[Federal Register: May 17, 2006 (Volume 71, Number 95)]
[Notices]
[Page 28728-28730]
[DOCID:fr17my06-95]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-53788; File No. SR-ISE-2006-19]

Self-Regulatory Organizations; International Securities Exchange,
Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule
Change and Amendment No. 1 Thereto Relating to PrecISE Fees

May 11, 2006.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on April 3, 2006, the International Securities Exchange, Inc.
(``ISE'' or ``Exchange'') filed with the Securities and Exchange
Commission (``Commission'') the proposed rule change as described in
Items I, II, and III below, which Items have been prepared by the ISE.
On May 10, 2006, ISE filed Amendment No. 1 to the proposed rule
change.\3\ The ISE has designated this proposal as one establishing or
changing a due, fee, or other charge imposed by the ISE under Section
19(b)(3)(A)(ii) of the Act,\4\ and Rule 19b-4(f)(2) thereunder,\5\
which renders the proposal effective upon filing with the Commission.
The Commission is publishing this notice to solicit comments on the
proposed rule change, as amended, from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ Amendment No. 1 revised the purpose section of the filing to
clarify that: (i) PrecISE is merely a new front-end system interface
to the Exchange's existing trading system, which does not require
changes to ISE's surveillance or communications rules and does not
impact the Exchange's market structure; (ii) ISE members will
continue to pay CLICK fees only to the extent that they continue to
have or use those terminals; (iii) the new away market routing
functionality is optional for members; and (iv) the $20 monthly fee
charged to IRDs for the away market routing functionality will be
charged per PrecISE trade terminal (which conformed the purpose
section to the text of the Schedule of Fees).
    \4\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \5\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The ISE is proposing to amend its Schedule of Fees to adopt fees
for the use of its new, proprietary PrecISE Trade[supreg] order entry
terminals. The text of the proposed rule change, as amended, is
available on the ISE's Web site (http://www.iseoptions.com/legal/proposed
 --rule--changes.asp), at the principal office of the ISE, and

at the Commission's Public Reference Room.

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

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

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

1. Purpose
    The purpose of this proposed rule change is to establish fees for
the use of ISE's new, proprietary PrecISE Trade order entry terminals.
PrecISE Trade is

the brand name of ISE's front-end order-entry terminal that,
ultimately, will replace ISE's current front-end CLICK[supreg] order-
entry terminal licensed to it by OMX Technology that Electronic Access
Members (``EAMs'') use to send orders to the ISE and view market
data.\6\ The Exchange currently charges EAMs $500 per CLICK terminal,
for the first terminal through the fifth terminal. For the sixth
terminal and all subsequent terminals, the Exchange charges EAMs $250
per CLICK terminal. However, all CLICK fees for the second and all
subsequent terminals are waived through June 30, 2006.\7\ The Exchange
proposes monthly PrecISE Trade terminal fees of $250 per terminal, with
a $500 minimum and $1500 maximum, per EAM, per month. These new PrecISE
Trade fees will enable the ISE to recoup the costs of developing,
maintaining, and supporting the PrecISE Trade terminals. To allow
members to become familiar with the PrecISE Trade terminals, the
Exchange proposes to waive the associated fees for a member's first two
months of PrecISE Trade terminal usage. Members that currently have
CLICK terminals will continue to pay fees for those terminals during
this period to the extent they continue to have or use those terminals.
The Exchange believes this will allow for a smooth transition to the
new PrecISE Trade terminals.
---------------------------------------------------------------------------

    \6\ After the introduction of PrecISE Trade terminals, the ISE
will begin phasing out CLICK terminals. Upon the completion of such
phase-out, ISE will submit a proposed rule change to the Commission
pursuant to which it will remove CLICK fees from its fee schedule.
The Exchange represents that a PrecISE Trade terminal is merely a
new front-end system interface to the existing trading system
operated by the Exchange known as CLICK (i.e., it is a new means of
connecting to the Exchange's existing trading system), and does not
require any changes to the Exchange's surveillance or communications
rules. Further, there is no change to, or impact on, the Exchange's
market structure as a result of the new PrecISE Trade terminals.
    \7\ See Securities Exchange Act Release No. 51775 (June 2,
2005), 70 FR 33569 (June 8, 2005).
---------------------------------------------------------------------------

    Additionally, PrecISE Trade terminals will have away market routing
functionality, enabling members to send option orders to other option
exchanges through the PrecISE Trade terminal, if a member so
desires.\8\ To accomplish ``away-market routing,'' an EAM must
establish a relationship with an Intermediate Routing Destination
(``IRD''). An IRD is an ISE member that has connectivity to, and is a
member of, other options exchanges. If an EAM sends an order to an IRD
using the away market routing functionality of a PrecISE Trade
terminal, the IRD will route that order to the designated away market
on behalf of the entering EAM. The Exchange proposes to charge IRDs a
flat monthly fee of $20 per PrecISE Trade terminal that is authorized
to send orders to that IRD if a member requests the away-market routing
functionality. This fee will enable the ISE to recoup the costs of
developing, maintaining, and supporting the away-market routing
functionality.
---------------------------------------------------------------------------

    \8\ The away market routing functionality is an added feature of
the new PrecISE Trade terminal. This functionality is offered as a
convenience to ISE members and is not an exclusive means to send
orders intermarket.
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes that the basis under the Act for this
proposed rule change is the requirement under Section 6(b)(4) of the
Act \9\ that an exchange have an equitable allocation of reasonable
dues, fees and other charges among its members and other persons using
its facilities. In particular, these fees would permit the Exchange to
recover the costs of developing, maintaining, and supporting PrecISE
Trade terminals and away-market routing.
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange believes that the proposed rule change, as amended,
does not impose any burden on competition that is not necessary or
appropriate in furtherance of the purposes of the Act.

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

    The Exchange has not solicited, and does not intend to solicit,
comments on this proposed rule change. The Exchange has not received
any unsolicited written comments from members or other interested
parties.

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

    Because the foregoing rule change, as amended, establishes or
changes a due, fee, or other charge imposed by the Exchange, it has
become effective pursuant to Section 19(b)(3) of the Act \10\ and Rule
19b-4(f)(2) \11\ thereunder. At any time within 60 days of the filing
of such amended proposed rule change, the Commission may summarily
abrogate such rule change if it appears to the Commission that such
action is necessary or appropriate in the public interest, for the
protection of investors, or otherwise in furtherance of the purposes of
the Act.\12\
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78s(b)(3)(A).
    \11\ 17 CFR 19b-4(f)(2).
    \12\ The effective date of the original proposed rule is April
3, 2006. The effective date of Amendment No. 1 is May 10, 2006. For
purposes of calculating the 60-day period within which the
Commission may summarily abrogate the proposed rule change under
Section 19(b)(3)(C) of the Act, the Commission considers the period
to commence on May 10, 2006, the date on which the ISE submitted
Amendment No. 1. See 15 U.S.C. 78s(b)(3)(C).
---------------------------------------------------------------------------

IV. Solicitation of Comments

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

Electronic Comments

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

File No. SR-ISE-2006-19 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-ISE-2006-19. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml
). Copies of the submission, all subsequent amendments, all

written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for inspection and
copying in the Commission's Public Reference Room. Copies of such
filing also will be available for inspection and copying at the
principal office of the ISE. All comments received will be posted
without change; the Commission does not edit personal identifying
information from submissions. You should submit only information that
you wish to make available publicly. All submissions should refer to
File

Number SR-ISE-2006-19 and should be submitted on or before June 7,
2006.
---------------------------------------------------------------------------

    \13\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\13\
Jill M. Peterson,
Assistant Secretary.
[FR Doc. E6-7465 Filed 5-16-06; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 86, Number 92 (Friday, May 14, 2021)]
[Notices]
[Pages 26512-26513]
[FR Doc No: 2021-10228]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2413-126]

Georgia Power Company; Notice of Application Accepted for Filing
and Soliciting Comments, Motions To Intervene, and Protests

