[Federal Register: September 22, 2009 (Volume 74, Number 182)]
[Notices]
[Page 48251-48253]
[DOCID:fr22se09-60]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 1

September 14, 2009.
    Take notice that the Commission received the following electric
corporate filings:

    Docket Numbers: EC09-108-000.
    Applicants: ALLETE, Inc.
    Description: Allete submits Application for Authorization to
Acquire Transmission Facilities.
    Filed Date: 09/04/2009.
    Accession Number: 20090909-0146.
    Comment Date: 5 p.m. Eastern Time on Friday, September 25, 2009.

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER06-1367-005; ER06-745-004; ER07-239-004; ER99-
1714-008.
    Applicants: BG Dighton Power, LLC, BG Energy Merchants, LLC,
MASSPOWER, Lake Road Generating Company, L.P.

    Description: BG Dighton Power, LLC, et al. Notice of Non-Material
Change in Status.
    Filed Date: 09/09/2009.
    Accession Number: 20090909-5053.
    Comment Date: 5 p.m. Eastern Time on Wednesday, September 30, 2009.

    Docket Numbers: ER09-1505-001.
    Applicants: Stony Creek Wind Farm, LLC.
    Description: Stony Creek submits supplement to its MBR application
in response to requests from FERC.
    Filed Date: 09/10/2009.
    Accession Number: 20090911-0056.
    Comment Date: 5 p.m. Eastern Time on Thursday, October 1, 2009.

    Docket Numbers: ER09-1684-000.
    Applicants: Mississippi Power Company.
    Description: Application of Mississippi Power Company Update Its
Depreciation Rates for the calculation of charges for service provided.
    Filed Date: 09/09/2009.
    Accession Number: 20090909-5014.
    Comment Date: 5 p.m. Eastern Time on Wednesday, September 30, 2009.

    Docket Numbers: ER09-1689-000.
    Applicants: Backyard Farms Energy LLC.
    Description: Backyard Farms Energy, LLC submits application for
authorization to make wholesale sales of energy and capacity at
negotiated, market based rates.
    Filed Date: 09/11/2009.
    Accession Number: 20090911-0054.
    Comment Date: 5 p.m. Eastern Time on Friday, October 2, 2009.

    Docket Numbers: ER09-1690-000.
    Applicants: Xcel Energy Services Inc.
    Description: Southwestern Public Service Company submits Notice of
Termination of Experimental Sales Rider Agreements.
    Filed Date: 09/09/2009.
    Accession Number: 20090910-0390.
    Comment Date: 5 p.m. Eastern Time on Wednesday, September 30, 2009.

    Docket Numbers: ER09-1691-000.
    Applicants: Pacific Gas and Electric Company.
    Description: Pacific Gas and Electric Company submits Notice of
Termination of PG&E Rate Schedule FERC 235, et al.
    Filed Date: 09/10/2009.
    Accession Number: 20090911-0058.
    Comment Date: 5 p.m. Eastern Time on Thursday, October 1, 2009.

    Docket Numbers: ER09-1692-000.
    Applicants: Southern California Edison Company.
    Description: Southern California Edison Co. submits revised rate
sheets to the Barre Peaker Project Large Generator Interconnection
Agreement et al.
    Filed Date: 09/10/2009.
    Accession Number: 20090911-0057.
    Comment Date: 5 p.m. Eastern Time on Thursday, October 1, 2009.

    Docket Numbers: ER09-1693-000.
    Applicants: New York Independent System Operator, Inc., Niagara
Mohawk Power Corporation, Green Power Energy, LLC.
    Description: New York Independent System Operator, Inc submits
Original Sheet 1 et al to FERC Electric Tariff, Original Volume 1,
Service Agreement 1483.
    Filed Date: 09/10/2009.
    Accession Number: 20090911-0052.
    Comment Date: 5 p.m. Eastern Time on Thursday, October 1, 2009.

    Docket Numbers: ER09-1694-000.
    Applicants: PacifiCorp.
    Description: PacifiCorp submits for filing Original Sheet 1 et al
to FERC Electric Tariff, 7th Revised Volume 11, First Revised Service
Agreement 347.
    Filed Date: 09/10/2009.
    Accession Number: 20090911-0053.
    Comment Date: 5 p.m. Eastern Time on Thursday, October 1, 2009.

    Docket Numbers: ER09-1696-000.
    Applicants: Midwest Independent Transmission System Operator, Inc.
    Description: Midwest Independent Transmission System Operator, Inc.
submits executed Amended and Restated Large Generator Interconnection
Agreement dated 9/3/09 among Midwest ISO, et al.
    Filed Date: 09/11/2009.
    Accession Number: 20090911-0102.
    Comment Date: 5 p.m. Eastern Time on Friday, October 2, 2009.

    Take notice that the Commission received the following electric
securities filings:

    Docket Numbers: ES09-52-000.
    Applicants: Louisville Gas & Electric Company.
    Description: Application of Louisville Gas and Electric Company for
Authority to Issue Short-Term Debt Securities.
    Filed Date: 09/10/2009.
    Accession Number: 20090910-5109.
    Comment Date: 5 p.m. Eastern Time on Thursday, October 1, 2009.

    Docket Numbers: ES09-53-000.
    Applicants: Kentucky Utilities Company.
    Description: Application of Kentucky Utilities Company for
Authority to Issue Short-Term Debt Securities.
    Filed Date: 09/10/2009.
    Accession Number: 20090910-5110.
    Comment Date: 5 p.m. Eastern Time on Thursday, October 1, 2009.

    Docket Numbers: ES09-54-000.
    Applicants: Midwest Independent Transmission System Operator, Inc.
    Description: Application of the Midwest Independent Transmission
System Operator, Inc. Under Section 204 of the Federal Power Act to
Issue Securities.
    Filed Date: 09/14/2009.
    Accession Number: 20090914-5060.
    Comment Date: 5 p.m. Eastern Time on Monday, October 5, 2009.

    Take notice that the Commission received the following open access
transmission tariff filings:

    Docket Numbers: OA07-58-005.
    Applicants: NorthWestern Corporation.
    Description: Compliance Filing of NorthWestern Corporation.
    Filed Date: 09/14/2009.
    Accession Number: 20090914-5033.
    Comment Date: 5 p.m. Eastern Time on Monday, October 5, 2009.

    Docket Numbers: OA08-23-002; OA08-28-003; OA08-31-003; OA08-40-002;
OA08-45-003; OA08-54-005; OA08-55-005; OA08-56-005; OA08-57-005; OA08-
118-002.
    Applicants: Idaho Power Company, Deseret Generation & Transmission
Co-op., Portland General Electric Company, NorthWestern Corporation,
PacifiCorp.
    Description: Compliance Filing of Idaho Power Company, et al.
    Filed Date: 09/14/2009.
    Accession Number: 20090914-5082.
    Comment Date: 5 p.m. Eastern Time on Monday, October 5, 2009.

    Docket Numbers: OA08-30-002.
    Applicants: El Paso Electric Company.
    Description: Attachment K Compliance Filing of El Paso Electric
Company.
    Filed Date: 09/11/2009.
    Accession Number: 20090911-5100.
    Comment Date: 5 p.m. Eastern Time on Friday, October 2, 2009.

    Docket Numbers: OA08-38-004.
    Applicants: Sierra Pacific Resources Operating Company.
    Description: Compliance Filing of Sierra Pacific Resources
Operating Companies for the OATT Attachment K--Transmission Planning
Process.
    Filed Date: 09/14/2009.
    Accession Number: 20090914-5165.
    Comment Date: 5 p.m. Eastern Time on Monday, October 5, 2009.

    Any person desiring to intervene or to protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214) on or before 5 p.m. Eastern time on the specified comment
date. It is not necessary to separately intervene again in a subdocket
related to a

compliance filing if you have previously intervened in the same docket.
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. Anyone filing a motion to intervene or
protest must serve a copy of that document on the Applicant. In
reference to filings initiating a new proceeding, interventions or
protests submitted on or before the comment deadline need not be served
on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://
www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St. NE., Washington, DC 20426.
    The filings in the above proceedings are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also 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 dockets(s). For assistance
with any FERC Online service, please e-mail<EMAIL_ADDRESS>
or call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. E9-22723 Filed 9-21-09; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 62 (Tuesday, April 1, 2014)]
[Rules and Regulations]
[Pages 18156-18159]
[FR Doc No: 2014-07220]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 516, 520, 522, 526, and 558

[Docket No. FDA-2013-N-0002]

New Animal Drugs; Amprolium; Bambermycins; Ceftiofur; Deslorelin;
Florfenicol; Florfenicol and Flunixin; Paclitaxel; Phenylbutazone;
Pimobendan; Salinomycin; Tilmicosin; Tiludronate; Change of Sponsor

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect approval actions for new animal drug
applications (NADAs) and abbreviated new animal drug applications
(ANADAs) during January and February 2014. FDA is also informing the
public of the availability of summaries of the basis of approval and of
environmental review documents, where applicable. The animal drug
regulations are also being amended to reflect previous approval of
revised food safety warnings. This is being done to improve the
accuracy of the regulations. The animal drug regulations are also being
amended to reflect a change of sponsorship of an NADA and a change to a
sponsor's address.

