EPA BIOPESTICIDES AND POLLUTION PREVENTION DIVISION

NOTICE OF FILING TEMPLATE FOR PESTICIDE PETITIONS PUBLISHED IN THE

FEDERAL REGISTER

EPA Biopesticides and Pollution Prevention Division contact: [insert
name and telephone number with area code]

EPA has received a pesticide petition [insert petition number] from
BioNext sprl, Passage des deportes, 2, B-5030 Gembloux, Belgium,
proposing pursuant to section 408(d) of the Federal Food, Drug, and
Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180 to
establish an exemption from the requirement of a tolerance for the
microbial pesticide Candida oleophila strain O in or on apples and
pears.

Pursuant to section 408(d)(2)(A)(i) of the FFDCA, as amended, BioNext
sprl has submitted the following summary of information, data, and
arguments in support of their pesticide petition. This summary was
prepared by BioNext sprl and EPA has not fully evaluated the merits of
the pesticide petition. The summary may have been edited by EPA if the
terminology used was unclear, the summary contained extraneous material,
or the summary unintentionally made the reader conclude that the
findings reflected EPA’s position and not the position of the
petitioner.

I. BioNext sprl Petition Summary

[Insert petition number]

A. Product name and Proposed Use Practices

The microbial pest control agent Candida oleophila strain O, a yeast
antagagonist for control of pathogens (Botrytis cinerea and Pencicillium
sp.) that cause post harvest decay on Pome fruits.

B. Product Identity/Chemistry

Identity of the pesticide and corresponding residues.

Phylum: Ascomycetes

Family: Saccharomycetaceae

Genus: Candida

Species, subspecies, strain: Candida oleophila strain O

Candida oleophila strain O is a single-celled budding organism,
approximately 1 (m in diameter.  It is a yeast found on plant tissues
(fruits, flowers, wood) and in water.  It has never been reported as a
pathogen of plants or animals (including humans).

Magnitude of residue at the time of harvest and method used to determine
the residue.

C. oleophila strain O naturally occurs on apples as it was originally
isolated in 1991 from the surface of apples cv. Golden Delicious.  On
harvested apples, population densities of white yeast can reach 1.5 x
103 cfu/cm².  This value includes C. oleophila natural population.
Consequently, it is expected that background levels of C. oleophila
strain O on apples are below 1.5 x 103 cfu/cm².  However, post-harvest
treatment with C.oleophila strain O leads to an increased level of the
yeast on apples.

C. oleophila strain O is intended to be used against fruit decay caused
by

Penicillium expansum and Botrytis cinerea. Since the mode of action is
competition for nutrients, sufficient colonization of apples surfaces
has to be reached in order to ensure efficacy. The level of C. oleophila
strain O population ensuring efficacy is reached when application is
conducted at the recommended dose rate (1010  cfu/L). This application
dose rate leads to a residual C. oleophila strain O population density
estimated around 4x104 cfu/cm2 (105 cfu/apple).

The oral acute toxicity study conducted on rats has shown that C.
oleophila strain O is neither

pathogenic nor infective when orally administered to the rat at > 1.1 x
109 cfu/kg/bw, a level which is 4 orders of magnitude higher than the
expected residue level.

Since no toxin or metabolite production is expected, residue is defined
as viable and non viable cells.

In order to recover cells from food surface (such as apples), two steps
must be applied: extraction of

cells from apples surface followed by quantification of these cells.

1. Extraction of cells from apples surface

A KPB buffer [0.016M K2HPO4, 0.034 M KH2PO4 and 0.05 % (w/v) Tween 80;
pH 6.5] is

produced as followed:

be adjusted with stock solutions if necessary. Finally, 500 μl of Tween
80 is added.  Four apples are washed in 500 ml of KPB buffer during 20
min. at 120 rpm. One milliter of washing is used for the quantification
step as described by Massart et al. (2005) (Ref. 1.10).

2. Quantification of cells within the extract

For quantification of viable cells of C. oleophila strain O, serial
dilution series are prepared and plated on semi-selective medium
HST-PDA. This medium is composed of PDA supplied with 12.5 mg/l
hygromycin B, 1.25 mg/L carbendazim, 1.25 mg/L diethofencarb, and 0.25
mg/L thiram.

Quantification of non-viable cells of C. oleophila strain O can be
achieved by PCR real-time as

described by Massart et al. (2005): this method allow quantification of
total cells (viable and nonviable cells). The non-viable cells level can
be reached by comparison between results obtained by numeration of
viable cells and quantification of total cells.

3. A statement of why an analytical method for detecting and measuring
the levels of the pesticide residue are not needed.

