, Engineer, U. S. EPA Office of Air Quality Planning and Standards Air Quality Strategies and Standards Division Integrated Policy and Strategies Group, C504 02 RTP, NC 27713 Date: June 15, 2005 Subject: Roll back Analysis The material that follows, documents a simple roll back analysis on five National Parks and Wilderness areas and the projected changes in the visibility parameters that would be expected. Write up of a Simple Roll back Analysis A simple roll back analysis was conducted for five National Parks and Wilderness Areas using the following assumptions and methodology. The assumptions were:

To use a NEI99 version 3 ( NEIv3) facility data set for establishing a baseline emissions inventory of facilities emitting greater than 250 tons annually of SO2 or of NOx or of PM10.

To use an EGU BART eligible emission inventory data set which is based on NEIv3, but adjusted for 2001 annual CEM emissions, as the EGU BARTeligible facility data set.

To use a nonEGU BART eligible emission inventory data set which is based on NEIv3, but adjusted for 2001 annual CEM emissions, as the non EGU BART eligible facility data set.

To use 2001 to 2003 IMPROVE data as the air quality indicators at the five areas being analyzed.

To use the following control assumption: that SO2 emissions from BART eligible sources would be reduced by 90% and that NOx emissions from BART eligible sources would be reduced by 50%.

The roll back methodology involved the use of a geospatial boundary file of the five Class 1 areas that contains the polygon description of each area and its related spatial coordinates for the five National Parks and Wilderness areas being analyzed. Next, a MapInfo GIS system was used to identify a 250 kilometer buffer zone around the boundary of each area and identify from the three emissions data sets the facilities that are within that buffer zone. From these subsets of emissions data for each area the " Baseline Total" that is the annual tonnage of SO2 plus NOx was obtained, along with the " BART eligible SO2" tonnage and the " BART eligible NOx" tonnage.

The simple roll back of any air quality indicator is then:

Baseline Total   [( BART eligible SO2 * 0.9) + ( BART eligible NOx * 0.5)] ( The Air Quality Indicator) x Baseline Total except for deciview which, because of its logarithmic relationship, is calculated from the B extinction indicator ( Bext) using the formula:

Deciview = 10* LN(( Bext+ 10)/ 10)

These resulting percent reduction, or roll back of the visibility parameters, represents the most optimistic percent reduction that one would expect from controls on BART eligible sources for two reasons. First, because it only accounted for point sources, not the total of all point, area and mobile emission activities within the 250 km buffer zone, which if it could have been accounted for would have increased the size of the " Baseline Total" and therefore would have driven the multiplier ratio nearer to 1.0. Second, this simple roll back didn't project the effects of the expected CAIR control activities in future years, which if it could have been accounted for would have reduced the amount of SO2 and NOx tonnages in the bracket that is subtracted from the " Baseline Total" in the numerator and therefore would have driven the multiplier ratio nearer to 1.0. Therefore, the justification for the previous statement that this analysis represents the most optimistic percent reduction that one would expect from controls on BART eligible sources.

The results show that the best that could be expected for a 2003 visibility projection in the five areas if BART had been implemented on all BART eligible sources within 250 kilometers of the Class 1 area boundary but before any CAIR reductions is:

A change from 24.1 deciview to 22.3 deciview at Mammoth Cave NP A change from 22.7 deciview to 20.0 deciview at Sipsey Wilderness A change from 21.4 deciview to 19.4 deciview at Mingo Wilderness A change from 13.0 deciview to 12.3 deciview at Theodore Roosevelt NP A change from 7.7 deciview to 7.7 deciview at Yellowstone NP The following pages show a page for each area which contains the details of the resulting air quality indicators as a result of applying this simple rollback relationship. Mammoth Cave NP Mammoth Cave Roll Back Analysis, Facilities only with greater than 250 annual tons.