DATES: This rule is effective April 1, 2014.

FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for
Veterinary Medicine (HFV-6), Food and Drug Administration, 7519
Standish Pl., Rockville, MD 20855,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: FDA is amending the animal drug regulations
to reflect approval actions for NADAs and ANADAs during January and
February 2014, as listed in table 1. In addition, FDA is informing the
public of the availability, where applicable, of documentation of
environmental review required under the National Environmental Policy
Act (NEPA) and, for actions requiring review of safety or effectiveness
data, summaries of the basis of approval (FOI Summaries) under the
Freedom of Information Act (FOIA). These public documents may be seen
in the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852,
between 9 a.m. and 4 p.m., Monday through Friday. Persons with access
to the Internet may obtain these documents at the Center for Veterinary
Medicine FOIA Electronic Reading Room: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/CVM/CVMFOIAElectronicReadingRoom/default.htm. Marketing exclusivity and patent information may be
accessed in FDA's publication, Approved Animal Drug Products Online
(Green Book) at: http://www.fda.gov/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/default.htm.
    In addition, the regulations are being amended to reflect the
previous approval of revised food safety warnings for florfenicol
injectable solutions, florfenicol and flunixin combination drug
injectable solution, ceftiofur hydrochloride intramammary infusions,
and salinomycin medicated feeds. These amendments are being done to
improve the accuracy of the regulations.
    The regulations are also being amended to reflect two changes of
sponsorship. Dechra, Ltd., Dechra House, Jamage Industrial Estate,
Talke Pits, Stoke-on-Trent, Staffordshire, ST7 1XW, United Kingdom, has
informed FDA that it has transferred ownership of, and all rights and
interest in, NADA 141-044 for OVUPLANT (deslorelin acetate implant) to
Virbac AH, Inc., 3200 Meacham Blvd., Fort Worth, TX 76137. Also, West-
Ward Pharmaceutical Corp., 465 Industrial Way West, Eatontown, NJ
07724, has informed FDA that it has transferred ownership of, and all
rights and interest in, ANADA 200-323 for Phenylbutazone Tablets to
Hikma Pharmaceuticals LLC, P.O. Box 182400, Bayader Wadi Seer, Amman,
Jordan 11118. Accordingly, the Agency is amending the regulations to
reflect these changes of sponsorship.

          Table 1--Original and Supplemental NADAs and ANADAs Approved During January and February 2014
----------------------------------------------------------------------------------------------------------------
                                     New animal drug                      21 CFR
    NADA/ANADA          Sponsor        product name        Action        section     FOIA summary   NEPA review
----------------------------------------------------------------------------------------------------------------
141-361..........  Elanco Animal     PULMOTIL AC      Original            520.2471  yes..........  EA/
                    Health, A         (tilmicosin      approval for                                FONSI \1\.
                    Division of Eli   phosphate)       the control of
                    Lilly & Co.,      Concentrate      swine
                    Lilly Corporate   Solution.        respiratory
                    Center,                            disease
                    Indianapolis,                      associated
                    IN 46285.                          with
                                                       Pasteurella
                                                       multocida and
                                                       Haemophilus
                                                       parasuis in
                                                       groups of
                                                       swine in
                                                       buildings
                                                       where a
                                                       respiratory
                                                       disease
                                                       outbreak is
                                                       diagnosed.
141-420..........  Ceva Sante        TILDREN          Original            522.2473  yes..........  CE 2 3.
                    Animale, 10       (tiludronate     approval for
                    Avenue de la      disodium).       the control of
                    Ballasti[egrave                    clinical signs
                    ]re, 33500                         associated
                    Libourne,                          with navicular
                    France.                            syndrome.
141-422..........  Oasmia            PACCAL VET-CA1   Conditional         516.1684  yes..........  CE 2 3.
                    Pharmaceutical    (paclitaxel      approval for
                    AB, Vallongatan   for injection).  the treatment
                    1, SE-752 28,                      of certain
                    Uppsala, 75228                     carcinomas in
                    Sweden.                            dogs that have
                                                       not received
                                                       previous
                                                       chemotherapy
                                                       or
                                                       radiotherapy.
130-185..........  Huvepharma AD,    AMPROL 25%       Supplemental      \4\ 558.55  yes..........  CE 2 5.
                    5th Floor, 3A     (amprolium)      approval for
                    Nikolay Haytov    plus             prevention of
                    Str., 1113        FLAVOMYCIN       coccidiosis
                    Sophia,           (bambermycins)   caused by
                    Bulgaria.         Type A           Eimeria
                                      medicated        tenella only
                                      articles.        or for
                                                       prevention of
                                                       coccidiosis
                                                       where immunity
                                                       to coccidiosis
                                                       is not
                                                       desired; and
                                                       for increased
                                                       rate of weight
                                                       gain and
                                                       improved feed
                                                       efficiency in
                                                       broiler
                                                       chickens.
141-246..........  Intervet, Inc.,   AQUAFLOR         Supplemental         558.261  yes..........  EA/FONSI \1\.
                    (d/b/a Merck      (florfenicol)    approval for
                    Animal Health),   Type A           an increase in
                    556 Morris        medicated        the maximum
                    Ave., Summit,     article.         daily dose for
                    NJ 07901.                          freshwater-
                                                       reared finfish
                                                       other than
                                                       freshwater-
                                                       reared
                                                       warmwater
                                                       finfish.
141-273..........  Boehringer        VETMEDIN         Supplemental        520.1780  no...........  CE 2 6.
                    Ingelheim,        (pimobendan)     approval for
                    Vetmedica,        Chewable         the addition
                    Inc., 2621        Tablets.         of a 10-
                    North Belt                         milligram
                    Hwy., St.                          chewable
                    Joseph, MO                         tablet.
                    64506-2002.
----------------------------------------------------------------------------------------------------------------
\1\ The Agency has carefully considered an environmental assessment (EA) of the potential environmental impact
  of this action and has made a finding of no significant impact (FONSI).
\2\ The Agency has determined that this action is categorically excluded (CE) from the requirement to submit an
  environmental assessment or an environmental impact statement because it is of a type that does not
  individually or cumulatively have a significant effect on the human environment.
\3\ CE granted under 21 CFR 25.33(d)(1).
\4\ The regulation in 21 CFR 558.55 has been amended in a separate rule (79 FR 10980, February 27, 2014).
\5\ CE granted under 21 CFR 25.33(a)(2).
\6\ CE granted under 21 CFR 25.33(a)(1).

    This rule does not meet the definition of ``rule'' in 5 U.S.C.
804(3)(A) because it is a rule of ``particular applicability.''
Therefore, it is not subject to the congressional review requirements
in 5 U.S.C. 801-808.

List of Subjects

21 CFR Part 510

    Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.

21 CFR Part 516

    Administrative practice and procedure, Animal drugs, Confidential
business information, Reporting and recordkeeping requirements.

21 CFR Parts 520, 522, and 526

    Animal drugs.

21 CFR Part 558

    Animal drugs, Animal feeds.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR parts 510,
516, 520, 522, 526, and 558 are amended as follows:

PART 510--NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 510 continues to read as
follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.

0
2. In Sec.  510.600, in the table in paragraph (c)(1), alphabetically
add entries for ``Hikma Pharmaceuticals LLC'' and ``Oasmia
Pharmaceutical AB'', and remove the entry for ``West-Ward
Pharmaceutical Corp.''; and in the table in paragraph (c)(2),
numerically add entries for ``052818'' and ``059115'', and remove the
entry for ``000143'' to read as follows:

Sec.  510.600  Names, addresses, and drug labeler codes of sponsors of
approved applications.

* * * * *
    (c) * * *
    (1) * * *

------------------------------------------------------------------------
             Firm name and address                  Drug labeler code
------------------------------------------------------------------------

                              * * * * * * *
Hikma Pharmaceuticals LLC, P.O. Box 182400,                       059115
 Bayader Wadi Seer, Amman, Jordan 11118........

