[Federal Register Volume 85, Number 106 (Tuesday, June 2, 2020)]
[Notices]
[Pages 33686-33687]
[FR Doc No: 2020-11883]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1302]

Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory
Committee; Notice of Meeting; Establishment of a Public Docket; Request
for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of a public docket; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming
public advisory committee meeting of the Pediatric Oncology
Subcommittee of the Oncologic Drugs Advisory Committee. The general
function of the committee is to provide advice and recommendations to
FDA on regulatory issues. The meeting will be open to the public. FDA
is establishing a docket for public comment on this document.

DATES: The meeting will be held on June 17, 2020, from 10 a.m. to 3:30
p.m. and June 18, 2020, from 10 a.m. to 3:30 p.m.

ADDRESSES: Please note that due to the impact of this COVID-19 public
health emergency, all meeting participants will be joining this
advisory committee meeting via an online teleconferencing platform.
Answers to commonly asked questions about FDA advisory committee
meetings may be accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
    FDA is establishing a docket for public comment on this meeting.
The docket number is FDA-2020-N-1302. The docket will close on June 16,
2020. Submit either electronic or written comments on this public
meeting by June 16, 2020. Please note that late, untimely filed
comments will not be considered. Electronic comments must be submitted
on or before June 16, 2020. The https://www.regulations.gov electronic
filing system will accept comments until 11:59 p.m. Eastern Time at the
end of June 16, 2020. Comments received by mail/hand delivery/courier
(for written/paper submissions) will be considered timely if they are
postmarked or the delivery service acceptance receipt is on or before
that date.
    Comments received on or before June 10, 2020, will be provided to
the subcommittee. Comments received after that date will be taken into
consideration by FDA. In the event that the meeting is cancelled, FDA
will continue to evaluate any relevant applications or information, and
consider any comments submitted to the docket, as appropriate.
    You may submit comments 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-2020-N-1302 for ``Pediatric Oncology Subcommittee of the Oncologic
Drugs Advisory Committee; Notice of Meeting; Establishment of a Public
Docket; Request for Comments.'' Received comments, those filed in a
timely manner (see ADDRESSES), 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. Please call<PHONE_NUMBER> ahead
of the meeting time to verify access.
     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.'' FDA 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 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 the 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.govinfo.gov/content/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,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: LaToya Bonner, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-
796-9001, Fax:<PHONE_NUMBER>, email<EMAIL_ADDRESS>or FDA Advisory
Committee Information Line, 1-800-741-8138<PHONE_NUMBER> in the
Washington, DC area). A notice in the Federal Register about last
minute modifications that impact a previously announced advisory
committee meeting cannot always be published quickly enough to provide
timely notice. Therefore, you should always check the FDA's website at
https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to
the appropriate advisory committee meeting link, or call the advisory
committee information line to learn about possible modifications before
coming to the meeting.

SUPPLEMENTARY INFORMATION:
    Agenda: The meeting presentations will be heard, viewed, captioned,
and recorded through an online teleconferencing platform. On June 17,
2020, information will be presented regarding pediatric development
plans for two products that are in development for an adult oncology
indication. The subcommittee will consider and discuss issues relating
to the development of each product for pediatric use and provide
guidance to facilitate the formulation of written requests for
pediatric studies, if appropriate. The two products under consideration
are: (1) SP 2577 presentation by Salarius Pharmaceuticals, Inc. and (2)
Marizomib, presentation by Celgene International II S[agrave]rl, a
wholly owned subsidiary of Bristol-Myers Squibb.
    On June 18, 2020, information will be presented regarding pediatric
development plans for two products that are in development for an adult
oncology indication. The subcommittee will consider and discuss issues
relating to the development of each product for pediatric use and
provide guidance to facilitate the formulation of written requests for
pediatric studies, if appropriate. The two products under consideration
are: (1) CD30.CAR-T, presentation by Tessa Therapeutics and (2) SNDX-
5613, presentation by Syndax Pharmaceuticals, Inc.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its website prior to the meeting, the
background material will be made publicly available on FDA's website at
the time of the advisory committee meeting. Background material and the
link to the online teleconferencing platform will be available at
https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll
down to the appropriate advisory committee meeting link. The meeting
will include slide presentations with audio components to allow the
presentation of materials in a manner that most closely resembles an
in-person advisory committee meeting.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the subcommittee.
All electronic and written submissions submitted to the Docket (see
ADDRESSES) on or before June 10, 2020, will be provided to the
subcommittee. Oral presentations from the public will be scheduled
between approximately 10:50 a.m. to 11:20 a.m. and 1:55 p.m. to 2:25
p.m. on June 17, 2020. Oral presentations from the public will also be
scheduled between approximately 10:50 a.m. to 11:20 a.m. and 1:55 p.m.
to 2:25 p.m. on June 18, 2020. Those individuals interested in making
formal oral presentations should notify the contact person and submit a
brief statement of the general nature of the evidence or arguments they
wish to present, the names and addresses of proposed participants, and
an indication of the approximate time requested to make their
presentation on or before June 5, 2020. Time allotted for each
presentation may be limited. If the number of registrants requesting to
speak is greater than can be reasonably accommodated during the
scheduled open public hearing session, FDA may conduct a lottery to
determine the speakers for the scheduled open public hearing session.
The contact person will notify interested persons regarding their
request to speak by June 8, 2020.
    For press inquiries, please contact the Office of Media Affairs at
<EMAIL_ADDRESS>or<PHONE_NUMBER>.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
disabilities. If you require accommodations due to a disability, please
contact LaToya Bonner (see FOR FURTHER INFORMATION CONTACT) at least 7
days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our website at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: May 28, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-11883 Filed 6-1-20; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: September 14, 2010 (Volume 75, Number 177)]
[Notices]
[Page 55836]
[DOCID:fr14se10-117]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-62849; File No. SR-NSCC-2010-07]

Self-Regulatory Organizations; National Securities Clearing
Corporation; Order Approving Proposed Rule Change To Amend Addendum C
of its Rules and Procedures To Implement Risk Enhancements To its Stock
Borrow Program

September 3, 2010.

I. Introduction

    On July 1, 2010, National Securities Clearing Corporation
(``NSCC'') filed with the Securities and Exchange Commission
(``Commission'') proposed rule change SR-NSCC-2010-07 pursuant to
Section 19(b)(1) of the Securities Exchange Act of 1934 (``Act'').\1\
The proposed rule change was published for comment in the Federal
Register on July 29, 2010.\2\ No comment letters were received on the
proposal. This order approves the proposal.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ Securities Exchange Act Release No. 62567 (July 14, 2010),
75 FR 44828 (July 29, 2010) (SR-NSCC-2010-07).
---------------------------------------------------------------------------

II. Description

    NSCC is amending its Rules to implement risk enhancements whereby
municipal and corporate bonds will be ineligible for lending through
NSCC's Stock Borrow Program (``SBP'') and Members will be prevented
from lending through the SBP securities that were issued by that Member
or any of its affiliates.