2,766,302   [( SO2 * 0.9) + ( NOx * 0.5)] Estimate of air quality impact = ( Air Quality Indicator) x 2,766,302 2,766,302   [( 443,621 * 0.9) + ( 242,154 * 0.5)] Estimated impact = ( Air Quality Indicator) x 2,766,302 Estimated impact = ( Air Quality Indicator) x 0.81   The Roll Back Factor for Mammoth Cave Mammoth Cave, Estimated Annual Air Quality Impacts with BART Tmass Bext Deciview 2003, 1 yr annual average 0.81 * 13.9 = 11.3 0.81 * 101.8 = 82.6 From 24.1 to 22.3 2001_ 2003, 3 yr annual average 0.81 * 14.9 = 12.1 0.81 * 105.5 = 85.6 From 24.5 to 22.6 Mammoth Cave, Estimated Daily Air Quality Impacts Year, Daily unit Air Quality Indicator Est. Air Quality Impact Day of year impact occurred 2003, 1st highest Peak Daily Extinction 0.81 * 378 = 306.2 168 2003, 2nd highest Peak Daily Extinction 0.81 * 306 = 247.9 201 2003, 3rd highest Peak Daily Extinction 0.81 * 297 = 240.6 252 2003, 4th highest Peak Daily Extinction 0.81 * 258 = 209.0 228 2003, 5th highest Peak Daily Extinction 0.81 * 231 = 187.1 177 2003, 1st highest Peak Daily SO4 0.81 * 25.0 = 20.3 252 2003, 2nd highest Peak Daily SO4 0.81 * 24.7 = 20.0 168 2003, 3rd highest Peak Daily SO4 0.81 * 21.7 = 17.6 228 2003, 4th highest Peak Daily SO4 0.81 * 19.9 = 16.1 201 2003, 5th highest Peak Daily SO4 0.81 * 17.9 = 14.5 255 2003, 1st highest Peak Daily NO3 0.81 * 7.3 = 5.9 18 2003, 2nd highest Peak Daily NO3 0.81 * 6.2 = 5.0 39 2003, 3rd highest Peak Daily NO3 0.81 * 5.7 = 4.6 42 2003, 4th highest Peak Daily NO3 0.81 * 5.7 = 4.6 24 2003, 5th highest Peak Daily NO3 0.81 * 5.5 = 4.5 354 2003, 1st highest Peak Daily PM2.5 0.81 * 33.9 = 27.5 168 2003, 2nd highest Peak Daily PM2.5 0.81 * 31.7 = 25.7 252 2003, 3rd highest Peak Daily PM2.5 0.81 * 31.0 = 25.1 201 2003, 4th highest Peak Daily PM2.5 0.81 * 29.0 = 23.5 255 2003, 5th highest Peak Daily PM2.5 0.81 * 27.9 = 22.6 228 Mammoth Cave, EI >= 250tons SO2 or NOX, annual tons. Mammoth Cave, NonEGU BART Eligible, annual tons. Mammoth Cave, EGU Bart Eligible, annual tons. Sum BART SO2 1,904,402 5,235 438,386 443,621 NOx 861,900 5,627 236,527 242,154 Sum 2,766,302 10,862 674,913 685,775 Sipsey Wilderness Sipsey Wilderness Roll Back Analysis, Facilities only with greater than 250 annual tons.