                              * * * * * * *
Oasmia Pharmaceutical AB, Vallongatan 1, 75228                    052818
 Uppsala, Sweden...............................

                              * * * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
           Drug labeler code                  Firm name and address
------------------------------------------------------------------------

                              * * * * * * *
052818................................  Oasmia Pharmaceutical AB,
                                         Vallongatan 1, 75228 Uppsala,
                                         Sweden.

                              * * * * * * *
059115................................  Hikma Pharmaceuticals LLC, P.O.
                                         Box 182400, Bayader Wadi Seer,
                                         Amman, Jordan 11118.

                              * * * * * * *
------------------------------------------------------------------------

PART 516--NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES

0
3. The authority citation for 21 CFR part 516 continues to read as
follows:

    Authority: 21 U.S.C. 360ccc, 360ccc-2, 371.

0
4. Add Sec.  516.1684 to subpart E to read as follows:

Sec.  516.1684  Paclitaxel.

    (a) Specifications. Each vial of powder contains 60 milligrams (mg)
paclitaxel. Each milliliter of constituted solution contains 1 mg
paclitaxel.
    (b) Sponsor. See No. 052818 in 510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Administer 150 mg per
square meter of body surface area intravenously over 15 to 30 minutes,
once every 3 weeks, for up to 4 doses.
    (2) Indications for use. For the treatment of nonresectable stage
III, IV, or V mammary carcinoma in dogs that have not received previous
chemotherapy or radiotherapy. For the treatment of resectable and
nonresectable squamous cell carcinoma in dogs that have not received
previous chemotherapy or radiotherapy.
    (3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian. It is a violation of Federal law
to use this product other than as directed in the labeling.

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

0
5. The authority citation for 21 CFR part 520 continues to read as
follows:

    Authority: 21 U.S.C. 360b.

Sec.  520.1780  [Amended].

0
6. In paragraph (a) of Sec.  520.1780, remove ``or 5 milligrams'' and
in its place add ``5, or 10 milligrams''.
0
7. Add Sec.  520.2471 to read as follows:

Sec.  520.2471  Tilmicosin.

    (a) Specifications. Each milliliter of concentrate solution
contains 250 milligrams (mg) tilmicosin as tilmicosin phosphate.
    (b) Sponsor. See No. 000986 in Sec.  510.600(c) of this chapter.
    (c) Tolerances. See Sec.  556.735 of this chapter.
    (d) Conditions of use in swine--(1) Amount. Administer in drinking
water at a concentration of 200 mg per liter for 5 consecutive days.
    (2) Indication for use. For the control of swine respiratory
disease associated with Pasteurella multocida and Haemophilus parasuis
in groups of swine in buildings where a respiratory disease outbreak is
diagnosed.
    (3) Limitations. Swine intended for human consumption must not be
slaughtered within 7 days of the last treatment with this product.
Federal law restricts this drug to use by or on the order of a licensed
veterinarian.

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

0
8. The authority citation for 21 CFR part 522 continues to read as
follows:

    Authority: 21 U.S.C. 360b.

Sec.  522.533  [Amended]

0
9. In paragraph (b)(1) of Sec.  522.533, remove ``043246'' and in its
place add ``051311''.
0
10. In Sec.  522.955, revise paragraphs (d)(1)(i)(C) and (d)(1)(ii)(C)
to read as follows:

Sec.  522.955  Florfenicol.

* * * * *
    (d) * * *
    (1) * * *
    (i) * * *
    (C) Limitations. Do not slaughter within 44 days of treatment. This
drug product is not approved for use in female dairy cattle 20 months
of age or older, including dry dairy cows. Use in these cattle may
cause drug residues in milk and/or in calves born to these cows. A
withdrawal period has not been established in preruminating calves. Do
not use in calves to be processed for veal. Federal law restricts this
drug to use by or on the order of a licensed veterinarian.
    (ii) * * *
    (C) Limitations. Do not slaughter within 28 days of last
intramuscular treatment or within 38 days of subcutaneous treatment.
This drug product is not approved for use in female dairy cattle 20
months of age or older, including dry dairy cows. Use in these cattle
may cause drug residues in milk and/or in calves born to these cows. A
withdrawal period has not been established in preruminating calves. Do
not use in calves to be processed for veal. Federal law restricts this
drug to use by or on the order of a licensed veterinarian.
* * * * *

0
11. In Sec.  522.956, revise paragraph (d)(3) to read as follows:

Sec.  522.956  Florfenicol and flunixin.

* * * * *

    (d) * * *
    (3) Limitations. Animals intended for human consumption must not be
slaughtered within 38 days of treatment. This drug product is not
approved for use in female dairy cattle 20 months of age or older,
including dry dairy cows. Use in these cattle may cause drug residues
in milk and/or in calves born to these cows. A withdrawal period has
not been established in preruminating calves. Do not use in calves to
be processed for veal. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.

0
12. Add Sec.  522.2473 to read as follows:

Sec.  522.2473  Tiludronate.

    (a) Specifications. Each vial of powder contains 500 milligrams
(mg) tiludronate disodium. Each milliliter of constituted solution
contains 20 mg tiludronate disodium.
    (b) Sponsor. See No. 013744 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in horses--(1) Amount. Administer a single
dose of 1 mg per kilogram (0.45 mg/pound) of body weight by intravenous
infusion.
    (2) Indication for use. For the control of clinical signs
associated with navicular syndrome.
    (3) Limitations. Do not use in horses intended for human
consumption. Federal law restricts this drug to use by or on the order
of a licensed veterinarian.

PART 526--INTRAMAMMARY DOSAGE FORM NEW ANIMAL DRUGS

0
13. The authority citation for 21 CFR part 526 continues to read as
follows:

    Authority: 21 U.S.C. 360b.

0
14. In Sec.  526.313, remove paragraph (d); redesignate paragraph (e)
as paragraph (d); and revise newly redesignated paragraphs (d)(1)(iii)
and (d)(2)(iii) to read as follows:

Sec.  526.313  Ceftiofur.

* * * * *
    (d) * * *
    (1) * * *
    (iii) Limitations. Milk taken from cows during treatment (a maximum
of eight daily infusions) and for 72 hours after the last treatment
must not be used for human consumption. Following label use for up to 8
consecutive days, a 2-day preslaughter withdrawal period is required.
Federal law restricts this drug to use by or on the order of a licensed
veterinarian. Federal law prohibits extra-label use of this drug in
lactating dairy cattle for disease prevention purposes; at unapproved
doses; frequencies, durations, or routes of administration; and in
unapproved major food producing species/production classes.
    (2) * * *
    (iii) Limitations. Milk taken from cows completing a 30-day dry-off
period may be used for food with no milk discard due to ceftiofur
residues. Following intramammary infusion, a 16-day preslaughter
withdrawal period is required for treated cows. Following label use, no
preslaughter withdrawal period is required for neonatal calves from
treated cows regardless of colostrum consumption. Federal law restricts
this drug to use by or on the order of a licensed veterinarian. Federal
law prohibits extra-label use of this drug in dry dairy cattle for
disease prevention purposes; at unapproved doses; frequencies,
durations, or routes of administration; and in unapproved major food
producing species/production classes.

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

0
15. The authority citation for 21 CFR part 558 continues to read as
follows:

    Authority: 21 U.S.C. 360b, 371.

Sec.  558.261  [Amended]

0
16. In Sec.  558.261, in paragraph (e)(2)(ii), in the ``Limitations''
column, remove ``10 mg florfenicol'' and in its place add ``10 to 15 mg
florfenicol''; and in paragraph (e)(2)(iii), in the ``Limitations''
column, remove ``10 mg florfenicol per kg of fish for''.

Sec.  558.550  [Amended]

0
17. In Sec.  558.550, in paragraph (d)(1)(i)(c), remove ``layers'' and
in its place add ``laying hens producing eggs for human consumption'';
and add at the end of paragraph (d)(2)(i)(c), ``Do not feed to laying
hens producing eggs for human consumption.''

    Dated: March 27, 2014.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2014-07220 Filed 3-31-14; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 84, Number 101 (Friday, May 24, 2019)]
[Proposed Rules]
[Pages 24069-24074]
[FR Doc No: 2019-10568]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 300

[EPA-HQ-SFUND-2003-0010; FRL-9993-17-Region 7]

National Oil and Hazardous Substances Pollution Contingency Plan;
National Priorities List: Partial Deletion of the Omaha Lead Superfund
Site

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule; notice of intent.

