[Federal Register Volume 85, Number 24 (Wednesday, February 5, 2020)]
[Notices]
[Pages 6561-6562]
[FR Doc No: 2020-02220]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-5404]

Mucopolysaccharidosis Type III (Sanfilippo Syndrome): Developing
Drugs for Treatment; Draft Guidance for Industry; Availability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the availability of a draft guidance for industry entitled
``Mucopolysaccharidosis Type III (Sanfilippo Syndrome): Developing
Drugs for Treatment.'' The purpose of this draft guidance is to foster
greater efficiency in drug development in this rare disease with the
goal of enhancing clinical trial data quality and supporting the
development of treatments for mucopolysaccharidosis type III.
Specifically, the draft guidance provides the Agency's current
recommendations regarding eligibility criteria, trial design
considerations, and efficacy endpoints for use in clinical development
programs of investigational drugs to treat mucopolysaccharidosis type
III.

DATES: Submit either electronic or written comments on the draft
guidance by May 5, 2020 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance 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-2019-D-5404 for ``Mucopolysaccharidosis Type III (Sanfilippo
Syndrome): Developing Drugs for Treatment.'' 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 the draft 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; or the
Office of Communication, Outreach, and Development, Center for
Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm. 3128, 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 draft guidance document.

FOR FURTHER INFORMATION CONTACT: Patroula Smpokou, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 5328, Silver Spring, MD 20993, 240-402-
9651; or Stephen Ripley, Center for Biologics Evaluation and Research,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm.
7301, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Mucopolysaccharidosis Type III (Sanfilippo Syndrome):
Developing Drugs for Treatment.'' This draft guidance provides the
Agency's recommendations regarding the structure of clinical
development programs for investigational drugs intended to treat
mucopolysaccharidosis type III. This draft guidance is intended to
facilitate greater consistency in approaches among development programs
and to ensure that sponsors receive clear and specific guidance to
foster greater efficiency of drug development in this rare disease. The
draft guidance describes specific considerations relating to
eligibility criteria and trial design and discusses the Agency's
current recommendations for efficacy endpoints to support approval of
drugs for mucopolysaccharidosis type III.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on
``Mucopolysaccharidosis Type III (Sanfilippo Syndrome): Developing
Drugs for Treatment.'' 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.

II. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved FDA collections
of information. These collections of information are subject to review
by the Office of Management and Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections of
information in 21 CFR part 312 (Investigational New Drug Application)
have been approved under OMB control number 0910-0014, and the
collections of information in 21 CFR part 314 (Applications for FDA
Approval to Market a New Drug) have been approved under OMB control
number 0910-0001, including 21 CFR 312.30, 314.50(d)(5), and
314.126(b)(6).

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, or https://www.regulations.gov.

    Dated: January 30, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-02220 Filed 2-4-20; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: September 7, 2007 (Volume 72, Number 173)]
[Notices]
[Page 51483-51485]
[DOCID:fr07se07-102]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-56347; File No. SR-NASD-2007-056]

Self-Regulatory Organizations; National Association of Securities
Dealers, Inc. (n/k/a Financial Industry Regulatory Authority, Inc.);
Notice of Filing of Proposed Rule Change and Amendment No. 1 Thereto To
Establish a Membership Waive-In Process for Certain NYSE Member
Organizations

August 31, 2007.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on July 25, 2007, the National Association of Securities Dealers, Inc.
(``NASD'') (n/k/a Financial Industry Regulatory Authority, Inc.) filed
with the Securities and Exchange Commission (``SEC'' or ``Commission'')
the proposed rule change as described in Items I, II, and III below,
which Items have been substantially prepared by NASD.\3\ On August 16,
2007, FINRA filed Amendment No. 1 to the proposed rule change. The
Commission is publishing this notice to solicit comments on the
proposed rule change, as amended, from interested persons.
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    \1\ 1 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ On July 26, 2007, the Commission approved a proposed rule
change filed by NASD to amend NASD's Certificate of Incorporation to
reflect its name change to the Financial Industry Regulatory
Authority, Inc., or FINRA, in connection with the consolidation of
the member firm regulatory functions of NASD and NYSE Regulation,
Inc. See Securities Exchange Act Release No. 56146 (July 26, 2007),
72 FR 42190 (August 1, 2007).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    NASD proposes to adopt Interpretive Material 1013-1 (``IM-1013-
1''), a membership waive-in process for certain New York Stock Exchange
(``NYSE'') member organizations, and Interpretive Material Section 4(e)
to Schedule A of the By-Laws, a membership application fee waiver for
those NYSE member organizations that apply for membership pursuant to
IM-1013-1. The proposed rule change is submitted in furtherance of the
consolidation of the member firm regulatory functions of NASD and NYSE
Regulation, Inc. (``NYSE Regulation'') (``Transaction'').\4\ The text
of the proposed rule change, including the FINRA Waive-In Membership
Application Form and Membership Agreement, is available at FINRA, the
Commission's Public Reference Room, and http://www.finra.org.

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    \4\ See Securities Exchange Act Release No. 56145 (July 26,
2007), 72 FR 42169 (August 1, 2007) (File No. SR-NASD-2007-023).
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II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

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

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

1. Purpose
    On November 28, 2006, NASD and the NYSE Group announced a plan to
consolidate their member regulation operations into a combined
organization intended to be the sole U.S. private-sector provider of
member firm regulation for securities firms that do business with the
public. Upon closing of the Transaction, NASD adopted the new corporate
name, FINRA.\5\ The consolidation is intended to streamline the broker-
dealer regulatory system, combine technologies, permit the
establishment of a single set of rules and group examiners with
complementary areas of expertise in a single organization--all of which
will serve to enhance oversight of U.S. securities firms and help
ensure investor protection. Moreover, the new organization will be
committed to reducing regulatory costs and burdens for firms of all
sizes through greater regulatory efficiency.
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    \5\ See supra note 3. The Commission notes that the Transaction
closed on July 30, 2007. See telephone conference between Nancy
Burke-Sanow, Assistant Director, Commission, and Patrice Gliniecki,
Senior Vice President and Deputy General Counsel, FINRA, on July 31,
2007.
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    On July 24, 2007, NYSE filed a proposed rule change requiring its
member organizations to become members of FINRA to achieve the
Transaction's goal to eliminate duplicative member firm regulation
(``Mandatory FINRA Membership filing'').\6\ Currently, there are
approximately 95 NYSE member organizations that were not also NASD