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection:
    a. Application Type: Non-Project Use of Project Lands and Waters--
Sand Mine.
    b. Project No: 2413-126.
    c. Date Filed: August 30, 2019, and supplemented on April 22, 2021,
and April 26, 2021.
    d. Applicant: Georgia Power Company (licensee).
    e. Name of Project: Wallace Pumped Storage Hydroelectric Project.
    f. Location: The proposed non-project sand mine is located in the
northern part of Lake Oconee, the project reservoir, in Greene County,
Georgia.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791a-825r.
    h. Applicant Contact: Herbie Johnston, Hydro General Manager, 600
North 18th Street, Bin 16N-8180, Birmingham, AL 35203,<PHONE_NUMBER>.
    i. FERC Contact: Michael Calloway at<PHONE_NUMBER> or
<EMAIL_ADDRESS>    j. Deadline for filing comments, motions to intervene, and
protests: May 10, 2021.
    The Commission strongly encourages electronic filing. Please file
comments, motions to intervene, and protests using the Commission's
eFiling system at http://www.ferc.gov/docs-filing/efiling.asp.
Commenters can submit brief comments up to 6,000 characters, without
prior registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact
information at the end of your comments. For assistance, please contact
FERC Online Support at<EMAIL_ADDRESS>(866) 208-3676 (toll
free), or<PHONE_NUMBER> (TTY). In lieu of electronic filing, you may
submit a paper copy. Submissions sent via the U.S. Postal Service must
be addressed to: Kimberly D. Bose, Secretary, Federal Energy Regulatory
Commission, 888 First Street NE, Room 1A, Washington, DC 20426.
Submissions sent via any other carrier must be addressed to: Kimberly
D. Bose, Secretary, Federal Energy Regulatory Commission, 12225 Wilkins
Avenue, Rockville, Maryland 20852. The first page of any filing should
include the docket number P-2413-126. Comments emailed to Commission
staff are not considered part of the Commission record.
    The Commission's Rules of Practice and Procedure require all
intervenors filing documents with the Commission to serve a copy of
that document on each person whose name appears 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.
    k. Description of Request: On August 30, 2019, the licensee filed a
request with the Commission for approval to permit a non-project use of
project lands and waters to allow River Sand Incorporated to dredge an
approximately 2-mile stretch of the upper project reservoir in Greene
County, Georgia for the purposes of commercial sand mining. The
Commission noticed the original application on October 21, 2019. On
April 22 and 26, 2021, the licensee filed an amendment to their
original application to provide avoidance and mitigation measures
regarding cultural resources that may exist within the area. The
licensee also filed a letter from the Georgia State Historic
Preservation Office providing a no adverse effect call provided the
prescribed measures were met. The sorting area will be located on 6
acres of privately-owned land within the project boundary that the
licensee has flowage rights over. The mine

operator expects the year-round operation of the sand mine will extract
5,000 to 25,000 tons of sediment per year. The operation will not be
conducted on U.S. Forest Service Land.
    l. Locations of the Application: This filing may be viewed on the
Commission's website at http://www.ferc.gov using the ``eLibrary''
link. Enter the docket number excluding the last three digits in the
docket number field to access the document. You may also register
online at http://www.ferc.gov/docs-filing/esubscription.asp to be
notified via email of new filings and issuances related to this or
other pending projects. For assistance, call 1-866-208-3676 or email
<EMAIL_ADDRESS>for TTY, call<PHONE_NUMBER>. Agencies may
obtain copies of the application directly from the applicant.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Comments, Protests, or Motions to Intervene: Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214, respectively. In determining the appropriate action to take, the
Commission will consider all protests or other comments filed, but only
those who file a motion to intervene in accordance with the
Commission's Rules may become a party to the proceeding. Any comments,
protests, or motions to intervene must be received on or before the
specified comment date for the particular application.
    o. Filing and Service of Documents: Any filing must (1) bear in all
capital letters the title ``COMMENTS'', ``PROTEST'', or ``MOTION TO
INTERVENE'' as applicable; (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 commenting, protesting or intervening; and (4) otherwise comply
with the requirements of 18 CFR 385.2001 through 385.2005. All
comments, motions to intervene, or protests must set forth their
evidentiary basis. Any filing made by an intervenor must be accompanied
by proof of service on all persons listed in the service list prepared
by the Commission in this proceeding, in accordance with 18 CFR
385.2010.

    Dated: May 10, 2021.
Kimberly D. Bose,
Secretary.
[FR Doc. 2021-10228 Filed 5-13-21; 8:45 am]
BILLING CODE 6717-01-P


Page 1 of 15 United States Prevention, Pesticides EPA 738 R 06 011 Environmental Protection and Toxic Substances June 2006 Agency ( 7508P)

Report of the Food Quality Protection Act ( FQPA) Tolerance Reassessment Progress and Risk Management Decision ( TRED) for Oxytetracycline Page 2 of 15 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES June 30, 2006 CERTIFIED MAIL Dear Registrant:

This is the Environmental Protection Agency's ( hereafter referred to as EPA or the Agency) " Report of the Food Quality Protection Act ( FQPA) Tolerance Reassessment Progress and Risk Management Decision for Oxytetracycline," which was approved on June 30, 2006. This document is also known as a Tolerance Reassessment Decision, or TRED. A Notice of Availability of this tolerance reassessment decision will be published in the Federal Register. Because of the extensive collaboration with registrants and other federal agencies prior to and during the 60 day public comment period and because relatively few comments were received during the 60 day public comment period, the TRED document and final risk assessments are being issued without an additional public comment period. The TRED, supporting risk assessments, and response to comments for oxytetracycline are available to the public in EPA's Pesticide Docket EPA HQ OPP 2005 0492 at: http:// www. regulations. gov. EPA issued a reregistration eligibility decision for oxytetracycline in March 1993.

The oxytetracycline TRED was developed through EPA's public participation process, published in the Federal Register on May 14, 2004, which provides opportunities for public involvement in EPA's pesticide tolerance reassessment and reregistration programs. Developed in partnership with USDA and with input from EPA's advisory committees and others, the public participation process encourages public involvement starting early and continuing throughout the pesticide risk assessment and risk mitigation decision making process. The public participation process encompasses full, modified, and streamlined versions that enable EPA to tailor the level of review to the level of refinement of the risk assessments, as well as to the amount of use, risk, public concern, and complexity associated with each pesticide. Through the public participation process, EPA is making a commitment to both involve the public and meet statutory deadlines.

Background The Federal Food, Drug and Cosmetic Act ( FFDCA), as amended by FQPA, requires EPA to reassess all the tolerances in effect on or before the enactment of FQPA on August 3, 1996. In reassessing these tolerances, EPA must consider, among other things, aggregate risks from non occupational sources of pesticide exposure, whether there is increased susceptibility to infants and children, and the cumulative effects of pesticides with a common mechanism of toxicity. Once a safety finding has been made, Page 3 of 15 the tolerances are considered reassessed. Existing tolerances associated with oxytetracycline have been reassessed in accordance with FFDCA, as amended by FQPA.

In addition to the assessment of direct risks posed by dietary exposure, EPA also assessed the potential for pesticidal uses of oxytetracycline to contribute to antibiotic resistance. In late 2004, EPA held an internal " problem formulation" meeting for the streptomycin and oxytetracycline TREDs. During this meeting EPA noted that these chemicals' potential contributions to antibiotic resistance were not fully understood. Recognizing that pesticidal uses of streptomycin and/ or oxytetracycline may possibly contribute to antibiotic resistance of bacterial pathogens with potential adverse public health consequences, and that other entities may have more expertise in evaluating antibiotic resistance, EPA requested input from three other agencies.

In May 2005, EPA hosted two conference calls with U. S. Centers for Disease Control and Prevention ( CDC), U. S. Food and Drug Administration ( FDA) Center for Drug Evaluation and Research and Center ( CDER) and Center for Veterinary Medicine ( CVM), and U. S. Department of Agriculture ( USDA) to discuss antibiotic resistance. EPA then met internally to discuss the options for addressing potential concerns resulting from the continued use of antibiotics as pesticides and evaluate the appropriateness and feasibility of conducting a qualitative antibiotic resistance risk assessment based on FDA CVM's Guidance for Industry # 152 ( Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to Their Microbiological Effects on Bacteria of Human Health Concern). Based on the discussion and evaluation, EPA included in its risk assessments a qualitative assessment of antibiotic resistance modeled on FDA CVM's Guidance for Industry # 152 ( see the Streptomycin HED Chapter dated February 7, 2006 and the Oxytetracycline HED Chapter dated June 19, 2006).

In February 2006, EPA opened a 60 day public comment period for the preliminary risk assessments. During the public comment period, EPA received 8 comments relating to the use of oxytetracycline. Comments were received from Rutgers University, U. S. Apple Association, Northwest Horticultural Council, Keep Antibiotics Working, and 4 plant pathologists from around the U. S. The majority of the respondents were supportive of the use of oxytetracycline on fruit trees and indicated that it is an integral and critical component in disease control programs. Another respondent urged EPA to implement steps to minimize the potential contribution to antibiotic resistance from the use of oxytetracycline. All of these comments were considered and incorporated into EPA's risk management decisions and this document represents EPA's response to public comments.