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SUMMARY: The Environmental Protection Agency (EPA) Region 7 is issuing
a Notice of Intent to Delete 500 residential parcels of the Omaha Lead
Superfund site (Site or OLS) located in Omaha, Nebraska, from the
National Priorities List (NPL) and requests public comments on this
proposed action. The NPL, promulgated pursuant to section 105 of the
Comprehensive Environmental Response, Compensation, and Liability Act
(CERCLA) of 1980, as amended, is an appendix of the National Oil and
Hazardous Substances Pollution Contingency Plan (NCP). The EPA and the
state of Nebraska, through the Nebraska Department of Environmental
Quality, determined that all appropriate response actions under CERCLA
were

completed at the identified parcels. However, this deletion does not
preclude future actions under CERCLA.
    This partial deletion pertains to 500 residential parcels. The
remaining parcels will remain on the NPL and are not being considered
for deletion as part of this action.

DATES: Comments must be received on or before June 24, 2019.

ADDRESSES: You may send comments, identified by Docket ID No. EPA-HQ-
SFUND-2003-0010, by one of the following methods: https://www.regulations.gov follow the online instructions for submitting
comments; email<EMAIL_ADDRESS>or 1c7a6e7979717d7232687d717d6e7d5c796c7d327b736a;
or by mail to Environmental Protection Agency Region 7, 11201 Renner
Boulevard, Lenexa, KS 66219, Attention: Elizabeth Hagenmaier, SUPR
Division or Tamara Freeman, ECO Office. The Omaha public libraries also
have computer resources available to assist the public. The W. Dale
Clark Library, located at 215 S. 15th Street, Omaha, NE 68102 is
centrally located within the site boundary.
    Publicly available docket materials are available either
electronically in https://www.regulations.gov or in hard copy at: EPA
Region 7 Records Center at 11201 Renner Boulevard, Lenexa, Kansas
66219, between 8:00 a.m. and 4:00 p.m. Monday-Friday, excluding Federal
holidays.
    Instructions: All submissions received must include the Docket ID
No. for this rulemaking. Comments received will be posted without
change to https://www.regulations.gov/, including any personal
information provided. For detailed instructions on sending comments and
additional information on the rulemaking process, see the ``Written
Comments'' heading of the SUPPLEMENTARY INFORMATION section of this
document.

FOR FURTHER INFORMATION CONTACT: Elizabeth Hagenmaier, Remedial Project
Manager, U.S. Environmental Protection Agency Region 7, SUPR/LMSE,
11201 Renner Boulevard, Lenexa, KS 66219, telephone<PHONE_NUMBER>,
email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document ``we,'' ``us,'' or
``our'' refer to the EPA. This section provides additional information
by addressing the following:

I. Written Comments
II. Introduction
III. NPL Deletion Criteria
IV. Deletion Procedures
V. Background and Basis for Intended Partial Site Deletion

I. Written Comments

    Submit your comments, identified by Docket ID No. EPA-HQ-SFUND-
2003-0010, at https://www.regulations.gov. Alternatively, you may
submit comments by email or mail to the persons and addresses listed in
the ADDRESSES section of this document. Once submitted, comments cannot
be edited or removed 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 https://www.epa.gov/dockets/commenting-epa-dockets.

II. Introduction

    The EPA Region 7 is proposing to delete 500 residential parcels of
the Omaha Lead Superfund site (Site or OLS), from the National
Priorities List (NPL) and is requesting public comment on this proposed
action. The table of 500 Properties Proposed for the 2019 Partial
Deletion of Properties from the Omaha Lead Superfund site. (EPA-HQ-
SFUND-2003-0010-1966) identifies specific properties included for this
proposed partial deletion. The location of the 500 properties are shown
on Figure 1 ``Map for the 2019 Partial Deletion Omaha Lead Site'' (EPA-
HQ-SFUND-2003-0010-1964). The NPL constitutes appendix B of 40 CFR part
300, which is the National Oil and Hazardous Substances Pollution
Contingency Plan (NCP), which the EPA promulgated pursuant to section
105 of the Comprehensive Environmental Response, Compensation and
Liability Act (CERCLA) of 1980, as amended. The EPA maintains the NPL
as those sites that appear to present a significant risk to public
health, welfare, or the environment. Sites on the NPL may be the
subject of remedial actions financed by the Hazardous Substance
Superfund (Fund). This partial deletion of the Omaha Lead Superfund
site is proposed in accordance with 40 CFR 300.425(e) and is consistent
with the Notice of Policy Change: Partial Deletion of Sites Listed on
the National Priorities List, 60 FR 55466 (November 1, 1995). As
described in 300.425(e)(3) of the NCP, a portion of a site deleted from
the NPL remains eligible for Fund-financed remedial action if future
conditions warrant such actions.
    The EPA will accept comments on the proposal to partially delete
this site for thirty (30) days after publication of this document in
the Federal Register.
    Section III of this document explains the criteria for deleting
sites from the NPL. Section IV discusses procedures that the EPA is
using for this action. Section V discusses the 500 residential parcels
of the Omaha Lead Superfund site and demonstrates how they meet the
deletion criteria.

III. NPL Deletion Criteria

    The NCP establishes the criteria that the EPA uses to delete sites
from the NPL. In accordance with 40 CFR 300.425(e), sites may be
deleted from the NPL where no further response is appropriate. In
making such a determination pursuant to 40 CFR 300.425(e), the EPA will
consider, in consultation with the state, whether any of the following
criteria have been met:
    i. Responsible parties or other persons have implemented all
appropriate response actions required;
    ii. All appropriate Fund-financed response under CERCLA has been
implemented, and no further response action by responsible parties is
appropriate; or
    iii. The remedial investigation has shown that the release poses no
significant threat to public health or the environment and, therefore,
the taking of remedial measures is not appropriate.
    Pursuant to CERCLA section 121(c) and the NCP, the EPA conducts
five-year reviews to ensure the continued protectiveness of remedial
actions where hazardous substances, pollutants, or contaminants remain
at a site above levels that allow for unlimited use and unrestricted
exposure. The EPA conducts such five-year reviews even if a site is
deleted from the NPL. The EPA may initiate further action to ensure
continued protectiveness at a deleted site if new information becomes
available that indicates it is appropriate. Whenever there is a
significant release from a site deleted from the NPL, the deleted site
may be restored to the NPL without application of the hazard ranking
system.

IV. Deletion Procedures

    The following procedures apply to deletion of the 500 residential
parcels of the Site:
    (1) The EPA consulted with the state before developing this Notice
of Intent for Partial Deletion.
    (2) The EPA has provided the state thirty working days for review
of this notice prior to publication of it in this notice.
    (3) In accordance with the criteria discussed above, the EPA has
determined that no further response is appropriate.
    (4) The state of Nebraska, through the Nebraska Department of
Environmental Quality, has concurred with the deletion of the 500
residential parcels of the Omaha Lead Superfund site, from the NPL.
    (5) Concurrently, with the publication of this Notice of Intent for
Partial Deletion in the Federal Register, a notice is being published
in a major local newspaper, the Omaha World Herald. The newspaper
announces the 30-day public comment period concerning the Notice of
Intent for Partial Deletion of the Site from the NPL.
    (6) The EPA placed copies of documents supporting the proposed
partial deletion in the deletion docket and made these items available
for public inspection and copying at the Site information repositories
identified above.
    If comments are received within the 30-day comment period on this
document, the EPA will evaluate and respond appropriately to the
comments before making a final decision to delete the 500 residential
parcels. If necessary, the EPA will prepare a Responsiveness Summary to
address any significant public comments received. After the public
comment period, if the EPA determines it is still appropriate to delete
the 500 residential parcels of the Omaha Lead Superfund site, the
Regional Administrator will publish a final Notice of Partial Deletion
in the Federal Register. Public notices, public submissions and copies
of the Responsiveness Summary, if prepared, will be made available to
interested parties and included in the site information repositories
listed above.
    Deletion of a portion of a site from the NPL does not itself
create, alter, or revoke any individual's rights or obligations.
Deletion of a portion of a site from the NPL does not in any way alter
EPA's right to take enforcement actions, as appropriate. The NPL is
designed primarily for informational purposes and to assist EPA
management. Section 300.425(e)(3) of the NCP states that the deletion
of a site from the NPL does not preclude eligibility for future
response actions, should future conditions warrant such actions.

V. Background and Basis for Partial Site Deletion

    The following information provides EPA's rationale for deleting the
500 residential parcels of the Omaha Lead Superfund site from the NPL,
as previously identified.