members that will be required to become FINRA members. In furtherance
of the consolidation, the proposed rule change would establish a waive-
in process for these firms to become members of FINRA. The proposed
rule change would apply to firms that, as of July 25, 2007: (1) Are
approved NYSE member organizations or (2) have submitted an application
to become an NYSE member organization and are subsequently approved for
NYSE membership (together ``NYSE-only member organizations''), provided
that such firms were not also NASD members as of the closing of the
Transaction (i.e., as of July 30, 2007).
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    \6\ See Securities Exchange Act Release No. 56173 (July 31,
2007), 72 FR 44205 (August 7, 2007) (SR-NYSE-2007-67).
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    NASD recognizes that NYSE has a comprehensive membership
application and review process based on similar principles and
standards to that of NASD. As such, those NYSE-only member
organizations that will become FINRA members already have been
subjected to an extensive screening process. Therefore, the proposed
rule change would establish IM-1013-1, a process that would make such
firms eligible to automatically become a FINRA member and to
automatically register all associated persons whose registrations are
approved with NYSE in registration categories recognized by FINRA upon
submission to FINRA's Member Regulation Department (``Department'') of
a signed waive-in membership application (``Waive-In Application'').
    FINRA does not intend to recognize any new registration categories
upon the closing of the Transaction. Thus, associated persons of the
NYSE-only member organizations will be automatically registered with
FINRA only for those registration categories that are recognized
jointly by NASD and NYSE--e.g., a General Securities Representative
(Series 7); provided, however, that the firm must, upon approval of
FINRA membership, submit an amended Form U4 for each such associated
person, denoting the corresponding NASD registration category(ies) for
such person.\7\ A list of those registration categories is included as
part of the Waive-In Application. (Please note that both NASD and NYSE
recognize the Series 9/10, but for NASD, persons who have passed the
Series 9/10 may function only as a General Securities Sales Supervisor
(see NASD Rule 1022(g).) For those associated persons registered in a
category recognized only by NYSE, FINRA will acknowledge such
registrations to permit such persons to continue to function in the
capacity for which they are registered.
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    \7\ FINRA intends to file a separate rule change to the Forms U4
and U5 to reflect NASD's change in corporate name to FINRA.
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    The Waive-In Application would require the following information:
    (1) General company information, including Central Registration
Depository (CRD[supreg]) Number and contact person.
    (2) An attestation that all information on the applicant's CRD
form, as of the date of submission of the Waive-In Application is
accurate and complete and fully reflects all aspects of the applicant's
current business, including, but not limited to, ownership structure,
management, product lines and disclosures.
    (3) The identity of the firm's Executive Representative.
    (4) Completed and signed Entitlement Forms.
    (5) A signed FINRA Membership Agreement.
    (6) Representations that the applicant's Uniform Application for
Broker-Dealer Registration (Form BD) will be amended as needed to keep
current and accurate; that all individual and entity registrations with
FINRA will be kept current; and that all information and statements
contained in the Waive-In Application are current, true and complete.
    The proposed rule change would require the Department to review the
Waive-In Application within three (3) business days of receipt and, if
complete, issue a letter notifying the applicant that it has been
approved for membership. The Membership Agreement would become
effective on the date of such notification letter.\8\
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    \8\ NASD understands that the Mandatory FINRA Membership filing
would extend the NYSE-only member organizations a 60-day grace
period within which they must apply for and be approved for FINRA
membership. This grace period would run from the later of the date
of Commission approval of either the instant proposed rule change or
the Mandatory FINRA Membership filing.
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    As set forth in proposed IM-1013-1, the NYSE-only member
organizations admitted pursuant to proposed IM-1013-1 would be subject
to the NYSE rules incorporated by FINRA, FINRA's By-Laws and Schedules
to By-Laws, including Schedule A (Assessments and Fees), and NASD Rule
8000 (Investigations and Sanctions) and Rule 9000 (Code of Procedure)
Series, provided that their securities business is limited to floor
brokerage on the NYSE, or routing away to other markets orders that are
ancillary to their core floor business under NYSE Rule 70.40
(``permitted floor activities'').\9\ If an NYSE-only member
organization admitted pursuant to proposed IM-1013-1 seeks to expand
its business operations to include any activities other than the
permitted floor activities, such firm must apply for and receive
approval to engage in such business activity pursuant to NASD Rule
1017. Upon approval of such business expansion, the firm would become
subject to all NASD rules, in addition to those NYSE rules incorporated
by FINRA.
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    \9\ For purposes of this filing, activities that are ancillary
to a Floor broker's core business include: (i) Routing orders in
NYSE-traded securities to an away market for any reason relating to
their ongoing Floor activity, including regulatory compliance or
meeting best-execution obligations; or (ii) provided that the
majority of transactions effected by the firm are effected on the
NYSE, sending to other markets orders in NYSE-traded or non-NYSE-
traded securities and/or futures if such orders relate to hedging
positions in NYSE-traded securities, or are part of arbitrage or
program trade strategies that include NYSE-traded securities.
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    Associated persons of an NYSE-only member organization admitted to
FINRA pursuant to proposed IM-1013-1 would be subject to the same set
of rules as the firm with which they are associated, namely the NYSE
rules incorporated by FINRA, FINRA's By-Laws and Schedules to By-Laws,
and the NASD Rule 8000 and 9000 Series. Inasmuch as these associated
persons would not be subject to NASD Rules 1021 or 1031, they would not
be required to register in a registration category recognized by FINRA.
To the extent that such persons continue to be associated solely with a
firm whose business complies with the limitations imposed on those
firms admitted to FINRA pursuant to proposed IM-1013-1, FINRA is not
imposing any registration requirements beyond those required by the
NYSE, provided their business is confined in scope as contemplated in
proposed IM-1013-1.\10\
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    \10\ The licensing and other requirements applicable to the
NYSE-only member organizations and their associated persons are
subject to change as part of the process of establishing a
consolidated rulebook applicable to all FINRA members.
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    Finally, the proposed rule change would create Interpretive
Material Section 4(b)(1) and 4(e) of Schedule A of the NASD By-Laws,
which would exempt the applicants from the assessment of a FINRA
membership application fee and from fees for each initial Form U4 filed
by the applicant with FINRA for the registration of a representative or
principal associated with the firm at the time it submits its
application for FINRA membership pursuant to proposed IM-1013-1. NASD
believes the exemption is appropriate, since NYSE is mandating FINRA
membership in furtherance of the Transaction and because the waive-in
application process will not require

the same resources by the Department as when a new applicant that is
not already a member of NYSE seeks membership.
    The effective date of the proposed rule change will be the date of
Commission approval of the proposed rule change.
2. Statutory Basis
    NASD believes that the proposed rule change is consistent with the
provisions of Section 15A of the Act, including Section 15A(b)(6) of
the Act,\11\ in that it is designed to prevent fraudulent and
manipulative acts and practices, promote just and equitable principles
of trade and, in general, to protect investors and the public interest.
The proposed rule change will facilitate the consolidation of member
regulation functions under a single self-regulatory organization,
resulting in more effective and efficient regulation of brokers and
dealers, thereby enhancing investor protection, while also ensuring
that those NYSE-only member organizations eligible for the waive-in
process meet suitable standards for admission into FINRA.
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    \11\ 15 U.S.C. 78o-3(b)(6).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    NASD does not believe that the proposed rule change will result in
any burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act.

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

    Written comments were neither solicited nor received.

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

    Within 35 days of the date of publication of this notice in the
Federal Register or within such longer period (i) as the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding or (ii) as to
which NASD consents, the Commission will:
    (A) By order approve such proposed rule change, or
    (B) institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml.
); or     Send an e-mail to<EMAIL_ADDRESS>Please include

File Number SR-NASD-2007-056 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NASD-2007-056. This file
number should be included on the subject line if e-mail 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 inspection and
copying in the Commission's Public Reference Room, 100 F Street, NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at the principal office of FINRA. 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-NASD-2007-056 and should be
submitted on or before September 28, 2007.

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\12\
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    \12\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Deputy Secretary.
 [FR Doc. E7-17699 Filed 9-6-07; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 76, Number 16 (Tuesday, January 25, 2011)]
[Notices]
[Page 4347]
[FR Doc No: 2011-1469]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-R09-OAR-2011-0024; FRL-9256-9]

Notice of Re-Issuance of the Prevention of Significant
Deterioration Applicability Determination for the Carlsbad Energy
Center Project, Carlsbad, CA

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of final action.

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SUMMARY: This notice announces that on January 10, 2011, the EPA issued
a determination that the proposal to modify the Encina Power Station is
not subject to the Prevention of Significant Deterioration (PSD) permit
program under the Clean Air Act (CAA). This determination corrects a
typographical error in the emission data in our previous determination
issued on October 13, 2010. Therefore, the determination issued on
January 10, 2011 replaces the one EPA issued on October 13, 2010.

ADDRESSES: EPA's determination and other related documents used in the
determination are available electronically on EPA's Web site at http://www.epa.gov/region9/air/permit/r9-permits-issued.html. These documents
are also available for public inspection during normal business hours
at the following address: EPA Region 9, 75 Hawthorne Street, San
Francisco, California 94105. For more information or to arrange viewing
of these documents, contact Shaheerah Kelly at<PHONE_NUMBER> or
<EMAIL_ADDRESS>
FOR FURTHER INFORMATION CONTACT: Shaheerah Kelly, EPA Region 9, Air
Division (AIR-3), 75 Hawthorne Street, San Francisco, CA 94105, (415)
947-4156<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Carlsbad Energy Center Project is a
proposed 540 MW net (558 MW gross) combined cycle natural gas-fired
power plant that will be built at the existing Encina Power Station in
the city of Carlsbad in San Diego County, California. The Carlsbad
Energy Center Project will replace three of five existing natural gas-
fired boilers located at the eastern end of the property site at the
Encina Power Station. The Encina Power Station is owned by NRG Energy,
Inc. (NRG), and currently has a total of five natural gas-fired
boilers, which are allowed to use No. 6 fuel oil during curtailments,
and three fuel oil storage tanks. The Encina Power Station is an
existing major source, and the addition of the Carlsbad Energy Center
Project would be a physical change to the facility.
    EPA Region 9 has authority to implement the Clean Air Act
Prevention of Significant Deterioration Program at 40 CFR 52.21 for San
Diego County, California. Because the Carlsbad Energy Center Project is
a physical change to an existing major stationary source, EPA Region 9
evaluated whether the physical change is a major modification by
determining whether the physical change will result in a net emission
increase for pollutants regulated under the PSD permit program. We
received emissions information from NRG on June 5, 2009, as well as
additional information since that time. This emissions information
addressed the following criteria pollutants associated with the
modification: nitrogen oxides, carbon monoxide, particulates, volatile
organic compounds, and sulfur oxides. On October 13, 2010, we issued a
determination that the Carlsbad Energy Center Project is not subject to
the PSD permit program under the Clean Air Act (CAA). EPA published a
Federal Register notice for this action on November 19, 2010 (75 FR
70916-70917).
    It has recently come to EPA's attention that Table 2 of the October
13, 2010 determination contained a typographical error in the emissions
data. Specifically, EPA changed the net emission increase for nitrogen
oxides (NOx) in Table 2 of the PSD applicability analysis from 39.2 tpy
(which is incorrect) to 31.2 tpy. The new emission level is still below
the PSD significant threshold for that pollutant. EPA made this
correction and issued a corrected determination on January 10, 2011. No
other changes to the previous determination were made. Therefore, the
determination issued on January 10, 2011 replaces the one issued on
October 13, 2010.
    If available, judicial review of EPA's determination may be sought
by filing a petition for review pursuant to section 307(b)(1) of the
CAA in the United States Court of Appeals for the Ninth Circuit within
60 days from the date on which this notice is published in the Federal
Register.