1,535,448   [( SO2 * 0.9) + ( NOx * 0.5)] Estimate of air quality impact = ( Air Quality Indicator) x 1,535,448 1,535,448   [( 361,032 * 0.9) + ( 168,827 * 0.5)] Estimated impact = ( Air Quality Indicator) x 1,535,448 Estimated impact = ( Air Quality Indicator) x 0.73   The Roll Back Factor for Sipsey Wilderness Sipsey Wilderness, Estimated Annual Air Quality Impacts with BART Tmass Bext Deciview 2003, 1 yr annual average 0.73 * 15.6 = 11.4 0.73 * 87.1 = 63.9 From 22.7 to 20.0 2001_ 2003, 3 yr annual average 0.73 * 17.0 = 12.5 0.73 * 91.5 = 67.1 From 23.2 to 20.4 Sipsey Wilderness, Estimated Daily Air Quality Impacts Year, Daily unit Air Quality Indicator Est. Air Quality Impact Day of year impact occurred 2003, 1st highest Peak Daily Extinction 0.73 * 252 = 184.0 237 2003, 2nd highest Peak Daily Extinction 0.73 * 194 = 141.6 255 2003, 3rd highest Peak Daily Extinction 0.73 * 193 = 140.9 222 2003, 4th highest Peak Daily Extinction 0.73 * 190 = 138.7 252 2003, 5th highest Peak Daily Extinction 0.73 * 187 = 136.5 207 2003, 1st highest Peak Daily SO4 0.73 * 20.4 = 14.9 237 2003, 2nd highest Peak Daily SO4 0.73 * 15.8 = 11.5 222 2003, 3rd highest Peak Daily SO4 0.73 * 14.8 = 10.8 252 2003, 4th highest Peak Daily SO4 0.73 * 14.6 = 10.7 207 2003, 5th highest Peak Daily SO4 0.73 * 14.0 = 10.2 255 2003, 1st highest Peak Daily NO3 0.73 * 6.7 = 4.9 60 2003, 2nd highest Peak Daily NO3 0.73 * 4.6 = 3.4 18 2003, 3rd highest Peak Daily NO3 0.73 * 4.3 = 3.1 57 2003, 4th highest Peak Daily NO3 0.73 * 4.3 = 3.1 24 2003, 5th highest Peak Daily NO3 0.73 * 3.8 = 2.8 15 2003, 1st highest Peak Daily PM2.5 0.73 * 32.2 = 23.5 237 2003, 2nd highest Peak Daily PM2.5 0.73 * 27.4 = 20.0 177 2003, 3rd highest Peak Daily PM2.5 0.73 * 25.0 = 18.2 255 2003, 4th highest Peak Daily PM2.5 0.73 * 23.5 = 17.2 207 2003, 5th highest Peak Daily PM2.5 0.73 * 23.5 = 17.2 252 Sipsey Wilderness, EI >= 250tons SO2 or NOX, annual tons. Sipsey Wilderness, NonEGU BART Eligible, annual tons. Sipsey Wilderness, EGU Bart Eligible, annual tons. Sum BART SO2 1,046,660 14,304 346,728 361,032 NOx 488,788 24,026 144,801 168,827 Sum 1,535,448 38,330 491,529 529,859 Mingo Wilderness Mingo Wilderness Roll Back Analysis, Facilities only with greater than 250 annual tons.

1,415,850   [( SO2 * 0.9) + ( NOx * 0.5)] Estimate of air quality impact = ( Air Quality Indicator) x 1,415,850 1,415,850   [( 224,392 * 0.9) + ( 185,862* 0.5)] Estimated impact = ( Air Quality Indicator) x 1,415,850 Estimated impact = ( Air Quality Indicator) x 0.79   The Roll Back Factor for Mingo Wilderness Mingo Wilderness, Estimated Annual Air Quality Impacts with BART Tmass Bext Deciview 2003, 1 yr annual average 0.79 * 18.3 = 14.5 0.79 * 75.2 = 59.5 From 21.4 to 19.4 2001_ 2003, 3 yr annual average 0.79 * 21.0 = 16.6 0.79 * 84.5 = 66.9 From 22.5 to 20.4 Mingo Wilderness, Estimated Daily Air Quality Impacts Year, Daily unit Air Quality Indicator Est. Air Quality Impact Day of year impact occurred 2003, 1st highest Peak Daily Extinction 0.79 * 208 = 164.3 185 2003, 2nd highest Peak Daily Extinction 0.79 * 190 = 150.1 194 2003, 3rd highest Peak Daily Extinction 0.79 * 153 = 120.9 206 2003, 4th highest Peak Daily Extinction 0.79 * 143 = 113.0 188 2003, 5th highest Peak Daily Extinction 0.79 * 139 = 109.8 197 2003, 1st highest Peak Daily SO4 0.79 * 19.0 = 15.0 173 2003, 2nd highest Peak Daily SO4 0.79 * 19.0 = 15.0 185 2003, 3rd highest Peak Daily SO4 0.79 * 17.8 = 14.1 194 2003, 4th highest Peak Daily SO4 0.79 * 13.1 = 10.3 206 2003, 5th highest Peak Daily SO4 0.79 * 12.8 = 10.1 188 2003, 1st highest Peak Daily NO3 0.79 * 7.1 = 5.6 95 2003, 2nd highest Peak Daily NO3 0.79 * 6.3 = 5.0 5 2003, 3rd highest Peak Daily NO3 0.79 * 4.4 = 3.5 92 2003, 4th highest Peak Daily NO3 0.79 * 4.2 = 3.3 17 2003, 5th highest Peak Daily NO3 0.79 * 4.1 = 3.2 77 2003, 1st highest Peak Daily PM2.5 0.79 * 34.3 = 27.1 194 2003, 2nd highest Peak Daily PM2.5 0.79 * 29.1 = 23.0 185 2003, 3rd highest Peak Daily PM2.5 0.79 * 26.3 = 20.8 182 2003, 4th highest Peak Daily PM2.5 0.79 * 26.0 = 20.5 197 2003, 5th highest Peak Daily PM2.5 0.79 * 23.3 = 18.4 206 Mingo Wilderness, EI >= 250tons SO2 or NOX, annual tons. Mingo Wilderness, NonEGU BART Eligible, annual tons. Mingo Wilderness, EGU Bart Eligible, annual tons. Sum BART SO2 931,856 18,484 205,908 224,392 NOx 483,994 16,969 168,893 185,862 Sum 1,415,850 35,453 374,801 410,254 Theodore Roosevelt NP Theodore Roosevelt NP Roll Back Analysis, Facilities only with greater than 250 annual tons.

