TELEPHONE CALL RECORD Incoming Call x Outgoing Call Account & Task Number 0<IP_ADDRESS> Project Name Other Solid Waste Incineration Date 5/ 23/ 05 Time 1230 EDT Person Calling Jason Huckaby ( ERG), Ruth Mead ( ERG), Mary Johnson ( EPA), Brian Shrager ( EPA) Activity Conference Call Person Called Brad Musick and Rita Trujillo ( NM Environmental Department) Telephone No.

( 505) 955 8024 General Subject Clarification of New Mexico's Comments on the Proposed OSWI Rules TOPICS DISCUSSED AND ACTION TAKEN The purpose of the conference call was to clarify some issues with New Mexico regarding their comments on the proposed OSWI rules. The comment portion EPA would like clarification on is item 7, found on page 5 of New Mexico's comments on the proposed OSWI regulations. The comment begins with " Applicability to temporary use incinerators ( including air curtain incinerators burning only wood waste, clean lumber, and yard waste, but not including incinerators used in disaster recovery) should be clarified." The next sentence proceeds with, " In non binding guidance from EPA, we have seen conflicting interpretations regarding applicability of the solid waste incineration ( NSPSs) and other air quality standards to incinerators used at a given location." 1. Could you please clarify the sources of this guidance so that we may review the prior interpretations that you refer to in your comment? Discussion: The guidance is Control number 0200040 from the Applicability Determination Index ( ADI) dated April 17, 2002 from Region V. In this determination, an air curtain incinerator used for clearing debris at a residential construction site is not considered " an industrial or commercial " facility" since the incinerator is not permanently located at the site. Neither is the residential construction site itself a permanent industrial or commercial " facility."

2. New Mexico later discusses " portable stationary sources" and " consistency with the current regulatory treatment of other portable and temporary sources would be desirable." Could you please clarify specific elements of the current regulatory treatment that is applied to other portable and temporary sources, so that we may better address your comments? Discussion: NM stated that the " other portable sources" refers to portable rock crushing and gravel processing plants subject to 40 CFR 60 subpart OOO. New Mexico issues several permits per year to these sources, and they are usually operated in one location for less than a year. EPA pointed out that, under the proposed rules, incinerators that meet the institutional waste incinerator or very small municipal waste combustor definition would be considered to be OSWI, regardless of whether they are portable or not. EPA asked if applicability was not clear in the proposal, and if some clarification of " temporary or portable" in the comment/ response document or final rule preamble would solve the issue. New Mexico did not know if this would work or not, and requested EPA look at how " facility" is used and perhaps define " facility" in the OSWI rules to make it clear for temporary situations. New Mexico stated that these units may be rented to different types of establishments, and suggested that the rule clarify applicability for units that may be rented to an institution only part of the time and then to non institutions at other times.

3. Finally, what types of portable incinerators are you referring to... air curtains incinerators only, or are there other designs you have encountered? What materials are being burned in these incinerators? Discussion: New Mexico is referring to air curtain incinerators burning vegetative material.


[Federal Register: March 13, 2006 (Volume 71, Number 48)]
[Notices]
[Page 12736-12738]
[DOCID:fr13mr06-84]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-53403; File No. SR-Amex-2006-04]

Self-Regulatory Organizations; American Stock Exchange LLC;
Notice of Filing of Proposed Rule Change and Amendment No. 1 Thereto
Relating to Procedures for Denying Initial and Continued Listing

March 2, 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 January 23, 2006, the American Stock Exchange LLC (``Amex'' 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 Amex. On February
22, 2006, Amex filed Amendment No. 1 to the proposed rule change.\3\
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 made technical changes to the rule text
submitted in Exhibit 5.
---------------------------------------------------------------------------

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

    The Exchange proposes to add new Section 127 and amend Sections
101, 401, 402, 710, 1002, and 1009 of the Amex Company Guide to
increase the transparency of the process associated with staff
determinations to deny the initial or continued listing of a company's
securities on the Amex.
    The text of the proposed rule change is available on the Amex's Web
site at http://www.amex.com, at the Amex's principal office, 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 Amex included statements
concerning the purpose of and basis for the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Amex 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

    Sections 101 and 1002 of the Amex Company Guide provide broad
discretionary authority to the Exchange to deny initial or continued
listing to a company, the condition or business of which raises public
interest or other qualitative concerns that could undermine investor
confidence in Amex listed securities. The Exchange proposes to add new
Section 127 and amend Sections 101 and 1002 of the Amex Company Guide
to clarify the circumstances in which the Exchange generally uses this
authority and provide greater transparency to listed companies and
applicants.\4\
---------------------------------------------------------------------------

    \4\ The Commission notes that this proposed rule change is
substantially similar to a proposal submitted by the National
Association of Securities Dealers, Inc. and approved by the
Commission. See Securities Exchange Act Release No. 52342 (August
26, 2005), 70 FR 52456 (September 2, 2005) (SR-NASD-2004-125).
---------------------------------------------------------------------------

    The proposed rule and rule amendments would specify that the
Exchange has authority to deny initial listing to an applicant, impose
additional or more stringent criteria on initial or continued listing
of a company's securities, or delist a company's securities under the
following circumstances:
     The listed company or applicant, or an individual
associated with the listed company or applicant, has a history of
regulatory misconduct; \5\
---------------------------------------------------------------------------

    \5\ Such individuals would typically be an officer, director,
substantial security holder or consultant to the issuer. The
Exchange proposes in new Section 127, Commentary .01 that an
interest consisting of more than either 5% of the number of shares
of common stock or 5% of the voting power outstanding of an issuer
or party shall be considered a substantial interest and cause the
holder of such an interest to be regarded as a substantial security
holder. Telephone conversation between Jan Woo, Attorney, Division
of Market Regulation, Commission, and Courtney McBride, Assistant
General Counsel, Amex, on February 23, 2006.

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

     The listed company or applicant files for protection under
any provision of the federal bankruptcy laws or comparable foreign
laws;
     The independent accountants of the listed company or
applicant issue a disclaimer opinion on financial statements required
to be audited;
     The financial statements of the listed company or
applicant do not contain a required certification; or
     The Exchange determines that the listed company or
applicant entity has violated or evaded applicable corporate governance
standards (for example, by delisting from another marketplace in order
to effect a violative transaction and seeking an Amex listing
thereafter).
    Proposed new Section 127 of the Amex Company Guide would explain
the factors used by the Exchange in evaluating whether the regulatory
misconduct of an individual associated with a company should be used as
a basis to deny initial or continued listing, as well as remedial
measures that may serve to mitigate public interest concerns. Section
127 would also state that Sections 101 and 1002 do not provide a basis
for the Exchange to grant exemptions or exceptions from the enumerated
initial or continued listing criteria.
    The Exchange is also proposing to update its disclosure policies by
amending Sections 402 and 1009 of the Amex Company Guide. These
proposed amendments would conform the Amex disclosure time frames to
those mandated by the Commission for current reports filed on Form 8-K,
specifically to instructions provided under General Instruction B.1. to
Form 8-K for material disclosed pursuant to Item 3.01 of Form 8-K
(Notice of Delisting or Failure to Satisfy a Continued Listing Rule or
Standard; Transfer of Listing), by reducing to four business days the
time within which a listed company must publicly disclose that the
Exchange has given it written notice that it is noncompliant with one
or more of the continued listing standards. The proposed amendments
would also extend the disclosure obligations applicable to a company
that receives a written delisting notice to include a company that
receives a written notice of noncompliance with a continued listing
requirement. A written notice of noncompliance with a continued listing
requirement may be in the form of either a Warning Letter or a
Deficiency Letter.\6\
---------------------------------------------------------------------------

    \6\ Telephone conversation between Jan Woo, Attorney, Division
of Market Regulation, Commission, and Courtney McBride, Assistant
General Counsel, Amex, on February 23, 2006.
---------------------------------------------------------------------------

    In addition, the Amex proposes certain clarifying amendments to
Section 710 of the Amex Company Guide. Section 710(b) provides that an
exception to the shareholder approval requirements contained in
Sections 711, 712, and 713 may be made upon application to the Exchange
when (i) the delay in securing shareholder approval would seriously
jeopardize the financial viability of the enterprise, and (ii) reliance
by the company on the exception is expressly approved by the audit
committee of the company's board of directors or a comparable body of
the board of directors. The Exchange proposes to add that the
comparable body of the board of directors which may approve a company's
reliance on the financial viability exception must be comprised solely
of independent and disinterested directors. The Exchange also proposes
to prohibit a company from issuing, or authorizing its transfer agent
or registrar to issue or register the securities subject to the
shareholder approval requirements until it has received written
notification from the Exchange that the financial viability exception
has been granted and the securities have been approved for listing.
    Section 710 of the Amex Company Guide currently requires a company
that receives the financial viability exception to provide notice to
shareholders of its reliance on such exception ten days before issuance
of the subject securities. The Exchange proposes to require increased
disclosure by requiring the company to issue a press release ten days
before issuance of the subject securities. Both the shareholder notice
and press release would need to specify: (i) The terms of the
transaction subject to the shareholder approval requirements (including
the number of shares of common stock that could be issued and the
consideration received), (ii) the fact that the company is relying on
the financial viability exception to the stockholder approval rules,
and (iii) that such reliance has been approved either by the audit
committee or by another body of the board of directors that is
comprised solely of independent and disinterested directors.
    Finally, the Exchange proposes minor, technical changes to Section
401 of the Amex Company Guide.
2. Statutory Basis
    The Exchange believes that the amended proposed rule change is
consistent with Section 6(b) of the Act,\7\ in general, and furthers
the objectives of Section 6(b)(5) of the Act,\8\ in particular, in that
it is designed to prevent fraudulent and manipulative acts and
practices, to promote just and equitable principles of trade, to foster
cooperation and coordination with persons engaged in regulating,
clearing, settling, processing information with respect to, and
facilitating transactions in securities, to remove impediments to and
perfect the mechanism of a free and open market and a national market
system, and, in general, to protect investors and the public interest.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78f(b).
    \8\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

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

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

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

    No written comments were solicited or received with respect to the
proposed rule change.