    Dated: January 13, 2011.
Deborah Jordan,
Director, Air Division, Region 9.
[FR Doc. 2011-1469 Filed 1-24-11; 8:45 am]
BILLING CODE 6560-50-P


<EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE
PETITIONS PUBLISHED IN THE FEDERAL REGISTER  (5/5/2011)>

<EPA Registration Division contact: [Shaja Joyner (PM-20)<PHONE_NUMBER>]>

<INSTRUCTIONS:  Please utilize this outline in preparing the pesticide
petition.  In cases where the outline element does not apply, please
insert “NA-Remove” and maintain the outline. Please do not change
the margins, font, or format in your pesticide petition. Simply replace
the instructions that appear in green and brackets, i.e., “[insert
company name],” with the information specific to your action.>

<TEMPLATE:>

<[Syngenta Crop Protection]>

<[Insert petition number]>

<	EPA has received a pesticide petition ([insert petition number]) from
[Syngenta Crop Protection], [P. O. Box 18300, Greensboro, NC  27409]
proposing, pursuant to section 408(d) of the Federal Food, Drug, and
Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180.516.>

<(Options (pick one)>

<	1. by establishing a tolerance for residues of>

<	[fludioxonil:  [4-(2,
2-difluoro-1,3-benzodioxol-4-yl)-1H-pyrrole-3-carbonitrile] in or on the
raw agricultural commodity [] at []  >

<

Leafy petioles subgroup 04B, at 14 parts per million

EPA has determined that the petition contains data or information
regarding the elements set forth in section 408 (d)(2) of  FDDCA;
however, EPA has not fully evaluated the sufficiency of the submitted
data at this time or whether the data supports granting of the petition.
Additional data may be needed before EPA rules on the petition.>

<A. Residue Chemistry>

<1. Plant metabolism.  The metabolism of fludioxonil is adequately
understood for the purpose of the proposed tolerances.

>

<2. Analytical method. Syngenta has developed and validated analytical
methodology for enforcement purposes. This method (Syngenta Crop
Protection Method AG-597B) has passed an Agency petition method
validation for several commodities, and is currently the enforcement
method for fludioxonil. This method has also been forwarded to the Food
and Drug Administration for inclusion into PAM II. An extensive database
of method validation data using this method on various crop commodities
is available.    >

<3. Magnitude of residues. Complete residue data to support the
requested tolerances have been submitted. The requested tolerances are
adequately supported.

>

In support of the requested tolerance, eight crop-field trials were
conducted with various commercially available celery cultivars, and the
soil types and meteorological conditions at the eight trial sites
adequately represented the diversity of conditions under which celery
may be commercially grown.  These trial sites satisfied the requirements
of OPPTS 860.1500 for number and regional distribution.  The study
design consisted of 2 plots at each trial site: a non-treated control
(UTC) plot and a treated (TRT) plot.  The TRT plot received four
broadcast foliar applications of 14 oz product/acre/application (or 56
oz product/acre/ season), which equates to 0.328 lb cyprodinil/acre +
0.219 lb fludioxonil/acre (or a seasonal rate of 1.3 lb Cyprodinil/acre
+ 0.9 lb Fludioxonil/acre).  The treatments were applied with a tank-mix
volume of 15 - 40 gallons/acre (GPA) at the minimum 7-day retreatment
interval (RTI), and the raw agricultural commodity (RAC) was harvested
on the day of the last application to support a 0-day pre-harvest
interval (PHI).  This use pattern would be the ‘worst-case’
application as per the proposed-use label.

<B. Toxicological Profile

>

An assessment of toxic effects caused by fludioxonil is discussed in
Unit III. A. and Unit III. B. of the Federal Register published by EPA
dated August 2, 2002 (67 FR 50354) (FRL-7188-7) and is repeated in part
below.

Carcinogenic and Other Toxicity

<>

Study Type             	Results

Carcino-genicity rats      	NOAEL = 590 mg/kg/day (M) and 715 mg/kg/day
(F). LOAEL: 851 mg/kg/day (M) and 1,008 mg/kg/ day (F) based on reduced
survival (F), decreased body weights (M), bile duct hyperplasia (M) and
severe nephropathy(both sexes). No evidence of carcinogenicity.

In vivo Rat hepatocyte micronucleus assay                	Male rats were
orally dosed at 50, 250, and 1,250 mg/kg and hepatocytes were harvested.
There was no evidence of a significant increase in micronucleated
hepatocytes in treated groups in comparison to controls.

Unscheduled DNA synthesis assay  	There was no evidence that unscheduled
DNA synthesis, as determined by nuclear silver grain counts, was induced
in hepatocyte cultures obtained from male rats dosed at 2,500 or 5,000
mg/kg.

Summary of Toxicological Dose and Endpoints for Fludioxonil for Use in
Human Risk Assessment

Exposure Scenario       	Dose Used in Risk Assessment, UF
      	FQPA SF and Level of Concern for Risk Assessment     	Study and
Toxicological Effects

Acute Dietary females 13-50 years of age
                            	NOAEL = 100 mg/kg/day

UF = 100

Acute RfD = 1.0 mg/kg/day.                         	FQPA SF = 1X

aPAD = acute RfD ÷ FQPA

SF = 1.0 mg/kg/day.                           	Developmental Toxicity
Study – rat

Developmental LOAEL =1,000 mg/kg/day based on increased incidence of
fetuses and litters dilated renal pelvis and with dilated ureter

Chronic Dietary all populations
                                                         	NOAEL= 3.3
mg/kg/day UF = 100

Chronic RfD = 0.03 mg/ kg/day.
                                             	FQPA SF = 1X

cPAD = chronic RfD FQPA SF = 0.03 mg/kg/day.

1 year chronic toxicity study – dog

LOAEL = 35.5 mg/kg/day based on decreased weight gain in female dogs

Incidental Oral, Short-Term
                                                       	NOAEL = 10
mg/kg/day
                             	LOC for MOE = 100	Rabbit developmental
study

LOAEL = 100 mg/kg/day based on decreased weight gain during gestation

Incidental Oral, Intermediate-Term
                                                     	NOAEL = 3.3
mg/kg/day    	LOC for MOE = 100        	1 year chronic toxicity study -
dog

LOAEL = 35.5 mg/kg/day based on decreased weight gain in female dogs

Short-and Intermediate Term Dermal (1-30 days and 1-6 months)
(Residential)                                        	None
      	No systemic toxicity      was seen at the limit dose (1,000
mg/kg/day) in the 28-day dermal toxicity study in rats  	Endpoint was
not selected

Long-Term (several months-lifetime) Dermal (Residential)

Oral study

NOAEL = 3.3 mg/kg/day (dermal penetration =  40%).

        	LOC for MOE = 100 (Occupational)

LOC for MOE = 100 (Residential).                         	1 year chronic
toxicity study - dog

LOAEL = 35.5 mg/kg/day based on decreased weight gain in female dogs

Short-Term (1-30 Days) Inhalation (Residential)
                                                              	Oral
NOAEL = 10 mg/kg/ day (inhalation absorption rate = 100%)
            	LOC for MOE = 100 (Occupational)

LOC for MOE = 100(Residential).                        	Rabbit
developmental study

LOAEL = 100 mg/kg/day based on decreased weight gain during gestation

Intermediate-term (1 month - 6 months) Inhalation (Residential)	Oral
NOAEL = 3.3 mg/kg/ day (inhalation absorption rate = 100%)
          	LOC for MOE = 100                        (Occupational)

LOC for MOE = 100(Residential).                            	 1 year
chronic toxicity study - dog                                     LOAEL =
35.5 mg/kg/day based on decreased weight gain in female dogs

Long-Term (several months-lifetime) Inhalation (Residential)   	Oral
NOAEL = 3.3 mg/kg/day (inhalation absorption rate = 100%)         	LOC
for MOE = 100(Occupational)  LOC for MOE = 100(Residential).
                       	1 year chronic toxicity study – dog

LOAEL = 35.5 mg/kg/day based on decreased weight gain in female dogs

<>

<6. Animal metabolism. The metabolism of fludioxonil in rats is
adequately understood.

                                                        >

<7. Metabolite toxicology. The residue of concern for tolerance setting
purposes is the parent compound. Consequently, there is no additional
concern for toxicity of metabolites.

>

<8. Endocrine disruption. Fludioxonil does not belong to a class of
chemicals known for having adverse effects on the endocrine system. No
estrogenic effects have been observed in the various short- and
long-term studies conducted with various mammalian species.