The acute toxicity and genotoxicity studies discussed in Section C of
this document are sufficient to show that there are no foreseeable human
or domestic health hazards likely to arise from the use of the product
to control post-harvest decay in pome fruit.  BioNext is requesting an
exemption from the requirement for a tolerance for any residues
remaining in/on pome fruit.  Since enforcement of residue levels would
not be needed, an enforcement analytical method is not required.

C. Mammalian Toxicological Profile

Acute oral toxicity/pathogenicity- rat (OPPTS 885.3050)

Twelve male and 12 female Crl:CD rats (Charles River) were dosed orally
by gavage with viable C. oleophila strain O, at a rate of 108 CFU per
animal.  Three animals of each sex were sacrificed on days 4, 8, 15 and
22 (six animals per sacrifice).  All rats survived to the scheduled
sacrifice.  There was no effect of treatment on bodyweight gain or
post-dose temperature.  No abnormalities were observed in any animal at
the macroscopic examination.  Viable C. oleophila strain O was not
recovered from the organs, blood, stomach contents, seventh loop of the
small intestine or caecum contents of any treated or control rats over
the study period.  It was concluded that C. oleophila strain O showed no
evidence of toxicity or pathogenicity to rats following a single oral
dose of 2.3 – 3.8 x 108 viable CFU/rat.

Acute pulmonary toxicity/pathogenicity- rat (OPPTS 885.3150)

Seventeen male and 17 female Crl:CD rats (Charles River) were dosed by
intratracheal instillation with viable C. oleophila strain O, at a rate
of 108 CFU/rat.  Three animals of each sex were sacrificed on days 1, 4,
8, and 15 and five animals of each sex were sacrificed on day 22.  Two
animals receiving viable test substance showed transient low body
temperatures.  Abnormalities observed at the macroscopic examination
comprised enlarged, swollen or thickened lungs in animals sacrificed on
day 1 (1 hour after dosing). No abnormalities were observed in any other
animal at the macroscopic examination.  Viable C. oleophila strain O was
recovered from the lungs of all rats sacrificed at one hour after
dosing.  Viable C. oleophila strain O was not recovered from any other
samples from treated rats over the study period confirming that rapid
loss of viability of the test organism following dosing into rats.  It
was concluded that C. oleophila strain O showed no evidence of toxicity
or pathogenicity to rats following a single intratrachael administration
of 1.2 – 5.2 x 108 viable CFU/rat.

Acute dermal toxicity/pathogenicity- rat (OPPTS 885.3200)

Three male and 3 female Crl:CD rats (Charles River) were dosed with a
single subcutaneous injection of at least 107 CFU/rat.  There were no
unscheduled deaths, clinical signs, body temperature changes or
macroscopic abnormalities that were considered to be related to
treatment during the study.  There were no bodyweight changes that were
considered to be of toxicological significance during the study.  Viable
C. oleophila strain O was not recovered from the organs, blood or
injection site of any rats treated with the test substance over the
study period. Viable C. oleophila strain O was not recovered from the
stomach, seventh loop or caecum contents of any rat treated with the
test substance over the study period.  It was concluded that C.
oleophila strain O showed no evidence of toxicity or pathogenicity to
rats following a single subcutaneous administration of 1.1 – 2.0 x 107
CFU/rat.

Primary eye irritation (OPPTS 870.2500)

Four rabbits were each administered a single ocular dose of 100 mg of C.
oleophila strain O technical grade active ingredient and observed for up
to 15 days after instillation.  There were no signs of toxicity or ill
health in any rabbit during the observation period.  Injection of the
conjunctival blood vessels was evident during the first 24 hours after
instillation.  The highest mean score (Kay and Calandra (1962)) was 6.7
occurring at the one hour observation; accordingly under the criteria of
Kay and Calandra, C. oleophila strain O was classified as minimally
irritating to the eye.

Dermal irritation – rabbit (OPPTS 870.2500)

Three rabbits received a single four-hour, semi-occlusive, dermal
administration of approximately 0.5 grams of C. oleophila strain O
technical grade of the active ingredient and were observed for four
days.  No dermal reaction was observed in any animal throughout the
duration of the study.  The Primary Irritation Index was calculated to
be 0.0 therefore C. oleophila strain O was classified as a non-irritant.

Mutagenicity Test on Salmonella Typhimurium (Ames Assay)

C. oleophila strain O technical grade of active ingredient was tested
for mutagenic effect on five strains of Salmonella typhimurium.  The
assay was carried out both with and without metabolic activation using
hepatic microsomes from rat livers induced by Aroclor 1254 with an
incubation period of 48 hours.  Doses were prepared as an extract from
one gram of C. oleophila strain O containing 3 x 1010 CFU in 3 mL of
DMSO (1.1010 CFU/mL).  Actual doses were 0, 1, 3, 10, 30 and 100 uL of
initial extract/plate.  Under the experimental conditions of the test,
C. oleophila strain O induced no mutagenic activity in the five
Salmonella typhimurium strains tested.