1. SBP Background

    In the course of daily operations, for various reasons, NSCC's
Continuous Net Settlement (``CNS'') system often requires a number of
shares for a particular security that exceeds the number of shares
available to NSCC through Member deliveries. To improve the efficiency
of the clearing system in such situations, NSCC's has implemented
automated stock borrow procedures to meet these needs for shares of a
particular CNS security.
    Members wishing to participate in the SBP notify NSCC each day of
the securities they have on deposit at The Depository Trust Company
(``DTC'') that are available to be borrowed by NSCC. After NSCC's
nighttime processing of regular deliveries, NSCC borrows from its
Members the securities that have been identified as available for the
SBP and that are needed to fulfill deliveries. The daytime and
nighttime SBP are separate processes. Members can choose to participate
only in the nighttime SBP, only in the daytime SBP, or in both.
Similarly, securities needed for unfulfilled delivery obligations
during the daytime processing are borrowed from Members that have made
securities available. NSCC place the borrowed securities in a special
CNS subaccount, and the lending Member is advanced the full market
value of the borrowed securities until they are returned. As securities
become available, borrowed securities are returned through normal long
allocations against the special subaccount.

2. Proposed Amendment to Addendum C of the NSCC's Rules

    After reviewing the SBP, NSCC determined that it faced increased
risk when it borrows municipal or corporate bonds and when it borrows
securities issued by the lending Member or any of its affiliates.
First, if NSCC is unable to close out in a timely manner long positions
in corporate or municipal bonds that were created by loans of such
securities from a Member that becomes insolvent, then NSCC may possess
high concentrations of corporate or municipal bonds that it cannot
deliver to the insolvent Member. Consequently, NSCC bears an increased
risk of loss because it would be forced to liquidate those corporate or
municipal bond positions in thinly traded markets. Second, NSCC incurs
credit exposure in instances where it borrows securities from a Member
that is also the issuer of the securities or is an affiliate of the
issuer. In the event that such a Member becomes insolvent, then NSCC
incurs the additional risk that the securities loaned through the SBP
issued by the Member or its affiliate and will likely decline in value.
    In both situations, NSCC believes that the risks posed by these SBP
practices outweigh the benefits to NSCC and its Members. Accordingly,
NSCC is amending its Rules so that municipal and corporate bonds will
be ineligible for lending through the SBP and so that Members will be
unable to lend securities through the SBP that are issued by the Member
or any of its affiliates. Members will be advised of the implementation
date for these changes through the issuance of NSCC Important Notices.

III. Discussion

    The Commission finds that the proposed rule change is consistent
with the requirements of the Act \3\ and the rules and regulations
thereunder applicable to NSCC. In particular, the Commission believes
that the changes NSCC is making to the SBP to establish appropriate
safeguards and enhanced efficiency to mitigate risks to NSCC from the
SBP are consistent with NSCC's obligations under Section
17A(b)(3)(F).\4\ That section requires, among other things, that the
rules of a clearing agency are designed to assure the safeguarding of
securities and funds which are in the custody or control of the
clearing agency or for which it is responsible.
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    \3\ 15 U.S.C. 78q-1.
    \4\ 15 U.S.C. 78q-1(b)(3)(F).
---------------------------------------------------------------------------

IV. Conclusion

    On the basis of the foregoing, the Commission finds that the
proposal is consistent with the requirements of the Act and in
particular with the requirements of Section 17A of the Act \5\ and the
rules and regulations thereunder.
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78q-1.
---------------------------------------------------------------------------

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\6\ that the proposed rule change (File No. SR-NSCC-2010-07) be,
and hereby is, approved.\7\
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    \6\ 15 U.S.C. 78s(b)(2).
    \7\ In approving the proposed rule change, the Commission
considered the proposal's impact on efficiency, competition, and
capital formation. 15 U.S.C. 78c(f).

    For the Commission by the Division of Trading and Markets,
pursuant to delegated authority.\8\
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    \8\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Deputy Secretary.
[FR Doc. 2010-22801 Filed 9-13-10; 8:45 am]
BILLING CODE 8010-01-P


[Federal Register Volume 84, Number 111 (Monday, June 10, 2019)]
[Notices]
[Pages 26934-26935]
[FR Doc No: 2019-12110]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket Number FRA-2019-0042]

Petition for Waiver of Compliance

    Under part 211 of Title 49 Code of Federal Regulations (CFR), this
document provides the public notice that on May 29, 2019, the Buffalo &
Pittsburgh Railroad, Inc. (BPRR), petitioned the Federal Railroad
Administration (FRA) for a waiver of compliance from certain provisions
of the Federal railroad safety regulations contained at 49 CFR part
240, Qualification and Certification of Locomotive Engineers, and part
242, Qualification and Certification of Conductors. FRA assigned the
petition Docket Number FRA-2019-0042.
    The relief is requested as part of BPRR's proposed implementation
of and participation in FRA's Confidential Close Call Reporting System
(C\3\RS) Program. BPRR seeks to shield reporting employees and the
railroad from mandatory punitive sanctions that would otherwise arise
as provided in 49 CFR 240.117(e)(1)-(4); 240.305(a)(l)-(4) and (a)(6);
240.307; 242.403(b), (c), (e)(l)-(4), (e)(6)-(11), and (f)(l)-(2). The
C\3\RS Program encourages certified operating crew members to report
close calls and protect the employees and the railroad from discipline
or sanctions arising from the incidents reported per the C\3\RS
Implementing Memorandum of Understanding.
    A copy of the petition, as well as any written communications
concerning the petition, is available for review online at
www.regulations.gov and in person at the U.S. Department of
Transportation's (DOT) Docket Operations Facility, 1200 New Jersey
Avenue SE, W12-140, Washington, DC 20590. The Docket Operations
Facility is open from 9 a.m. to 5 p.m., Monday through Friday, except
Federal Holidays.
    Interested parties are invited to participate in these proceedings
by submitting written views, data, or comments. FRA does not anticipate
scheduling a public hearing in connection with these proceedings since
the facts do not appear to warrant a hearing. If any interested parties
desire an opportunity for oral comment and a public hearing, they
should notify FRA, in writing, before the end of the comment period and
specify the basis for their request.
    All communications concerning these proceedings should identify the
appropriate docket number and may be submitted by any of the following
methods:
     Website: http://www.regulations.gov. Follow the online
instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: Docket Operations Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue SE, W12-140, Washington, DC
20590.
     Hand Delivery: 1200 New Jersey Avenue SE, Room W12-140,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal Holidays.
    Communications received by July 25, 2019 will be considered by FRA
before final action is taken. Comments received after that date will be
considered if practicable.
    Anyone can search the electronic form of any written communications
and comments received into any of our dockets by the name of the
individual submitting the comment (or signing the document, if
submitted on behalf of an association, business, labor union, etc.).

Under 5 U.S.C. 553(c), DOT solicits comments from the public to better
inform its processes. DOT posts these comments, without edit, including
any personal information the commenter provides, to
www.regulations.gov, as described in the system of records notice (DOT/
ALL-14 FDMS), which can be reviewed at https://www.transportation.gov/privacy. See also https://www.regulations.gov/privacyNotice for the
privacy notice of regulations.gov.

    Issued in Washington, DC.
John Karl Alexy,
Acting Associate Administrator, Office of Railroad Safety.
[FR Doc. 2019-12110 Filed 6-7-19; 8:45 am]
 BILLING CODE 4910-06-P


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF

PREVENTION, PESTICIDES AND

TOXIC SUBSTANCES

MEMORANDUM

Date:	February 4, 2009

SUBJECT:	Dicloran (DCNA).   Response to Waiver Request on Residue Data
Requirements.