EPA has completed its review of the dietary risks and is issuing its risk management decision for oxytetracycline. Page 4 of 15 Regulatory Decision EPA has evaluated the dietary and residential risks from the supported registered uses and has determined that there is a reasonable certainty that no harm to any population subgroup will result from exposure to oxytetracycline.

Acute dietary exposure was not estimated because no acute toxicity was identified in any of the relevant studies in the oxytetracycline database. The chronic dietary exposure estimate ( food + water) for the U. S. population is 32% of the chronic Population Adjusted Dose ( cPAD). The chronic dietary exposure estimate for the most highly exposed population subgroup, all infants ( children < 1 year of age), is 95% of the cPAD using conservative, screening level exposure assumptions. Dietary risk estimates for food and water are below EPA's level of concern.

The 2 tolerances currently established at 40 CFR 180.337 for residues of oxytetracycline in/ on raw agricultural commodities are now considered reassessed under section 408( q) of the FFDCA ( see Table 6).

Use Profile Oxytetracycline ( Case Number 0655) includes the active ingredients oxytetracycline ( PC Code 006304), hydroxytetracycline monohydrochloride ( PC Code 006308), and oxytetracycline calcium ( PC Code 006321). In this document, unless specified otherwise, " oxytetracycline" refers to both oxytetracycline hydrochloride and oxytetracycline calcium; there is no active product for PC Code 006304.

Table 1. Chemicals in Case Number 0655 PC Code Chemical Name 006304 oxytetracycline, a. k. a. 2 Naphthacenecarboxamide, 4( dimethylamino) 1,4,4a, 5,5a, 6,11,12a octahydro 3,5,6,10,12,12a hexahydroxy 6 methyl 1,11 dioxo, ( 4S( 4. alpha., 4a. alpha., 5. alpha., 5a. alpha., 6. beta., 12a. alpha.))

006308 oxytetracycline hydrochloride, a. k. a. hydroxytetracycline monohydrochloride 006321 oxytetracycline calcium, a. k. a. calcium oxytetracycline Oxytetracycline is an antibiotic pesticide used to control bacteria, fungi, and mycoplasma like organisms. The majority of oxytetracycline is used on pears. Other crops treated include peaches, nectarines, and apples. Oxytetracycline use on apples has been approved under emergency exemption ( Section 18) for several years due to the lack of efficacious alternatives. A full registration ( Section 3) is currently under review by EPA as a separate action. Oxytetracycline is also registered for use on forest trees and ornamental trees, shrubs, and vines. The estimated total domestic pesticidal use ( annual average) is approximately 15,000 lbs. active ingredient ( ai) per year. Approximately 8,000 lbs. ai are used annually on pears and 2,000 lbs. ai are used annually on peaches, and 2,000 lbs. ai are used annually on apples. All other uses are less than 500 lbs. ai annually. There are no residential pesticidal uses of oxytetracycline. Oxytetracycline is Page 5 of 15 also registered with FDA to treat infectious diseases in animals and humans and also as a food additive to increase animal weight gain. Although firm estimates are not available, literature studies report that the estimated percentage of antibiotics applied to plants compared to all other antibiotic use is < 0.5% ( McManus, 2002).

Oxytetracycline is typically applied to foliage by ground or aerial spray, and is also used as a tree injection. Oxytetracycline may be used every 4 to 6 days and up to 10 times per season depending on crop type and application method.

Alternative Control Measures:

Oxytetracycline is one of few tools available to combat fire blight, a potentially devastating disease in fruit trees. Non antibiotic alternatives include copper, prohexadione, biological controls, fosetyl Al, pruning, and planting resistant cultivars. Antibiotic alternatives include streptomycin.

Copper: Copper provides reasonable protection against fire blight disease if applied as preventive sprays in combination with use of disease forecasting models. Copper is effective in reducing the percent of infected blossom cluster infections on apples. The efficacy of copper is dependent upon many factors such as disease pressure, application timing, and its persistence on plant surfaces. The persistence is dependent upon weather conditions. In current disease management, copper plays an important part in a fire blight management program, but can only be safely applied in the early spring or autumn when the trees are dormant.

Prohexadione: Prohexadione ® has no pesticidal properties. It reduces linear growth of branches resulting in reduced tree canopy volume. Prohexadione treatment of trees reduces their susceptibility to fire blight. It may be an additional tool in the management of fire blight.

Biological Control Agent: BlightBan ® ( a. i. Pseudomonas fluorescens strain A506) is used to complement streptomycin ( see below); it is not a replacement for streptomycin and other antibiotics. Commercial use of Blightban is limited due to poor efficacy and high cost.

Fosetyl Al: Aliette ® , a fungicide, is also registered for fire blight control, but data supporting this use are not convincing of its efficacy against fire blight. No practical control activity was observed in experimental trials in Michigan. Fosetyl Al is not used commercially for the control of fire blight because it does not appear to be efficacious.

Pruning: The branches and tree limbs that show fire blight disease symptoms in the late season are removed from the trees and destroyed to prevent the spread of disease and source of inoculums for the next year. This practice is effective in reducing the primary inoculums and tree death. Page 6 of 15 Resistant Cultivars: Red Delicious variety of apple has some resistance against the fire blight disease but it is not grown widely because most consumers prefer other varieties. All other commercially grown varieties are susceptible.

Streptomycin: Streptomycin is a registered antibiotic for the control of fire blight, but in some areas the pathogen has developed resistance to the antibiotic.

Human Health Effects ( For a complete discussion, see the Oxytetracycline HED Chapter dated June 19, 2006.)

No acute dietary endpoint was selected because no acute toxicity was identified in any of the relevant studies in the oxytetracycline database.

The chronic dietary endpoint for all populations is based on microbiological effects observed in a resistance study in dogs at the lowest observed adverse effect level ( LOAEL) of 0.25 mg/ kg/ day. The no observed adverse effect level ( NOAEL) in this study was 0.05 mg/ kg/ day. An uncertainty factor of 100 ( 10X for intra species variation and 10X for inter species extrapolation) was applied to the NOAEL resulting in a chronic reference dose ( cRfD) of 0.0005 mg/ kg/ day. A summary of the toxicological dose and endpoints for oxytetracycline that were used in the dietary risk assessment is shown below in Table 2.

Table 2. Toxicological Dose and Endpoints used in the Dietary Risk Assessment Exposure Scenario Dose Used in Risk Assessment, UF FQPA SF and Level of Concern for Risk Assessment Study and Toxicological Effects Acute Dietary N/ A  toxicity attributable to acute exposure was not identified Chronic Dietary ( All populations) NOAEL= 0.05 mg/ kg/ day UF = 100 cRfD1 = 0.0005 mg/ kg/ day FQPA SF = 1X cPAD2 = 0.0005 mg/ kg/ day Microbial study in dogs LOAEL = 0.25 mg/ kg/ day based on microbial effects Cancer Not Classifiable as to Human Carcinogenicity3 UF = uncertainty factor, FQPA SF = FQPA safety factor, NOAEL = no observed adverse effect level, LOAEL = lowest observed adverse effect level, chronic RfD = chronic reference dose, N/ A = not applicable 1 cRfD = NOAEL UF 2 cPAD = cRfD FQPA SF 3 No evidence of carcinogenicity was found in a literature search of toxicity in animals. In the mouse, there was no evidence of carcinogenicity at the highest dose tested in the carcinogenicity study. In the rat carcinogenicity study, only benign tumors were observed. Therefore, there is low concern for carcinogenicity and no quantitative assessment is required.

The drug oxytetracycline is administered to humans orally or intravenously to treat infectious diseases caused by a wide variety of microorganisms. The dose for adults Page 7 of 15 is approximately 15 to 30 mg/ kg. The daily dose for children is approximately 25 to 50 mg/ kg.

There is no evidence of increased sensitivity in pups versus adults based on rat and mouse developmental studies and the rat multi generation reproduction study. In prenatal developmental studies in both rats and mice treated with oxytetracycline, there was no toxicity identified in the pups at any dose tested. In the two generation study, there was no toxicity identified in pups at the highest dose tested ( 18 mg/ kg/ day). The degree of concern is low for pre and/ or post natal toxicity resulting from exposure to oxytetracycline and the special FQPA SF can be reduced ( 1X) since there are no residual uncertainties for pre and/ or post natal toxicity.