Mutagenicity Test on L5178Y Mouse Lymphoma cells (TK Locus)

C. oleophila strain O technical grade of active ingredient was tested
for mutagenic effect on L5178Y mouse lymphoma cells.  The assay was
carried out both with and without metabolic activation using hepatic
microsomes from rat livers induced by Aroclor 1254.  Doses were prepared
as an extract containing 3 x 1010 CFU in 3 mL of DMSO (1.1010 CFU/mL).
Actual doses were 0.63, 1.25, 2.5 and 5 uL/mL of the intial extract.
Under the experimental conditions of the test, C. oleophila strain O
induced no mutagenic activity at the TK locus in L5178Y mouse lymphoma
cells.

D. Aggregate Exposure

1. Dietary exposure.   C. oleophila strain O naturally occurs on apples
as it was originally isolated in 1991 from the surface of apples cv.
Golden Delicious.  On harvested apples, population densities of white
yeast can reach 1.5 x 103 cfu/cm².  This value includes C. oleophila
natural population. Consequently, it is expected that background levels
of C. oleophila strain O on apples are below 1.5 x 103 cfu/cm².
However, post-harvest treatment with C.oleophila strain O leads to an
increased level of the yeast on apples. C. oleophila strain O is
intended to be used against fruit decay caused by Penicillium expansum
and Botrytis cinerea. Since the mode of action is competition for
nutrients, sufficient colonization of apples surfaces has to be reached
in order to ensure efficacy. The level of C. oleophila strain O
population ensuring efficacy is reached when application is conducted at
the recommended dose rate (1010  cfu/L). This application dose rate
leads to a residual C. oleophila strain O population density estimated
around 4x104 cfu/cm2 (105 cfu/apple).

i. Food.  C. oleophila is a yeast naturally occurring on plant tissues,
which means it is also found in/on food.  The table below gives an
overview of the plant origin of C. oleophila strains found in important
micro-organisms collections.

 Origin of strains from micro-organisms collections

Strain reference	Origin

CBS2219

CBS4371

CBS7419

CBS8269

IGC4709

ATCC MYA1208	Olives, Olea europaea

Cider

Oil-pipes in food-processing plant

Strawberries

Fermenting grapes

Tomatos

Moreover, from open literature it appears that species of the genus
Candida are ubiquitous as they have been recovered in a high number of
foods including fruits, fruit juices, soft drinks, alcoholic beverages
and grains, salted and acid preserved foods, dairy products, and meat
and meat-derived products.

. Drinking water. No drinking water exposure is anticipated because of
the use pattern and use sites.  There are no aquatic use sites permitted
for this pesticide, so exposure to drinking water is not expected.
Further, there is no evidence of adverse effects from exposure to this
organism.  Exposure from the proposed use of C. oleophila strain O is
not likely to pose any incremental risk via consumption of drinking
water to adult humans, infants and children.

2. Non-dietary exposure. Since C. oleophila is a yeast that is naturally
occurring on plant tissues, there may be non-dietary exposure from these
naturally occurring background levels.   However, it is not expected
that the pesticidal use of C. oleophila will significantly increase the
non-dietary and non-occupational exposure to the yeast.

E. Cumulative Exposure

Because C. oleophila strain O is non-toxic and non-pathogenic in
mammals, no mechanism of toxicity or pathogenicity has been identified.
Therefore no cumulative effects from the residues of this product with
other related microbial pesticides are anticipated.

F. Determination of Safety for U.S. population, Infants and Children

There is reasonable certainty that no harm will result to the U.S.
population, including infants and children, from aggregate exposures to
residues of Candida oleophila strain O, as a result of its proposed
uses.  This includes all anticipated dietary exposures and all other
exposures for which there is reliable information.  As discussed
previously, there appears to be no potential for harm, from this yeast
in its use as a microbial pesticide in apple and pear post harvest
treatments.  Furthermore, the organism is naturally occurring in food
items, and non-toxic and non-pathogenic to animals and humans.  This
conclusion is based on the results of the mammalian toxicity tests
discussed in Section C.  Moreover, potential non-occupational inhalation
or dermal exposure is not expected to pose any adverse effects to
exposed populations via aggregate and cumulative exposure.

G. Effects on the Immune and Endocrine Systems

There is no information to indicate that Candida oleophila strain O
would have an effect in humans similar to an effect produced by a
naturally-occurring estrogen or other endocrine effects.  There is no
known metabolite produced by this yeast that acts as an endocrine
disruptor.  The submitted toxicity/pathogenicity studies in rodents
indicate that following dosing that no viable yeast were found in organs
or tissues of test animals.  It is concluded that there will be no
incremental adverse effects to the endocrine system.