C. Aggregate Exposure>

<1. Dietary exposure.  Tier III acute and chronic dietary exposure
evaluations were performed for fludioxonil using the Dietary Exposure
Evaluation Model (DEEM-FCIDTM, version 2.16) from Exponent.  These
exposure assessments included all current uses as well as a proposed
foliar use on celery plus pending foliar uses on peppers (bell and
non-bell) and spinach, a irrigation use on ginseng, and post-harvest
uses on pineapples, potatoes, tropical fruits and tomatoes.  These
assessments utilized residue data from field trials where fludioxonil
was applied at the maximum intended use rate and samples were harvested
at the minimum pre-harvest interval (PHI) to obtain maximum residues.
Empirically derived processing factors for apple juice (0.09X), apple
pomace (6.77X), tomato puree (0.34X), tomato paste (1.1X), and citrus
oil (50X) were used in these assessments.  The apple juice processing
factor was used as a surrogate for pear juice.  All other processing
factors used the DEEMTM defaults.  All consumption data for these
assessments was taken from the USDA’s Continuing Survey of Food Intake
by individuals (CSFII) with the 1994-96 consumption database and the
Supplemental CSFII children’s survey (1998) consumption database.
Percent of crop treated values were estimated based upon economic, pest
and competitive pressures.  Secondary residues in animal commodities
were estimated based on “maximum reasonably balanced diets” and
transfer information from metabolism studies.

>

<i. Food.  Acute exposure.  The acute dietary (food only) risk
assessment for females 13 to 49 years old (the only population subgroup
for which an acute toxicological endpoint has been established) was
performed using an acute reference dose (aRfD) of 1.0 mg/kg-bw/day,
based upon a rat teratology study with a no observed adverse effect
level (NOAEL) of 100 mg/kg/day and an uncertainty factor (UF) of 100X
for intra- and inter-species variations; no additional FQPA safety
factor was applied.  For the purpose of the aggregate risk assessment,
the exposure value was expressed in terms of margin of exposure (MOE),
which was calculated by dividing the no observed adverse effect level
(NOAEL) by the exposure for each population subgroup.  In addition,
exposure was expressed as a percent of the acute reference dose (%
aRfD).  Acute exposure to the females 13-49 years subpopulation resulted
in a MOE of 1,182 or 8.5% of the aRfD (Benchmark MOE = 100; aRfD= 1.0
mg/kg-bw/day).  Since the Benchmark MOE for this assessment was 100 and
since the EPA generally has no concern for exposures below 100% of the
aRfD, Syngenta believes that there is a reasonable certainty that no
harm will result from dietary (food) exposure to residues arising from
the current, pending and proposed uses for fludioxonil.

Chronic exposure.  The chronic reference dose (RfD) for fludioxonil is
0.033 mg/kg-bw/day, based upon a one-year study in dogs with a NOAEL of
3.3 mg/kg-bw/day and an uncertainly factor of 100X; no additional FQPA
safety factor was applied.  For the purpose of the aggregate risk
assessment, the exposure values were expressed in terms of margin of
exposure (MOE), which was calculated by dividing the no observed adverse
effect level (NOAEL) by the exposure for each population subgroup.  In
addition, exposure was expressed as a percent of the chronic reference
dose (%cRfD).  Chronic exposure to the U.S. population resulted in a MOE
of 708 or 14.1% of the cRfD (Benchmark MOE = 100; cRfD = 0.033
mg/kg-bw/day).  Chronic exposure to the most exposed subpopulation
(children 1-2 years old) resulted in a MOE of 243 or 41.1% of the cRfD
(Benchmark MOE = 100; cRfD = 0.033 mg/kg-bw/day).  Since the Benchmark
MOE for this assessment was 100 and since the EPA generally has no
concern for exposures below 100% of the cRfD, Syngenta believes that
there is a reasonable certainty that no harm will result from dietary
(food) exposure to residues arising from the current, pending and
proposed uses for fludioxonil.

>

<ii. Drinking water. The Estimated Drinking Water Concentrations (EDWCs)
of fludioxonil were determined using Tier l SCI-GROW, which estimates
pesticide concentrations in ground water and Tier II PRZM/EXAMS which
estimates pesticide concentrations in surface water.  This drinking
water assessment was conducted to assess all currently registered uses,
the pending uses on spinach, peppers, ginseng, potatoes, pineapples,
tropical fruits, and tomatoes as well as the proposed use on celery.
For ground water, the currently registered use on professional turf
provided the highest EDWC of 2.02E-01 ppb (acute and chronic).  For
surface water, the currently registered field grown and landscape
ornamental provided the highest acute EDWC of 44.102 ppb and the
currently registered use on turf provided the highest chronic EDWC of
32.79 ppb.  No Percent Cropped Area (PCA) adjustments were made for the
surface water EDWCs.  Since the surface water EDWCs exceed the ground
water EDWC, the surface water values were used for risk assessment
purposes and will be considered protective for any ground water exposure
concerns.

Acute Exposure from Drinking Water:  The acute EDWC of 44.102 ppb
(0.044102 ppm) was incorporated with food residues as “water, direct
and indirect, all sources” directly into the DEEM-FCID™ software to
obtain acute dietary (food and water) exposures.  Drinking water
exposures at the 99.9th percentile to fludioxonil for females 13-49
years old (the only population subgroup for which an acute toxicological
endpoint has been established) resulted in a MOE of 97,847 (0.1% of the
aRfD of 1.0 mg/kg-bw/day).  Since the Benchmark MOE for this assessment
was 100, and since the EPA generally has no concern for exposures below
100% of the aRfD, Syngenta believes that there is a reasonable certainty
that no harm will result from acute drinking water exposure to residues
arising from all current, pending and proposed fludioxonil uses.

Chronic Exposure from Drinking Water:  The chronic EDWC of 32.79 ppb
(0.03279 ppm) was incorporated with food residues as “water, direct
and indirect, all sources” directly into the DEEM-FCID™ software to
obtain chronic dietary (food and water) exposures.  Chronic drinking
water exposure to the U.S. population resulted in a MOE of 4,775 (2.1%
of the cRfD of 0.033 mg/kg-bw/day).  The most sensitive sub-population
was all infants (<1 year old), with a MOE of 1,456 (6.9% of the cRfD of
0.033 mg/kg-bw/day).  Since the Benchmark MOE for this assessment was
100 and since the EPA generally has no concern for exposures below 100%
of the cRfD, Syngenta believes that there is a reasonable certainty that
no harm will result from chronic drinking water exposure to residues
arising from all current, pending and proposed fludioxonil uses.

Cancer.  A chronic cancer exposure analysis was not performed, since
there is no evidence of human carcinogenic potential for fludioxonil.

	>

<2. Non-dietary exposure.  There is a potential for residential
post-application exposure to adults and children entering residential
areas treated with fludioxonil.  Fludioxonil is currently registered for
professionally applied uses on turf grass and ornamentals in residential
landscapes.  The Syngenta short-term and intermediate-term residential
risk assessments were based on the maximum label rate for turf grass of
0.68 lb a.i./A (0.50 oz product/1000ft2) with a maximum of three
applications allowed per year (0.68 lb a.i./A x 3 apps = 2 lb
a.i./A/year).  In these residential risk assessments, a short-term NOAEL
of 10 mg/kg-bw/day from a rabbit developmental study was selected as
well as an intermediate-term NOAEL of 3.3 mg/kg-bw/day from a one year
dog feeding study.  Residential post-application dermal assessments were
not conducted since short-term and intermediate-term dermal endpoints
were not established by the EPA and there were no developmental concerns
with fludioxonil.  The residential risk assessments were limited to
children since the only route of exposure was incidental oral ingestion
via hand-to-mouth activity and object-to-mouth (grass and soil
ingestion).  The combined short-term MOE for children 1-6 years was 784
and the combined intermediate-term MOE for children 1-6 years was 445.
Since the Benchmark MOE for this assessment was 100, Syngenta believes
that there is a reasonable certainty that no harm will result from
exposures arising from residential uses of fludioxonil.

>

<D. Cumulative Effects>

<Cumulative Exposure to Substances with a Common Mechanism of Toxicity.
Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether
to establish, modify, or revoke a tolerance, the Agency consider
“available information” concerning the cumulative effects of a
particular pesticide’s residues and “other substances that have a
common mechanism of toxicity.”  Unlike other pesticides for which the
EPA has followed a cumulative risk approach based on a common mechanism
of toxicity, the EPA has not made a common mechanism of toxicity finding
as to fludioxonil and any other substances, and fludioxonil does not
appear to produce a toxic metabolite produced by other substances.  For
the purposes of this tolerance action, the EPA has not assumed that
fludioxonil has a common mechanism of toxicity with other substances.

>

<E. Safety Determination>

<1. U.S. population. An acute toxicological endpoint has not been
established for the U.S. population, so an acute exposure assessment was
not performed for the U.S. population.  The chronic aggregate exposure
analysis showed that exposure from all current and proposed fludioxonil
uses resulted in a MOE of 617 or 16.2% of the cRfD (Benchmark MOE = 100;
cRfD= 0.033 mg/kg-bw/day).  A cancer exposure analysis was not performed
since there is no evidence of human carcinogenic potential for
fludioxonil.  Since the worst-case aggregate MOE of 617 exceeds the
benchmark MOE of 100, Syngenta believes that there is a reasonable
certainty that no harm will result from aggregate exposure to residues
arising from all current, pending and proposed fludioxonil uses,
including anticipated dietary exposure from food, water, and all other
types of non-occupational exposures.