Site Background and History

    The Omaha Lead Superfund site (Site or OLS [CERCLIS ID
#NESFN0703481]) includes surface soils present at residential
properties, child-care centers, and other residential-type properties
in the city of Omaha, Douglas County, Nebraska. The properties were
contaminated as a result of deposition of aerial emissions from
historic lead smelting and refining operations. The OLS encompasses the
eastern portion of the greater metropolitan area in Omaha, Nebraska.
The site extends from the Douglas-Sarpy County line on the south, north
to Read Street and from the Missouri River on the east to 56th Street
on the west. The Site is centered around downtown Omaha, Nebraska,
where two former lead-processing facilities operated. American Smelting
and Refining Company, Inc. (ASARCO) operated a lead refinery at 500
Douglas Street in Omaha, Nebraska, for over 120 years. Aaron Ferer &
Sons Company (Aaron Ferer), and later Gould Electronics, Inc., (Gould)
operated a lead battery recycling plant located at 555 Farnam Street.
Both ASARCO and Aaron Ferer/Gould facilities released lead-containing
particulates into the atmosphere from their smokestacks. The lead
particles were subsequently deposited on surrounding residential
properties.
    Beginning in 1984, the Douglas County Health Department (DCHD)
monitored ambient air quality around the ASARCO facility. This air
monitoring routinely measured ambient air lead concentrations in excess
of the ambient air standard. Between 1972 and 1998 the DCHD measured
the blood lead level in children within the county. The results of the
measurements indicated a high incidence of elevated blood lead level in
children. Blood lead screening of children living in zip codes located
east of 45th Street consistently exceeded 10 micrograms per deciliter
([mu]g/dl) more frequently than children living elsewhere in the
county.
    In 1998, the Omaha City Council requested assistance from the EPA
to address the high incidence of children found with elevated blood
lead levels by the DCHD. In 1999, the EPA initiated an investigation
into the lead contamination under the authority of Comprehensive
Environmental Response, Compensation, and Liability Act (CERCLA). On
February 26, 2002, the OLS was proposed for the NPL (67 FR 8836), and
on April 30, 2003, the OLS was listed on the NPL (68 FR 23077).
    The OLS includes those residential properties where the EPA
determined through soil sampling that soil lead levels represent an
unacceptable risk to human health. Residential properties where soil
sampling indicates that lead concentrations in the soil are below a
level that represent an unacceptable risk are not included in the Site.
Residential properties include those with high accessibility to
sensitive populations (children seven years of age and younger [0 to 84
months] and pregnant or nursing women). The properties include single
and multi-family dwellings, apartment complexes, child daycare
facilities, vacant lots in residential areas, schools, churches,
community centers, parks, greenways, and any other areas where children
may be exposed to site-related contaminated media. Commercial and
industrial properties are excluded from the definition of the Site.
    The residential properties proposed for deletion from the NPL site
were cleaned up under both CERCLA removal and remedial authority.
Regardless of the authority used for the remediation of yards, the
cleanup levels for soils for all the properties proposed for deletion
were the same.

Response Actions

    The initial EPA response was conducted under CERCLA removal
authority. Due to the size of the site and the very large number of
individual properties, it was necessary to prioritize sites for
cleanup. The prioritization was based on factors such as the elevated
blood level of children at each property and the lead concentration in
the soil at each property. The result was a series of action levels
that reflected the priority of categories of sites. Consequently, the
action level for the site soils changed over time from 2500 mg/kg to
400 mg/kg, as the highest priority sites were cleaned up first. The
cleanup level was established using the Integrated Exposure Uptake
Biokinetic (IEUBK) model to determine the concentration to which the
lead is cleaned up at each property within the site. The cleanup level
for the OLS is 400 mg/kg of lead in the soil. The cleanup level of 400
mg/

kg was selected to allow for unlimited use and unrestricted exposure.
The cleanup level has not changed, and all properties, regardless of
the action level, were cleaned up to 400 mg/kg.

Removal Activities

    Beginning in March 1999, the EPA began collecting soil samples from
properties that provided licensed child daycare services. The initial
removal action dated August 2, 1999, consisted of excavation and
replacement of contaminated soil where the lead concentration exceeded
the action levels identified in the Action Memorandum. Response actions
were implemented at properties that met either of the following
criteria:
     A child seven years of age or younger (0 to 84 months)
residing at the property was identified with an elevated blood level
(EBL) exceeding 15 [mu]g/dl (this EBL was reduced to 10 [mu]g/dl in
August 2001) and a soil sample collected from a non-foundation quadrant
exhibited lead concentrations greater than 400 mg/kg, or
     A property was used as a child-care facility and a soil
sample collected from a non-foundation quadrant exhibited a lead
concentration greater than 400 mg/kg.
    On August 22, 2002, the EPA initiated a second removal action. This
second removal action included all other residential type properties
where the maximum non-foundation soil lead concentration exceeded an
action level of 2,500 mg/kg. The 2002 Action Memorandum explicitly
identifies the possibility of lead-based paint as a potential
contributor to lead contamination of soils within thirty inches of the
foundation of a painted structure. Due to the potential contribution of
deteriorating lead-based paint near the foundations of structures, a
lead concentration greater than 400 mg/kg in the soil in the drip zone
(areas near structure foundations) was not, in itself, sufficient to
trigger soil removal. However, if a soil sample from any mid-yard
quadrant exceeded the action level, soil was removed from all areas of
the property exceeding the 400 mg/kg cleanup level, including the drip
zone. In November 2003, the EPA amended the second removal action to
reduce the action level to 1,200 mg/kg concentration of lead in soil.
In March 2004, the EPA amended the second removal action to combine the
two removal actions. In March 2005, the EPA amended the removal action
to reduce the action level from 1200 mg/kg to 800 mg/kg.
    At properties determined to be eligible for response under either
of the Action Memoranda, soil with lead concentrations greater than the
cleanup level was excavated and replaced with clean soil and the
excavated areas were revegetated.
    EPA signed an Interim Recored of Decision on December 15, 2004.
Beginning with the construction season of 2005, the scope of the
removal action was expanded to address the requirements of the 2004
Interim ROD to include: (1) Stabilization of deteriorating exterior
lead-based paint at properties where the continued effectiveness of the
soil remediation was threatened; (2) response to interior dust at
properties where interior dust lead levels exceeded applicable
criteria; (3) public health education; and (4) participation in a
comprehensive remedy with other agencies and organizations that
addresses all identified lead hazards in the Omaha community.

Remedial Investigation/Feasibility Study (RI/FS)--Human Health Risk
Assessment

    As part of the RI/FS, the EPA developed a Human Health Risk
Assessment (HHRA) for the Site using site-specific information
collected during the OLS Remedial Investigation. Lead was identified as
the primary contaminant of concern. The HHRA also identified arsenic as
a potential contaminant of concern, but arsenic was eliminated based on
its relatively low overall risk to residents and lack of connection to
the release from the industrial sources being addressed by this
Superfund action.
    The risk assessment for lead focused on young children under the
age of seven (0 to 84 months) who are site residents. Young children
are most susceptible to lead exposure because they have higher contact
rates with soil or dust, absorb lead more readily than adults, and are
more sensitive to the adverse effects of lead than are older children
and adults. The effect of greatest concern in children is impairment of
the nervous system, including learning deficits, reduced intelligence,
and adverse effects on behavior. The IEUBK model for lead in children
was used to evaluate the risks posed to young children (0 to 84 months)
resulting from the lead contamination at the site. Because lead does
not have a nationally-approved reference dose (RfD), cancer slope
factor, or other accepted toxicological factor which can be used to
assess risk, standard risk assessment methods cannot be used to
evaluate the health risks associated with lead contamination. The
modeling results determined that there was an unacceptable risk to
young children from exposure to soils above 400 mg/kg.
    In October 2008, the EPA released a draft Final Remedial
Investigation. Based on the 2008 data set, EPA established the boundary
of the Final Focus Area for the Site. The Final Focus Area is generally
bounded by Read Street to the north, 56th Street to the west, Harrison
Street (Sarpy County line) to the south, and the Missouri River to the
east, and encompasses 17,280 acres (27.0 square miles). By the time the
Final Remedial Investigation was completed, the EPA had collected soil
samples from 37,076 residential properties, including 34,565 properties
within the Final Focus Area's boundary. In total, 34.2 percent of
properties sampled through completion of the 2008 RI had at least one
mid-yard sample with a soil lead level exceeding 400 mg/kg. In addition
to soil sampling, the EPA collected dust samples from the interior of
159 residences to support the OLS Human Health Risk Assessment.