PC Code:  031301	DP Barcode:  D358087

Decision No.:  334070	Registration No.:  Not Applicable

Petition No.: Not Applicable	Regulatory Action: Response to DCI Comments

Risk Assessment Type: Not Applicable	Case No.: 0113

TXR No.: Not Applicable	CAS No.: 99-30-9

MRID No.: 47573501	40 CFR: 180.200

FROM:	Christine L. Olinger, Chemist

		Risk Assessment Branch 7

		Health Effects Division (7509P)

		Office of Pesticide Programs

THRU:	Donna S. Davis, Chemist

		Michael S. Metzger, Chief,

		Risk Assessment Branch 7

		Health Effects Division (7509P)

		Office of Pesticide Programs

TO:	James Parker, CRM

		Reregistration Branch 1

		Special Review and Reregistration Division (7508P)

		Office of Pesticide Programs

I.  ACTION REQUESTED

Gowan Company has submitted a request for waiving several residue
studies required in the residue chemistry chapter of the Reregistration
Eligibility Decision (RED) for the fungicide dicloran (aka DCNA,
2,6-dichloro-4-nitrobenzenamine).   These studies were levied in a
Generic Data Call-In (DCI) dated July 29, 2008 and identified as
GDCI-031301-27262.

II. CONCLUSIONS

HED agrees that the storage stability information requested under
guideline number 860.1300 can be waived.  The confirmatory method
requested under 860.1340 can also be waived, but the remaining requests
under 860.1340 are still needed.  All of the other residue chemistry
studies requested in the DCI are needed to support the registration and
tolerances for dicloran (DCNA).

III. DETAILED CONSIDERATIONS

A brief description of the rationale for the waiver request for each
guideline is provided below, followed by the HED response.

860.1300 Nature of the Residue in Livestock

Additional storage stability data demonstrating stability for 24 months
were requested to support the poultry and ruminant nature of the residue
studies.

Registrant Position

Gowan responded that sufficient data are available to support these
studies, specifically that residues of dicloran per se has been shown to
be stable in poultry commodities.  In addition, the registrant stated a
study amendment was submitted to the Agency describing analyses of that
the tissues from the metabolism study after 12 months of storage and
they are concerned about the stability of the residues.

Agency Response

The need for additional storage stability information was originally
identified when the studies were initially reviewed (DP Barcodes D270711
and D270712; 5/22/01; T. Bloem), and also required in the Residue
Chemistry Chapter to the Reregistration Eligibility Decision (RED) (C.
Olinger, 8/9/05, DP Barcode D318895).  Although these studies did not
include the storage stability data typically submitted to support nature
of the residue studies, there is enough information from the DCNA
database to waive this study.  Nature of the residue studies are
primarily used to determine the residues of concern for tolerance and
risk assessment.  The additional storage stability information requested
is not likely to affect the HED decision on the residues of concern in
livestock.  HED agrees that this study can be waived and no further
nature of the residue studies in livestock are required.

860.1340 Residue Analytical Method - Plants

A confirmatory method enforcing plant tolerances was required in the RED
(C. Olinger, 8/9/05, DP Barcode D318895).

Registrant Position

The registrant believes that sufficient methodology is available to
confirm DCNA residues by enforcement agencies, as DCNA is recovered by
one of the FDA multiresidue methods, according to the FDA PESTDATA
listing.

Agency Response

HED agrees that a confirmatory method for residues in plant is no longer
required.  HED has confirmed that PESTDATA does report very good
recoveries for DCNA.  Therefore, no additional methods are required for
plant commodities; however, the requirement for residue analytical
methods in livestock cannot be waived, as described below.

860.1340 Residue Analytical Method – Livestock Commodities

860.1360 Multi-Residue Method Testing – Livestock Commodities

860.1380 Storage Stability Data – Livestock Commodities

860.1480 Magnitude of the Residue – Meat, Milk, Poultry, and Eggs

A livestock feeding study in ruminants was required in the DCI.  If the
results of this study indicates the need for livestock tolerances, then
additional supporting studies are needed, including a tolerance
enforcement method for livestock commodities (if the plant method is not
applicable),  multi-residue method testing for one of the livestock
metabolites, and storage stability data if the samples from the feeding
study are stored greater than 30 days.

Registrant Position

Gowan is concerned that a method for determining the livestock
metabolites is not feasible, based on studies conducted in soil.  They
also believe sufficient mammalian feeding studies are available,
including studies in cows, pigs, rats, goats, and humans, and no further
studies should be required.

Agency Response

HED based the need for a livestock feeding study on a goat metabolism
study reviewed in 2001 (DP Barcodes D270711 and D270712; 5/22/01; T.
Bloem); results are summarized in Table 1.  Goats were dosed at a
feeding level of approximately 360 ppm for five days, and quantifiable
residues were found in all matrices tested.  The highest residues in
milk were found in the final samples collected, which may indicate that
the residues may not have reached a plateau.  The Metabolism Assessment
Review Committee (T. Bloem, DP Barcode D274726, 5/8/01) determined that
the parent dicloran and the metabolite DCAP, a major milk metabolite,
should be included in the tolerance expression, and that dicloran, DCAA,
DCHA, DCAP, DCNP, and A-1, should be included in the dietary risk
assessment for livestock commodities.

Table 1.  Summary of Goat Metabolism Study Conducted at a Dosing Level
of 360 ppm for Five Days 1

	ppm Dicloran Equivalents (% TRR)

	Liver	Kidney	Fat	Muscle	Milk

Total Radioactive Residues, ppm	17.70	1.39	1.24	0.11	3.57

	dicloran	--	--	1.00 (80.7%)	0.02 (15.7%)	0.70 (19.6%)

	DCAA	0.12 (0.7%)	--	0.03 (2.3%)	0.02 (14.7%)	--

	DCHA	0.18 (1.0%)	--	0.05 (4.3%)	0.01 (12.8%)	0.04 (1.1%)

	DCPD	0.04 (0.2%)	0.07 (4.9%)	--	<0.01 (3.0%)	0.06 (1.7%)

	DCNP	0.28 (1.6%)	0.05 (3.4%)	--	<0.01 (1.1%)	0.04 (1.0%)

	DCAP	1.32 (7.5%)	0.05 (3.4%)	--	--	0.92 (25.7%)

	3,5-DCHA	--	--	--	<0.01 (2.8%)	--

	A-1	6.80 (38.5%)	 0.49 (35.3%)	0.01 (1.0%)	<0.01 (3.0%)	1.12 (31.5%)

	A-2	1.56 (8.8%)	0.13 (9.4%)	--	0.01 (6.9%)	0.13 (3.6%)

	A-3	2.11 (11.9%)	0.26 (18.6%)	--	--	--

total

identified	1.91

(10.8%)	0.17

(11.7%)	1.08

(87.3%)	0.06

(50.1%)	1.76

(49.1%)

total identified/characterized	12.38

(70.0%)	1.05

(75.0%)	1.09

(88.3%)	0.07

(60.0%)	3.01

(84.2%)

1Table excerpted from DP Barcodes D270711 and D270712; 5/22/01; T.
Bloem. Dicloran = 2,6-dichloro-4-nitroaniline; DCPD =
4-amino-2,6-dichloroaniline; DCHA = 2,6-dichloro-4-hydroxyaniline; DCAA
= 4-amino-3,5-dichloroacetanilide; DCAP = 4-amino-2,6-dichlorophenol;
DCNP = 2,6-dichloro-4-nitrophenol; the petitioner proposed that A-1 was
partially comprised of 2,6-dichloro-3-glutathione-4-nitroaniline and
4-amino-3-chloro-5-glutathioneacetanilide.