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

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

IV. Solicitation of Comments

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

Electronic Comments

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

File No. SR-Amex-2006-04 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-Amex-2006-04. 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 Amex. 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-Amex-2006-04 and should be submitted on or before April
3, 2006.

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\9\
---------------------------------------------------------------------------

    \9\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Nancy M. Morris,
Secretary.
[FR Doc. E6-3485 Filed 3-10-06; 8:45 am]

BILLING CODE 8010-01-P


[2000 0680 and 2001 0304 / PLG] ~ PROTECTED ~ Acute Pulmonary Infectivity and Toxicity / 1 [Pseudozyma flocculosa / STF] DACO M4. 2. 3 / USEPA OPPTS 885.3150 Reviewer: Esther Seto , Date January 21, 2002 Peer Review: Ibrahim Barsoum, PhD Microbial Pesticides Branch Biopesticides and Pollution Prevention Division U. S. Environmental Protection Agency _______________

STUDY TYPE: Acute Pulmonary Toxicity / Pathogenicity PMRA DATA CODE M4. 2. 3 USEPA OPPTS 885.3150 TEST MATERIAL (PURITY): Sporothrix flocculosa, pure culture (MPCA) in sterile water 1.15 x 10 8 CFU/ mL SYNONYMS: Pseudozyma flocculosa, STF, Stephanoascus flocculosa CITATION: Harrington, Kelly, A. (June 19, 1997). "Acute Intratracheal Infectivity Testing of Sporothrix flocculosa, a Fungal Pesticide" IIT Research Institute, Chicago, Illinois, USA. IITRI Project No. L08641, Study No. 3 In Life Study Dates: October 9, 1996  October 14, 1996 (toxicity range finding assay) and October 15. 1996  November 5, 1996 (infectivity assay). Unpublished.

SPONSOR: Université Laval Québec, Canada G1K 7P4 EXECUTIVE SUMMARY: In an acute pulmonary toxicity/ infectivity study, groups of young adult CD rats (4/ sex/ scheduled sacrifice date) were exposed by the intratracheal route to an undiluted suspension of Sporothrix flocculosa (TS) at a dose of 3. 2 x 10 7 cfu/ animal (in 0. 1 mL). Animals were then observed for up to 14 days. An equal number of young adult CD rats were similarly injected with heat killed test substance (KTS). An undosed naive control (NC) group consisting of 4 rats/ sex was also included in the study. Cage side observations for clinical symptoms was performed daily and animal body weights and food consumption were monitored.

Designated test animals from the TS and KTS groups were sacrificed on days 0, 7 and 14 and gross necropsies were performed. During the course of the study, 5 TS dosed and 10 KTS dosed animals died prior to their scheduled sacrifice dates. These animals were also necropsied. The NC group of animals was sacrificed and necropsied at the end of the 14 day study. Infectivity and clearance were assessed by quantitatively recovering the MPCA from the blood, lungs and lymph nodes, spleen, kidneys, liver, heart, stomach and small intestine, caecum and brain.

Laboured respiration was observed in 3/ 12 TS dosed male rats, 1/ 12 TS dosed female rats, 1/ 12 KTSdosed male rats and 4/ 12 KTS dosed female rats. The posture of one female TS dosed animal was [2000 0680 and 2001 0304 / PLG] ~ PROTECTED ~ Acute Pulmonary Infectivity and Toxicity / 2 [Pseudozyma flocculosa / STF] DACO M4. 2. 3 / USEPA OPPTS 885.3150 hunched. Rough hair coat was observed in 3/ 12 TS dosed male rats, 1/ 12 KTS dosed male rats and 4/ 8 KTS dosed female rats. One rat from each of the male TS dosed, male KTS dosed and female KTS dosed groups had ocular discharge. Nasal discharge was noted in 2/ 12 male TS dosed rats, 1/ 12 KTS dosed rat and 2/ 12 female KTS dosed rats. One male TS dosed rat appeared lethargic on day 4. The presence or absence of clinical symptoms were not indicative of spontaneous deaths.

Due to the large number of spontaneous deaths (3/ 12 male TS dosed rats, 6/ 12 male KTS dosed rats, 2/ 12 female TS dosed rats and 4/ 12 female KTS dosed rats) and a number of missed data collections, data for evaluating body weights, food consumption and relative organ weight were limited. At the end of the 14day long study, administration of S. flocculosa did not have a statistically significant effect on body weight. Analysis of daily food consumption and relative organ weights was skewed as it was not determined or did not include animals that died prior to their scheduled sacrifice dates.

At necropsy, lesions and enlargement of the lung were observed in 6/ 12 male TS dosed rats, 5/ 12 male KTS dosed rats, 4/ 12 female TS dosed rats and 6/ 12 female KTS dosed rats. Confluent dark areas were seen in the kidneys of one male TS dosed rat. Lesions and enlargement of the spleen were noted in 1/ 12 male TS and KTS dosed rats and 2/ 12 female KTS dosed rats. Liver lesions were observed in one animal from each of the male TS dosed, male KTS dosed and female KTS dosed groups. These necropsy findings were considered consistent with the method of dosing and the body's normal immunological response to a foreign substance.

Sporothrix flocculosa was detected in the lungs and lymph nodes and the stomach and small intestine of TS dosed animals only. Counts in these tissues were below the limit of detection by day 7.

Based on this study, S. flocculosa is toxic, but not infective or pathogenic, at the dose administered when introduced by the intratracheal route to male and female CD rats. This acute pulmonary study, however, is classified as UNACCEPTABLE due to major deficiencies in the collected data and a possible dosing error, as indicated by the presence of the MPCA in the stomach and small intestines on the day of dosing. A subsequent range finding acute pulmonary toxicity study was conducted and reviewed.

COMPLIANCE: Signed and dated GLP compliance and Quality Assurance statements were provided. An unsigned Data Confidentiality statement was included.

I. MATERIALS AND METHODS A. MATERIALS:

1. Test Material: Sporothrix flocculosa (produced by test facility) Description: MPCA Lot/ Batch #: UK34 35 Purity: toxicity range finding asay: 7. 5 x 10 8 cells/ mL or 1. 15 x 10 8 cfu/ mL infecitivity assay: 6. 0 x 10 8 cells/ mL or 3. 2 x 10 8 cfu/ mL CAS #: n/ a [2000 0680 and 2001 0304 / PLG] ~ PROTECTED ~ Acute Pulmonary Infectivity and Toxicity / 3 [Pseudozyma flocculosa / STF] DACO M4. 2. 3 / USEPA OPPTS 885.3150 Test substance homogeneity was determined by withdrawing aliquots from three locations (top, centre and bottom) of a 10 mL tube containing test substance in ASTM type 1 water. Samples from the three locations were plated in triplicate on YM plates. Colonies were counted after incubation for three days at 25  C. The average plate count of the triplicate samples taken from each location were comparable, indicating that the test substance was homogeneous throughout the volume of the tube.

2. Sample Preparation: Sporothrix flocculosa (batch number UK34 45) was provided to the test facility in the form of two petri dishes (P1 and P2) of yeast malt agar with white mould. IITRI then inoculated two malt agar plates (P3 and P4) with a colony from P1. One week prior to dosing in the toxicity range finding component of the study, 300 mL of yeast malt broth was inoculated with test substance from P4 and incubated at room temperature for seven days. On the day of dosing, the broth culture was centrifuged and the pellet was resuspended in 5 mL of ASTM type 1 water. The titre of the resuspended solution was determined to be 7. 5 x 10 8 cells/ mL by hemacytometer count (corresponding to 1. 15 x 10 8 cfu/ mL as determined by plate count). This solution was used undiluted for dosing. One week before the start of the infectivity assay, 300 mL of yeast malt broth was inoculated with test substance from P4 and incubated at room temperature for seven days. On the day of dosing, the broth culture was centrifuged and resuspended in 7 mL of ASTM type 1 water. The titre of the resuspended solution was determined to be 6. 0 x 10 8 cells/ mL by hemacytometer count. Half of the solution was heat treated for 20 minutes at approximately 82  C to render the active ingredient non viable and was used as KTS (killed test substance). The rest of the solution was used as TS (test substance). Both KTS and TS were plated to verify titre and inactivation, respectively. The titre of the TS solution was 3.2 x 10 8 cfu/ mL and the titre of the KTS solution was 0 cfu/ mL.

3. Test animals: Species / Strain: CD Rat Age/ weight at dosing: approximately 6 weeks of age males: 222.93  274.76 g females: 160.07  214.38 g Source: Charles River Laboratories Portage, MI Housing: The animals were housed 2/ cage in polypropylene cages with hardwood chip bedding. Animal rooms and cages were cleaned and sanitized prior to initiation of the study and cages were cleaned twice weekly thereafter. Control group animals (naive control and killed test substance dosed groups) were housed in one room while test substance dosed groups were housed in a second room. Diet: Certified Purina Rodent Chow 5002 (PMI Feeds Inc., St. Louis, MO) was provided ad libitum. Water: City of Chicago tap water was provided ad libitum. Environmental conditions: Temperature: Humidity: Air changes: Photoperiod: 18  25  C 27  70 % Not reported 12 hrs dark / 12 hrs light Acclimation period: One week acclimation period for animals used in toxicity range finding assay. Two week acclimation period for animals used in infectivity assay. [2000 0680 and 2001 0304 / PLG] ~ PROTECTED ~ Acute Pulmonary Infectivity and Toxicity / 4 [Pseudozyma flocculosa / STF] DACO M4. 2. 3 / USEPA OPPTS 885.3150 B. STUDY DESIGN and METHODS:

1. In life dates  October 9, 1996  October 14, 1996 (toxicity range finding assay) October 15. 1996  November 5, 1996 (infectivity assay)

2. Animal assignment and treatment  After one week of quarantine, three rats per sex were selected randomly, weighed and used in the 5 day preliminary range finding toxicity assay. Rats were anesthetized with ether and dosed intratracheally with 0. 1 mL of the test substance, containing 1. 15 x 10 7 cfu, prepared for the toxicity range finding assay. The rats were observed for five days post dosing.