Record of Decision

    The EPA completed the Final Record of Decision (ROD) for the OLS in
May 2009. The Remedial Action Objective is to reduce the risk of
exposure of young children to lead such that an individual child, or
group of similarly exposed children, have no greater than a five
percent chance of having a blood-lead concentration exceeding 10 [mu]g/
dl. The selected remedy includes the following components:

 Excavation and Replacement of Soils Exceeding 400 mg/kg Lead
 Stabilization of Deteriorating Exterior Lead-Based Paint
 Response to Lead-Contaminated Interior Dust
 Health Education
 Operation of a Local Lead Hazard Registry as a type of
Institutional Control

    Each of these components is described below.

Remedial Actions

Excavation and Replacement of Soils Exceeding 400 mg/kg Lead

    Excavation of soils was accomplished using lightweight excavation
equipment and hand tools in the portions of the yard where the
concentration of lead in the surface soil exceeded 400 mg/kg.
Excavation continued in all quadrants, play zones, and drip zone areas
exceeding 400 mg/kg lead until the residual lead concentration measured
at the exposed surface of the excavation was less than 400 mg/kg in the
upper foot, or less than 1,200 mg/kg at depths

greater than one foot. Typically, soil excavation depths were between
six and ten inches in depth. Soils in garden areas were excavated until
reaching a residual concentration of less than 400 mg/kg in the upper
two feet measured from the original surface, or less than 1,200 mg/kg
at depths greater than two feet.
    After confirmation sampling verified that cleanup goals were
achieved, the excavated areas were backfilled with clean soil to
original grade and sod was placed over the remediated areas.
    EPA's remediation contractors stockpiled contaminated soil in
staging areas, collected samples, and subsequently transported soil to
an off-site subtitle D solid waste disposal landfill for use as daily
cover and/or disposal.

Stabilization of Deteriorating Exterior Lead-Based Paint

    The EPA used the lead-based paint assessment protocol, presented in
the Final Lead-Based Paint Recontamination Study Report prepared for
the OLS, to determine eligibility for exterior lead-based paint
stabilization at those properties where soil lead concentrations
exceeded 400 mg/kg. At those properties where the exterior lead-based
paint assessment identified a threat from deteriorating paint to the
continued protectiveness of the soil remedy, the owner of the property
was offered stabilization of painted surfaces on structures located on
the property. Exterior lead-based paint stabilization is not mandatory
and was provided to those qualifying property owners who chose to have
their exterior paint stabilized. Removal of loose and flaking lead-
based paint was performed using lead-safe practices as described in
EPA's Renovate, Repair and Painting Rule. The practices include wet
scraping, and collection of paint chips using plastic sheeting. Scraped
areas were primed and all previously painted surfaces had two coats of
paint applied.

Response to Lead-Contaminated Interior Dust

    As part of the final remedy, residents at eligible properties are
provided the opportunity to have interior dust sampled. The interior
dust response is not mandatory, and the resident may choose to decline.
If the property owner agrees, the EPA collects samples of dust from
interior surfaces. The analytical data is provided to the resident/
tenant in a letter and the letter informs them whether any HUD criteria
are exceeded. The Douglas County Health Department conducts follow up
activities at any residence where the concentration of lead in the
interior dust levels exceed the HUD criteria. For those residences that
qualify and where the resident agrees, the residents are provided with
a high-efficiency household vacuum cleaner, training on the maintenance
and the importance of proper usage of the vacuum, and education on
mitigation of household lead hazards. The Douglas County Health
Department also provides training and education regarding the need to
mitigate interior dust.
    Exterior lead-based paint stabilization and interior dust response
were conducted retroactively at properties where soil cleanups were
performed under CERCLA removal authority, as well as to properties
addressed under CERCLA remedial authority.

Health Education

    There are a number of identified lead hazards within the OLS, not
all of which are connected to the contaminant source of the OLS. To
better address all potential lead sources within the OLS, a health
education program was developed and continues to be implemented to
increase public awareness and mitigate exposure. An active educational
program continues in cooperation with agencies and organizations that
include Agency for Toxic Substances and Disease Registry (ATSDR), the
Nebraska Department of Health and Human Services (NDHHS), DCHD, local
non-governmental organizations, and other interested parties. The
following, although not an exhaustive list, indicate the types of
educational activities provided at the Site:
     Support for in-home assessments for children identified
with elevated blood lead levels.
     Development and implementation of lead poisoning
prevention curriculum in schools.
     Support for efforts to increase community-wide blood lead
monitoring.
     Physicians' education for diagnosis, treatment, and
surveillance of lead exposure.
     Operation of Public Information Centers to distribute
information and respond to questions about the EPA response activities
and lead hazards in the community.
     Use of mass media (television, radio, internet, print
media, etc.) to distribute health education messages.
     Development and distribution of informational tools such
as fact sheets, brochures, refrigerator magnets, etc., to inform the
public about lead hazards and measures that can be taken to avoid or
eliminate exposure.

Institutional Controls

    The Omaha Lead Registry, (available at www.omahalead.org) is a GIS
based database that provides the public with on-line access to the
status of the EPA investigation and response actions. The EPA notifies
residents and property owners about the information that is available
through the lead hazard registry as part of the transmittal sent at the
completion of soil remediation at each individual property.

Community Involvement

    The EPA worked extensively with the Omaha community through a
variety of communication vehicles including, but not limited to: Local
speaking engagements, participation in citizens' groups and city
council meetings, local public access television, public service
announcements on local cable television, coverage on radio, television,
in local and national newspapers, mass mailings of informational
materials, public outreach by telephone, conducting public meetings,
and through the EPA website.
    The EPA has been performing outreach to Omaha citizens, elected
officials, school officials, health officials, the media, nonprofit
groups, and others since becoming involved in the project in an effort
to convey information about the hazards of lead poisoning, particularly
the ways that lead affects the health of children. The EPA participated
in numerous formal and informal meetings to explain EPA's role and
commitment in Omaha, convey information about the Superfund process,
and provide general information about the site and lead contamination.
The EPA responds to inquiries on a daily basis regarding the site and
individual property owner's sampling results.
    In January 2004, a Community Advisory Group (CAG) was formed for
the OLS site. A CAG is a committee, task force, or board made up of
residents affected by a Superfund site. The CAG provided a public forum
where representatives with diverse community interests could present
and discuss their needs and concerns related to the site and the
cleanup process. The CAG was discontinued after the last meeting was
held in October 2011. A new group, Child Lead Poisoning Prevention
Group, formed. The first meeting of the Child Lead Poisoning Group was
held at City Hall in May 2012. The Group is no longer active.

Five-Year Review

    The EPA completed the first Five-Year Review for the site in
September

2014. Five-Year Reviews for the site are statutory. The triggering
action for the Five-Year Review is the completion of the Final Record
of Decision for Operable Unit 2, completed in May 2009.
    The protectiveness of the remedy was deferred in the Five-Year
Review because the remedy had not been completed at all of the
properties within the site boundary. However, cleanup activities at the
500 residential parcels included in this partial deletion action are
complete and protective of human health. There are no issues or
recommendations in the Five-Year Review related to these 500
residential parcels proposed for deletion.
    The next Five-Year Review will be completed in September 2019.

Summary of EPA Work Completed

Soil Testing and Remediation

    The EPA Region 7 completed the EPA lead portion of the remedial
action on December 29, 2015. The city of Omaha and the Douglas County
Health Department will be performing the remaining field work. As of
December 29, 2015, the EPA collected soil samples from 42,047
properties. There are 489 remaining properties to be sampled. The EPA
has obtained access to collect samples from 163 of the 489 properties.
    Based on the soil sampling results, 14,019 properties were eligible
for soil remediation. The EPA remediated lead contaminated soil at
13,090 properties (93 percent) of the properties that were eligible for
remediation. There are approximately 929 remaining properties that are
eligible for soil remediation. The EPA obtained access to remediate
fifty-one of the remaining properties.

Lead-Based Paint Testing and Stabilization

    The EPA tested 12,057 properties for the presence of lead-based
paint (LBP). Six thousand seven hundred and eighty-two (6,782)
properties qualify for LBP stabilization. The EPA completed LBP
stabilization on 6,249, (92 percent) of the eligible properties.

Dust Sampling

    The EPA collected dust samples from 3,933 properties consisting of
4,477 residences for lead contaminated dust. These numbers reflect the
fact that some of the properties are multi-residence properties.

Continuing Remedial Action

    The EPA completed Cooperative Agreements with the city of Omaha and
the Douglas County Health Department that provide funds to allow these
local government agencies to continue efforts to obtain access to the
remaining properties and conduct sampling and remediation activities at
those properties where they obtain access.