The Residue Chemistry Chapter to the RED (C. Olinger, 8/9/05, DP Barcode
D318895) provided an estimate of the maximum theoretical dietary burden.
 Recently HED has updated the approach to estimating livestock dietary
burdens, so a revised dietary burden is provided in Table 2.  The
estimated dietary burdens have decreased from 55 ppm to 20 ppm for dairy
cattle and from 59 ppm to 6.1 ppm for beef cattle.  Despite these
reductions, there is still potential for quantifiable residues in
livestock commodities.  For example, in the livestock metabolism study
(at a dosing level of 360 ppm), the total identified residues of risk
assessment concern in milk were 1.63 ppm.  If the residues are
extrapolated to the maximum reasonable dietary burden, and assuming
residues are linear, the total residues would be 0.09 ppm.  Since these
residues cannot be considered negligible residues, and residues in milk
may not have reached a plateau, a livestock feeding study reflecting 28
days of dosing is needed to determine if quantifiable residues would be
expected at the maximum reasonable dietary burden.

Table 2. Maximum Reasonable Livestock Dietary Burdens for DCNA.

	%  Diet	Dietary Contributions (ppm)

Feedstuff	Type	Tolerance (ppm)	% Dry Matter	Beef	Dairy	Poul-try	Swine
Beef	Dairy	Poul-try	Swine

Roughage

Untreated	R	0	--	15	45	NU	NU	0	0	0	0

Carbohydrate Concentrate

Carrot Culls	CC	24	12	NU	10	NU	NU	0	20	0	0

Potato culls	CC	1.75	20	30	0	NU	NU	2.6	0	0	0

Potato processed waste	CC	1.75	15	30	0	NU	NU	3.5	0	0	0

Untreated	CC	0	--	20	35	75	85	0	0	0	0

Protein Concentrate

Untreated	PC	0	--	5	10	25	15	0	0	0	0

Totals	--	--	--	100	100	100	100	6.1	20	0	0

The registrant has stated that many mammalian feeding studies are
available.  However, the Residue Chemistry Data Requirements (860
series) clearly state that a 28-day feeding study is required when the
metabolism studies indicate the potential for quantifiable residues in
livestock commodities used for human food.  According to the
registrant’s chart of available mammalian feeding studies (p. 22 of
MRID 47573501) only one dairy cattle 28-day study is available, which
was conducted in 1968 (MRID No. 00095935).  Livestock commodities were
analyzed only for the parent dicloran.  The parent was the predominant
residue in only one commodity in the metabolism study, fat.  One of the
residues, DCAP, was found in greater amounts than the parent compound in
milk.  Therefore, HED needs a 28-day day feeding study to accurately
quantify exposure to dicloran and its metabolites in livestock
commodities.

If the feeding study demonstrates the need for livestock tolerances then
reliable enforcement methods for the determination of dicloran and DCAP
residues will be needed.  Multi-residue method testing will be required
for DCAP as well.  If the samples from the livestock feeding study are
stored for more than 30 days, a storage stability study will be needed
to support the feeding study as well.  The registrant has argued that
they have tried to develop methods for these compounds in soil and found
that they were unstable.  However, the characteristics of soil are very
different than livestock commodities.  The registrant was successful in
analyzing for these compounds in the livestock metabolism studies.  In
milk, residues were extracted with methanol and the extract was analyzed
directly.

In conclusion, HED recommends against waiving the livestock feeding
study, the residue analytical method for livestock, the multiresidue
method testing for the livestock metabolite DCAP, and the storage
stability testing for livestock commodities.

860.1380 Storage Stability Data – Plant Commodities

860.1500 Crop Field Trials

860.1520 Processing Studies

860.1900 Field Accumulation in Rotational Crops

In association with some proposed new uses of DCNA, HED reviewed new
plant metabolism studies (DP Barcodes D270711 and D270712; 5/22/01; T.
Bloem) and identified new residues of concern, DCHA and A-1.  The RED
chapter required additional crop field trial and processing studies (for
the pre-harvest uses of DCNA) including the analysis for the metabolites
of concern, not just the parent.  In the interim, HED used metabolite
ratios from the plant metabolism studies to obtain a rough estimate of
exposure to the metabolite in order to conduct a dietary risk assessment
for the RED.

Registrant’s Position

The registrant believes that they will be unable to develop analytical
methods for these metabolites, based on difficulties obtained when
analyzing for these compounds in soil.  In addition, since no dietary
risks of concern were identified when using the rough metabolite ratios,
the registrant believes that the studies will not affect any regulatory
decision.

Agency Response

The registrant has not provided documentation of any attempts to develop
residue methods in plant commodities, only soil.  The characteristics of
soil and plant commodities are very different.   The registrant was able
to identify and quantify these compounds in plant metabolism and
confined rotational crop studies.   HED would need extensive
documentation of attempts to develop methods in plant commodities before
we would consider waiving these studies based on the inability to
develop data collection methods for the metabolites.

The registrant has also argued that the use of ratios from the plant
metabolism studies is sufficient for risk assessment purposes.  In the
absence of crop field trial, rotational crop, and processing studies for
metabolites, HED uses ratios from metabolism studies to obtain a
reasonable rough estimate of exposure to metabolite residues.  However,
HED recognizes that there can be considerable uncertainty in applying
these ratios from controlled studies from a few crops to many different
commodities and different use conditions.  Therefore, HED requires
residue data for all residues of significant risk assessment concern
unless the registrant demonstrates that methods cannot be developed.

Page   PAGE  1  of   NUMPAGES  6


[Federal Register Volume 76, Number 178 (Wednesday, September 14, 2011)]
[Proposed Rules]
[Pages 56701-56706]
[FR Doc No: 2011-23527]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R04-OAR-2010-0604-201140; FRL-9464-1]

Approval and Promulgation of Implementation Plans and
Designations of Areas for Air Quality Planning Purposes; Georgia:
Atlanta; Determination of Attaining Data for the 1997 Annual Fine
Particulate Matter Standards

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: EPA is proposing to make two determinations regarding the
Atlanta, Georgia, fine particulate (PM2.5) nonattainment
area (hereafter referred to as the ``Atlanta Area'' or ``Area'').
First, EPA is proposing to determine that the Area has attained the
1997 annual average PM2.5 National Ambient Air Quality
Standards (NAAQS). This proposed determination of attaining data is
based upon complete, quality-assured and certified ambient air
monitoring data for the 2008-2010 period showing that the Area has
monitored attainment of the 1997 annual PM2.5 NAAQS. If EPA
finalizes this proposed determination of attaining data, the
requirements for the Area to submit an attainment demonstration and
associated reasonably available control measures (RACM), a reasonable
further progress (RFP) plan, contingency measures, and other planning
State Implementation Plan (SIP) revisions related to attainment of the
standard shall be suspended so long as the Area continues to attain the
annual PM2.5 NAAQS. Second, EPA is also proposing to
determine, based on quality-assured and certified monitoring data for
the 2007-2009 monitoring period, that the area has attained the 1997
annual PM2.5 NAAQS by its applicable attainment date of
April 5, 2010.