>

<2. Infants and children. An acute toxicological endpoint has not been
established for infants and children, so an acute exposure assessment
was not performed for infants and children.  The chronic aggregate
exposure analysis showed that exposure from all established and proposed
fludioxonil uses resulted in a MOE of 226 or 44.2% of the cRfD
(Benchmark MOE = 100; cRfD= 0.033 mg/kg-bw/day) for children (1-2 years
old).  A cancer exposure analysis was not performed, since there is no
evidence of human carcinogenic potential for fludioxonil.  The short-
term aggregate assessment resulted in MOE of 403, for the children (1-6
years old) population subgroup (Benchmark MOE = 100).  The intermediate-
term aggregate assessment resulted in MOE of 169, for the children (1-6
years old) population subgroup (Benchmark MOE = 100).   Since the
worst-case aggregate MOE of 169 exceeds the Benchmark MOE of 100,
Syngenta believes that there is a reasonable certainty that no harm will
result from aggregate exposure to residues arising from all current,
pending and proposed fludioxonil uses, including anticipated dietary
exposure from food, water, and all other types of non-occupational
exposures.

3. Females 13-49 years of age.  The acute aggregate exposure analysis
showed that exposure to all current, pending and proposed fludioxonil
uses would result in a MOE of 1,168 or 8.6% of the aRfD (Benchmark MOE =
100; aRfD= 1.0 mg/kg-bw/day)) for females 13-49 years old.  The chronic
aggregate exposure analysis showed that exposure to all current and
proposed fludioxonil uses would result in a MOE of 761 or 13.1% of the
cRfD (Benchmark MOE = 100; cRfD= 0.033 mg/kg-bw/day) for females 13-49
years old. A cancer exposure analysis was not performed, since there is
no evidence of human carcinogenic potential for fludioxonil.  Since the
worst-case aggregate MOE of 761 exceeds the Benchmark MOE of 100,
Syngenta believes that there is a reasonable certainty that no harm will
result from aggregate exposure to residues arising from all current,
pending and proposed fludioxonil uses, including anticipated dietary
exposure from food, water, and all other types of non-occupational
exposures.

>

<F. International Tolerances>

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Codex Maximum Residue Limits (MRLs) for residues of fludioxonil per se
have been established on a number of commodities, including apples,
beans, berries, cabbage, citrus fruits, cucumber, egg plant, kiwifruit,
lettuce, melons (except watermelon), peas (dry), peas (pods and
succulent=immature seeds), peas (pods and succulent seeds), peppers,
sweet, pome fruits, squash, summer, straw and fodder (dry) of cereal
grains, tomato, and potato.

 PAGE

 PAGE   8


[Federal Register Volume 82, Number 161 (Tuesday, August 22, 2017)]
[Proposed Rules]
[Pages 39712-39715]
[FR Doc No: 2017-17626]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 63

[EPA-HQ-OAR-2016-0442; FRL-9966-63-OAR]
RIN 2060-AT57

National Emission Standards for Hazardous Air Pollutants From the
Portland Cement Manufacturing Industry: Alternative Monitoring Method

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: The U.S. Environmental Protection Agency (EPA) is proposing to
amend the National Emission Standards for Hazardous Air Pollutants From
the Portland Cement Manufacturing Industry (Portland Cement NESHAP). We
are proposing to revise the testing and monitoring requirements for
hydrochloric acid (HCl) due to the current unavailability of HCl
calibration gases used for quality assurance purposes.

DATES: The EPA must receive written comments on this proposed rule on
or before October 6, 2017.
    Public Hearing. If a public hearing is requested by August 29,
2017, then we will hold a public hearing on September 6, 2017 at the
EPA WJC East Building, 1201 Constitution Avenue NW., Washington, DC
20004. If a public hearing is requested, then we will provide
additional details about the public hearing on our Web site at https://www.epa.gov/stationary-sources-air-pollution/portland-cement-manufacturing-industry-national-emission-standards and https://www3.epa.gov/airquality/cement/actions.html. To request a hearing, to
register to speak at a hearing, or to inquire if a hearing will be
held, please contact Aimee St. Clair at<PHONE_NUMBER> or by email at
<EMAIL_ADDRESS>The EPA does not intend to publish any future
notices in the

Federal Register regarding a public hearing on this proposed action and
directs all inquiries regarding a hearing to the Web site and contact
person identified above. The last day to pre-register in advance to
speak at the public hearing will be September 5, 2017.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
OAR-2016-0442, at http://www.regulations.gov. Follow the online
instructions for submitting comments. Once submitted, comments cannot
be edited or withdrawn from Regulations.gov. The EPA may publish any
comment received to its public docket. Do not submit electronically any
information you consider to be Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute.
Multimedia submissions (audio, video, etc.) must be accompanied by a
written comment. The written comment is considered the official comment
and should include discussion of all points you wish to make. The EPA
will generally not consider comments or comment contents located
outside of the primary submission (i.e., on the Web, cloud, or other
file sharing system). For additional submission methods, the full EPA
public comment policy, information about CBI or multimedia submissions,
and general guidance on making effective comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Mr. Brian Storey, Sector Policies and
Programs Division (D243-04), Office of Air Quality Planning and
Standards, U.S. Environmental Protection Agency, Research Triangle
Park, North Carolina 27711; telephone number:<PHONE_NUMBER>; fax
number:<PHONE_NUMBER>; and email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    Organization of This Document. The information in this preamble is
organized as follows:

I. General Information
    A. Does this proposed rule apply to me?
    B. What should I consider as I prepare my comments for the EPA?
II. What are the amendments made by this proposed rule?
III. Statutory and Executive Order Reviews
    A. Executive Order 12866: Regulatory Planning and Review and
Executive Order 13563: Improving Regulation and Regulatory Review
    B. Paperwork Reduction Act (PRA)
    C. Regulatory Flexibility Act (RFA)
    D. Unfunded Mandates Reform Act (UMRA)
    E. Executive Order 13132: Federalism
    F. Executive Order 13175: Consultation and Coordination with
Indian Tribal Governments
    G. Executive Order 13045: Protection of Children from
Environmental Health Risks and Safety Risks
    H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use
    I. National Technology Transfer and Advancement Act (NTTAA)
    J. Executive Order 12898: Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations

I. General Information

A. Does this proposed rule apply to me?

    Categories and entities potentially regulated by this proposed rule
include:

------------------------------------------------------------------------
                                                                 NAICS
                           Category                             Code \1\
------------------------------------------------------------------------
Portland cement manufacturing facilities.....................     327310
------------------------------------------------------------------------
\1\ North American Industry Classification System.

    This table is not intended to be exhaustive, but rather provides a
guide for readers regarding entities likely to be regulated by this
proposed rule. To determine whether your facility is affected, you
should examine the applicability criteria in the Code of Federal
Regulations (CFR) at 40 CFR 63.1340. If you have questions regarding
the applicability of any aspect of this action to a particular entity,
consult either the air permitting authority for the entity or your EPA
Regional representative as listed in 40 CFR 63.13.

B. What should I consider as I prepare my comments for the EPA?

    On June 23, 2017, the EPA published a direct final rule that
provided a compliance alternative for sources that would otherwise be
required to use a HCl continuous emissions monitoring system (CEMS) to
demonstrate compliance with the HCl emissions limit (82 FR 28562). At
the same time, we published a parallel proposal in which we proposed to
make the same amendment to the NESHAP. The EPA indicated that it would
withdraw the direct final rule if it received adverse comment. The EPA
received adverse comment on that direct final rule, but was not able to
timely withdraw the rule. In this proposal, the EPA is re-proposing and
providing additional opportunity for public comment on the same
amendment to the NESHAP that was proposed on June 23, 2017.
Simultaneously with this proposal, the EPA is taking final action to
withdraw the June 23, 2017, direct final rule. Comments received on the
June 23, 2017, direct final rule and/or parallel proposal will be
deemed to be submitted on this proposal, unless the commenter withdraws
the original comment.
    For comments on this proposal, do not submit information containing
CBI to the EPA through http://www.regulations.gov or email. Clearly
mark the part or all of the information that you claim to be CBI. For
CBI information on a disk or CD-ROM that you mail to the EPA, mark the
outside of the disk or CD-ROM as CBI and then identify electronically
within the disk or CD-ROM the specific information that is claimed as
CBI. In addition to one complete version of the comments that includes
information claimed as CBI, a copy of the comments that does not
contain the information claimed as CBI must be submitted for inclusion
in the public docket. Information so marked will not be disclosed
except in accordance with procedures set forth in 40 CFR part 2. Send
or deliver information identified as CBI only to the following address:
OAQPS Document Control Officer (C404-02), U.S. Environmental Protection
Agency, Research Triangle Park, North Carolina 27711, Attention Docket
ID No. EPA-HQ-OAR-2016-0442.