322,626   [( SO2 * 0.9) + ( NOx * 0.5)] Estimate of air quality impact = ( Air Quality Indicator) x 322,626 322,626   [( 26,313 * 0.9) + ( 10,733 * 0.5)] Estimated impact = ( Air Quality Indicator) x 322,626 Estimated impact = ( Air Quality Indicator) x 0.91   The Roll Back Factor for Theodore Roosevelt NP Theodore Roosevelt NP, Estimated Annual Air Quality Impacts with BART Tmass Bext Deciview 2003, 1 yr annual average 0.91 * 10.2 = 9.3 0.91 * 26.7 = 24.3 From 13.0 to 12.3 2001_ 2003, 3 yr annual average 0.91 * 10.9 = 9.9 0.91 * 27.7 = 25.2 From 13.3 to 12.6 Theodore Roosevelt NP, Estimated Daily Air Quality Impacts Year, Daily unit Air Quality Indicator Est. Air Quality Impact Day of year impact occurred 2003, 1st highest Peak Daily Extinction 0.91 * 78.2 = 71.2 249 2003, 2nd highest Peak Daily Extinction 0.91 * 70.7 = 64.3 45 2003, 3rd highest Peak Daily Extinction 0.91 * 68.0 = 61.9 240 2003, 4th highest Peak Daily Extinction 0.91 * 63.2 = 57.5 66 2003, 5th highest Peak Daily Extinction 0.91 * 59.5 = 54.1 51 2003, 1st highest Peak Daily SO4 0.91 * 5.6 = 5.1 66 2003, 2nd highest Peak Daily SO4 0.91 * 4.9 = 4.5 45 2003, 3rd highest Peak Daily SO4 0.91 * 3.8 = 3.5 228 2003, 4th highest Peak Daily SO4 0.91 * 3.4 = 3.1 51 2003, 5th highest Peak Daily SO4 0.91 * 2.9 = 2.6 171 2003, 1st highest Peak Daily NO3 0.91 * 3.2 = 2.9 48 2003, 2nd highest Peak Daily NO3 0.91 * 3.0 = 2.7 114 2003, 3rd highest Peak Daily NO3 0.91 * 2.9 = 2.6 45 2003, 4th highest Peak Daily NO3 0.91 * 2.8 = 2.5 12 2003, 5th highest Peak Daily NO3 0.91 * 2.8 = 2.5 51 2003, 1st highest Peak Daily PM2.5 0.91 * 20.2 = 18.4 249 2003, 2nd highest Peak Daily PM2.5 0.91 * 16.8 = 15.3 240 2003, 3rd highest Peak Daily PM2.5 0.91 * 10.9 = 9.9 228 2003, 4th highest Peak Daily PM2.5 0.91 * 10.6 = 9.6 234 2003, 5th highest Peak Daily PM2.5 0.91 * 9.3 = 8.5 237 Theodore Roosevelt NP, EI >= 250tons SO2 or NOX, annual tons. Theodore Roosevelt NP, NonEGU BART Eligible, annual tons. Theodore Roosevelt NP, EGU Bart Eligible, annual tons. Sum BART SO2 237,527 0 26,313 26,313 NOx 85,099 0 10,733 10,733 Sum 322,626 0 37,046 37,046 Yellowstone NP Yellowstone NP Roll Back Analysis, Facilities only with greater than 250 annual tons.