DATES: Comments must be received on or before October 14, 2011.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R04-
OAR-2010-0604, by one of the following methods:

    1. http://www.regulations.gov: Follow the on-line instructions for
submitting comments.
    2. E-mail<EMAIL_ADDRESS>    3. Fax:<PHONE_NUMBER>.
    4. Mail: EPA-R04-OAR-2010-0604, Regulatory Development Section, Air
Planning Branch, Air, Pesticides and Toxics Management Division, U.S.
Environmental Protection Agency, Region 4, 61 Forsyth Street, SW.,
Atlanta, Georgia 30303-8960.
    5. Hand Delivery: Lynorae Benjamin, Chief, Regulatory Development
Section, Air Planning Branch, Air, Pesticides and Toxics Management
Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth
Street, SW., Atlanta, Georgia 30303-8960. Such deliveries are only
accepted during the Regional Office normal hours of operation, and
special arrangements should be made for deliveries of boxed
information. The Regional Office official hours of business are Monday
through Friday, 8:30 to 4:30, excluding federal holidays.
    Instructions: Direct your comments to Docket ID No. EPA-R04-OAR-
2010-0604. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit through http://www.regulations.gov or e-mail, information that you consider to be CBI
or otherwise protected. The http://www.regulations.gov website 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 e-mail comment directly to EPA without
going through http://www.regulations.gov, your e-mail 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.
    Docket: All documents in the electronic docket are listed in the
http://www.regulations.gov index. Although listed in the index, some
information is not publicly available, i.e., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, is not placed on the Internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available either electronically in http://www.regulations.gov or in hard copy at the Regulatory Development
Section, Air Planning Branch, Air, Pesticides and Toxics Management
Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth
Street, SW., Atlanta, Georgia 30303-8960. EPA requests that if at all
possible, you contact the person listed in the FOR FURTHER INFORMATION
CONTACT section to schedule your inspection. The Regional Office's
official hours of business are Monday through Friday, 8:30 to 4:30,
excluding federal holidays.

FOR FURTHER INFORMATION CONTACT: Sara Waterson or Joel Huey, Regulatory
Development Section, Air Planning Branch, Air, Pesticides and Toxics
Management Division, U.S. Environmental Protection Agency, Region 4, 61
Forsyth Street, SW., Atlanta, Georgia 30303-8960. Ms. Waterson may be
reached by phone at<PHONE_NUMBER> or via electronic mail at
<EMAIL_ADDRESS>Mr. Huey may be reached by phone at (404) 562-
9104. Mr. Huey can also be reached via electronic mail at
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. What actions is EPA taking?
II. What is the background for these actions?
III. Does the Atlanta Area meet the snnual PM2.5 NAAQS?
    A. Criteria
    B. Atlanta Area Air Quality
    C. Has the Atlanta Area met the 1997 annual PM2.5 air
quality standard?
IV. What is the effect of these actions?
V. Statutory and Executive Order Reviews

I. What actions is EPA taking?

    EPA is proposing to determine that the Atlanta Area (comprised of
Barrow, Bartow, Carroll, Cherokee, Clayton, Cobb, Coweta, De Kalb,
Douglas, Fayette, Forsyth, Fulton, Gwinnett, Hall, Heard, Henry,
Newton, Paulding, Putnam, Rockdale, Spalding and Walton Counties) has
attaining data for the 1997 annual PM2.5 NAAQS. The proposal
is based upon complete, quality-assured and certified ambient air
monitoring data for the 2008-2010 monitoring period that show that the
Area has monitored attainment of the 1997 annual PM2.5
NAAQS. EPA is also proposing to determine, in accordance with EPA's
PM2.5 Implementation Rule of April 25, 2007 (72 FR 20664),
that the Atlanta Area has attained the 1997 annual PM2.5
NAAQS by its applicable attainment date of April 5, 2010.

II. What is the background for these actions?

    On July 18, 1997 (62 FR 36852), EPA established an annual
PM2.5 NAAQS at 15.0 micrograms per cubic meter ([mu]g/m\3\)
based on a 3-year average of annual mean PM2.5
concentrations. At that time, EPA also established a 24-hour NAAQS of
65 [mu]g/m\3\. See 40 CFR 50.7. On January 5, 2005 (70 FR 944), EPA
published its air quality designations and classifications for the 1997
PM2.5 NAAQS based upon air quality monitoring data from
those monitors for calendar years 2001-2003. These designations became
effective on April 5, 2005. The Atlanta Area was designated
nonattainment for the 1997 annual PM2.5 NAAQS. See 40 CFR
81.301.
    On October 17, 2006 (71 FR 61144), EPA retained the 1997 annual
PM2.5 NAAQS at 15.0 [mu]g/m\3\ based on a 3-year average of
annual mean PM2.5 concentrations, and promulgated a 24-hour
NAAQS of 35 [mu]g/m\3\ based on a 3-year average of the 98th percentile
of 24-hour concentrations. On November 13, 2009, EPA designated the
Atlanta Area as nonattainment for the 2006 24-hour NAAQS (74 FR 58688).
In that action, EPA also clarified the designations for the NAAQS
promulgated in 1997, stating that the Atlanta Area was designated as
nonattainment for the annual NAAQS but attainment for the 24-hour
NAAQS. Thus, today's action does not address attainment of either the
1997 or the 2006 24-hour NAAQS.
    In response to legal challenges of the annual NAAQS promulgated in
2006, the U.S. Court of Appeals for the District of Columbia Circuit
(D.C. Circuit) remanded this NAAQS to EPA for further consideration.
See American Farm Bureau Federation and National Pork Producers
Council, et al. v. EPA, 559 F.3d 512 (D.C. Cir. 2009). However, given
that the 1997 and 2006 annual NAAQS are essentially identical,
attainment of the 1997 annual NAAQS would also indicate attainment of
the remanded 2006 annual NAAQS.
    On April 25, 2007 (72 FR 20664), EPA promulgated its
PM2.5 implementation rule, codified at 40 CFR part 51,
subpart Z, in which the Agency provided guidance for state and tribal
plans to implement the 1997 PM2.5 NAAQS. This

rule, at 40 CFR 51.1004(c), specifies some of the regulatory
consequences of attaining the NAAQS, as discussed below.

III. Does the Atlanta area meet the annual PM2.5 NAAQS?

A. Criteria

    Today's proposed rulemaking assesses whether (1) The Atlanta Area
has attained the 1997 annual PM2.5 NAAQS, based on the most
recent three years of quality-assured data, and (2) whether the Area
attained that NAAQS by its applicable attainment date of April 5, 2010.
The Atlanta Area is comprised of Barrow, Bartow, Carroll, Cherokee,
Clayton, Cobb, Coweta, De Kalb, Douglas, Fayette, Forsyth, Fulton,
Gwinnett, Hall, Heard, Henry, Newton, Paulding, Putnam, Rockdale,
Spalding and Walton Counties.
    Under EPA regulations at 40 CFR 50.7, the 1997 annual primary and
secondary PM2.5 standards are met when the annual arithmetic
mean concentration, as determined in accordance with 40 CFR part 50,
Appendix N, is less than or equal to 15.0 [micro]g/m\3\ at all relevant
monitoring sites in the subject area.