II. What are the amendments made by this proposed rule?

    On July 25, 2016, the EPA published an alternative monitoring
method for sources that would otherwise be required to use an HCl CEMS
to demonstrate compliance with the National Emission Standards for
Hazardous Air Pollutants From the Portland Cement Manufacturing
Industry (81 FR 48356). The alternative was provided for a period of 1
year. The alternative monitoring method allowed sources to demonstrate
compliance by using CEMS readouts as a parameter monitor to indicate
relative changes from the observed CEMS HCl reading. Specifically, the
alternative required installation of an HCl CEMS to provide a
continuous readout of HCl emissions. However, actual compliance with
the HCl emissions limit of 3 parts per million by volume (ppmv) was
determined by a three-run stack test. During the stack test, the
average HCl CEMS reading was determined. The alternative allows this
CEMS reading to become a continuous operating parameter that must be
met on a 30-day rolling average. The EPA determined it was appropriate
to allow this alternative because some facilities have been unable to
obtain National Institute of Standards and Technology (NIST)-

traceable calibration gases. As a result, these facilities cannot
calibrate their CEMS with sufficient accuracy for the CEMS readout to
be used to directly determine compliance with the 3 ppmv HCl emissions
limit. The alternative addresses this problem by allowing sources to
use the CEMS readouts as a parameter monitor to indicate relative
changes from the observed CEMS HCl reading obtained during the stack
performance test used to demonstrate compliance.
    In this action, the EPA is proposing to extend the use of the
alternative monitoring method, as described in the July 25, 2016,
direct final rulemaking (81 FR 48356). Because this alternative is only
needed until such time as the NIST-traceable calibration gases become
available, the EPA intends to remove the alternative once such gases
become available.

III. Statutory and Executive Order Reviews

    Additional information about these statutes and Executive Orders
can be found at http://www2.epa.gov/laws-regulations/laws-and-executive-orders.

A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulation and Regulatory Review

    This action is not a significant regulatory action and was,
therefore, not submitted to the Office of Management and Budget (OMB)
for review.

B. Paperwork Reduction Act (PRA)

    This action does not impose any new information collection burden
under the PRA. OMB has previously approved the information collection
activities contained in the existing regulation (40 CFR part 63,
subpart LLL) and has assigned OMB control number 2060-0416. This action
does not change the information collection requirements.

C. Regulatory Flexibility Act (RFA)

    I certify that this action will not have a significant economic
impact on a substantial number of small entities under the RFA. This
action will not impose any requirements on small entities. This action
does not create any new requirements or burdens and no costs are
associated with this proposed action.

D. Unfunded Mandates Reform Act (UMRA)

    This action does not contain any unfunded mandate as described in
UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect
small governments. The action imposes no enforceable duty on any state,
local, or tribal governments or the private sector.

E. Executive Order 13132: Federalism

    This action does not have federalism implications. It will 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.

F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

    This action does not have tribal implications, as specified in
Executive Order 13175. It will neither impose substantial direct
compliance costs on federally recognized tribal governments, nor
preempt tribal law. The EPA is aware of one tribally owned Portland
cement facility currently subject to 40 CFR part 63, subpart LLL that
will be subject to this proposed rule. However, the provisions of this
proposed rule are not expected to impose new or substantial direct
compliance costs on tribal governments since the provisions in this
proposed rule are extending the use of an alternative to the HCl
monitoring provisions, including an option which provides operational
flexibility. Thus, Executive Order 13175 does not apply to this action.

G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks

    The EPA interprets Executive Order 13045 as applying only to those
regulatory actions that concern environmental health or safety risks
that the EPA has reason to believe may disproportionately affect
children, per the definition of ``covered regulatory action'' in
section 2-202 of the Executive Order. This action is not subject to
Executive Order 13045 because it does not concern an environmental
health risk or safety risk.

H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use

    This action is not subject to Executive Order 13211 because it is
not a significant regulatory action under Executive Order 12866.

I. National Technology Transfer and Advancement Act (NTTAA)

    This rulemaking does not involve technical standards.

J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations

    The EPA believes that this action does not have disproportionately
high and adverse human health or environmental effects on minority
populations, low-income populations, and/or indigenous peoples, as
specified in Executive Order 12898 (59 FR 7629, February 16, 1994).
This action does not affect the level of protection provided to human
health or the environment.

List of Subjects in 40 CFR Part 63

    Environmental protection, Administrative practice and procedures,
Air pollution control, Hazardous substances, Intergovernmental
relations, Reporting and recordkeeping requirements.

    Dated: August 11, 2017.
E. Scott Pruitt,
Administrator.

    For the reasons stated in the preamble, the Environmental
Protection Agency is proposing to amend title 40, chapter I, part 63 of
the Code of Federal Regulations (CFR) as follows:

PART 63--NATIONAL EMISSION STANDARDS FOR HAZARDOUS AIR POLLUTANTS
FOR SOURCE CATEGORIES

0
1. The authority citation for part 63 continues to read as follows:

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

Subpart LLL--National Emission Standards for Hazardous Air
Pollutants From the Portland Cement Manufacturing Industry

0
2. Section 63.1349 is amended by:
0
a. Revising paragraph (b)(6)(v) introductory text.
0
b. Removing paragraph (b)(6)(v)(H).
    The revision reads as follows:

Sec.  63.1349  Performance testing requirements.

* * * * *
    (b) * * *
    (6) * * *
    (v) As an alternative to paragraph (b)(6)(ii) of this section, the
owner or operator may demonstrate initial compliance by conducting a
performance test using Method 321 of appendix A to this part. You must
also monitor continuous performance through use of an HCl CPMS
according to paragraphs (b)(6)(v)(A) through (G) of this section. For
kilns with inline raw mills, compliance testing and monitoring HCl to
establish the site specific operating limit must be

conducted during both raw mill on and raw mill off conditions.
* * * * *
0
3. Section 63.1350 is amended by revising paragraph (l)(4) introductory
text to read as follows:

Sec.  63.1350  Monitoring requirements.

* * * * *
    (l) * * *
    (4) If you monitor continuous performance through the use of an HCl
CPMS according to paragraphs (b)(6)(v)(A) through (G) of Sec.  63.1349,
for any exceedance of the 30-kiln operating day HCl CPMS average value
from the established operating limit, you must:
* * * * *
[FR Doc. 2017-17626 Filed 8-21-17; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 81, Number 76 (Wednesday, April 20, 2016)]
[Notices]
[Pages 23287-23288]
[FR Doc No: 2016-09091]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. CP15-115-000; CP15-115-001]

National Fuel Gas Supply Corporation, Empire Pipeline, Inc.;
Notice of Schedule for Environmental Review of the Northern Access 2016
Project

    On March 17, 2015, National Fuel Gas Supply Corporation (National
Fuel) and Empire Pipeline, Inc. (Empire) (collectively referred to as
National Fuel) filed an application in Docket No. CP15-115-000
requesting a Certificate of Public Convenience and Necessity pursuant
to Section 7(c) of the Natural Gas Act to construct and operate certain
natural gas pipeline facilities in Pennsylvania and New York. National
Fuel amended its application on November 4, 2015. The proposed project
is known as the Northern Access 2016 Project (Project), and would
expand the National Fuel pipeline system to provide 497,000 dekatherms
per day of new firm natural gas transportation capacity and the Empire
pipeline system to provide 350,000 dekatherms per day of new firm
natural gas transportation capacity.
    On March 27, 2015, the Federal Energy Regulatory Commission
(Commission or FERC) issued its Notice of Application for the Project.
Among other things, that notice alerted agencies issuing federal
authorizations of the requirement to complete all necessary reviews and
to reach a final decision on a request for a federal authorization
within 90 days of the date of issuance of the Commission staff's
Environmental Assessment (EA) for the Project. This instant notice
identifies the FERC staff's planned schedule for the completion of the
EA for the Project.

Schedule for Environmental Review

Issuance of EA--July 27, 2016

90-day Federal Authorization Decision Deadline--October 25, 2016

    If a schedule change becomes necessary, additional notice will be
provided so that the relevant agencies are kept informed of the
Project's progress.

Project Description

    The Project involves the construction and operation of certain
facilities to provide natural gas transportation service from a receipt
point in McKean County, Pennsylvania to an existing Empire pipeline
system in Niagara County, New York.
    National Fuel's proposed facilities include: Installation of about
96.9 miles of new 24-inch-diameter natural gas pipeline in McKean
County, Pennsylvania and Cattaraugus and Erie Counties, New York;
modifications at the existing Porterville Compressor Station in Erie
County; addition or modification of interconnect/tie-in facilities;
addition of 13 mainline valve sites; and cathodic protection
facilities.
    Empire's proposed facilities in Niagara County include: The new
Pendleton Compressor Station; 2.1 miles of new 24-inch-diameter
pipeline for the compressor station; the new Wheatfield Dehydration
Facility; construction/modification of tie-in facilities; and removal
of an existing meter and odorizer station.