For the infectivity assay, the remaining animals were weighed one week later and assigned to treatment groups such that no animal's body weight varied from the group mean body weight by more than 20%. Treatment groups included TS dosed rats, KTS dosed rats and a naive control (NC) group of rats. The number of animals and the sacrifice time for each of the test groups is shown in Table 1. The rats were anesthetized with ether, dosed intratracheally and observed for 14 days.

TABLE 1. Treatment, mortality/ animals treated Group Number Treatment Scheduled Sacrifice Mortality (# dead/ total)

Males Females Combined 1 TS b 0 0/ 4 0/ 4 0/ 8 2 KTS c 0 0/ 4 0/ 4 0/ 8 3 TS b 7 3/ 4 a 2/ 4 5/ 8 4 KTS c 7 4/ 4 4/ 4 8/ 8 5 TS b 14 0/ 4 a 0/ 4 0/ 8 6 KTS c 14 2/ 4 0/ 4 2/ 8 7 NC d 14 0/ 4 0/ 4 0/ 8 a one male rat in the group was inadvertently dosed twice b dosed with 0. 1 mL of TS containing 3. 2 x 10 7 cfu c dosed with 0.1 mL of KTS containing the equivalent of 3.2 x 10 7 cfu of heat killed active ingredient d naive control group 3. Body Weight  Animal body weights were determined upon receipt, prior to randomization, at the time of test substance dosing (day 0) and weekly thereafter.

4. Food Consumption  Food consumption was monitored when food was replenished. Average daily food consumption per rat was calculated.

5. Clinical Observations  Cageside observations were made daily during the toxicity range finding and infectivity assays.

6. Necropsies  Necropsies were performed upon death or at scheduled sacrifice times. Organ weights [2000 0680 and 2001 0304 / PLG] ~ PROTECTED ~ Acute Pulmonary Infectivity and Toxicity / 5 [Pseudozyma flocculosa / STF] DACO M4. 2. 3 / USEPA OPPTS 885.3150 (relative to body weights) were recorded. Gross observations of external features and internal organs and cavities of each animal were made.

7. Microbial Enumeration  Samples of blood (from surviving animals only), brain, caecum, kidney, liver, heart, lung and lymph nodes, spleen, stomach and small intestines were aseptically removed and placed in sterile blending bags containing 0. 1% peptone. The tissues were blended and aliquots were serially diluted in 0. 1% peptone and plated onto YM or MA (see study for determination sensitivity of detection). The plates were incubated for at least 72 hours at approximately 25  C. Counts were reported as viable cfu/ mL of blood or cfu/ gram of tissue.

8. Statistics  Mean body weights, cumulative body weight gains, average daily food consumption and organ weights (as a percentage of total body weight) were calculated for each combination of sex and treatment along with corresponding standard deviations. Treatment groups were compared using analysis of variance (ANOVA) followed, where appropriate, by Dunnett's test. A p  0.05 was considered significant for all statistical analyses.

II. RESULTS AND DISCUSSION:

A. Mortality  None of the three male and three female rats dosed in the range finding assay died during the 5 day observation period.

A total of 15 rats (3/ 8 male TS dosed rats, 6/ 8 male KTS dosed rats, 2/ 8 female TS dosed rats and 4/ 8 female KTS dosed rats) died on days 2 and 3 of the infectivity assay. These mortalities are summarized in Table 1. The male rat in group 3 that was inadvertently dosed twice was one of the rats that died.

The LC50 of S. flocculosa formalesis> 3.2 x 10 7 cfu/ animal. for females is > 3. 2 x 10 7 cfu/ animal combined is > 3. 2 x 10 7 cfu/ animal.

Thehigh spontaneousdeath ratein TS and KTS dosedratsmay havebeenpartiallydueto thelargesize of S. flocculosa. The higher death rate of KTS dosed versus TS dosed rats may have been due to toxins which were activated by the autoclaving step used to produce the KTS. Regardless of the cause of deaths, the large number of deaths made it difficult to properly assess the data collected in this study.

B. Clinical Observations  During the toxicity range finding assay, one female exhibited laboured respiration on the day of dosing. No other adverse clinical signs were observed in the other animals used for the toxicity range finding assay.

Results of clinical observations of the test animals over the course of the 14 day infectivity assay are summarized in Table2. Theseresultsincludethoseofanimalswhich weresacrificed on day0( 4 animals/ sex/ treatment group).

TABLE 2. Clinical Observations TS (12 animals / sex) KTS (12 animals / sex) NC (12 animals / sex)

Observation M F M F M F [2000 0680 and 2001 0304 / PLG] ~ PROTECTED ~ Acute Pulmonary Infectivity and Toxicity / 6 [Pseudozyma flocculosa / STF] DACO M4. 2. 3 / USEPA OPPTS 885.3150 founddead3 2 6 40 0 labouredrespiration3 1 1 40 0 hunchedposture0 1 0 00 0 roughhaircoat3 0 1 40 0 oculardischarge1 0 1 10 0 nasaldischarge2 0 1 20 0 lethargic1 0 0 00 0 no observed signs 7 11 11 7 4 4 Rough hair coat and laboured respiration was first observed between days 0  2 and persisted in some animals up until day 11. The onset of hunched posture, nasal discharge, ocular discharge and lethargy occurred between days 2  4 and persisted for only one to two days.

Of the 15 rats that died, only 6 exhibited adverse clinical symptoms prior to their death, and not all of the rats displaying symptoms died.

C. Body Weight  The body weights of a number of animals that died and the body weights of whole groups of animals on particular days were inadvertently not measured. These omissions in body weight measurements were considered a major deficiency. Based on the available data, mean body weights and body weight gains are summarized in Tables 3 and 4. Analysis of the limited data indicated no statistically significant differences in mean body weight or mean body weight gain between groups at the end of the 14day observation period.

Individual body weight data revealed that all animals that died prior to their scheduled sacrifice dates had lost a significant amount of weight (35. 74  63. 05 g for TS dosed rats; 30. 09  50. 26 g for KTS dosed rats) within two to three days after dosing.

Two female rats in the NC group were deprived of water during the second week of the study leading to a loss in weight. The duration of time for which these animals were deprived was not available.

TABLE 3. Mean Body Weights Body Weight (g)

Treatment Group Sex Parameter Day 0 Day 2 Day 3 Day 7 Day 14 TS M Mean SD N 261.63 12.79 12 200.62 7.67 2 191.21

1 267.1

1 317.96 48.17 4 KTS M Mean SD N 253.73 11.52 12 210.81 15.49 5

297.45 17.65 2 [2000 0680 and 2001 0304 / PLG] ~ PROTECTED ~ Acute Pulmonary Infectivity and Toxicity / 7 [Pseudozyma flocculosa / STF] DACO M4. 2. 3 / USEPA OPPTS 885.3150 NC M Mean SD N 254.20 13.88 4

338.24 27.08 4 TS F Mean SD N 192.39 10.80 12 145.75

1

242.71 32.94 2 233.01 9.74 4 KTS F Mean SD N 192.13 13.74 12 157.03 2.01 2

225.32 21.93 4 NC F Mean SD N 191.33 9.72 4

190.96 50.39 4  data not available due to spontaneous deaths, death of all animals in group or missed body weight measurements TABLE 4. Mean Body Weight Gains Total Gain (g)

Treatment Group Sex Parameter Day 0  14 TS M Mean SD N 68.13 29.52 4 KTS M Mean SD N 56.88 23.01 2 NC M Mean SD N 84.04 17.16 4 TS F Mean SD N 41.35 2.86 4 KTS F Mean SD N 30.18 15.27 4 NC F Mean SD N 0.38 53.19 4 D. Food Consumption  Food consumption data are presented in Table 5. Food consumption was not determined for animals which died prior to their scheduled sacrifice dates. Analysis of the limited data indicated no statistically significant differences between treatment groups.

TABLE 5. Average Daily Food Consumption [2000 0680 and 2001 0304 / PLG] ~ PROTECTED ~ Acute Pulmonary Infectivity and Toxicity / 8 [Pseudozyma flocculosa / STF] DACO M4. 2. 3 / USEPA OPPTS 885.3150 Treatment Group Sex Parameter Average Daily Consumption (g)

TS M Mean SD N 23.0 4.6 5 KTS M Mean SD N 20.6 1.6 4 NC M Mean SD N 25.9 1.6 4 TABLE 5. Average Daily Food Consumption contd.

Treatment Group Sex Parameter Average Daily Consumption (g)

TS F Mean SD N 16.3 2.1 6 KTS F Mean SD N 15.1 3.3 4 NC F Mean SD N 15.6 3.6 4 E. Necropsy Results  Lung lesions were observed in TS and KTS dosed animals and in both animals that died prior to their scheduled sacrifice dates and those that survived until sacrifice. Other lesions in the spleen, liver and kidney were observed primarily in the animals that died. Three of the 15 animals that died exhibited no gross lesions. No lesions were found in any of the NC animals or in any of the 4/ sex TS and KTS dosed animals sacrificed post dosing on day 0. Necropsy findings are summarized in Table 6.