Determination That the Criteria for Deletion Has Been Achieved

    In accordance with 40 CFR 300.425(e), Region 7 of the EPA finds
that the 500 residential parcels of the Omaha Lead Superfund site (the
subject of this deletion action) meet the substantive criteria for
deletion from the NPL. The EPA has consulted with and has the
concurrence of the state of Nebraska. All responsible parties or other
persons have implemented all appropriate response actions required. All
appropriate Fund-financed response under CERCLA was implemented, and no
further response action by responsible parties is appropriate.
    The implemented remedy at the 500 residential parcels has achieved
the degree of cleanup specified in the ROD for all pathways of
exposure. All selected remedial action objectives and associated
cleanup levels are consistent with agency policy and guidance. No
further Superfund response is needed to protect human health and the
environment.

List of Subjects in 40 CFR Part 300

    Environmental protection, Air pollution control, Chemicals,
Hazardous waste, Hazardous substances, Intergovernmental relations,
Penalties, Reporting and recordkeeping requirements, Superfund, Water
pollution control, Water supply.

    Authority:  33 U.S.C. 1321(d); 42 U.S.C. 9601-9657; E.O. 13626,
77 FR 56749, 3 CFR, 2013 Comp., p. 306; E.O. 12777, 56 FR 54757, 3
CFR, 1991 Comp., p. 351; E.O. 12580, 52 FR 2923, 3 CFR, 1987 Comp.,
p. 193.

    Dated: May 8, 2019.
Edward H. Chu,
Acting Regional Administrator, Region 7.
[FR Doc. 2019-10568 Filed 5-23-19; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 80, Number 66 (Tuesday, April 7, 2015)]
[Notices]
[Pages 18693-18695]
[FR Doc No: 2015-07905]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2014-0300]

Qualification of Drivers; Exemption Applications; Vision

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

ACTION: Notice of final disposition.

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SUMMARY: FMCSA announces its decision to exempt 51 individuals from the
vision requirement in the Federal Motor Carrier Safety Regulations
(FMCSRs). They are unable to meet the vision requirement in one eye for
various reasons. The exemptions will enable these individuals to
operate commercial motor vehicles (CMVs) in interstate commerce without
meeting the prescribed vision requirement in one eye. The Agency has
concluded that granting these exemptions will provide a level of safety
that is equivalent to or greater than the level of safety maintained
without the exemptions for these CMV drivers.

DATES: The exemptions were granted February 18, 2015. The exemptions
expire on February 18, 2017.

FOR FURTHER INFORMATION CONTACT: Charles A. Horan, III, Director,
Carrier, Driver and Vehicle Safety Standards,<PHONE_NUMBER>,
<EMAIL_ADDRESS>FMCSA, Department of Transportation, 1200 New
Jersey Avenue SE., Room W64-224, Washington, DC 20590-0001. Office
hours are from 8:30 a.m. to 5 p.m., Monday through Friday, except
Federal holidays. If you have questions on viewing or submitting
material to the docket, contact Docket Services, telephone (202) 366-
9826.

SUPPLEMENTARY INFORMATION:

I. Electronic Access

    You may see all the comments online through the Federal Document
Management System (FDMS) at http://www.regulations.gov.
    Docket: For access to the docket to read background documents or
comments, go to http://www.regulations.gov and/or Room W12-140 on the
ground level of the West Building, 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m.

and 5 p.m., Monday through Friday, except Federal holidays.
    Privacy Act: In accordance with 5 U.S.C. 553(c), DOT solicits
comments from the public to better inform its rulemaking process. DOT
posts these comments, without edit, including any personal information
the commenter provides, to www.regulations.gov, as described in the
system of records notice (DOT/ALL-14 FDMS), which can be reviewed at
www.dot.gov/privacy.

II. Background

    On January 16, 2015, FMCSA published a notice of receipt of
exemption applications from certain individuals, and requested comments
from the public (80 FR 2473). That notice listed 51 applicants' case
histories. The 51 individuals applied for exemptions from the vision
requirement in 49 CFR 391.41(b)(10), for drivers who operate CMVs in
interstate commerce.
    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption
for a 2-year period if it finds ``such exemption would likely achieve a
level of safety that is equivalent to or greater than the level that
would be achieved absent such exemption.'' The statute also allows the
Agency to renew exemptions at the end of the 2-year period.
Accordingly, FMCSA has evaluated the 51 applications on their merits
and made a determination to grant exemptions to each of them.

III. Vision and Driving Experience of the Applicants

    The vision requirement in the FMCSRs provides:
    A person is physically qualified to drive a commercial motor
vehicle if that person has distant visual acuity of at least 20/40
(Snellen) in each eye without corrective lenses or visual acuity
separately corrected to 20/40 (Snellen) or better with corrective
lenses, distant binocular acuity of a least 20/40 (Snellen) in both
eyes with or without corrective lenses, field of vision of at least
70[deg] in the horizontal meridian in each eye, and the ability to
recognize the colors of traffic signals and devices showing red, green,
and amber (49 CFR 391.41(b)(10)).
    FMCSA recognizes that some drivers do not meet the vision
requirement but have adapted their driving to accommodate their vision
limitation and demonstrated their ability to drive safely. The 51
exemption applicants listed in this notice are in this category. They
are unable to meet the vision requirement in one eye for various
reasons, including refractive amblyopia, amblyopia, corneal scar,
macular scar, advanced cataract, esotropia, aphakia, atypical macular
degeneration, prosthetic eye, glaucoma, enucleation, strabismic
amblyopia, central retinal vein occlusion, complete loss of vision,
optic nerve hypoplasia, retinal detachment, macular hole, decreased
vision, loss of central field, myopic macular degeneration, exotropia,
ischemic optic neuropathy, high myopia, retinal vascular occlusion,
full thickness macular hole, ophthalmic artery calcium embolus, optic
nerve damage, and dense cataract. In most cases, their eye conditions
were not recently developed. Thirty of the applicants were either born
with their vision impairments or have had them since childhood.
    The 21 individuals that sustained their vision conditions as adults
have had it for a range of four to 56 years.
    Although each applicant has one eye which does not meet the vision
requirement in 49 CFR 391.41(b)(10), each has at least 20/40 corrected
vision in the other eye, and in a doctor's opinion, has sufficient
vision to perform all the tasks necessary to operate a CMV. Doctors'
opinions are supported by the applicants' possession of valid
commercial driver's licenses (CDLs) or non-CDLs to operate CMVs. Before
issuing CDLs, States subject drivers to knowledge and skills tests
designed to evaluate their qualifications to operate a CMV.
    All of these applicants satisfied the testing requirements for
their State of residence. By meeting State licensing requirements, the
applicants demonstrated their ability to operate a CMV, with their
limited vision, to the satisfaction of the State.
    While possessing a valid CDL or non-CDL, these 51 drivers have been
authorized to drive a CMV in intrastate commerce, even though their
vision disqualified them from driving in interstate commerce. They have
driven CMVs with their limited vision in careers ranging from two to 50
years. In the past three years, five of the drivers were involved in
crashes and six were convicted of moving violations in a CMV.
    The qualifications, experience, and medical condition of each
applicant were stated and discussed in detail in the January 16, 2015
notice (80 FR 2473).

IV. Basis for Exemption Determination

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption
from the vision requirement in 49 CFR 391.41(b)(10) if the exemption is
likely to achieve an equivalent or greater level of safety than would
be achieved without the exemption. Without the exemption, applicants
will continue to be restricted to intrastate driving. With the
exemption, applicants can drive in interstate commerce. Thus, our
analysis focuses on whether an equal or greater level of safety is
likely to be achieved by permitting each of these drivers to drive in
interstate commerce as opposed to restricting him or her to driving in
intrastate commerce.
    To evaluate the effect of these exemptions on safety, FMCSA
considered the medical reports about the applicants' vision as well as
their driving records and experience with the vision deficiency.
    To qualify for an exemption from the vision requirement, FMCSA
requires a person to present verifiable evidence that he/she has driven
a commercial vehicle safely with the vision deficiency for the past 3
years. Recent driving performance is especially important in evaluating
future safety, according to several research studies designed to
correlate past and future driving performance. Results of these studies
support the principle that the best predictor of future performance by
a driver is his/her past record of crashes and traffic violations.
Copies of the studies may be found at Docket Number FMCSA-1998-3637.
    FMCSA believes it can properly apply the principle to monocular
drivers, because data from the Federal Highway Administration's (FHWA)
former waiver study program clearly demonstrate the driving performance
of experienced monocular drivers in the program is better than that of
all CMV drivers collectively (See 61 FR 13338, 13345, March 26, 1996).
The fact that experienced monocular drivers demonstrated safe driving
records in the waiver program supports a conclusion that other
monocular drivers, meeting the same qualifying conditions as those
required by the waiver program, are also likely to have adapted to
their vision deficiency and will continue to operate safely.
    The first major research correlating past and future performance
was done in England by Greenwood and Yule in 1920. Subsequent studies,
building on that model, concluded that crash rates for the same
individual exposed to certain risks for two different time periods vary
only slightly (See Bates and Neyman, University of California
Publications in Statistics, April 1952). Other studies demonstrated
theories of predicting crash proneness from crash history coupled with
other factors. These factors--such as age, sex, geographic location,
mileage driven and conviction history--are used every day by insurance
companies and motor