Background

    On October 22, 2014, the Commission issued a Notice of Intent to
Prepare an Environmental Assessment for the Planned Northern Access
2016 Project and Request for Comments on Environmental Issues, and
Notice of Public Scoping Meetings (NOI). The NOI was issued during the
pre-filing review of the Project in Docket No. PF14-18-000. On April
29, 2015, the Commission issued a supplemental NOI for the newly
identified locations for the Pendleton Compressor Station and
Wheatfield Dehydration Facility. After National Fuel filed a new site
for the Pendleton Compressor Station in the amended docket, the
Commission issued an additional supplemental NOI on November 19, 2015.
    The NOIs were sent to affected landowners; federal, state, and
local government agencies; elected officials; environmental and public
interest groups; Native American tribes; other interested parties; and
local libraries and newspapers. In response to the NOI, the Commission
received comments from U.S. Environmental Protection Agency; U.S. Fish
and Wildlife Service; New York State Department of Environmental
Conservation; New York Office of Parks, Recreation & Historic
Preservation; and numerous individuals and landowners. The primary
issues raised by the commentors include potential impacts on wetlands;
waterbodies; forested areas; groundwater; threatened and endangered
species; socioeconomic; land use and recreational; air quality; noise;
safety; and potential cumulative impacts.
    The U.S. Army Corps of Engineers and the New York Department of
Agriculture and Markets are cooperating agencies in the preparation of
the EA.

Additional Information

    In order to receive notification of the issuance of the EA and to
keep track of all formal issuances and submittals in specific dockets,
the Commission offers a free service called eSubscription. This can
reduce the amount of time you spend researching proceedings by
automatically providing you with notification of these filings,
document summaries, and direct links to the documents. Go to
www.ferc.gov/docs-filing/esubscription.asp.
    Additional information about the Project is available from the
Commission's Office of External Affairs at (866) 208-FERC or on the
FERC Web site (www.ferc.gov). Using the ``eLibrary'' link, select
``General Search'' from the eLibrary menu, enter the selected date
range and ``Docket Number'' excluding the last three digits (i.e.,
CP15-115), and follow the instructions. For assistance with access to
eLibrary, the helpline can be reached at<PHONE_NUMBER>, TTY (202) 502-
8659, or at<EMAIL_ADDRESS>The eLibrary link on the FERC
Web site also provides access to the texts of formal documents issued
by the Commission, such as orders, notices, and rule makings.

    Dated: April 14, 2016.
Kimberly D. Bose,
Secretary.
[FR Doc. 2016-09091 Filed 4-19-16; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 10 (Tuesday, January 17, 2012)]
[Notices]
[Page 2287]
[FR Doc No: 2012-693]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project Nos. 12865-002 and 14072-000]

FFP Project 17, LLC and Northland Power Mississippi River LLC;
Notice Announcing Preliminary Permit Drawing

    The Commission has received two preliminary permit applications
deemed filed on February 1, 2011, at 8:30 a.m.,\1\ for proposed
projects to be located on the Mississippi River, near the town of North
Vacherie, in St. James Parish, Louisiana. The applications were filed
by FFP Project 17, LLC for Project No. 12865-002, and Northland Power
Mississippi River LLC for Project No. 14072-000.
---------------------------------------------------------------------------

    \1\ Under the Commission's Rules of Practice and Procedure, any
document received after regular business hours is considered filed
at 8:30 a.m. on the next regular business day. 18 CFR 385.2001(a)(2)
(2011).
---------------------------------------------------------------------------

    On January 17, 2012, at 9 a.m. (eastern time), the Secretary of the
Commission, or her designee, will conduct a random drawing to determine
the filing priority of the applicants identified in this notice. The
Commission will select among competing permit applications as provided
in section 4.37 of its regulations.\2\ The priority established by this
drawing will be used to determine which applicant, among those with
identical filing times, will be considered to have the first-filed
application.
---------------------------------------------------------------------------

    \2\ 18 CFR 4.37 (2011).
---------------------------------------------------------------------------

    The drawing is open to the public and will be held in room 2C, the
Commission Meeting Room, located at 888 First St. NE., Washington, DC
20426. A subsequent notice will be issued by the Secretary announcing
the results of the drawing.

    Dated: January 10, 2012.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2012-693 Filed 1-13-12; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 85 (Friday, May 2, 2014)]
[Proposed Rules]
[Pages 25074-25077]
[FR Doc No: 2014-10134]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 80

[EPA-HQ-OAR-2012-0546; FRL-9910-24-OAR]
RIN 2060-AS21

Regulation of Fuels and Fuel Additives: 2013 Cellulosic Biofuel
Standard

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is proposing to
revise the 2013 cellulosic biofuel standard published on August 15,
2013. This action follows from EPA having granted two petitioners'
requests for reconsideration of the 2013 cellulosic biofuel standard.
EPA granted reconsideration because one of the two companies that EPA
expected to produce cellulosic biofuel in 2013 announced soon after EPA
signed its final rule that it intended to produce substantially lower
volumes of cellulosic biofuel in 2013 than it had earlier reported to
EPA. Since the cellulosic biofuel standard was based on EPA's
projection of cellulosic biofuel production in 2013, EPA deemed this
new information to be of central relevance to the rule, warranting
reconsideration. On reconsideration, EPA is directed to base the
standard on the lower of ``projected'' production of cellulosic fuel in
2013 or the cellulosic biofuel applicable volume set forth in the
statute. Since data are available to show actual production volumes for
2013, EPA's ``projection'' and proposal are based on actual cellulosic
biofuel production in 2013. This action only affects the 2013
cellulosic biofuel standard; all other RFS standards remain unchanged.
EPA is proposing a revised cellulosic biofuel standard of 0.0005% for
2013. In the ``Rules and Regulations'' section of this Federal
Register, we are making this same amendment as a direct final rule. If
we receive no adverse comment, the direct final rule will go into
effect and we will not take further action on this proposed rule.

DATES: A request for a public hearing must be received by May 19, 2014.
If a public hearing request is received, EPA will publish a document in
the Federal Register indicating the time and place for the hearing. If
a public hearing is held, written comments must be received within 30
days after the date of the hearing. If no public hearing is held

then comments must be received on or before June 2, 2014.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
OAR-2012-00546, by one of the following methods:
     www.regulations.gov: Follow the on-line instructions for
submitting comments.
     Email<EMAIL_ADDRESS>     Mail: Air and Radiation Docket and Information Center,
Environmental Protection Agency, Mailcode: 2822T, 1200 Pennsylvania
Ave. NW., Washington, DC 20460.
     Hand Delivery: EPA Docket Center, EPA West Building, Room
3334, 1301 Constitution Ave. NW., Washington, DC 20460. Such deliveries
are only accepted during the Docket's normal hours of operation, and
special arrangements should be made for deliveries of boxed
information.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-OAR-
2012-0546. 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 information that you consider to
be CBI or otherwise protected through www.regulations.gov or email. 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. For additional
information about EPA's public docket visit the EPA Docket Center
homepage at http://www.epa.gov/epahome/dockets.htm. For additional
instructions on submitting comments, go to Section I.B of the
SUPPLEMENTARY INFORMATION section of this document.
    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, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in www.regulations.gov or in hard copy at the Air and Radiation Docket
and Information Center, EPA/DC, EPA West, Room 3334, 1301 Constitution
Ave. NW., Washington, DC. The Public Reading Room is open from 8:30
a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Public Reading Room is<PHONE_NUMBER>, and the
telephone number for the Air Docket is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Julia MacAllister, Office of
Transportation and Air Quality, Assessment and Standards Division,
Environmental Protection Agency, 2000 Traverwood Drive, Ann Arbor MI
48105; Telephone number:<PHONE_NUMBER>; Fax number:<PHONE_NUMBER>; Email
address<EMAIL_ADDRESS>or the public information line for
the Office of Transportation and Air Quality; telephone number (734)
214-4333; Email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Why is EPA issuing a proposed rule?

    EPA is proposing to amend the 2013 cellulosic biofuel standard that
was finalized in ``Regulation of Fuels and Fuel Additives: 2013
Renewable Fuel Standards; Final Rule,'' (August 15, 2013; 78 FR 49794).
This action follows from EPA having granted, on January 23, 2014,
requests for reconsideration of the 2013 cellulosic biofuel standard
submitted by the American Petroleum Institute and the American Fuel &
Petrochemical Manufacturers. In granting reconsideration, EPA
determined that petitioners had met the statutory criteria of section
307(d)(7)(B) of the Clean Air Act, since petitioners had identified new
information of central relevance that became available after the
comment period closed but within the time period specified for parties
to seek judicial review. A direct final rule that would make the same
changes as those proposed in this document appears in the ``Rules and
Regulations'' section of this Federal Register. The EPA is taking
direct final action because we view this action as noncontroversial. We
have explained our reasons for granting reconsideration in the preamble
to the direct final rule.
    If we receive no relevant adverse comment or hearing request on the
direct final rule, we will not take further action on this proposed
rule. If EPA receives relevant adverse comment or a hearing request, we
will publish a timely withdrawal in the Federal Register of the direct
final rule. We will address all public comments in any subsequent final
rule based on this proposed rule. We will not institute a second
comment period on this action. Any parties interested in commenting
must do so at this time. For further information about commenting on
this rule see the ADDRESSES section of this document.
    The proposed changes to the regulatory text are identical to those
presented in the direct final rule published in the ``Rules and
Regulations'' section of this Federal Register. For further
information, including a detailed explanation and rationale for the
proposal and the text of the proposed regulatory revisions, see the
direct final rule published in the ``Rules and Regulations'' section of
this Federal Register.