B. Atlanta Area Air Quality

    EPA has reviewed the ambient air monitoring data for the Atlanta
Area in accordance with the provisions of 40 CFR part 50, Appendix N.
All data considered have been quality-assured, certified, and recorded
in EPA's Air Quality System (AQS) database. This review addresses air
quality data collected in two 3-year periods. The period 2007-2009 is
used for the determination of attainment by attainment date because
that was the last period of certified data prior to the required
attainment date of April 5, 2010. The period 2008-2010 is used for the
determination of attaining data because that is the most recent period
of certified data available now available to EPA.
    Table 1 and the related discussion below show that, based on EPA's
analysis of data for 2007-2009, the Area attained the 1997 annual
PM2.5 standard by its attainment date of April 5, 2010. In
addition, Table 2 and the related discussion below show that the Area
continues to attain the standard based on available data for 2008-2010.
There were data completeness issues at the Powder Springs, E. Rivers
School, Fire Station 8/Georgia Tech, Gwinnett Tech, and
Yorkville monitors for both the 2007-2009 and 2008-2010 periods. EPA
performed a quarterly maximum data substitution test using 40 CFR Part
50 Appendix N and the April 1999 Guideline on Data Handling Conventions
for the PM NAAQS (http://epa.gov/ttncaaa1/t1/memoranda/pmfinal.pdf) for
the monitors with less than 75 percent complete data. Further
discussion on the data substitution can be found in the technical
support document (TSD) for this proposal. The three year annual design
values both with and without data substitution are provided in Table 1
and Table 2 below. EPA's review of these data indicates that the
Atlanta Area has met the 1997 annual PM2.5 NAAQS by the
attainment date of April 5, 2010.
---------------------------------------------------------------------------

    \1\ Fire Station 8 was relocated to the Georgia Tech
campus in 2007 and assigned a separate AQS number. It moved back to
Fire Station 8 at the end of 2008 and resumed normal
operation. The annual average design value with data substitution
was calculated by combining the data records for Fire Station
8 and Georgia Tech.

 Table 1--2007-2009 Annual Average PM2.5 Concentrations for Monitors in the Atlanta, Georgia Nonattainment Area
----------------------------------------------------------------------------------------------------------------
                                                                            Annual average
                                                                             concentration      Annual average
                      Location                             Site No.          ([mu]g/m\3\)        concentration
                                                                             without data      ([mu]g/m\3\) with
                                                                             substitution     data  substitution
----------------------------------------------------------------------------------------------------------------
Georgia DOT.........................................         13-063-0091                13.5                 N/A
GA National Guard...................................         13-067-0003                13.4                 N/A
Powder Springs......................................         13-067-0004                12.6                13.1
South DeKalb........................................         13-089-0002                13.0                 N/A
Police Dept.........................................         13-089-2001                13.3                 N/A
E. Rivers School....................................         13-121-0032                13.4                14.2
Fire Station 8 \1\.........................         13-121-0039                 9.8                13.8
Gwinnett Tech.......................................         13-135-0002                12.7                13.3
Gainesville.........................................         13-139-0003                11.8                12.8
Yorkville...........................................         13-223-0003                12.0                12.7
----------------------------------------------------------------------------------------------------------------
N/A--Not Applicable.

 Table 2--2008-2010 Annual Average PM2.5 Concentrations for Monitors in the Atlanta, Georgia Nonattainment Area
----------------------------------------------------------------------------------------------------------------
                                                                            Annual average
                                                                             concentration      Annual average
                      Location                             Site No.          ([mu]g/m\3\)        concentration
                                                                             without data      ([mu]g/m\3\) with
                                                                             substitution     data  substitution
----------------------------------------------------------------------------------------------------------------
Georgia DOT.........................................         13-063-0091                12.9                 N/A
GA National Guard...................................         13-067-0003                12.3                 N/A
Powder Springs......................................         13-067-0004                11.9                12.3
South Dekalb........................................         13-089-0002                12.1                 N/A
Police Dept.........................................         13-089-2001                12.3                 N/A
E. Rivers School....................................         13-121-0032                12.3                13.0
Fire Station 8 \2\.........................         13-121-0039                11.4                13.6
Gwinnett Tech.......................................         13-135-0002                12.1                12.5
Gainesville.........................................         13-139-0003                11.2                11.9

Yorkville...........................................         13-223-0003                11.0                11.6
----------------------------------------------------------------------------------------------------------------
N/A--Not Applicable.

    The Powder Springs monitor has a 2007-2009 PM2.5 annual
design value of 12.6 [mu]g/m\3\. Since the monitor had one incomplete
quarter during the second quarter of 2009, data substitution was
conducted. The annual mean was recalculated, and the resulting 2007-
2009 PM2.5 annual design value is 13.1 [mu]g/m\3\. The
current 2008-2010 PM2.5 annual design value is 11.9 [mu]g/
m\3\. Data substitution was conducted for the second quarter of 2009.
The annual mean was recalculated, and the resulting 2008-2010
PM2.5 annual design value is 12.3 [mu]g/m\3\. This monitor
is considered attaining with design values of 12.6 [mu]g/m\3\ and 11.9
[mu]g/m\3\.
---------------------------------------------------------------------------

    \2\ Fire Station 8 was relocated to the Georgia Tech
campus in 2007 and assigned a separate AQS number. It moved back to
Fire Station 8 at the end of 2008 and resumed normal
operation. The annual average design value with data substitution
was calculated by combining the data records for Fire Station
8 and Georgia Tech.
---------------------------------------------------------------------------

    The E. Rivers School monitor did not meet data completeness for the
second and third quarters of 2009 due to roof repairs during the summer
of 2009 that were out of the State's control. Georgia Environmental
Protection Division appropriately notified Region 4 of the temporary
site closure. Additionally, the fourth quarter in 2008 is also
incomplete. The 2007-2009 PM2.5 annual design value is 13.4
[mu]g/m\3\ and the 2008-2010 PM2.5 annual design value is
12.3 [mu]g/m\3\. Data substitution was conducted and the recalculated
annual design values are 14.2 [mu]g/m\3\ and 13.0 [mu]g/m\3\
respectively. This monitor is considered attaining with design values
of 13.4 [mu]g/m\3\ for the 2007-2009 monitoring period and 12.3 [mu]g/
m\3\ for the 2008-2010 monitoring period.
    EPA's Office of Air Quality Planning and Standards (OAQPS)
conducted an additional statistical analysis for the E. Rivers School
monitor which indicates, as a weight of evidence, that despite the
prolonged shut-down of the E. Rivers School monitor, the monitor would
have attained in the 2007-2009 design value period. To evaluate air
quality at the E. Rivers School monitor, EPA applied statistical
analysis using data from other sites in the area. The approach,
summarized in this section and further described in the TSD, is
appropriate for this Area but may or may not be suitable for other
areas with less than complete data. EPA will evaluate the
appropriateness of this analytical approach on a case-by-case basis for
determinations regarding each area with less than complete data.
    The first step in the analysis was to assess the correlation of
concentrations at the E. Rivers School site with concentrations at
other sites in the Area. The monitor in the Area that had the highest
correlation with the E. Rivers School site was the Georgia DOT monitor;
therefore, subsequent analyses used data from this site. The second
step was to develop a regression equation expressing the relationship
between concentrations at the E. Rivers School and the Georgia DOT
monitors. This regression equation was used to estimate values at the
E. Rivers School site on days during quarters with incomplete data when
the E. Rivers School site did not measure concentrations. A 2007-2009
design value for the E. Rivers School site was then calculated using
these estimated values. Under this method, the 2007-2009 design value
for the E. Rivers School site was estimated to be 13.6 [mu]g/m\3\.
    This estimated design value was then analyzed using a statistical
method, referred to as the ``bootstrap method,'' that involves the use
of regression residuals. In this analysis, EPA repeated the regression
analysis 1,000 times with different values within the probability
distribution of E. Rivers School concentrations that could be
associated with given concentrations at the Georgia DOT monitor. From
this analysis, as described in detail in the TSD, EPA determined that
the upper end of the range of potential 2007-2009 design values
obtained did not exceed the NAAQS. No exceedances of the NAAQS resulted
from application of the statistical analysis. Therefore, EPA concluded
that for 2007-2009, the annual average concentration of the E. Rivers
School monitor is below the NAAQS.
    The Fire Station 8 monitor was relocated to the Georgia
Tech campus and was assigned a separate AQS number. It was moved back
to Fire Station 8 at the end of 2008 and resumed normal
operation. There were no data completeness issues at either site during
the times each site was operated. The data records of the two sites
were combined and resulted in a 13.8 [mu]g/m\3\ design value for the
2007-2009 design value period. As an additional weight of evidence, the
bootstrap analysis described above for the E. Rivers School site was
also conducted for the Fire Station 8 monitor and passed with
a 2007-2009 design value of 14.1 [mu]g/m\3\. The South DeKalb monitor
had the highest correlation with the Fire Station 8 monitor.
This bootstrap analysis is further explained in the TSD for this
document. The data records of the two sites were also combined for the
2008-2010 design value period, which resulted in a 13.6 [mu]g/m\3\
design value.
    The Gwinnett Tech monitor has a 2007-2009 PM2.5 annual
design value of 12.7 [mu]g/m\3\. Since the monitor had one incomplete
quarter during the fourth quarter of 2008, data substitution was
conducted. The annual mean was recalculated, and the resulting 2007-
2009 PM2.5 annual design value is 13.3 [mu]g/m\3\. The 2008-
2010 PM2.5 annual design value is 12.1 [mu]g/m\3\. Data
substitution was conducted for the fourth quarter of 2008. The annual
mean was recalculated, and the resulting 2008-2010 PM2.5
annual design value is 12.5 [mu]g/m\3\. This monitor is considered
attaining with design values of 12.7 [mu]g/m\3\ and 12.1 [mu]g/m\3\,
respectively.
    The Gainesville monitor has a 2007-2009 PM2.5 annual
design value of 11.8 [mu]g/m\3\. Since the monitor had two incomplete
quarters during the third and fourth quarters of 2008, data
substitution was conducted. The annual mean was recalculated, and the
resulting 2007-2009 PM2.5 annual design value is 12.8 [mu]g/
m\3\. The current 2008-2010 PM2.5 annual design value is
11.2 [mu]g/m\3\. Data substitution was conducted for the third and
fourth quarters of 2008. The annual mean was recalculated, and the
resulting 2008-2010 PM2.5 annual design value is 11.9 [mu]g/
m\3\. This monitor is considered