TABLE 6. Necropsy Findings TS( 12 animals/ sex) KTS( 12 animals/ sex) NC(4 animals/ sex)

Organ observation M FMFMF Kidneys confluent dark 1––––– Liver confluent dark diffuse dark red foci, diffuse dark red 1 – – – – – – – 1 – 1 – – – – – – – [2000 0680 and 2001 0304 / PLG] ~ PROTECTED ~ Acute Pulmonary Infectivity and Toxicity / 9 [Pseudozyma flocculosa / STF] DACO M4. 2. 3 / USEPA OPPTS 885.3150 Lung cyst diffuse red lesion enlarged focus, multiple dark red granular, diffuse dark red mass pigmentation, mottled single red lesion focus, multiple diffuse 1 1 2 – – 1 – 1 – – 1 1 – – 2 – – – 1 – 1 – 1 – 1 – 1 2 – 3 – 1 – – – – – – – – – – – – – – – – – – – – – – Spleen confluent dark enlarged nodule, multiple 1 – – – – – – 1 – – 1 1 – – – – – – No gross lesions 78 7 4 44 F. Organ Weights  The effectsoftestsubstance onrelative organweightsaresummarizedinTables7 and 8. Relative organ weights were not calculated for 1 KTS dosed male, 1 TS dosed female and 2 KTSdosed females were not calculated since their body weights were inadvertently not taken at the time of their spontaneous deaths.

Statistical analysis was conducted only on Day 14 data as relative organ weights of NC rats were only available for Day 14. The relative weights of the lungs and lymph nodes of TS and KTS dosed male rats and KTS dosed female rats were significantly increased compared to their NC counterparts. The KTSdosed rats also had significantly increased relative spleen weights as compared to NC animals.

TABLE 7. Relative Organ Weights of Male Rats Relative Organ Weight (%) a Treatment Group Day Parameter Lungs and Lymph Nodes Spleen Kidneys Liver Heart Stomach and Small Intestine Caecum Brain TS 0 Mean SD N 0.588 0.0399 4 0.234 0.0231 4 1.041 0.0432 4 4.781 0.1789 4 0.497 0.0995 4 5.812 1.0454 4 2.246 0.2904 4 0.788 0.0495 4 KTS 0 Mean SD N 0.783 0.1431 4 0.268 0.0303 4 1.019 0.0695 4 5.217 0.1936 4 0.448 0.0297 4 5.954 1.4792 4 2.188 0.3856 4 0.768 0.0304 4 TS 2 Mean SD N 0.3288 0.3103 2 0.313 0.0568 2 1.298 0.1407 2 6.476 0.0102 2 0.555 0.2100 2 5.835 1.7558 2 0.861 0.0411 2 1.004 0.0183 2 KTS b 2 Mean SD N 2.978 0.2469 5 0.323 0.0434 5 1.252 0.1407 5 6.085 0.6457 5 0.414 0.0360 5 3.136 1.3865 5 1.128 0.2886 5 0.910 0.0263 5 [2000 0680 and 2001 0304 / PLG] ~ PROTECTED ~ Acute Pulmonary Infectivity and Toxicity / 10 [Pseudozyma flocculosa / STF] DACO M4. 2. 3 / USEPA OPPTS 885.3150 TS 3 Mean SD N 3.962 – 1 0.538 – 1 1.311 – 1 7.137 – 1 0.467 – 1 1.545 – 1 0.882 – 1 0.966 – 1 TS 7 Mean SD N 1.201 – 1 0.352 – 1 0.999 – 1 4.444 – 1 0.638 – 1 5.560 – 1 1.962 – 1 0.776 – 1 TS 14 Mean SD N 1.378* 0.4414 4 0.281 0.0324 4 0.903 0.0534 4 4.407 0.2441 4 0.396 0.0406 4 2.783 0.7500 4 2.637 0.4895 4 0.646 0.1204 4 KTS 14 Mean SD N 1.524* 0.5578 2 0.617* 0.3987 2 0.994 0.0628 2 4.678 0.7775 2 0.364 0.0047 2 3.544 0.4449 2 2.333 0.1315 2 0.698 0.0024 2 NC 14 Mean SD N 0.738 0.2227 4 0.199 0.0172 4 0.920 0.0448 4 4.778 0.3979 4 0.401 0.0345 4 3.339 0.1582 4 2.411 0.4032 4 0.578 0.0543 4 a Relative organ weight = [absolute organ weight (g) / body weight (g)] x 100% b Mean and standard deviation calculated for only 5/ 6 rats which died on day 2. The body weight of the 6 th animal was inadvertently not taken. *statistically significant from NC, p  0. 05 (ANOVA and Dunnett's test performed on Day 14 data only)

TABLE 8. Relative Organ Weights of Female Rats Relative Organ Weight (%) a Treatment Group Day Parameter Lungs and Lymph Nodes Spleen Kidneys Liver Heart Stomach and Small Intestine Caecum Brain TS 0 Mean SD N 0.686 0.0858 4 0.228 0.0329 4 0.960 0.0438 4 0.4271 0.5159 4 0.485 0.0486 4 5.218 0.5456 4 2.309 0.1835 4 0.994 0.0427 4 KTS 0 Mean SD N 0.854 0.0835 4 0.242 0.0339 4 0.870 0.0834 4 4.355 0.3931 4 0.416 0.0174 4 4.588 1.3688 4 2.293 0.4117 4 0.932 0.0908 4 TS 2 Mean SD N 3.862 – 1 0.297 – 1 1.260 – 1 5.777 – 1 0.428 – 1 3.683 – 1 1.164 – 1 1.215 – 1 KTS 2 Mean SD N 3.207 0.3977 2 0.274 0.0094 2 1.250 0.0822 2 5.959 0.1208 2 0.425 0.0355 2 4.916 3.2068 2 0.896 0.1083 2 1.154 0.0613 2 TS 3 Mean SD N ND b ND 1 ND ND 1 ND ND 1 ND ND 1 ND ND 1 ND ND 1 ND ND 1 ND ND 1 KTS 3 Mean SD N ND ND 2 ND ND 2 ND ND 2 ND ND 2 ND ND 2 ND ND 2 ND ND 2 ND ND 2 [2000 0680 and 2001 0304 / PLG] ~ PROTECTED ~ Acute Pulmonary Infectivity and Toxicity / 11 [Pseudozyma flocculosa / STF] DACO M4. 2. 3 / USEPA OPPTS 885.3150 TS 7 Mean SD N 1.247 0.2855 2 0.312 0.0065 2 0.825 0.2751 2 3.763 1.1773 2 0.380 0.0169 2 4.850 1.4324 2 1.661 0.0163 2 0.795 0.0829 2 TS 14 Mean SD N 1.271 0.1771 4 0.360 0.0802 4 0.896 0.0570 4 4.197 0.2994 4 0.441 0.1002 4 3.203 0.1360 4 2.345 0.2067 4 0.799 0.0947 4 KTS 14 Mean SD N 1.645* 0.4418 4 0.761* 0.3774 4 0.976 0.1646 4 4.865 0.7747 4 0.415 0.0561 4 3.284 0.4018 4 2.265 0.6521 4 0.832 0.1178 4 NC 14 Mean SD N 0.891 0.1105 4 0.218 0.0296 4 1.127 0.1010 4 4.370 0.3211 4 0.449 0.0684 4 5.175 2.2565 4 1.739 0.5391 4 1.006 0.2046 4 a Relative organ weight = [absolute organ weight (g) / body weight (g)] x 100% b ND  not determined; body weight not determined *statistically significant from NC, p  0. 05 (ANOVA and Dunnett's test performed on Day 14 data only)

G. Microbial Enumeration  Enumeration of the test substance from various organs and blood is summarized in Tables 9 and 10. No test substance was recovered from any NC or KTS dosed animals. Viable S. flocculosa was recovered only from the lungs and lymph nodes (day 0) and the stomach and small intestines (day 0 and day 2) from TS dosed animals.

TABLE 9. Recovery of Sporothrix flocculosa from Selected Tissues and Blood of Male Rats Log [( cfu/ g of tissue) + 1] or Log [( cfu/ mL of blood) + 1]

Group Day Parameter Blood Lung & Lymph Nodes Spleen Kidneys Liver Heart Stomach & Small Intestine Caecum Brain TS 0 Mean SD GeoMn b N BDL a BDL BDL 4 7.239 0.322 1.73 x 10 7 4 BDL BDL BDL 4 BDL BDL BDL 4 BDL BDL BDL 4 BDL BDL BDL 4 4.320 0.667 2.09 x 10 4 4 BDL BDL BDL 4 BDL BDL BDL 4 KTS 0 Mean SD GeoMn N BDL BDL BDL 4 BDL BDL BDL 4 BDL BDL BDL 4 BDL BDL BDL 4 BDL BDL BDL 4 BDL BDL BDL 4 BDL BDL BDL 4 BDL BDL BDL 4 BDL BDL BDL 4 TS 2 Mean SD GeoMn N ND c ND ND 2 BDL BDL BDL 2 BDL BDL BDL 2 BDL BDL BDL 2 BDL BDL BDL 2 BDL BDL BDL 2 1.791 2.533 6.18 x 10 1 2 BDL BDL BDL 2 BDL BDL BDL 2 KTS 2 Mean SD GeoMn N ND ND ND 6 BDL BDL BDL 6 BDL BDL BDL 6 BDL BDL BDL 6 BDL BDL BDL 6 BDL BDL BDL 6 BDL BDL BDL 6 BDL BDL BDL 6 BDL BDL BDL 6 [2000 0680 and 2001 0304 / PLG] ~ PROTECTED ~ Acute Pulmonary Infectivity and Toxicity / 12 [Pseudozyma flocculosa / STF] DACO M4. 2. 3 / USEPA OPPTS 885.3150 TS 3 Mean SD ND ND ND 1 BDL