The dose used in human medicine ranges from 1000 mg to 2000 mg per day ( orally or intravenously). Based on the dose used in human medicine, a theoretical NOAEL of 16.7 mg/ kg/ day could be calculated by dividing the dose ( 1000 mg/ day) by the approximate weight of an adult ( 60 kg). This theoretical NOAEL could then be used to derive a cRfD to estimate dietary risk. Instead of deriving the cRfD from a theoretical NOAEL based on human drug use, EPA used the NOAEL of 0.05 mg/ kg/ day in dogs to derive the cRfD and cPAD of 0.0005 mg/ kg/ day. Since the cPAD derived from the chronic RfD is several orders of magnitude lower than the dose that would be derived from using the theoretical human NOAEL, the cRfD is protective for all effects and is not likely to underestimate exposure. There are no further residual uncertainties and the FQPA safety factor can be removed ( 1X).

Oxytetracycline has a low acute toxicity ( Category IV) for oral toxicity in mice ( LD50 > 7200 mg/ kg). Based on the availability of extensive information from oxytetracycline use as a human drug, the data requirements for the acute dermal, inhalation, primary eye irritation, and skin sensitization studies in animals have been waived.

No evidence of carcinogenicity was found in a literature search of toxicity in animals. However, in accordance with EPA's Guidelines for Carcinogen Risk Assessment, oxytetracycline is classified as " Not Classifiable as to Human Carcinogenicity" due to the lack of guideline carcinogenicity studies.

EPA's use of information derived from the pharmaceutical uses of streptomycin is in accordance with EPA's Final Rule promulgated on January 26, 2006 related to Protection for Subjects in Human Research, which is codified in 40 CFR Part 26.

Drinking Water Exposure and Risk Assessment ( For a complete discussion, see the Oxytetracycline Tier 1 Drinking Water Assessment dated May 22, 2006.)

Drinking water exposure to pesticides can occur through ground and surface water contamination. EPA considers both acute ( one day) and chronic ( lifetime) drinking Page 8 of 15 water risks and uses either modeling or actual monitoring data, if available, to estimate those risks. Since available water monitoring data are considered inadequate to determine surface and ground water drinking water exposure estimates, estimated drinking water concentrations ( EDWCs) are calculated from surface and ground water models FIRST V 1.0 and SCI GROW V 2.3, respectively. The EDWCs are based on application methods, rates, and use sites that would likely yield the highest drinking water concentrations.

Table 3 presents Tier 1 ( screening level) chronic EDWCs for surface water and groundwater assuming nine separate applications of oxytetracycline calcium to peaches and/ or nectarines at a rate of 0.64 lb ai/ A with a 7 day retreatment interval.

Table 3. Highest surface/ ground water EDWCs for oxytetracycline Exposure Duration Surface Water Chronic EDWC Ground Water EDWC Chronic 4.6 ppb 0.033 ppb Concentrations in surface water ( 4.6 ppb) and ground water ( 0.033 ppb) represent upper bound estimates of the concentrations that might be found in surface water and groundwater due to the use of oxytetracycline calcium on peaches/ nectarines. These drinking water exposure estimates are incorporated into an aggregate chronic dietary assessment using both food and water concentrations.

Acute and Chronic Dietary ( Food + Water) Exposure and Risk Assessment ( For a complete discussion, see the Oxytetracycline Chronic Dietary Exposure Assessment dated February 6, 2006.)

Acute dietary risk assessments were not conducted because no toxicity attributable to acute exposure could be identified based on the data currently available for oxytetracycline.

Chronic dietary risk assessments were conducted using the Dietary Exposure Evaluation Model ( DEEM FCID   ) , Version 2.03, which used food consumption data from the United States Department of Agriculture's ( USDA's) Continuing Surveys of Food Intakes by Individuals ( CSFII) from 1994 1996 and 1998. Based on the registered uses of oxytetracycline on pears, peaches, and nectarines, and the proposed Section 3 use on apples, no quantifiable residues in meat, milk, poultry, and eggs ( MMPE) are expected. However, FDA has established tolerances in MMPE commodities for the sum of the residues of the tetracyclines including chlortetracycline, oxytetracycline, and tetracycline as listed in 21 CFR 556.500. Accordingly, EPA's dietary analysis includes estimates of possible oxytetracycline residues in livestock commodities making use of monitoring data from the Food Safety and Inspection Service ( FSIS) collected in 2002, 2003, and 2004. These data were taken from the FSIS National Residue Program Data publications ( Red Books). Page 9 of 15 The relevant FSIS data sampled kidney tissue from a variety of livestock ( cattle, swine, poultry, goats, etc), analyzing for oxytetracycline residues. As tetracycline residues partition preferentially into fat and kidney, measured oxytetracycline residues in kidney were used as worst case level for all other livestock tissues. In 2004 and 2002, no oxytetracycline residues were detected in 4270 and 6942 samples, respectively. In 2003, three kidney samples had finite oxytetracycline residue levels out of 5260 samples. To compute an estimated residue level for use in DEEM FCID, an average residue level was calculated using ½ level of detection for nondetects ( 0.005 ppm) together with the three detected levels of 2.5, 5.0, and 5.0 ppm. This provided a conservative estimated residue level of oxytetracycline in livestock commodities of 0.0058 ppm and this value was used for all livestock commodities in the DEEM FCID analyses.

The chronic dietary assessments assumed tolerance level residues on treated crops and incorporated percent crop treated information. Modeled EDWCs for surface water sources were also included. The highest exposure and risk estimates were for all infants (< 1 year old) using surface water as the drinking water source. The exposure for all infants was 0.000473 mg/ kg/ day, which utilized 95% of the cPAD. The chronic dietary exposure estimates for food and water are below EPA's level of concern ( see Table 4).

Table 4. Summary of Dietary ( Food + Water) Exposure and Risk Surface Water Population Subgroup cPAD ( mg/ kg/ day) EDWC ( ppb) Total ( Food + Water) Exposure ( mg/ kg/ day) % cPAD General U. S. Population 0.0005 4.6 0.000160 32 All Infants (< 1 year old) 0.0005 4.6 0.000473 95 EDWC = estimated drinking water concentration, cPAD = chronic population adjusted dose Residential Risk At this time, no product containing oxytetracycline is registered for residential use and there is no anticipated exposure in or around homes or recreational areas.

Aggregate Risk ( For a complete discussion, see the Oxytetracycline HED Chapter dated June 19, 2006.)

In accordance with the FQPA, EPA must consider and aggregate pesticide exposures and risks from all potential sources including food, drinking water, and residential exposures. Since no product containing oxytetracycline is registered for residential use, only food and drinking water were considered in the aggregate assessment. In an aggregate assessment, exposures are combined and compared to quantitative estimates of hazard ( e. g., a NOAEL). When aggregating exposures and risks from various sources, EPA considers both the route and duration of exposure. In general, exposures from various sources are aggregated only when the toxic effect determined by the endpoint selected for each route is the same. In the case of oxytetracycline, an Page 10 of 15 aggregate assessment was performed using high end exposures and conservative endpoints. Further refinements would have been incorporated into the risk assessment if exposures of concern had been identified. Since the screening level aggregate assessment did not show risks of concern, EPA concludes with reasonable certainty that combined residues of oxytetracycline from food and drinking water exposures will not result in an aggregate risk of concern to any population subgroup.

An acute aggregate assessment was not conducted because acute toxicological effects attributable to oxytetracycline could not be identified. Short term and intermediate term aggregate risk assessments were not conducted because there are no existing or proposed residential uses for oxytetracycline.

A chronic aggregate assessment for food and water exposure was conducted because a chronic toxicological endpoint was identified for oxytetracycline. EPA's aggregate assessment for food includes estimates of possible oxytetracycline residues in livestock commodities making use of monitoring data from the Food Safety and Inspection Service ( FSIS) National Residue Program Data collected in 2002, 2003, and 2004. The highest aggregate exposure and risk estimates were for all infants (< 1 year old) using surface water as the drinking water source, which utilized 95% of the cPAD. The chronic dietary exposure estimates for food and water are below EPA's level of concern. Results of the dietary ( food + drinking water) exposure and risk assessment are presented in Table 4.