vehicle bureaus to predict the probability of an individual
experiencing future crashes (See Weber, Donald C., ``Accident Rate
Potential: An Application of Multiple Regression Analysis of a Poisson
Process,'' Journal of American Statistical Association, June 1971). A
1964 California Driver Record Study prepared by the California
Department of Motor Vehicles concluded that the best overall crash
predictor for both concurrent and nonconcurrent events is the number of
single convictions. This study used 3 consecutive years of data,
comparing the experiences of drivers in the first 2 years with their
experiences in the final year.
    Applying principles from these studies to the past 3-year record of
the 51 applicants, five of the drivers were involved in crashes, and
six were convicted of moving violations in a CMV. All the applicants
achieved a record of safety while driving with their vision impairment,
demonstrating the likelihood that they have adapted their driving
skills to accommodate their condition. As the applicants' ample driving
histories with their vision deficiencies are good predictors of future
performance, FMCSA concludes their ability to drive safely can be
projected into the future.
    We believe that the applicants' intrastate driving experience and
history provide an adequate basis for predicting their ability to drive
safely in interstate commerce. Intrastate driving, like interstate
operations, involves substantial driving on highways on the interstate
system and on other roads built to interstate standards. Moreover,
driving in congested urban areas exposes the driver to more pedestrian
and vehicular traffic than exists on interstate highways. Faster
reaction to traffic and traffic signals is generally required because
distances between them are more compact. These conditions tax visual
capacity and driver response just as intensely as interstate driving
conditions. The veteran drivers in this proceeding have operated CMVs
safely under those conditions for at least 3 years, most for much
longer. Their experience and driving records lead us to believe that
each applicant is capable of operating in interstate commerce as safely
as he/she has been performing in intrastate commerce. Consequently,
FMCSA finds that exempting these applicants from the vision requirement
in 49 CFR 391.41(b)(10) is likely to achieve a level of safety equal to
that existing without the exemption. For this reason, the Agency is
granting the exemptions for the 2-year period allowed by 49 U.S.C.
31136(e) and 31315 to the 51 applicants listed in the notice of January
16, 2015 (80 FR 2473).
    We recognize that the vision of an applicant may change and affect
his/her ability to operate a CMV as safely as in the past. As a
condition of the exemption, therefore, FMCSA will impose requirements
on the 51 individuals consistent with the grandfathering provisions
applied to drivers who participated in the Agency's vision waiver
program.
    Those requirements are found at 49 CFR 391.64(b) and include the
following: (1) That each individual be physically examined every year
(a) by an ophthalmologist or optometrist who attests that the vision in
the better eye continues to meet the requirement in 49 CFR
391.41(b)(10) and (b) by a medical examiner who attests that the
individual is otherwise physically qualified under 49 CFR 391.41; (2)
that each individual provide a copy of the ophthalmologist's or
optometrist's report to the medical examiner at the time of the annual
medical examination; and (3) that each individual provide a copy of the
annual medical certification to the employer for retention in the
driver's qualification file, or keep a copy in his/her driver's
qualification file if he/she is self-employed. The driver must have a
copy of the certification when driving, for presentation to a duly
authorized Federal, State, or local enforcement official.

V. Discussion of Comments

    FMCSA received three comments in this proceeding. The comments are
discussed below.
    Letitia Robinson, David Wang, and Eliezer Lebron are all in favor
of granting Vantha Yeam an exemption from the Federal vision standard.

IV. Conclusion

    Based upon its evaluation of the 51 exemption applications, FMCSA
exempts the following drivers from the vision requirement in 49 CFR
391.41(b)(10), subject to the requirements cited above (49 CFR
391.64(b)):

David C. Berger (PA)
Phillip J. Boes (MN)
Ronald Bostick (SC)
Raymond L. Bradshaw (TX)
Ricky D. Cain (NM)
Jeffrey L. Coachman (NY)
Dewayne L. Cunningham (IL)
Robert W. Cushing (NH)
Joel K. Cutchin (VA)
Keith Dionisi (MI)
Wolfgang K. Faulkingham (ME)
John D. Fortino Jr. (NY)
Ricky J. Franklin (OR)
James P. Gapinski (MN)
Harley D. Gray (IL)
David N. Groff (PA)
Robert J. Hansen (MN)
Adrian Haro (CO)
Kevin L. Himes (CO)
Ervin A. James, Jr. (NC)
Jeffrey G. Kalla (NV)
Jackie Lee (FL)
Joseph J. Lewis (WA)
Keith A. Looney, Jr. (AR)
Van C. Mac (IL)
Michael P. McCabe (MI)
Chris D. McCance (IL)
Michael W. McCann (VA)
O'Dell M. McKnight (SC)
Anthony R. Melton (SC)
Preston S. Nehring (FL)
Dennis J. Oie (MN)
Orlan R. Ott (IA)
Rodney W. Phelps (KY)
Leonardo Polonski (MA)
Don C. Powell, Jr. (NY)
Luis A. Ramos (FL)
Kevin C. Rich (NC)
Ronald D. Schwab (MN)
Gary W. Shelton, Jr. (FL)
Gerardo Silva (IL)
James A. Spittal (OR)
Paul J. Stewart (CO)
David A. Stinelli (PA)
Ingrid V. Taylor (MI)
Roger A. Thein, Jr. (WI)
Russell E. Ward (NH)
Bobby M. Warren (KY)
Steven E. Williams (GA)
Rex A. Wright (IL)
Vantha Yeam (PA)

    In accordance with 49 U.S.C. 31136(e) and 31315, each exemption
will be valid for 2 years unless revoked earlier by FMCSA. The
exemption will be revoked if: (1) The person fails to comply with the
terms and conditions of the exemption; (2) the exemption has resulted
in a lower level of safety than was maintained before it was granted;
or (3) continuation of the exemption would not be consistent with the
goals and objectives of 49 U.S.C. 31136 and 31315.
    If the exemption is still effective at the end of the 2-year
period, the person may apply to FMCSA for a renewal under procedures in
effect at that time.

    Issued on: April 1, 2015.
 Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2015-07905 Filed 4-6-15; 8:45 am]
BILLING CODE CODE 4910-EX-P


Fred Butterfield/DC/USEPA/US

02/23/2007 05:54 PM

To

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Subject

Fw: Tentative-Final Agenda for Monday, March 5, 2007 CASAC Ozone Review Panel TeleConf re: Chapter 6 (Primary Ozone NAAQS) and Chapter 8 (Secondary Ozone NAAQS) in EPA's Final Ozone Staff Paper; Panel Member (Zidek) Review Comments on EPA's Final Ozone Staff Paper

*** IMPORTANT ***

To:  CASAC Ozone Review Panel Members

The tentative-final agenda for the Monday, March 5, 2007 teleconference meeting of the CASAC Ozone Review Panel to review the Agency's Final Ozone Staff Paper is attached below as an Adobe PDF file.  Please provide any comments on this directly to Rogene and me.

Those designated as lead discussants for the Ozone Primary (James, Frank & Fred) and Secondary (Ellis & Rich) NAAQS will be called-upon first during the discussion and deliberation period; however, all other Panel members are invited to read and of course to comment-upon the appropriate chapter(s) of the Final O3 Staff Paper during this conference, and to prepare any written individual review comments as you deem appropriate.

Finally, the individual review comments of Panel member Jim Zidek on this document are forwarded as an MS Word file in his message to me below.

As always, please feel free to contact me if you have any questions or comments.

Best,

Fred

***************************************************

Fred Butterfield

Designated Federal Officer

Clean Air Scientific Advisory Committee (CASAC)

EPA Science Advisory Board (SAB) Staff Office

U.S. Environmental Protection Agency

Phone:<PHONE_NUMBER>

Cell:<PHONE_NUMBER>

Fax:<PHONE_NUMBER>/0645

E-mail<EMAIL_ADDRESS> SAB Home page: http://www.epa.gov/sab