1 BDL

1 BDL

1 BDL

1 BDL

1 BDL

1 BDL

1 BDL GeoMn N 1 TS 7 Mean SD BDL

1 BDL

1 BDL

1 BDL

1 BDL

1 BDL

1 BDL

1 BDL

1 BDL GeoMn N 1 TS 14 Mean SD GeoMn N BDL BDL BDL 4 BDL BDL BDL 4 BDL BDL BDL 4 BDL BDL BDL 4 BDL BDL BDL 4 BDL BDL BDL 4 BDL BDL BDL 4 BDL BDL BDL 4 BDL BDL BDL 4 KTS 14 Mean SD GeoMn N BDL BDL BDL 2 BDL BDL BDL 2 BDL BDL BDL 2 BDL BDL BDL 2 BDL BDL BDL 2 BDL BDL BDL 2 BDL BDL BDL 2 BDL BDL BDL 2 BDL BDL BDL 2 NC 14 Mean SD GeoMn N BDL BDL BDL 4 BDL BDL BDL 4 BDL BDL BDL 4 BDL BDL BDL 4 BDL BDL BDL 4 BDL BDL BDL 4 BDL BDL BDL 4 BDL BDL BDL 4 BDL BDL BDL 4 a BDL  below detection limit b GeoMn  geometric mean of cfu/ tissue or cfu/ mL c ND  not done TABLE 10. Recovery of Sporothrix flocculosa from Selected Tissues and Blood of Female Rats Log [( cfu/ g of tissue) + 1] or Log [( cfu/ mL of blood) + 1]

Group Day Parameter Blood Lung & Lymph Nodes Spleen Kidneys Liver Heart Stomach & Small Intestine Caecum Brain TS 0 Mean SD GeoMn b N BDL a BDL BDL 4 7.014 0.354 1.03 x 10 7 4 BDL BDL BDL 4 BDL BDL BDL 4 BDL BDL BDL 4 BDL BDL BDL 4 3.867 0.553 7.35 x 10 3 4 BDL BDL BDL 4 BDL BDL BDL 4 KTS 0 Mean SD GeoMn N BDL BDL BDL 4 BDL BDL BDL 4 BDL BDL BDL 4 BDL BDL BDL 4 BDL BDL BDL 4 BDL BDL BDL 4 BDL BDL BDL 4 BDL BDL BDL 4 BDL BDL BDL 4 TS 2 Mean SD ND c ND ND 1 BDL

1 BDL

1 BDL

1 BDL

1 BDL

1 3.202

1.59 x 10 3 1 BDL

1 BDL GeoMn N 1 KTS 2 Mean SD GeoMn N ND ND ND 2 BDL BDL BDL 2 BDL BDL BDL 2 BDL BDL BDL 2 BDL BDL BDL 2 BDL BDL BDL 2 BDL BDL BDL 2 BDL BDL BDL 2 BDL BDL BDL 2 [2000 0680 and 2001 0304 / PLG] ~ PROTECTED ~ Acute Pulmonary Infectivity and Toxicity / 13 [Pseudozyma flocculosa / STF] DACO M4. 2. 3 / USEPA OPPTS 885.3150 TS 3 Mean SD ND ND ND 1 BDL

1 BDL

1 BDL

1 BDL

1 BDL

1 BDL

1 BDL

1 BDL GeoMn N 1 KTS 3 Mean SD GeoMn N ND ND ND 2 BDL BDL BDL 2 BDL BDL BDL 2 BDL BDL BDL 2 BDL BDL BDL 2 BDL BDL BDL 2 BDL BDL BDL 2 BDL BDL BDL 2 BDL BDL BDL 2 TS 7 Mean SD GeoMn N BDL BDL BDL 2 BDL BDL BDL 2 BDL BDL BDL 2 BDL BDL BDL 2 BDL BDL BDL 2 BDL BDL BDL 2 BDL BDL BDL 2 BDL BDL BDL 2 BDL BDL BDL 2 TS 14 Mean SD GeoMn N BDL BDL BDL 4 BDL BDL BDL 4 BDL BDL BDL 4 BDL BDL BDL 4 BDL BDL BDL 4 BDL BDL BDL 4 BDL BDL BDL 4 BDL BDL BDL 4 BDL BDL BDL 4 KTS 14 Mean SD GeoMn N BDL BDL BDL 4 BDL BDL BDL 4 BDL BDL BDL 4 BDL BDL BDL 4 BDL BDL BDL 4 BDL BDL BDL 4 BDL BDL BDL 4 BDL BDL BDL 4 BDL BDL BDL 4 NC 14 Mean SD GeoMn N BDL BDL BDL 4 BDL BDL BDL 4 BDL BDL BDL 4 BDL BDL BDL 4 BDL BDL BDL 4 BDL BDL BDL 4 BDL BDL BDL 4 BDL BDL BDL 4 BDL BDL BDL 4 a BDL  below detection limit b GeoMn  geometric mean of cfu/ tissue or cfu/ mL c ND  not done H. Reviewer's Conclusions  Among the animals whose scheduled sacrifice dates were on days 7 or 14, laboured respiration was observed in 3/ 8 TS dosed male rats, 1/ 8 TS dosed female rats, 1/ 8 KTS dosed male rats and 4/ 8 KTS dosed female rats. Laboured respiration was first noted in some animals on day 2 and, in some cases, would re occur sporadically up to day 11. The posture of one female TS dosed animal was hunched on day 2. Rough hair coat was observed as early as on day 0 and up until day 11 in 3/ 8 TSdosed male rats, 1/ 4 KTS dosed male rats and 4/ 8 KTS dosed female rats. One rat from each of the male TS dosed, male KTS dosed and female KTS dosed groups had ocular discharge. Nasal discharge was noted in 2/ 8 male TS dosed rats, 1/ 8 KTS dosed rat and 2/ 8 female KTS dosed rats. Ocular and nasal discharge occurred between days 2  3. One male TS dosed rat appeared lethargic on day 4. The presence or absence of clinical symptoms were not indicative of spontaneous deaths.

Due to the large number of spontaneous deaths (3/ 8 male TS dosed rats, 6/ 8 male KTS dosed rats, 2/ 8 female TS dosed rats and 4/ 8 female KTS dosed rats) and a number of missed data collections, data for evaluating body weights, food consumption and relative organ weight were limited. At the end of the 14day long study, administration of S. flocculosa did not have a statistically significant effect on body weight. Analysis of daily food consumption and relative organ weights was skewed as it was not determined or did not include animals that died prior to their scheduled sacrifice dates.

At necropsy, lesions and enlargement of the lung were observed in 6/ 12 male TS dosed rats, 5/ 12 male KTS dosed rats, 4/ 12 female TS dosed rats and 6/ 12 female KTS dosed rats. Confluent dark areas were seen in the kidneys of one male TS dosed rat. Lesions and enlargement of the spleen were noted in 1/ 12 [2000 0680 and 2001 0304 / PLG] ~ PROTECTED ~ Acute Pulmonary Infectivity and Toxicity / 14 [Pseudozyma flocculosa / STF] DACO M4. 2. 3 / USEPA OPPTS 885.3150 male TS and KTS dosed rats and 2/ 12 female KTS dosed rats. Lung lesions were observed in one animal from each of the male TS dosed, male KTS dosed and female KTS dosed groups. These necropsy findings were considered consistent with the method of dosing and the body's normal immunological response to a foreign substance.

Sporothrix flocculosa was detected in the lungs and lymph nodes and the stomach and small intestine of TS dosed animals only. Counts in these tissues were below the limit of detection by day 7.

A number of explanations could be provided for the significant number of deaths of both TS and KTSdosed Both viable and heat killed test substance may have been toxic. Clinical observations (i. e., laboured breathing) and gross necropsy findings (i. e., lung abnormalities) may have been the result of pulmonary blockage following intratracheal administration of either TS or KTS. The higher death rate of KTS dosed versus TS dosed rats may have been due to toxins which were activated by the autoclaving step used to produce the KTS. The relatively large size of the test substance may have contributed to the deaths. An alternative explanation may be a possible problem with the dosing technique, as indicated by the presence of S. flocculosa in the stomach and small intestines on day 0, since none of the undosed NC group animals died prior to their scheduled sacrifice dates. The probability of a dosing error was reinforced by a subsequent acute pulmonary range finding study (see review for separate Acute Pulmonary  Range Finding Study) in which no deaths were observed despite a higher dose of TS.

Based on this study, S. flocculosa is toxic, but not infective or pathogenic, at the dose administered when introduced by the intratracheal route to male and female CD rats. This study, however, is classified as unacceptable due to major deficiencies in the collected data. According to USEPA OPPTS 885.3150, the minimum dose level is 10 8 cfu per animal. Animals in this study were only dosed with 3. 2 x 10 7 cfu. Furthermore, the test substance used in this study was not the technical grade active ingredient (as recommended by USEPA OPPTS 885.3150) but was instead prepared by the test facility using a method different from the proposed manufacturing method. The applicant has agreed, however, to upgraded label statements requiring a respirator for all workers and bystanders during times of potential exposure.

I. Deficiencies  In addition to the deficiencies already noted above, the number of air changes was not reported. This additional deficiency is not considered to have any impact on the interpretation of this study.


UNITED STATES OF AMERICA

DEPARTMENT OF TRANSPORTATION

OFFICE OF THE SECRETARY

WASHINGTON, D.C.

Issued by the Department of Transportation on October 13, 2005

NOTICE OF ACTION TAKEN -- DOCKET OST-2004-18718

________________________________________________________________________
________________________________________________________

This serves as notice to the public of the action described below, taken
by the Department official indicated (no additional confirming order
will be issued in this matter).

Joint Applicants:  COMPANIA MEXICANA de AVIACION, S.A. de C.V.
(Mexicana)	&		Date Filed:  July 12, 2005

	                AEROVIAS de MEXICO, S.A. de C.V. (Aeromexico)

Relief requested:  Renewal of exemption from 49 USC § 41301 to permit
Mexicana to conduct scheduled, combination services between:  1) Mexico
City, Mexico, and Boston, Massachusetts; and 2) San Jose del Cabo,
Mexico, and Ontario, California.  These services would be conducted
under a codeshare arrangement with Aeromexico, only on flights operated
by Aeromexico.

Renewal of exemption from 49 U.S.C. § 41301 to permit Aeromexico to
conduct scheduled, combination services between Guadalajara, Mexico, and
the three U.S. coterminal points Portland, Oregon, Sacramento,
California, and San Jose, California.  These services would be conducted
under a codeshare arrangement with Mexicana, only on flights operated by
Mexicana.