Pharmaceutical Aggregate Risk Section 408 of the FFDCA requires EPA to consider potential sources of exposure to a pesticide and related substances in addition to the dietary sources expected to result from a pesticide use subject to the tolerance. In order to determine whether to maintain a pesticide tolerance, EPA must " determine that there is a reasonable certainty of no harm." Under FFDCA section 505, the Food and Drug Administration reviews human drugs for safety and effectiveness and may approve a drug notwithstanding the possibility that some users may experience adverse side effects. EPA does not believe that, for purposes of the section 408 dietary risk assessment, it is compelled to treat a pharmaceutical user the same as a non user, or to assume that combined exposures to pesticide and pharmaceutical residues that lead to a physiological effect in the user constitutes " harm" under the meaning of section 408 of the FFDCA.

Rather, EPA believes the appropriate way to consider the pharmaceutical use of oxytetracycline in its risk assessment is to examine the impact that the additional nonoccupational pesticide exposures would have to a pharmaceutical user exposed to a related ( or, in some cases, the same) compound. Where the additional pesticide exposure has no more than a minimal impact on the pharmaceutical user, EPA could make a reasonable certainty of no harm finding for the pesticide tolerances of that compound under section 408 of the FFDCA. If the potential impact on the pharmaceutical user as a result of co exposure from pesticide use is more than minimal, then EPA would not be able to conclude that dietary residues were safe, and would need to discuss with FDA Page 11 of 15 appropriate measures to reduce exposure from one or both sources. EPA provided its findings with respect to oxytetracycline to FDA in a letter dated May 24, 2006, which is available in the public docket ( EPA HQ OPP 2005 0492).

The pesticidal exposure estimates described in the May 24, 2006 letter reflect the dietary dose from pesticidal uses of oxytetracycline that a user treated with a pharmaceutical oxytetracycline product would receive in a reasonable worst case scenario. EPA's pesticide exposure assessment has taken into consideration the appropriate population, exposure route, and exposure duration for comparison with exposure to the pharmaceutical use of oxytetracycline.

EPA estimates that the pharmaceutical oxytetracycline exposure a user is expected to receive from a typical therapeutic dose ( 25 mg/ kg/ day for children) is 50,000 to 200,000 times greater than the estimated dietary exposure from the pesticidal sources of oxytetracycline ( 0.000121 mg/ kg/ day to 0.000473 mg/ kg/ day). Therefore, because the pesticide exposure has no more than a minimal impact on the total dose to a pharmaceutical user, EPA believes that there is a reasonable certainty that the potential dietary pesticide exposure will result in no harm to a user being treated therapeutically with oxytetracycline. FDA is aware of EPA's conclusions regarding pesticide exposure in users receiving treatment with a pharmaceutical oxytetracycline drug product and FDA's June 7, 2006 response to EPA is available the public docket ( EPA HQ OPP 2005 0492).

Cumulative Risk Assessment FQPA requires that EPA consider " available information" concerning the cumulative effects of a particular pesticide's residues and " other substances that have a common mechanism of toxicity." The Agency considers other substances because lowlevel exposures to multiple chemical substances that cause a common toxic effect by a common mechanism could lead to the same adverse health effect, as would a higher level of exposure to any of the other substances individually.

Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to oxytetracycline and any other substances, and oxytetracycline does not appear to produce a toxic metabolite that is also produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that oxytetracycline has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the policy statements released by EPA's Office of Pesticide Programs concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on EPA's website at http:// www. epa. gov/ pesticides/ cumulative/. Page 12 of 15 Tolerance Reassessment Summary Tolerances for the pesticidal residues of oxytetracycline are established under 40 CFR 180.337. A summary of the oxytetracycline tolerance reassessment is presented in Table 5.

Table 5. Tolerance Reassessment Summary for Oxytetracycline Commodity Current Tolerance ( ppm) Reassessed Tolerances ( ppm) Comments Tolerances Under 40 CFR § 180.337 Peach 0.35 0.35 Pear 0.35 0.35 Tolerances To Be Proposed Under 40 CFR § 180.337 Apple None 0.35 EPA has adequate data to support apple.

FDA has established tolerances for the sum of the tetracyclines ( chlortetracycline, oxytetracycline, tetracycline) residues for beef cattle, dairy cattle, calves, swine, sheep, chickens, turkeys, finfish, and lobster as listed under 21 CFR Part 556.500. These tolerances are regulated by FDA and are not included in this tolerance reassessment decision; however, the residues from these uses were included in EPA's dietary risk assessment.

Antibiotic Resistance ( For a complete discussion, see the Oxytetracycline HED Chapter dated June 19, 2006.)

Bacterial resistance to oxytetracycline as a result of drug use has long been recognized. EPA recognizes that pesticidal uses of oxytetracycline may contribute to antibiotic resistance of bacterial pathogens with potential adverse public health consequences. After evaluating available data and consulting with CDC, FDA CDER, FDA CVM, and USDA, EPA determined that insufficient data were available to conduct a quantitative antibiotic resistance assessment and instead conducted a qualitative antibiotic resistance assessment based on FDA CVM's Guidance for Industry # 152.

Because anticipated dietary residues are extremely low ( conservatively estimated at 0.000160 mg/ kg/ day for the General U. S. Population), it is unlikely that antibiotic resistance from pesticidal use of oxytetracycline would result from food exposure. Bacterial resistance to oxytetracycline from pesticidal use of oxytetracycline with adverse public health consequences could theoretically occur from ( 1) development of resistance in bacterial pathogens present in orchards or ( 2) from development of resistance from non pathogenic bacteria in orchards which later transferred their resistance to human bacterial pathogens.

The possibility of antibiotic resistance resulting in adverse human health consequences is determined principally by the likelihood of non pathogenic organisms in orchards transferring their resistance to pathogens in the human environment. Antibiotic resistance from pesticidal use of oxytetracycline is unlikely to result directly from dietary Page 13 of 15 residues of oxytetracycline because dietary residues are very low. The maximum aggregate dietary exposure was 0.000473 mg/ kg/ day which is very small when compared to a 25 mg/ kg/ day drug dose. The drug dose is 50,000 times greater than the estimated pesticidal dietary exposure. The small dose from pesticidal exposure would not be expected to select for resistant bacteria because very few bacteria would be killed by this small dose. If bacterial resistance to oxytetracycline from pesticidal use occurs, it is most likely that it would be caused by development of resistance from non pathogenic bacteria in orchards which later transferred their resistance to human bacterial pathogens.

In setting or revising tolerances under section 408 of the FFDCA, EPA must determine that " there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue." Because the risk of antibiotic resistance does not arise from the ingestion of pesticide residues, the risk has not been aggregated for the purposes of this action. EPA may consider the risk of antibiotic resistance in future actions such as registration review or approval of new uses for oxytetracycline. EPA is requiring use and usage information as well as additional environmental fate data to address the uncertainties regarding potential antibiotic resistance from the pesticidal uses ( see Table 6). Based on these new data, EPA may also require an antibiotic resistance monitoring study to be conducted in orchards or other high use areas. This study is held in reserve and, if deemed appropriate, will be required through a separate data call in. Additional label statements will also be required that will ensure judicious use of oxytetracycline.

Additional Generic Data Requirements Toxicity for oxytetracycline was assessed using the extensive database for oxytetracycline from its use as a human drug and using animal toxicity studies submitted to FDA. Toxicological and environmental fate data requirements were waived for oxytetracycline in the 1993 RED. Since the RED, EPA has become aware of the increasing importance of antibiotic resistance. Therefore, the following environmental fate and use data requirements presented in Table 6 are necessary to better understand the fate of pesticidal oxytetracycline in the environment and to support the continued registration of oxytetracycline.

Table 6. Oxytetracycline Generic Data Requirements Guideline Study Title 810.1000 Use and Usage Information 810.1000 Antibiotic Resistance in Orchards1 835.2120 Hydrolysis of Parent and Degradates as a Function of pH at 25oC 835.2240 Direct Photolysis Rate of Parent and Degradates in Water 835.2410 Photodegradation of Parent and Degradates in Soil 835.4100 Aerobic Soil Metabolism 835.4200 Anaerobic Soil Metabolism 835.4400 Anaerobic Aquatic Metabolism 835.4300 Aerobic Aquatic Metabolism 835.1240 Soil Column Leaching 835.1410 Laboratory Volatilization from Soil Page 14 of 15 Guideline Study Title 835.6100 Terrestrial Field Dissipation 850.1730 Fish BCF 860.1340 Analytical Enforcement Method 1 Based on the results of the required environmental fate data, EPA may require a special study to be conducted on antibiotic resistance in orchards. This study is being held in reserve and, if deemed appropriate, will be required through a separate data call in.