attaining with design values of 11.8 [mu]g/m\3\ and 11.2 [mu]g/m\3\.
    The Yorkville monitor has a 2007-2009 PM2.5 annual
design value of 12.0 [mu]g/m\3\. Since the monitor had one incomplete
quarter during the third quarter of 2009, data substitution was
conducted. The annual mean was recalculated, and the resulting 2007-
2009 PM2.5 annual design value is 12.7 [mu]g/m\3\. The
current 2008-2010 PM2.5 annual design value is 11.0 [mu]g/
m\3\. Data substitution was conducted for the third quarter of 2009.
The annual mean was recalculated, and the resulting 2008-2010
PM2.5 annual design value is 11.6 [mu]g/m\3\. This monitor
is considered attaining with design values of 12.0 [mu]g/m\3\ and 11.0
[mu]g/m\3\.
    EPA believes that the Atlanta Area is now meeting the 1997 annual
PM2.5 NAAQS. Since few data are available for 2011, the
2008-2010 data represent the most recent available data for EPA to use
in its assessment. On the basis of this review, EPA is proposing to
determine that the Atlanta Area has attained the 1997 annual
PM2.5 NAAQS. EPA is soliciting public comments on its
proposal to determine that the Atlanta Area has attained the 1997
annual PM2.5 NAAQS with 2007-2009 as well as 2008-2010 data,
and attained the 1997 annual PM2.5 NAAQS by the April 5,
2010, attainment date using 2007-2009 data.

C. Has the Atlanta area met the 1997 annual PM2.5 air
quality standard?

    EPA has reviewed the ambient air monitoring data for
PM2.5, consistent with the requirements contained in 40 CFR
part 50 and recorded the data in the EPA AQS database, for the Atlanta
Area from 2007 through the present time. On the basis of that review,
EPA proposes to determine that this Area has attained and continues to
attain the 1997 annual PM2.5 NAAQS based on the quality-
assured data for the 2007-2009 monitoring period, which demonstrates
attainment by April 5, 2010, and the 2008-2010 monitoring period. In
addition, based on EPA's review of the data for 2007-2009, and in
accordance with section 179(c)(1) of the CAA and EPA's regulations, EPA
proposes to determine that the Area attained the 1997 annual
PM2.5 NAAQS by its applicable attainment date of April 5,
2010.

IV. What is the effect of these actions?

    If this proposed determination of attaining data is made final, the
requirements for the Atlanta Area to submit an attainment demonstration
and associated RACM, a RFP plan, contingency measures, and any other
planning SIPs related to attainment of the 1997 annual PM2.5
NAAQS would be suspended for so long as the Area continues to attain
the PM2.5 NAAQS. See 40 CFR 51.1004(c). Notably, as
described below, any such determination would not be equivalent to the
redesignation of the Area to attainment for the annual PM2.5
NAAQS.
    If this proposed rulemaking is finalized and EPA subsequently
determines, after notice-and-comment rulemaking in the Federal
Register, that the Area has violated the annual PM2.5 NAAQS,
the basis for the suspension of the specific requirements would no
longer exist for the Atlanta Area, and the Area would thereafter have
to address the applicable requirements. See 40 CFR 51.1004(c).
    Finalizing this proposed action would not constitute a
redesignation of the Area to attainment of the annual PM2.5
NAAQS under section 107(d)(3) of the Clean Air Act (CAA). Further,
finalizing this proposed action does not involve approving a
maintenance plan for the Area as required under section 175A of the
CAA, nor would it find that the Area has met all other requirements for
redesignation. Even if EPA finalizes the proposed action, the
designation status of the Atlanta Area would remain nonattainment for
the 1997 annual PM2.5 NAAQS until such time as EPA
determines that the Area meets the CAA requirements for redesignation
to attainment and takes action to redesignate the Area.
    This action is only a proposed determination that the Atlanta Area
has attained the 1997 annual PM2.5 NAAQS and has done so by
the April 5, 2010, attainment date. Today's action does not address the
24-hour PM2.5 NAAQS.
    If the Atlanta Area continues to monitor attainment of the annual
PM2.5 NAAQS, the requirements for the Atlanta Area to submit
an attainment demonstration and associated RACM, a RFP plan,
contingency measures, and any other planning SIPs related to attainment
of the annual PM2.5 NAAQS will remain suspended.
    In addition, if EPA's separate and independent proposed
determination that the Area has attained the 1997 annual
PM2.5 standard by its applicable attainment date (April 5,
2010) is finalized, EPA will have met its requirement pursuant to
section 179(c)(1) of the CAA to make a determination based on the
Area's air quality data as of the attainment date whether the Area
attained the standard by that date.
    These two actions described above are proposed determinations
regarding the Atlanta Area's attainment only with respect to the 1997
annual PM2.5 NAAQS. Today's actions do not address the 24-
hour PM2.5 NAAQS.

V. Statutory and Executive Order Reviews

    These actions propose to make determinations of attainment based on
air quality, and would, if finalized, result in the suspension of
certain federal requirements, and it would not impose additional
requirements beyond those imposed by state law. For that reason, these
proposed actions:
     Are not ``significant regulatory actions'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     Do not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Are certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Do not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Do not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Are not economically significant regulatory actions based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Are not significant regulatory actions subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Are not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Do not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994). In addition,
these proposed 1997 annual PM2.5 NAAQS determinations for
the Atlanta Area do not have tribal implications as specified by
Executive Order 13175 (65 FR 67249, November 9, 2000), because the SIP
is not approved to apply in Indian country located in the state, and
EPA notes that it will not impose substantial direct costs on tribal
governments or preempt tribal law.