If renewal, date and citation of last action:  August 4, 2004, in this
Docket.

Applicant representatives:  Charles F. Donley II,<PHONE_NUMBER>
(Mexicana) & 	      DOT analyst:  Robert J. Finamore,<PHONE_NUMBER>

                                            William C. Evans,
202-861-6459 (Aeromexico)

Responsive pleadings:  None

	DISPOSITION

Action:  Approved. (See remarks below).						Action date:  October 13,
2005

Effective dates of authority granted:  October 13, 2005, through October
13, 2006.

Basis for approval (bilateral agreement/reciprocity): United
States-Mexico Air Transport Services Agreement (“the Agreement”).

Except to the extent exempted/waived, this authority is subject to the
terms, conditions, and limitations of our standard exemption and
codeshare conditions (attached).  In addition, Mexicana shall adhere to
the otherwise applicable terms, conditions, and limitations of its
foreign air carrier permit (Order 78-6-127), and Aeromexico shall adhere
to the otherwise applicable terms, conditions, and limitations of its
foreign air carrier permit (Order 91-5-25).

Special conditions/Remarks:  In the conduct of the authorized
operations, Mexicana and Aeromexico must adhere to all applicable
provisions of the Agreement.  Mexicana may only conduct the Mexico
City-Boston and San Jose del Cabo-Ontario services authorized above,
under a codeshare arrangement with Aeromexico, only on flights operated
by Aeromexico.  Additionally, Aeromexico may only conduct the
Guadalajara-Portland/Sacramento/San Jose services authorized above under
a codeshare arrangement with Mexicana, only on flights operated by
Mexicana.

Action taken by:   Paul L. Gretch, Director

		 Office of International Aviation

________________________________________________________________________
_________________

Under authority assigned by the Department in its regulations, 14 CFR
Part 385, we found that (1) our action was consistent with Department
policy; (2) the applicant was qualified to perform its proposed
operations; (3) grant of the authority was consistent with the public
interest; and (4) grant of the authority would not constitute a major
regulatory action under the Energy Policy and Conservation Act of 1975.
To the extent not granted/deferred/dismissed, we denied all requests in
the referenced Docket.  We may amend, modify, or revoke the authority
granted in this Notice at any time without hearing at our discretion.

Persons entitled to petition the Department for review of the action set
forth in this Notice under the Department’s regulations, 14 CFR
§385.30, may file their petitions within seven (7) days after the date
of issuance of this Notice.  This action was effective when taken, and
the filing of a petition for review will not alter such effectiveness.

An electronic version of this document is available on the World Wide
Web at:

http://dms.dot.gov//reports/reports_aviation.asp

FOREIGN CARRIER EXEMPTION CONDITIONS
                              			ATTACHMENT

In the conduct of the operations authorized, the foreign carrier
applicant(s) shall:

1) Not conduct any operations unless it holds a currently effective
authorization from its homeland for such operations, and it has filed a
copy of such authorization with the Department;

2) Comply with all applicable requirements of the Federal Aviation
Administration, including, but not limited to, 14 CFR Parts 129, 91, and
36, and with all applicable U.S. Government requirements concerning
security, including, but not limited to, 49 CFR Part 1546 or 1550, as
applicable.  To assure compliance with all applicable U.S. Government
requirements concerning security, the holder shall, before commencing
any new service (including charter flights) from a foreign airport that
would be the holder’s last point of departure for the United States,
contact its International Principal Security Inspector (IPSI) to advise
the IPSI of its plans and to find out whether the Transportation
Security Administration has determined that security is adequate to
allow such airport(s) to be served;

3) Comply with the requirements for minimum insurance coverage contained
in 14 CFR Part 205, and, prior to the commencement of any operations
under this authority, file evidence of such coverage, in the form of a
completed OST Form 6411, with the Federal Aviation Administration’s
Program Management Branch (AFS-260), Flight Standards Service (any
changes to, or termination of, insurance also shall be filed with that
office);

4) Not operate aircraft under this authority unless it complies with
operational safety requirements at least equivalent to Annex 6 of the
Chicago Convention;

5) Conform to the airworthiness and airman competency requirements of
its Government for international air services;

6) Except as specifically exempted or otherwise provided for in a
Department Order, comply with the requirements of 14 CFR Part 203,
concerning waiver of Warsaw Convention liability limits and defenses;

7) Agree that operations under this authority constitute a waiver of
sovereign immunity, for the purposes of 28 U.S.C. 1605(a), but only with
respect to those actions or proceedings instituted against it in any
court or other tribunal in the United States that are: a) based on its
operations in international air transportation that, according to the
contract of carriage, include a point in the United States as a point of
origin, point of destination, or agreed stopping place, or for which the
contract of carriage was purchased in the United States; or b) based on
a claim under any international agreement or treaty cognizable in any
court or other tribunal of the United States.  In this condition, the
term “international air transportation” means “international
transportation” as defined by the Warsaw Convention, except that all
States shall be considered to be High Contracting Parties for the
purpose of this definition;

8) Except as specifically authorized by the Department, originate or
terminate all flights to/from the United States in its homeland;

9) Comply with the requirements of 14 CFR Part 217, concerning the
reporting of scheduled, nonscheduled, and charter data;

10) If charter operations are authorized, except as otherwise provided
in the applicable aviation agreement, comply with the Department’s
rules governing charters (including 14 CFR Parts 212 and 380); and

11) Comply with such other reasonable terms, conditions, and limitations
required by the public interest as may be prescribed by the Department,
with all applicable orders or regulations of other U.S. agencies and
courts, and with all applicable laws of the United States.

This authority shall not be effective during any period when the holder
is not in compliance with the conditions imposed above.  Moreover, this
authority cannot be sold or otherwise transferred without explicit
Department approval under Title 49 of the U.S. Code.

 05/2004

Mexicana/Aeromexico Code-Share Conditions (OST-2004-18718)

The codeshare operations authorized here are subject to the following
conditions:

(a)  The statement of authorization will remain in effect only as long
as (i) Mexicana and Aeromexico continue to hold the necessary underlying
authority to operate the codeshare services at issue, and (ii) the
codeshare agreement providing for the codeshare operations remains in
effect.

(b) Mexicana and/or Aeromexico must promptly notify the Department if
the codeshare agreement providing for the codeshare operations is no
longer effective or the carriers decide to cease operating any or all of
the approved codeshare services.    We expect this notification to be
received within 10 days of such non-effectiveness or of such decision.
Such notices should be filed in docket OST-2004-18718.

(c)  The codesharing operations conducted under this authority must
comply with 14 C.F.R. Part 257 and with any amendments to the
Department’s regulations concerning codeshare arrangements that may be
adopted.  Notwithstanding any provisions in the contract between the
carriers, our approval here is expressly conditioned upon the
requirements that the subject foreign air transportation be sold in the
name of the carrier holding out such service in computer reservation
systems and elsewhere; that the carrier selling such transportation
(i.e., the carrier shown on the ticket) accept responsibility for the
entirety of the codeshare journey for all obligations established in its
contract of carriage with the passenger; and that the passenger
liability of the operating carrier be unaffected.

(d)  The authority granted here is specifically conditioned so that
neither Mexicana or Aeromexico shall give any force or effect to any
contractual provisions between themselves that are contrary to these
conditions.

We may amend, modify, or revoke this authority at any time without
hearing, at our discretion.


[Federal Register: December 27, 2007 (Volume 72, Number 247)]
[Notices]
[Page 73392-73393]
[DOCID:fr27de07-106]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-56984; File No. SR-NYSE-2007-110]

Self-Regulatory Organizations; New York Stock Exchange LLC;
Notice of Filing of a Proposed Rule Change as Modified by Amendment No.
1 Thereto To Amend Listing Fees for Structured Products, Short-Term
Securities, and Debt Securities

December 18, 2007.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on November 28, 2007, New York Stock Exchange, LLC (the ``NYSE'' or the
``Exchange'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been substantially prepared by the
Exchange. On December 17, 2007, NYSE filed Amendment No. 1 to the
proposed rule change. The Commission is publishing this notice to
solicit comments on the proposed rule change, as amended, from
interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

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

    The Exchange proposes to alter the listing fees applicable to
structured products, short-term securities, and debt securities. The
text of the proposed rule change is available at the Exchange's
principal office, in the Commission's Public Reference Room, and at
http://www.nyse.com.

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

    In its filing with the Commission, NYSE 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. NYSE 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 Exchange proposes to amend Section 902 of the Listed Company
Manual to alter the Exchange's listing fees applicable to structured
products, short-term securities, and debt securities. This filing does
not amend the listing fees applicable to equity securities of operating
companies.
    Annual fees for structured products (Section 902.05) and short-term
securities (Section 902.06) are currently subject to a minimum fee of
$5,000 per year. The Exchange proposes to charge a supplement to the
2008 Annual Fees for the period from February 1, 2008, until year end.
An issuer that would pay less than $15,000 in Annual Fees for 2008
would be required to pay a supplemental amount equal to the difference
between its Annual Fee and $15,000. For 2009 and thereafter, the
Exchange would increase the minimum annual fee to $15,000, as the
Exchange believes that this is more appropriate than the current $5,000
minimum in light of the costs it incurs in connection with the listing
of such securities. Annual fees will not be increased for short-term
warrants to purchase equity securities (which would continue to be
subject to a $5,000 minimum annual fee) and such warrants would not be
subject to the supplemental payment for 2008.
    The Exchange currently applies the debt securities fee schedule set
forth in Section 902.08 to securities listed under Section 703.19 and
traded on NYSE Bonds. The Exchange proposes to amend Section 902.08 to
impose a flat initial listing fee of $15,000 on all structured products
(including short-term securities) listed under Section 703.19 and
traded on NYSE Bonds. Currently, NYSE-listed companies and their
affiliates pay no fees on structured products that trade on NYSE Bonds;
the new proposed $15,000 initial listing fee would apply to all
structured products listed on NYSE Bonds going forward. Section 902.08
would also be amended to impose a $15,000 initial listing fee on
securities listed under the debt standard of Section 102.03 in place of
the current fees. Debt listed under Section 102.03 of NYSE equity
issuers and affiliated companies and of issuers exempt from
registration under the Exchange Act would continue to be exempt from
listing fees.
2. Statutory Basis
    The proposed rule change is consistent with Section 6(b) of the
Exchange Act \3\ in general, and furthers the objectives of Section
6(b)(5) \4\ in particular in that it is designed to prevent fraudulent
and manipulative acts and practices, to promote just and equitable
principles of trade, to foster cooperation and coordination with
persons engaged in facilitating transactions in securities, and to
remove impediments to and perfect the mechanisms of a free and open
market and a national market system.
---------------------------------------------------------------------------

    \3\ 15 U.S.C. 78f(b).
    \4\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

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

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

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

    Written comments were neither solicited nor received.