II. Does this action apply to me?

    Entities potentially affected by this proposed rule are those
involved with the production, distribution, and sale of transportation
fuels, including gasoline and diesel fuel or renewable fuels such as
ethanol and biodiesel. Potentially regulated categories include:

----------------------------------------------------------------------------------------------------------------
                                                NAICS \1\                     Examples of potentially regulated
                  Category                        Codes       SIC \2\ Codes                entities
----------------------------------------------------------------------------------------------------------------
Industry...................................          324110            2911  Petroleum Refineries.
Industry...................................          325193            2869  Ethyl alcohol manufacturing.
Industry...................................          325199            2869  Other basic organic chemical
                                                                              manufacturing.
Industry...................................          424690            5169  Chemical and allied products
                                                                              merchant wholesalers.
Industry...................................          424710            5171  Petroleum bulk stations and
                                                                              terminals.
Industry...................................          424720            5172  Petroleum and petroleum products
                                                                              merchant wholesalers.

Industry...................................          454319            5989  Other fuel dealers.
----------------------------------------------------------------------------------------------------------------
\1\ North American Industry Classification System (NAICS).
\2\ Standard Industrial Classification (SIC) system code.

    This table is not intended to be exhaustive, but rather provides a
guide for readers regarding entities likely to be regulated by this
proposed action. This table lists the types of entities that EPA is now
aware could potentially be regulated by this proposed action. Other
types of entities not listed in the table could also be regulated. To
determine whether your activities would be regulated by this action,
you should carefully examine the applicability criteria in 40 CFR part
80. If you have any questions regarding the applicability of this
proposed action to a particular entity, consult the person listed in
the preceding section.

III. What should I consider as I prepare my comments for EPA?

A. Submitting CBI

    Do not submit confidential business information (CBI) to EPA
through www.regulations.gov or email. Clearly mark the part or all of
the information that you claim to be CBI. For CBI information in a disk
or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM
as CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.

B. Tips for Preparing Your Comments

    When submitting comments, remember to:
     Identify the rulemaking by docket number and other
identifying information (subject heading, Federal Register date and
page number).
     Follow directions--The agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
     Explain why you agree or disagree, suggest alternatives,
and substitute language for your requested changes.
     Describe any assumptions and provide any technical
information and/or data that you used.
     If you estimate potential costs or burdens, explain how
you arrived at your estimate in sufficient detail to allow for it to be
reproduced.
     Provide specific examples to illustrate your concerns, and
suggest alternatives.
     Explain your views as clearly as possible, avoiding the
use of profanity or personal threats.
     Make sure to submit your comments by the comment period
deadline identified.

C. Docket Copying Costs

    You may be charged a reasonable fee for photocopying docket
materials, as provided in 40 CFR part 2.

IV. Statutory and Executive Order Reviews

A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulation and Regulatory Review

    This proposed action is not a ``significant regulatory action''
under the terms of Executive Order 12866 (58 FR 51735, October 4, 1993)
and is therefore not subject to review under Executive Orders 12866 and
13563 (76 FR 3821, January 21, 2011).

B. Paperwork Reduction Act

    There are no new information collection requirements associated
with the proposed standards in this rulemaking. The proposed standards
would impose no new or different reporting requirements on regulated
parties. The existing information collection requests (ICR) that apply
to the RFS program are sufficient to address the reporting requirements
in the proposed regulations.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid OMB control number. The OMB control numbers for EPA's
regulations in 40 CFR are listed in 40 CFR part 9.

C. Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA) generally requires an agency
to prepare a regulatory flexibility analysis of any rule subject to
notice and comment rulemaking requirements under the Administrative
Procedures Act or any other statute unless the agency certifies that
the rule will not have a significant economic impact on a substantial
number of small entities. Small entities include small businesses,
small organizations, and small governmental jurisdictions.
    For purposes of assessing the impacts of today's proposed rule on
small entities, small entity is defined as: (1) A small business as
defined by the Small Business Administration's (SBA) regulations at 13
CFR 121.201; (2) a small governmental jurisdiction that is a government
of a city, county, town, school district or special district with a
population of less than 50,000; and (3) a small organization that is
any not-for-profit enterprise which is independently owned and operated
and is not dominant in its field.
    After considering the economic impacts of today's rule on small
entities, I certify that this proposed rule will not have a significant
economic impact on a substantial number of small entities. This
proposed rule reconsiders the annual volume requirement for cellulosic
biofuel for 2013 which is being reduced from the total of 6 million
ethanol-equivalent gallons finalized in the 2013 RFS annual rule and
published on August 15, 2013 to 810,185 ethanol-equivalent gallons. The
impacts of the RFS2 program on small entities were already addressed in
the RFS2 final rule promulgated on March 26, 2010 (75 FR 14670), and
this proposed rule will not impose any additional requirements on small
entities beyond those already analyzed.

D. Unfunded Mandates Reform Act

    This proposed action contains no Federal mandates under the
provisions of Title II of the Unfunded Mandates Reform Act of 1995
(UMRA), 2 U.S.C. 1531-1538 for State, local, or tribal governments or
the private sector. This action implements mandate(s) specifically and
explicitly set forth by the Congress in Clean Air Act section 211(o)
without the exercise of any policy discretion by EPA. Therefore, this
action is not subject to the requirements of sections 202 or 205 of the
UMRA.
    This action is also not subject to the requirements of section 203
of UMRA because it contains no regulatory requirements that might
significantly or uniquely affect small governments. This

proposed rule only applies to gasoline, diesel, and renewable fuel
producers, importers, distributors and marketers and merely proposes to
revise the 2013 cellulosic biofuel standard to reflect actual
production in 2013 for the RFS program.

E. Executive Order 13132: Federalism

    This action does not have federalism implications. It will 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. This action proposes to revise the
2013 annual cellulosic biofuel standard for the RFS program and only
applies to gasoline, diesel, and renewable fuel producers, importers,
distributors and marketers. Thus, Executive Order 13132 does not apply
to this rule.

F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

    This action does not have tribal implications, as specified in
Executive Order 13175 (65 FR 67249, November 9, 2000). This proposed
rule will be implemented at the Federal level and affects
transportation fuel refiners, blenders, marketers, distributors,
importers, exporters, and renewable fuel producers and importers.
Tribal governments would be affected only to the extent they purchase
and use regulated fuels. Thus, Executive Order 13175 does not apply to
this action.

G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks

    EPA interprets EO 13045 (62 FR 19885, April 23, 1997) as applying
only to those regulatory actions that concern health or safety risks,
such that the analysis required under section 5-501 of the EO has the
potential to influence the regulation. This action is not subject to EO
13045 because it does not establish an environmental standard intended
to mitigate health or safety risks and because it implements specific
standards established by Congress in statutes (section 211(o) of the
Clean Air Act).

H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use

    This action is not a ``significant energy action'' as defined in
Executive Order 13211, ``Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use'' (66 FR 28355
(May 22, 2001)) because it is not likely to have a significant adverse
effect on the supply, distribution, or use of energy. This action
simply proposes to revises the 2013 annual cellulosic standard for
renewable fuel under the RFS program.

I. National Technology Transfer and Advancement Act

    Section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (``NTTAA''), Public Law 104-113, 12(d) (15 U.S.C. 272 note)
directs EPA to use voluntary consensus standards in its regulatory
activities unless to do so would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., materials specifications, test methods, sampling
procedures, and business practices) that are developed or adopted by
voluntary consensus standards bodies. NTTAA directs EPA to provide
Congress, through OMB, explanations when the Agency decides not to use
available and applicable voluntary consensus standards.
    This proposed rulemaking does not involve technical standards.
Therefore, EPA is not considering the use of any voluntary consensus
standards.

J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations

    Executive Order (EO) 12898 (59 FR 7629 (Feb. 16, 1994)) establishes
federal executive policy on environmental justice. Its main provision
directs federal agencies, to the greatest extent practicable and
permitted by law, to make environmental justice part of their mission
by identifying and addressing, as appropriate, disproportionately high
and adverse human health or environmental effects of their programs,
policies, and activities on minority populations and low-income
populations in the United States.
    EPA has determined that this proposed rule will not have
disproportionately high and adverse human health or environmental
effects on minority or low-income populations because it does not
affect the level of protection provided to human health or the
environment. This action does not relax the control measures on sources
regulated by the RFS regulations and therefore will not cause emissions
increases from these sources.

V. Statutory Authority

    Statutory authority for this proposed action comes from section 211
of the Clean Air Act, 42 U.S.C. 7545.

List of Subjects in 40 CFR Part 80

    Administrative practice and procedure, Air pollution control,
Diesel fuel, Environmental protection, Fuel additives, Gasoline,
Imports, Oil imports, Petroleum, Renewable fuel.

    Dated: April 22, 2014.
Gina McCarthy,
Administrator.
[FR Doc. 2014-10134 Filed 5-1-14; 8:45 am]
BILLING CODE 6560-50-P