Required Label Changes Table 7 presents the label amendments required for all products containing oxytetracycline.

Table 7. Oxytetracycline Label Changes Summary Table Description Amended Labeling Language Placement on Label General Application Restrictions " This product contains the antibiotic oxytetracycline. To reduce the development of drug resistant bacteria and maintain the effectiveness of this and other antibacterial products, this product should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria." Directions for Use General Application Restrictions " This material is not to be used for medical or veterinary purposes." Directions for Use Conclusions EPA has evaluated the dietary risks from the supported registered uses and has determined that there is a reasonable certainty that no harm to any population subgroup will result from chronic exposure to oxytetracycline and considers the existing tolerances reassessed. Although not related to the FQPA safety finding, there are uncertainties about the pesticidal contributions to antibiotic resistance. To better understand the fate of pesticidal oxytetracycline in the environment and its potential contribution to antibiotic resistance, EPA is requiring additional use and environmental fate data. EPA is also requiring label amendments that will ensure judicious use of oxytetracycline.

Please contact Lance Wormell of my staff with any questions regarding this decision. He may be reached by phone at ( 703) 603 0523 or by e mail at wormell. lance@ epa. gov.

Sincerely,

Debra Edwards, Ph. D., Director Special Review and Reregistration Division Page 15 of 15 Technical Support Documents for the Oxytetracycline TRED 1. William Donovan and Kimyata Morgan ( USEPA/ OPPTS/ OPP/ HED). Oxytetracycline: HED Chapter of the Tolerance Reregistration Eligibility Decision Document ( TRED) and Proposed New Uses on Apples. Revised After Phase 3 Public Comments. DP Barcode D330129. June 19, 2006.

2. William H. Donovan ( USEPA/ OPPTS/ OPP/ HED). Oxytetracycline Tolerance Reregistration Eligibility Decision ( TRED). Summary of Product Chemistry and Residue Data. DP Barcode D315689. September 27, 2005.

3. William H. Donovan ( USEPA/ OPPTS/ OPP/ HED). Oxytetracycline Chronic Dietary Exposure Assessment for the Tolerance Reregistration Eligibility Decision ( TRED). Revised After Phase 1 Error Only Corrections. DP Barcode D315686. February 6, 2006.

4. Greg Orrick ( USEPA/ OPPTS/ OPP/ EFED). Oxytetracycline: Tier I Drinking Water Exposure Assessment of Oxytetracycline Supporting the Reassessment Under FQPA of Pear and Peach & Nectarine Use Patterns and the Assessment of the New Use Pattern, Apple. DP Barcode D315682. May 22, 2006.


[Federal Register Volume 87, Number 69 (Monday, April 11, 2022)]
[Notices]
[Page 21118]
[FR Doc No: 2022-07677]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

    Take notice that the Commission received the following exempt
wholesale generator filings:

     Docket Numbers: EG22-81-000.
     Applicants: WPL Crawfish River Solar, LLC.
      Description: Self-Certification of EWG Status of WPL Crawfish
River Solar, LLC.
     Filed Date: 4/5/22.
      Accession Number: 20220405-5112.
      Comment Date: 5 p.m. ET 4/26/22.

      Docket Numbers: EG22-82-000.
      Applicants: WPL Bear Creek Solar, LLC.
      Description: Self-Certification of EWG Status of WPL Bear Creek
Solar, LLC.
     Filed Date: 4/5/22.
     Accession Number: 20220405-5113.
     Comment Date: 5 p.m. ET 4/26/22.

     Docket Numbers: EG22-83-000.
      Applicants: WPL Wood County Solar, LLC.
      Description: Self-Certification of EWG Status of WPL Wood County
Solar, LLC.
      Filed Date: 4/5/22.
     Accession Number: 20220405-5119.
     Comment Date: 5 p.m. ET 4/26/22.

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

      Docket Numbers: ER22-1433-000; ER22-1536-000.
     Applicants: PJM Interconnection, L.L.C., Borough of Chambersburg,
Pennsylvania.
     Description: PJM Interconnection, L.L.C. submits an Informational
filing to its March 31, 2022 filing of an executed Service Agreement
for Network Integration Transmission Service.
    Filed Date: 4/1/22.
     Accession Number: 20220401-5605.
     Comment Date: 5 p.m. ET 4/22/22.

     Docket Numbers: ER22-1574-000.
    Applicants: WPL Bear Creek Solar, LLC.
     Description: Baseline eTariff Filing: WPL Bear Creek Solar MBR
Application to be effective 5/15/2022.
      Filed Date: 4/5/22.
     Accession Number: 20220405-5082.
     Comment Date: 5 p.m. ET 4/26/22.

      Docket Numbers: ER22-1575-000.
     Applicants: WPL Crawfish River Solar, LLC.
      Description: Baseline eTariff Filing: WPL Crawfish River Solar
MBR Application Filing to be effective 5/15/2022.
      Filed Date: 4/5/22.
      Accession Number: 20220405-5084.
      Comment Date: 5 p.m. ET 4/26/22.

      Docket Numbers: ER22-1576-000.
      Applicants: WPL North Rock Solar, LLC.
      Description: Baseline eTariff Filing: WPL North Rock Solar MBR
Application Filing to be effective 5/15/2022.
      Filed Date: 4/5/22.
      Accession Number: 20220405-5085.
      Comment Date: 5 p.m. ET 4/26/22.

     Docket Numbers: ER22-1577-000.
      Applicants: PacifiCorp.
     Description: Sec.  205(d) Rate Filing: UAMPS Agmt Re SSAS Rev 1 to
be effective 3/30/2022.
     Filed Date: 4/5/22.
      Accession Number: 20220405-5088.
      Comment Date: 5 p.m. ET 4/26/22.

      Docket Numbers: ER22-1578-000.
      Applicants: WPL Wood County Solar, LLC.
      Description: Baseline eTariff Filing: WPL Wood County Solar MBR
Application Filing to be effective 5/15/2022.
      Filed Date: 4/5/22.
     Accession Number: 20220405-5090.
      Comment Date: 5 p.m. ET 4/26/22.

      Docket Numbers: ER22-1579-000.
      Applicants: Midcontinent Independent System Operator, Inc.
      Description: Sec.  205(d) Rate Filing: 2022-04-05_Electric
Storage Resources Pre-Implementation Filing to be effective 6/6/2022.
     Filed Date: 4/5/22.
      Accession Number: 20220405-5100.
      Comment Date: 5 p.m. ET 4/26/22.

      Docket Numbers: ER22-1581-000.
     Applicants: Sun Streams 4, LLC.
      Description: Tariff Amendment: Notice of Cancellation to be
effective 4/6/2022.
      Filed Date: 4/5/22.
     Accession Number: 20220405-5128.
      Comment Date: 5 p.m. ET 4/26/22.

    The filings are accessible in the Commission's eLibrary system
(https://elibrary.ferc.gov/idmws/search/fercgensearch.asp) by querying
the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: April 5, 2022.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2022-07677 Filed 4-8-22; 8:45 am]
BILLING CODE 6717-01-P