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

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

IV. Solicitation of Comments

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

Electronic Comments

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

File Number SR-NYSE-2007-110 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NYSE-2007-110. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml
). Copies of the submission, all subsequent amendments, all

written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for inspection and
copying in the Commission's Public Reference Room, 100 F Street, NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at the principal office of NYSE. 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-NYSE-2007-110 and should be
submitted on or before January 17, 2008.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\5\
---------------------------------------------------------------------------

    \5\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Deputy Secretary.
 [FR Doc. E7-24985 Filed 12-26-07; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register: May 4, 2010 (Volume 75, Number 85)]
[Notices]
[Page 23755-23756]
[DOCID:fr04my10-76]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 1

April 22, 2010.
    Take notice that the Commission received the following exempt
wholesale generator filings:

    Docket Numbers: EG10-36-000.
    Applicants: Otay Acquisition Company, LLC.
    Description: Notice of Self-Certification of Exempt Wholesale
Generator Status of Otay Acquisition Company, LLC.
    Filed Date: 04/22/2010.
    Accession Number: 20100422-5110.
    Comment Date: 5 p.m. Eastern Time on Thursday, May 13, 2010.

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

    Docket Numbers: ER00-2885-029; ER01-2765-028; ER02-2102-028; ER05-
1232-025; ER07-1358-015; ER09-1141-008.
    Applicants: J.P. Morgan Ventures Energy Corporation, BE Louisiana
LLC, Cedar Brakes I, L.L.C., Utility Contract Funding, L.L.C., Cedar
Brakes II, L.L.C., J.P. Morgan Commodities Canada Corporation.
    Description: J.P. Morgan submits supplement to notice of change in
status.
    Filed Date: 04/16/2010.
    Accession Number: 20100421-0034.
    Comment Date: 5 p.m. Eastern Time on Friday, May 7, 2010.

    Docket Numbers: ER01-424-011; ER01-313-011.
    Applicants: Pacific Gas and Electric Company; California
Independent System Operator Corporation.
    Description: Refund Report of the California Independent System
Operator Corporation.
    Filed Date: 04/21/2010.
    Accession Number: 20100421-5180.
    Comment Date: 5 p.m. Eastern Time on Wednesday, May 12, 2010.

    Docket Numbers: ER07-771-004.
    Applicants: E.ON U.S., LLC.
    Description: E.ON U.S. LLC Annual true-up filing under Open Access
Transmission Tariff.
    Filed Date: 04/22/2010.
    Accession Number: 20100422-5159.
    Comment Date: 5 p.m. Eastern Time on Thursday, May 13, 2010.

    Docket Numbers: ER09-1051-003.
    Applicants: ISO New England Inc., New England Power Pool
    Description: ISO New England, Inc et al submits response to the
compliance requirements set forth in the Jan 21 Order.
    Filed Date: 04/21/2010.
    Accession Number: 20100422-0202.
    Comment Date: 5 p.m. Eastern Time on Wednesday, May 12, 2010.

    Docket Numbers: ER10-1071-000.
    Applicants: Midwest Independent Transmission System Operator, Inc.
    Description: Midwest Independent Transmission System Operator, Inc
submits an executed Amended and Restated Generator Interconnection
Agreement etc.
    Filed Date: 04/21/2010.
    Accession Number: 20100421-0203.
    Comment Date: 5 p.m. Eastern Time on Wednesday, May 12, 2010.

    Docket Numbers: ER10-1072-000.
    Applicants: Westar Energy, Inc.
    Description: Westar Energy, Inc. submits Supplemental Generation
Agreements between Westar and the Cities of Herington and Wamego,
Kansas designated as Rate Schedule FERC 338 and 339.
    Filed Date: 04/21/2010.
    Accession Number: 20100421-0209.
    Comment Date: 5 p.m. Eastern Time on Wednesday, May 12, 2010.

    Docket Numbers: ER10-1073-000.
    Applicants: Electrade Corporation.
    Description: Electrade Corporation submits tariff filing per 35.12:
Baseline Tariff Filing to be effective 4/21/2010.
    Filed Date: 04/21/2010.
    Accession Number: 20100421-5112.
    Comment Date: 5 p.m. Eastern Time on Wednesday, May 12, 2010.

    Docket Numbers: ER10-1074-000; ER10-1075-000; ER10-1076-000.
    Applicants: Raven One, LLC; Raven Two, LLC; Raven Three, LLC
    Description: Raven One, LLC et al submits notice of cancellation of
the Companies' market-based rate tariffs currently on file with the
Commission.
    Filed Date: 04/21/2010.
    Accession Number: 20100422-0201.
    Comment Date: 5 p.m. Eastern Time on Wednesday, May 12, 2010.

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

    Docket Numbers: ES10-35-000.
    Applicants: American Transmission Company LLC, ATC Management Inc.
    Description: American Transmission Company LLC and ATC. Management
Inc under Section 204 of the Federal Power Act for Authorization to
Issue Securities.
    Filed Date: 04/21/2010.
    Accession Number: 20100421-5145.
    Comment Date: 5 p.m. Eastern Time on Wednesday, May 12, 2010.

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

    Docket Numbers: RD10-11-000.
    Applicants: North American Electric Reliability Corporation.
    Description: Petition of the North American Electric Reliability
Corporation for Approval of Interpretation to Reliability Standard CIP-
001--Cyber Security--Sabotage Reporting, Requirement R2.
    Filed Date: 04/21/2010.
    Accession Number: 20100421-5077.
    Comment Date: 5 p.m. Eastern Time on Wednesday, May 12, 2010.

    Docket Numbers: RD10-12-000.
    Applicants: North American Electric Reliability Corporation.
    Description: Petition of the North American Electric Reliability
Corporation for Approval of Interpretation to Reliability Standard

CIP-005-2, Cyber Security, Electronic Security Perimeter(s), Section
4.2.2 and Requirement R1.3.
    Filed Date: 04/21/2010.
    Accession Number: 20100421-5078.

    Comment Date: 5 p.m. Eastern Time on Wednesday, May 12, 2010.

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

    Docket Numbers: RR10-1-001.
    Applicants: North American Electric Reliability Corporation.
    Description: Compliance Filing of the North American Electric
Reliability Corp in Response to January 21, 2010 Commission Order
Concerning Appendix 4D to the NERC Rules of Procedure- Procedure for
Requesting and Receiving Technical Feasibility Exceptions.
    Filed Date: 04/21/2010.
    Accession Number: 20100421-5166.
    Comment Date: 5 p.m. Eastern Time on Wednesday, May 12, 2010.

    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. 2010-10353 Filed 5-3-10; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 85, Number 187 (Friday, September 25, 2020)]
[Notices]
[Pages 60453-60454]
[FR Doc No: 2020-21204]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

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

    Docket Numbers: EC20-103-000.
    Applicants: New Athens Generating Company, LLC, Millennium Power
Partners, L.P.
    Description: Application for Authorization Under Section 203 of the
Federal Power Act, et al. of New Athens Generating Company, LLC.
    Filed Date: 9/18/20.
    Accession Number: 20200918-5171.
    Comments Due: 5 p.m. ET 10/9/20.

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

    Docket Numbers: EG20-246-000.
    Applicants: Altamont Winds LLC.
    Description: Self-Certification of Exempt Wholesale Generator
Status of Altamont Winds LLC.
    Filed Date: 9/18/20.
    Accession Number: 20200918-5153.
    Comments Due: 5 p.m. ET 10/9/20.

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

    Docket Numbers: ER15-2187-001.
    Applicants: Chief Conemaugh Power, LLC.
    Description: Compliance filing: Informational Filing Pursuant to
Schedule 2 of the PJM OATT & Request for Waiver to be effective N/A.
    Filed Date: 9/21/20.
    Accession Number: 20200921-5148.
    Comments Due: 5 p.m. ET 10/13/20.

    Docket Numbers: ER15-2188-001.
    Applicants: Chief Keystone Power, LLC.
    Description: Compliance filing: Informational Filing Pursuant to
Schedule 2 of the PJM OATT & Request for Waiver to be effective N/A.
    Filed Date: 9/21/20.
    Accession Number: 20200921-5161.
    Comments Due: 5 p.m. ET 10/13/20.

    Docket Numbers: ER20-2158-001.
    Applicants: Midcontinent Independent System Operator, Inc., Ameren
Illinois Company.
    Description: Tariff Amendment: 2020-09-21_SA 3527 Deficiency
Response Ameren Illinois-Hoopeston Wind (H094) FSA to be effective 8/
25/2020.
    Filed Date: 9/21/20.
    Accession Number: 20200921-5134.
    Comments Due: 5 p.m. ET 10/13/20.

    Docket Numbers: ER20-2671-000.
    Applicants: Water Strider Solar, LLC.
    Description: Report Filing: Water Strider Solar MBR Informational
Supplement to be effective N/A.
    Filed Date: 9/16/20.
    Accession Number: 20200916-5074.
    Comments Due: 5 p.m. ET 10/7/20.