95,101   [( SO2 * 0.9) + ( NOx * 0.5)] Estimate of air quality impact = ( Air Quality Indicator) x 95,101 95,101   [( 0 * 0.9) + ( 433 * 0.5)] Estimated impact = ( Air Quality Indicator) x 95,101 Estimated impact = ( Air Quality Indicator) x 0.998   The Roll Back Factor for Yellowstone NP Yellowstone NP, Estimated Annual Air Quality Impacts Tmass Bext Deciview 2003, 1 yr annual average 0.99 * 4.7 = 4.7 0.99 * 11.7 = 11.6 From 7.7 to 7.7 2001_ 2003, 3 yr annual average 0.99 * 4.9 = 4.9 0.99 * 12.8 = 12.8 From 8.2 to 8.2 Yellowstone NP, Estimated Daily Air Quality Impacts Year, Daily unit Air Quality Indicator Est. Air Quality Impact Day of year impact occurred 2003, 1st highest Peak Daily Extinction 0.998 * 34.8 = 34.7 246 2003, 2nd highest Peak Daily Extinction 0.998 * 30.4 = 30.3 237 2003, 3rd highest Peak Daily Extinction 0.998 * 29.6 = 29.5 204 2003, 4th highest Peak Daily Extinction 0.998 * 27.8 = 27.7 213 2003, 5th highest Peak Daily Extinction 0.998 * 25.1 = 25.0 201 2003, 1st highest Peak Daily SO4 0.998 * 1.8 = 1.8 228 2003, 2nd highest Peak Daily SO4 0.998 * 1.5 = 1.5 126 2003, 3rd highest Peak Daily SO4 0.998 * 1.3 = 1.3 225 2003, 4th highest Peak Daily SO4 0.998 * 1.2 = 1.2 222 2003, 5th highest Peak Daily SO4 0.998 * 1.2 = 1.2 273 2003, 1st highest Peak Daily NO3 0.998 * 1.2 = 1.2 42 2003, 2nd highest Peak Daily NO3 0.998 * 1.2 = 1.2 336 2003, 3rd highest Peak Daily NO3 0.998 * 0.9 = 0.9 126 2003, 4th highest Peak Daily NO3 0.998 * 0.9 = 0.9 222 2003, 5th highest Peak Daily NO3 0.998 * 0.8 = 0.8 99 2003, 1st highest Peak Daily PM2.5 0.998 * 8.5 = 8.5 246 2003, 2nd highest Peak Daily PM2.5 0.998 * 7.2 = 7.2 204 2003, 3rd highest Peak Daily PM2.5 0.998 * 6.7 = 6.7 213 2003, 4th highest Peak Daily PM2.5 0.998 * 6.7 = 6.7 237 2003, 5th highest Peak Daily PM2.5 0.998 * 6.5 = 6.5 201 Yellowstone NP, EI >= 250tons SO2 or NOX, annual tons. Yellowstone NP, NonEGU BART Eligible, annual tons. Yellowstone NP, EGU Bart Eligible, annual tons. Sum BART SO2 66,597 0 0 0 NOx 28,504 433 0 433 Sum 95,101 433 0 433