    For purposes of judicial review, the two of the these
determinations approved by today's action are severable from one
another.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Particulate
matter, Reporting and recordkeeping requirements.

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

    Dated: September 1, 2011.
A. Stanley Meiburg,
Acting Regional Administrator, Region 4.
[FR Doc. 2011-23527 Filed 9-13-11; 8:45 am]
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[Federal Register: June 26, 2008 (Volume 73, Number 124)]
[Notices]
[Page 36310-36311]
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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. P-2244-022]

Energy Northwest; Notice of Application Ready for Environmental
Analysis and Soliciting Comments, Recommendations, Terms and
Conditions, and Prescriptions

June 19, 2008.
    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection.
    a. Type of Application: New Major License.
    b. Project No.: P-2244-022.
    c. Date filed: February 25, 2008.
    d. Applicant: Energy Northwest.
    e. Name of Project: Packwood Lake Hydroelectric Project.
    f. Location: The existing project is on Lake Creek, a tributary to
Cowlitz River, in Lewis County in southwestern Washington near the
unincorporated town of Packwood. The upper portion of the lake lies
within the Goat Rocks Wilderness Area. The project occupies

511.65 acres of United States Forest Service land, 23.66 acres of
Energy Northwest-owned land, 8.78 acres of Washington State lands, and
1.52 acres of Lewis County Public Utility District lands.
    g. Filed Pursuant to: Federal Power Act 16 U.S.C. 791 (a)-825(r).
    h. Applicant Contact: Jack W. Baker, Vice President, Energy
Northwest, Mail Drop 1035, P.O. Box 968, Richland, WA 99352-0968;
telephone<PHONE_NUMBER>, or e-mail at<EMAIL_ADDRESS>or
D.L. Ross, Energy Northwest, Mail Drop 1030, P.O. Box 968, Richland, WA
99352-0968.
    i. FERC Contact: Kenneth Hogan, telephone<PHONE_NUMBER>, or e-mail
at<EMAIL_ADDRESS>    j. The deadline for filing comments, recommendations, terms and
conditions, and prescriptions is 60 days from the issuance of this
notice (August 18, 2008) reply comments are due 105 days from the
issuance date of this notice (October 2, 2008).
    All documents (original and eight copies) should be filed with:
Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888
First Street, NE., Washington, DC 20426.
    The Commission's Rules of Practice require all intervenors filing
documents with the Commission to serve a copy of that document on each
person on the official service list for the project. Further, if an
intervenor files comments or documents with the Commission relating to
the merits of an issue that may affect the responsibilities of a
particular resource agency, they must also serve a copy of the document
on that resource agency.
    Comments, recommendations, terms and conditions, and prescriptions
may be filed electronically via the Internet in lieu of paper. The
Commission strongly encourages electronic filings. See 18 CFR
385.2001(a)(1)(iii) and the instructions on the Commission's Web site
(http://www.ferc.gov) under the ``e-Filing'' link.
    k. This application has been accepted and is ready for
environmental analysis at this time.
    l. Project description: The existing project consists of the
following: (1) An intake canal, a concrete drop structure (dam), intake
building on Lake Creek located about 424 feet downstream from the
outlet of Packwood Lake, a 21,691-foot system of concrete pipe and
tunnels, a 5,621-foot penstock, a surge tank, and a powerhouse with a
26.1-megawatt turbine generator; (2) a 452-acre reservoir (Packwood
Lake) at a normal full pool elevation of 2,857 feet above mean sea
level with approximately 4,162 acre-feet of usable storage; and (3)
appurtenant facilities. The average annual generation at the project is
about 90,998 megawatt-hours.
    The applicant proposes a modified reservoir operational regime and
higher instream flow releases to the bypassed reach on Lake Creek.
Several other proposed measures for the project include: (1) Developing
and implementing a stream restoration and enhancement plan in the
anadromous zone in lower Lake Creek; (2) improving fish passage on
Snyder Creek where it crosses the tailrace canal; (3) maintaining and
monitoring of tailrace fish barrier; and (4) developing and
implementing numerous resource protection and enhancement plans.
    m. A copy of the application is available for review at the
Commission in the Public Reference Room or may be viewed on the
Commission's Web site at http://www.ferc.gov using the ``eLibrary
link''. Enter the docket number excluding the last three digits in the
docket number field to access the document. For assistance, contact
FERC Online Support at<EMAIL_ADDRESS>or toll-free at 1-
866-208-3676, or for TTY,<PHONE_NUMBER>. A copy is also available for
inspection and reproduction at the address in item h above.
    All filings must: (1) Bear in all capital letters the title
``COMMENTS'', ``REPLY COMMENTS,'' ``RECOMMENDATIONS,'' ``TERMS AND
CONDITIONS,'' or ``PRESCRIPTIONS''; (2) set forth in the heading the
name of the applicant and the project number of the application to
which the filing responds; (3) furnish the name, address, and telephone
number of the person submitting the filing; and (4) otherwise comply
with the requirements of 18 CFR 385.2001 through 385.2005. All
comments, recommendations, terms and conditions, or prescriptions must
set forth their evidentiary basis and otherwise comply with the
requirements of 18 CFR 4.34(b). Agencies may obtain copies of the
application directly from the applicant. Each filing must be
accompanied by proof of service on all persons listed on the service
list prepared by the Commission in this proceeding, in accordance with
18 CFR 4.34(b), and 385.2010.
    You may also register online at http://www.ferc.gov/docs-filing/
esubscription.asp to be notified via e-mail of new filings and
issuances related to this or other pending projects. For assistance,
contact FERC Online Support.
    n. A license applicant must file no later than 60 days following
the date of issuance of this notice: (1) A copy of the water quality
certification; (2) a copy of the request for certification, including
proof of the date on which the certifying agency received the request;
or (3) evidence of waiver of water quality certification.

Kimberly D. Bose,
Secretary.
[FR Doc. E8-14452 Filed 6-25-08; 8:45 am]

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[Federal Register: December 2, 2009 (Volume 74, Number 230)]
[Notices]
[Page 63146-63147]
[DOCID:fr02de09-30]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

 [Docket No. EL05-146-010]

Independent Energy Producers Association v. California
Independent System Operator Corporation; Notice of Compliance Filing

November 24, 2009.
    Take notice that on November 20, 2009, Mirant Energy Trading, LLC
filed an amendment to their compliance refund report submitted on
October 2, 2009, pursuant to the Commission's order issued on August
18, 2009, 128 FERC ] 61,165 (2009) (Order on Remand).
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of

the Commission's Rules of Practice and Procedure (18 CFR 385.211,
385.214). Protests will be considered by the Commission in determining
the appropriate action to be taken, but will not serve to make
protestants parties to the proceeding. Any person wishing to become a
party must file a notice of intervention or motion to intervene, as
appropriate. Such notices, motions, or protests must be filed on or
before the comment date. Anyone filing a motion to intervene or protest
must serve a copy of that document on the Applicant and all the parties
in this proceeding.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://
www.ferc.gov. Persons unable to file electronically should submit an
original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on December 11, 2009.

Kimberly D. Bose,
Secretary.
[FR Doc. E9-28796 Filed 12-1-09; 8:45 am]

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