    Docket Numbers: ER20-2922-000.
    Applicants: California Independent System Operator Corporation.
    Description: Sec.  205(d) Rate Filing: 2020-09-18 Settlement Rules
Amdt--Post-Day-Ahead Exceptional Dispatch Schedules to be effective 11/
18/2020.
    Filed Date: 9/18/20.
    Accession Number: 20200918-5135.
    Comments Due: 5 p.m. ET 10/9/20.

    Docket Numbers: ER20-2923-000.
    Applicants: Duke Energy Florida, LLC.
    Description: Sec.  205(d) Rate Filing: DEF-Southern Companies
Concurrence Filing to be effective 8/4/2020.
    Filed Date: 9/18/20.
    Accession Number: 20200918-5137.
    Comments Due: 5 p.m. ET 10/9/20.

    Docket Numbers: ER20-2924-000.
    Applicants: Idaho Power Company.
    Description: Sec.  205(d) Rate Filing: Revised SA 324 and 342 to be
effective 7/1/2021.
    Filed Date: 9/18/20.
    Accession Number: 20200918-5139.
    Comments Due: 5 p.m. ET 10/9/20.

    Docket Numbers: ER20-2925-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Tariff Cancellation: Notice of Cancellation of ISA, SA
No. 4758; Queue No. AA2-177 to be effective 10/12/2017.
    Filed Date: 9/18/20.
    Accession Number: 20200918-5141.
    Comments Due: 5 p.m. ET 10/9/20.

    Docket Numbers: ER20-2926-000.
    Applicants: Altamont Winds LLC.
    Description: Baseline eTariff Filing: Altamont Winds LLC MBR Tariff
to be effective 11/1/2020.
    Filed Date: 9/18/20.
    Accession Number: 20200918-5143.
    Comments Due: 5 p.m. ET 10/9/20.

    Docket Numbers: ER20-2927-000.
    Applicants: The Connecticut Light and Power Company.
    Description: Sec.  205(d) Rate Filing: Preliminary Engineering and
Design Agreement with The University of Connecticut to be effective 9/
21/2020.
    Filed Date: 9/21/20.
    Accession Number: 20200921-5030.
    Comments Due: 5 p.m. ET 10/13/20.

    Docket Numbers: ER20-2928-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Original ISA, Service
Agreement No. 5756; Queue Nos. AC1-109/AC1-111 to be effective 8/24/
2020.
    Filed Date: 9/21/20.
    Accession Number: 20200921-5031.
    Comments Due: 5 p.m. ET 10/13/20.

    Docket Numbers: ER20-2929-000.
    Applicants: Tri-State Generation and Transmission Association.
    Description: Tariff Cancellation: Notice of Cancellation of Rate
Schedule FERC No. 206 to be effective 9/22/2020.
    Filed Date: 9/21/20.
    Accession Number: 20200921-5041.
    Comments Due: 5 p.m. ET 10/13/20.

    Docket Numbers: ER20-2930-000.
    Applicants: Southern California Edison Company.
    Description: Sec.  205(d) Rate Filing: Letter Agreement 326FW 8ME
LLC Arida Solar Farm SA No. 253 to be effective 9/22/2020.
    Filed Date: 9/21/20.
    Accession Number: 20200921-5075.
    Comments Due: 5 p.m. ET 10/13/20.

    Docket Numbers: ER20-2931-000.
    Applicants: PPL Electric Utilities Corporation, PJM
Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: PPL submits ECSA No. 5770 to
be effective 9/22/2020.
    Filed Date: 9/21/20.
    Accession Number: 20200921-5086.
    Comments Due: 5 p.m. ET 10/13/20.

    Docket Numbers: ER20-2932-000.
    Applicants: Big Sky North, LLC.
    Description: Sec.  205(d) Rate Filing: First Amended and Restated
Master Interconnection Services Agreement to be effective 9/22/2020.
    Filed Date: 9/21/20.
    Accession Number: 20200921-5087.
    Comments Due: 5 p.m. ET 10/13/20.

    Docket Numbers: ER20-2933-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Tariff Cancellation: Notice of Cancellation of ISA, SA
No. 4762; Queue No. AC1-018 to be effective 11/16/2020.
    Filed Date: 9/21/20.
    Accession Number: 20200921-5088.
    Comments Due: 5 p.m. ET 10/13/20.

    Docket Numbers: ER20-2934-000.
    Applicants: PPL Electric Utilities Corporation, PJM
Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: PPL submits ECSA No. 5771 to
be effective 9/22/2020.
    Filed Date: 9/21/20.
    Accession Number: 20200921-5091.
    Comments Due: 5 p.m. ET 10/13/20.

    Docket Numbers: ER20-2935-000.
    Applicants: Summer Solar LLC.
    Description: Sec.  205(d) Rate Filing: Fourth Amended and Restated
Shared

Facilities Agreement to be effective 9/22/2020.
    Filed Date: 9/21/20.
    Accession Number: 20200921-5108.
    Comments Due: 5 p.m. ET 10/13/20.

    Docket Numbers: ER20-2936-000.
    Applicants: Alabama Power Company.
    Description: Sec.  205(d) Rate Filing: Amended and Restated GA
Solar 5 (Hickory Solar) LGIA Filing to be effective 9/4/2020.
    Filed Date: 9/21/20.
    Accession Number: 20200921-5129.
    Comments Due: 5 p.m. ET 10/13/20.

    Docket Numbers: ER20-2937-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Amendment to WMPA, Service
Agreement No. 4760; Queue No. AC1-147 re: CAAA to be effective 7/24/
2017.
    Filed Date: 9/21/20.
    Accession Number: 20200921-5140.
    Comments Due: 5 p.m. ET 10/13/20.

    Docket Numbers: ER20-2938-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Amendment to AD2-180 IISA
No. 5627 to be effective 3/17/2020.
    Filed Date: 9/21/20.
    Accession Number: 20200921-5143.
    Comments Due: 5 p.m. ET 10/13/20.

    Docket Numbers: ER20-2939-000.
    Applicants: Chief Conemaugh Power, LLC.
    Description: Compliance filing: Informational Filing Pursuant to
Schedule 2 of the PJM OATT and eTariff Baseline to be effective 9/22/
2020.
    Filed Date: 9/21/20.
    Accession Number: 20200921-5156.
    Comments Due: 5 p.m. ET 10/13/20.

    Docket Numbers: ER20-2940-000.
    Applicants: Chief Keystone Power, LLC.
    Description: Compliance filing: Informational Filing Pursuant to
Schedule 2 of the PJM OATT and eTariff Baseline to be effective 9/22/
2020.
    Filed Date: 9/21/20.
    Accession Number: 20200921-5162.
    Comments Due: 5 p.m. ET 10/13/20.

    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: September 21, 2020.
Kimberly D. Bose,
Secretary.
[FR Doc. 2020-21204 Filed 9-24-20; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 87, Number 117 (Friday, June 17, 2022)]
[Notices]
[Pages 36555-36556]
[FR Doc No: 2022-13049]

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SECURITIES AND EXCHANGE COMMISSION

[SEC File No. 270-242, OMB Control No. 3235-0206]

Submission for OMB Review; Comment Request Extension: Rule 19d-1

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, 100 F Street, NE Washington, DC
20549-2736

    Notice is hereby given that pursuant to the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.) (``PRA''), the Securities and Exchange
Commission (``Commission'') has submitted to the Office of Management
and Budget (``OMB'') a request for approval of extension of the
previously approved collection of information provided for in Rule 19d-
1 (17 CFR 240.19d-1) under the Securities Exchange Act of 1934 (17
U.S.C. 78a et seq.) (``Exchange Act'').
    Rule 19d-1 prescribes the form and content of notices to be filed
with the Commission by self-regulatory organizations (``SROs'') for
which the Commission is the appropriate regulatory agency concerning
the following final SRO actions: (1) disciplinary actions with respect
to any person; (2) denial, bar, prohibition, or limitation of
membership, participation or association with a member or of access to
services offered by an SRO or

member thereof; (3) summarily suspending a member, participant, or
person associated with a member, or summarily limiting or prohibiting
any persons with respect to access to or services offered by the SRO or
a member thereof; and (4) delisting a security.
    The Rule enables the Commission to obtain reports from the SROs
containing information regarding SRO determinations to delist a
security, discipline members or associated persons of members, deny
membership or participation or association with a member, and similar
adjudicated findings. The Rule requires that such actions be promptly
reported to the Commission. The Rule also requires that the reports and
notices supply sufficient information regarding the background, factual
basis and issues involved in the proceeding to enable the Commission:
(1) to determine whether the matter should be called up for review on
the Commission's own motion; and (2) to ascertain generally whether the
SRO has adequately carried out its responsibilities under the Exchange
Act.
    It is estimated that approximately 19 respondents will file a total
of approximately 912 submissions per year (an average of 48 per
respondent). The Commission estimates that the average number of hours
necessary to comply with the requirements of Rule 19d-1 for each
submission is 1 hour. The total annual burden for all respondents is
thus 912 hours. The Commission estimates that the internal compliance
cost per respondent is approximately $319 per response. The annual
internal cost of compliance for all respondents is thus approximately
$290,928 (19 respondents x 48 responses x $319 per response).
    The filing of notices pursuant to Rule 19d-1 is mandatory for the
SROs, but does not require the collection of confidential information.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information under the PRA unless it
displays a currently valid OMB control number.
    The public may view background documentation for this information
collection at the following website: www.reginfo.gov. Find this
particular information collection by selecting ``Currently under 30-day
Review--Open for Public Comments'' or by using the search function.
Written comments and recommendations for the proposed information
collection should be sent by July 18, 2022 to (i) www.reginfo.gov/public/do/PRAMain and (ii) David Bottom, Director/Chief Information
Officer, Securities and Exchange Commission, c/o John Pezzullo, 100 F
Street NE, Washington, DC 20549, or by sending an email to:
[email protected].

    Dated: June 13, 2022.
J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2022-13049 Filed 6-16-22; 8:45 am]
BILLING CODE 8011-01-P