the report pertains, the railroad shall take the appropriate action
required by subpart C of this part.
    (2) If a railroad receives a report pursuant to Sec.  234.303(b)(1)
that is a credible report of warning system malfunction at a highway-
rail grade crossing and that railroad does not have maintenance
responsibility for the warning system to which the report pertains, the
railroad shall immediately contact all trains that are authorized to
operate through the highway-rail grade crossing and warn the trains of
the reported malfunction. The railroad shall then immediately contact
the railroad that has maintenance responsibility for the warning system
and inform it of the reported malfunction. The railroad that has
maintenance responsibility for the warning system at the highway-rail
grade crossing shall take the appropriate action required by subpart C
of this part.
    (b) General rule on response to other reports of warning system
malfunction at highway-rail grade crossing. (1) If a railroad receives
a report of warning system malfunction pursuant to Sec.  234.303(b)(1)
that is not a credible report of warning system malfunction at a
highway-rail grade crossing and that railroad has maintenance
responsibility for the warning system to which the report pertains, the
railroad shall immediately contact all trains that are authorized to
operate through the highway-rail grade crossing and warn the trains of
the reported malfunction. The railroad shall also promptly contact the
law enforcement agency having jurisdiction over the highway-rail grade
crossing and provide the necessary information for the law enforcement
agency to direct traffic or carry out other activities to maintain
safety at the highway-rail grade crossing. The railroad shall then
promptly investigate the report and determine the nature of the
malfunction and shall take the appropriate action required by Sec.
234.207(a).
    (2) If a railroad receives a report of warning system malfunction
pursuant to Sec.  234.303(b)(1) that is not a credible report of
warning system malfunction and that railroad has dispatching
responsibility for the crossing but does not have maintenance
responsibility for the warning system at the highway-rail grade
crossing, the railroad shall immediately contact all trains that are
authorized to operate through the highway-rail grade crossing to which
the report pertains and warn the trains of the reported malfunction.
The railroad shall also promptly contact the law enforcement agency
having jurisdiction over the highway-rail grade crossing and provide
the necessary information for the law enforcement agency to direct
traffic or carry out other activities to maintain safety at the
highway-rail grade crossing. The railroad shall then promptly contact
the railroad that has maintenance responsibility for the warning system
and inform it of the reported malfunction. The railroad having
maintenance responsibility shall promptly investigate the report and
determine the nature of the malfunction and shall take the appropriate
action required by Sec.  234.207(a).
    (c) General rule on response to warning system failure at a pathway
grade crossing. (1) If a railroad receives a report of warning system
failure at a pathway grade crossing pursuant to Sec.  234.303(c)(1) and
that railroad has maintenance responsibility for the warning system to
which the report pertains, the railroad shall immediately contact all
trains that are authorized to operate through the pathway grade
crossing and warn the trains of the reported failure. The railroad
shall also promptly contact the law enforcement agency having
jurisdiction over the pathway grade crossing and provide the necessary
information for the law enforcement agency to direct traffic or carry
out other activities to maintain safety at the pathway grade crossing.
The railroad shall then promptly investigate the report and determine
the nature of the failure and repair the active warning system if
necessary.
    (2) If a railroad receives a report of warning system failure at a
pathway grade crossing pursuant to Sec.  234.303(c)(1) and that
railroad has dispatching responsibility for the pathway grade crossing
but does not have maintenance responsibility for the warning system to
which the report pertains, the railroad shall immediately contact all
trains that are authorized to operate through the pathway grade
crossing to which the report pertains and warn the trains of the
reported failure. The railroad shall also promptly contact the law
enforcement agency having jurisdiction over the pathway grade crossing
and provide the necessary information for the law enforcement agency to
direct traffic or carry out other activities to maintain safety at the
pathway grade crossing. The railroad shall then promptly contact the
railroad that has maintenance responsibility for the warning system and
inform it of the reported failure. The railroad having maintenance
responsibility shall then promptly investigate the report and determine
the nature of the failure and shall repair the warning system if
necessary.
    (d) General rule on dispatching railroad's response to reports of a
disabled vehicle or other obstruction blocking a railroad track at a
highway-rail or pathway grade crossing. Upon receiving a report
pursuant to Sec.  234.303(b)(2) or (c)(2), the railroad shall
immediately contact all trains that are authorized to operate through
the highway-rail or pathway grade crossing to which the report pertains
and warn the trains of the reported disabled vehicle or other track
obstruction. After contacting the necessary trains, the railroad shall
promptly contact the law enforcement agency having jurisdiction over
the highway-rail or pathway grade crossing to provide it with the
information necessary to assist in the removal of the reported track
obstruction or to carry out other activities as appropriate.
    (e) Special rule on contacting a train that is not required to have
communication equipment. If a railroad is not required by Sec.  220.9
of this chapter to have a working radio or working wireless
communications in each occupied controlling locomotive of its trains
and the dispatching railroad receives a report pursuant to Sec.
234.303(b)(1), (b)(2), (c)(1), or (c)(2)

about a crossing that one of the trains is authorized to operate
through, the dispatching railroad shall immediately contact the
occupied controlling locomotive of the train as required by Sec.
234.305(a), (b), (c), or (d) by the quickest means available consistent
with Sec.  220.13(a) of this chapter.
    (f) General rule on response to reports of obstruction of view at
highway-rail or pathway grade crossings. Upon receiving a report
pursuant to Sec.  234.303(b)(3) or (c)(3), the dispatching railroad, if
it is also the maintaining railroad, shall timely investigate the
report and shall remove the obstruction if it is feasible and lawful to
do so. If the dispatching railroad is not the maintaining railroad, the
dispatching railroad shall promptly contact the maintaining railroad,
which shall timely investigate the report and which shall remove the
obstruction, if it is lawful and feasible to do so.
    (g) General rule on response to reports of other unsafe conditions
at highway-rail or pathway grade crossings. (1) Upon receiving a report
pursuant to Sec.  234.303(b)(4) or (c)(4) related to the maintenance of
a crossbuck sign or other similar grade crossing safety device not
covered by Sec.  234.305(a), (b), or (c), the dispatching railroad, if
it also has maintenance responsibility for the device, shall timely
investigate the report; and, if it finds that the unsafe condition
exists, the dispatching railroad shall timely correct it if it is
lawful and feasible to do so. If the dispatching railroad does not have
maintenance responsibility for the device, the dispatching railroad
shall timely inform the railroad with maintenance responsibility for
the device, and the maintaining railroad shall timely investigate the
report; and, if the maintaining railroad finds that the unsafe
condition exists, the railroad shall timely correct it if it is lawful
and feasible to do so.
    (2) Upon receiving a report pursuant Sec.  234.303(b)(4) or (c)(4),
not covered by Sec.  234.305(g)(1), the dispatching railroad, if it is
also the maintaining railroad, shall timely investigate the report;
and, if it finds that the unsafe condition exists, the dispatching
railroad shall timely correct it if it is lawful and feasible to do so.
If the dispatching railroad is not the maintaining railroad, the
dispatching railroad shall timely inform the maintaining railroad of
the report, and the maintaining railroad shall timely investigate the
report; and, if the maintaining railroad finds that the unsafe
condition exists, the railroad shall timely correct it if it is lawful
and feasible to do so.
    (h) General rule on contacting the maintaining railroad and use of
an automated answering service. If the dispatching railroad is required
under this section to contact the maintaining railroad, the maintaining
railroad shall--
    (1) Provide the dispatching railroad with sufficient contact
information by which the dispatching railroad may immediately contact
the maintaining railroad upon receipt of a report; and
    (2) Not use an automated answering service for the purpose of
receiving a call from the dispatching railroad.

Sec.  234.307  Third-party telephone service.

    (a) Use of a third-party service. A railroad may use a third-party
service to directly receive reports pursuant to Sec.  234.303. The
third-party service shall be reached directly by the telephone number
placed on the sign pursuant to Sec.  234.309. The third-party service
shall not use an automated answering service for the purpose of
receiving such reports, and the contracting railroad shall ensure that
the third-party service does not use an automated answering service for
the purpose of receiving such reports.
    (b) Duties of railroad using third-party service. If a railroad
uses a third-party service to directly receive reports pursuant to
Sec.  234.303, the railroad--
    (1) Shall provide the third-party service with sufficient contact
information by which the third-party service may immediately contact
the contracting railroad upon receipt of a report;
    (2) Shall not use an automated answering service to receive calls
from the third-party service for the purpose of receiving reports
pursuant to Sec.  234.303;
    (3) Shall promptly inform FRA of its intent to use a third-party
service and shall provide FRA with contact information for the third-
party service, and information identifying the highway-rail and pathway
grade crossings about which the third-party service will receive
reports; and
    (4) Upon being contacted by the third-party service about a report
pursuant to Sec.  234.303, the railroad shall take appropriate action
as required by Sec.  234.305.
    (c) Duties of third-party service. Upon receiving a report pursuant
to Sec.  234.303, the third-party service shall immediately contact the
contracting railroad, and, at a minimum, provide the railroad with the
following:
    (1) Information on the nature of the reported unsafe condition;
    (2) Information on the location of the unsafe condition, including
the U.S. DOT National Crossing Inventory File Number;
    (3) Information on whether the person reporting the unsafe
condition is a railroad employee, law enforcement officer, highway
traffic official, or other employee of a public agency acting in an
official capacity; and
    (4) Any additional information provided by the caller that may be
useful to restore the crossing to a safe condition.
    (d) Third-party service and contracting railroad liability. A
third-party service is responsible for complying with this subpart. In
addition, the contracting railroad is vicariously liable for the acts
or omissions of the third-party service under the contract in violation
of this subpart.

Sec.  234.309  ENS signs in general.

    (a) No later than 30 days before the implementation of an ENS, the
dispatching railroad for a highway-rail or pathway grade crossing shall
provide to the maintaining railroad for the crossing the telephone
number to be posted on the ENS sign at the crossing if the dispatching
railroad and the maintaining railroad are not the same.
    (b) Each ENS sign located at each highway-rail or pathway grade
crossing as required by Sec.  234.311 shall have the necessary
information for the dispatching railroad to receive reports of unsafe
conditions at the crossing. This information, at a minimum, includes
the toll-free number (or non-toll-free number as provided for in Sec.
234.303(d)) established to receive reports pursuant to Sec.
234.303(a), an explanation of the purpose of the sign, and the U.S. DOT
National Crossing Inventory File Number assigned to that crossing.
    (c) Each ENS sign shall be at least 12 inches wide by 9 inches
high, have lettering measuring, at a minimum, 1 inch in height, and
have a white legend and border on a blue background.

Sec.  234.311  ENS sign placement and maintenance.

    (a) The maintaining railroad for a highway-rail or pathway grade
crossing shall place and maintain a sign that conforms to Sec.  234.309
at the crossing for each direction of traffic at that crossing. A
pathway grade crossing is considered to have a minimum of two
directions of traffic unless specifically designed for traffic in one
direction only.
    (b) Each sign required by paragraph (a) of this section shall be
located and maintained by the maintaining railroad so that it--
    (1) Is conspicuous to users of the roadway or pathway;

    (2) Optimizes its visibility at nighttime;
    (3) Minimizes the effect of mud splatter and debris; and
    (4) Does not obscure any other sign at the crossing.
    (c) A sign placed on the signal bungalow shall not be deemed to
comply with Sec.  234.311(b).

Sec.  234.313  Recordkeeping.

    (a) Each railroad subject to this subpart shall keep records in
accordance with paragraph (b) of this section pertaining to its
compliance with this subpart. Records may be kept either on paper forms
provided by the railroad or by electronic means in a manner that
conforms with Sec.  234.315. Each railroad responsible for receiving
reports pursuant to Sec.  234.303(a) and, if applicable, each railroad
with maintenance responsibility shall keep, at a minimum, the following
information for each report received under this subpart:
    (1) The nature of the reported unsafe condition;
    (2) Location of the highway-rail or pathway grade crossing (by
highway name, if applicable, and U.S. DOT National Crossing Inventory
File Number);
    (3) Time and date of receipt of the report by the railroad;
    (4) Whether the person who provided the report was a railroad
employee, law enforcement officer, highway traffic official, or other
employee of a public agency acting in an official capacity;
    (5) Actions taken by the railroad prior to rectifying the reported
unsafe condition at the grade crossing;
    (6) If the reported unsafe condition is substantiated, actions
taken by the railroad to rectify the reported unsafe condition, if
possible;
    (7) Time and date at which the reported unsafe condition was
rectified; and
    (8) If a railroad is required by this subpart to contact a railroad
with maintenance responsibility, the time and date the railroad
contacted the railroad having maintenance responsibility.
    (b) A railroad having maintenance responsibility over warning
devices at a highway-rail grade crossing that maintains records
pursuant to Sec.  234.109, shall be deemed to comply with the
recordkeeping requirements of this subpart with regards to credible
reports of warning system malfunctions.
    (c) Each railroad shall retain for at least one year (from the
latest date of railroad activity in response to a report received under
this subpart) all records referred to in paragraph (a) of this section.
Records required to be kept shall be made available to the FRA as
provided by 49 U.S.C. 20107.

Sec.  234.315  Electronic recordkeeping.

    (a) If a railroad subject to this subpart keeps a record required
by this subpart electronically in lieu of on paper, the system for
keeping the electronic record must meet all of the following
conditions:
    (1) The railroad adequately limits and controls accessibility to
the record retained in its electronic database system and identifies
those individuals who have such access;
    (2) The railroad has a terminal at the location designated by the
railroad as the general office for the railroad system and at each
division headquarters;
    (3) Each such terminal has a computer and either a facsimile
machine or a printer connected to the computer to retrieve and produce
information in a usable format for immediate review by FRA
representatives;
    (4) The railroad has a designated representative who is authorized
to authenticate retrieved information from the electronic system as a
true and accurate copy of the electronically kept record; and
    (5) The railroad provides FRA representatives with immediate access
to the record for inspection and copying during normal business hours
and provides a printout of such record upon request.
    (b) If a record required by this part is in the form of an
electronic record kept by an electronic recordkeeping system that does
not comply with paragraph (a) of this section, then the record must be
kept on paper.

Sec.  234.317  Compliance dates.

    (a) If a railroad subject to this subpart does not have an ENS of
any kind in place on the effective date of this subpart, the railroad
shall implement an ENS that conforms to this subpart no later than 18
months after the effective date of this subpart.
    (b) If a railroad subject to this subpart already has its own ENS
telephone service or is using a third-party ENS telephone service on
the effective date of this subpart, and that telephone service does not
conform to the requirements in Sec.  234.303 or Sec.  234.307,
respectively, the railroad shall comply with Sec.  234.303 or Sec.
234.307, respectively, no later than six months after the effective
date of this subpart.
    (c)(1) If a railroad subject to this subpart already has ENS signs
in place on the effective date of this subpart and those signs do not
conform to the requirements in Sec.  234.309, subject to Sec.
234.317(c)(2), the railroad's ENS signs shall conform to Sec.  234.309
no later than five years after the effective date of this subpart. If
the railroad replaces a non-conforming sign before the expiration of
the five-year period, the railroad shall replace that sign with a sign
that conforms to Sec.  234.309.
    (2) If a railroad subject to this subpart already has ENS signs in
place on the effective date of this subpart and those signs measure
less than 60 square inches, those ENS signs shall conform to Sec.
234.309 no later than 18 months after the effective date of this
subpart. If the railroad replaces a non-conforming sign before the
expiration of the 18-month period, the railroad shall replace that sign
with a sign that conforms to Sec.  234.309.
    (d) If a railroad subject to this subpart already has ENS signs in
place on the effective date of this subpart and the placement of those
signs does not conform to the requirements in Sec.  234.311, the
placement of the railroad's ENS signs shall conform to Sec.  234.311 no
later than five years after the effective date of this subpart. If a
railroad replaces a sign before the five-year period so that the sign
conforms with Sec.  234.309, and the placement of that sign does not
conform with Sec.  234.311, the railroad shall also change the
placement of the sign so that it conforms to Sec.  234.311.
    (e) If a railroad subject to this subpart already conducts
recordkeeping as part of its ENS on the effective date of this subpart
and that recordkeeping does not conform to Sec.  234.313 or Sec.
234.315, the railroad's recordkeeping shall conform to Sec.  234.313 or
Sec.  234.315 no later than six months after the effective date of this
subpart.

    Issued in Washington, DC, on February 28, 2011.
Joseph C. Szabo,
Administrator, Federal Railroad Administration.
[FR Doc. 2011-4759 Filed 3-3-11; 8:45 am]
BILLING CODE 4910-06-P


[Federal Register Volume 77, Number 243 (Tuesday, December 18, 2012)]
[Notices]
[Page 74894]
[FR Doc No: 2012-30552]

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

SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meeting

    Notice is hereby given, pursuant to the provisions of the
Government in the Sunshine Act, Public Law 94-409, that the Securities
and Exchange Commission will hold a Closed Meeting on Thursday,
December 20, 2012 at 2:00 p.m.
    Commissioners, Counsel to the Commissioners, the Secretary to the
Commission, and recording secretaries will attend the Closed Meeting.
Certain staff members who have an interest in the matters also may be
present.
    The General Counsel of the Commission, or his designee, has
certified that, in his opinion, one or more of the exemptions set forth
in 5 U.S.C. 552b(c)(3), (5), (7), 9(B) and (10) and 17 CFR
200.402(a)(3), (5), (7), 9(ii) and (10), permit consideration of the
scheduled matters at the Closed Meeting.
    Commissioner Walter, as duty officer, voted to consider the items
listed for the Closed Meeting in a closed session.
    The subject matter of the Closed Meeting will be:
    Adjudicatory matters;
    Institution and settlement of injunctive actions;
    Institution and settlement of administrative proceedings; and
    Other matters relating to enforcement proceedings.
    At times, changes in Commission priorities require alterations in
the scheduling of meeting items.
    For further information and to ascertain what, if any, matters have
been added, deleted or postponed, please contact:
    The Office of the Secretary at<PHONE_NUMBER>.

    Dated: December 13, 2012.
Elizabeth M. Murphy,
Secretary.
[FR Doc. 2012-30552 Filed 12-14-12; 4:15 pm]
BILLING CODE 8011-01-P