H. Existing Tolerances

EPA has established an exemption from the requirement of a tolerance for
Candida oleophila isolate I-182 at 40 CFR Sec. 180.1144.  The exemption
is for:

“Sec. 180.1144  Candida oleophila isolate I-182, when used as a
post-harvest biological fungicide, is exempted from the requirement of a
tolerance in or on all raw agricultural commodities.”

I. International Tolerances

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[Federal Register: September 8, 2010 (Volume 75, Number 173)]
[Notices]
[Page 54615-54616]
[DOCID:fr08se10-62]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 1

August 25, 2010.
    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER08-850-001.
    Applicants: New York Independent System Operator, Inc.
    Description: New York Independent System Operator, Inc.
Informational report on Operation of Rate Schedule 7, Charges for Wind
Forecasting Service.
    Filed Date: 08/16/2010.
    Accession Number: 20100816-5156.
    Comment Date: 5 p.m. Eastern Time on Tuesday, September 07, 2010.

    Docket Numbers: ER10-842-002.
    Applicants: Energy Plus Holdings LLC.
    Description: Report of Energy Plus Holdings LLC.
    Filed Date: 06/04/2010.
    Accession Number: 20100604-5053.
    Comment Date: 5 p.m. Eastern Time on Wednesday, September 21, 2010.

    Docket Numbers: ER10-1621-001.
    Applicants: Golden State Water Company.
    Description: Golden State Water Company submits tariff filing per
35: Baseline Tariff Filing to be effective 6/29/2010.
    Filed Date: 08/25/2010.
    Accession Number: 20100825-5042.
    Comment Date: 5 p.m. Eastern Time on Wednesday, September 15, 2010.

    Docket Numbers: ER10-2370-000.
    Applicants: NSTAR Electric Company.
    Description: NSTAR Electric Company submits tariff filing per
35.12: Baseline Filing for NSTAR Electric Company Market-Based Rate
Tariff to be effective 8/24/2010.
    Filed Date: 08/24/2010.
    Accession Number: 20100824-5137.
    Comment Date: 5 p.m. Eastern Time on Tuesday, September 14, 2010.

    Docket Numbers: ER10-2371-000.
    Applicants: New York Independent System Operator, Inc.
    Description: New York Independent System Operator submits tariff
filing per 35: Compliance Filing resubmittal--Dockets EL07-39 and ER08-
695 to be effective 6/30/2010.
    Filed Date: 08/24/2010.
    Accession Number: 20100824-5138.
    Comment Date: 5 p.m. Eastern Time on Tuesday, September 14, 2010.

    Docket Numbers: ER10-2372-000.
    Applicants: Midwest Independent Transmission System Operator, Inc.
    Description: Midwest Independent Transmission System Operator, Inc.
submits tariff filing per 35.15: Cancellation of Tariff ID to be
effective 12/31/1998.
    Filed Date: 08/24/2010.
    Accession Number: 20100824-5152.
    Comment Date: 5 p.m. Eastern Time on Tuesday, September 14, 2010.

    Docket Numbers: ER10-2373-000.
    Applicants: Puget Sound Energy, Inc.
    Description: Puget Sound Energy, Inc. submits its baseline filing
of its Residential Purchase and Sale Agreement designated as Rate
Schedule No. 448, to be effective 8/25/2010.
    Filed Date: 08/25/2010.
    Accession Number: 20100825-5000.
    Comment Date: 5 p.m. Eastern Time on Wednesday, September 15, 2010.

    Docket Numbers: ER10-2374-000.
    Applicants: Puget Sound Energy, Inc.
    Description: Puget Sound Energy, Inc. submits its baseline filing
of its Market-Based Rates Tariff designated as FERC Electric Tariff,
Fifth Revised Volume No. 8, to be effective 8/25/2010.
    Filed Date: 08/25/2010.
    Accession Number: 20100825-5001.
    Comment Date: 5 p.m. Eastern Time on Wednesday, September 15, 2010.

    Docket Numbers: ER10-2375-000.
    Applicants: Puget Sound Energy, Inc.
    Description: Puget Sound Energy, Inc. submits its baseline filing
of its Electric Transmission Reassignment Tariff designated as FERC
Electric Tariff, First Revised Volume No. 449, to be effective 8/25/
2010.
    Filed Date: 08/25/2010.
    Accession Number: 20100825-5002.
    Comment Date: 5 p.m. Eastern Time on Wednesday, September 15, 2010.

    Docket Numbers: ER10-2376-000.
    Applicants: Puget Sound Energy, Inc.
    Description: Puget Sound Energy, Inc. submits its baseline filing
of its Jackson Prairie Gas Storage Project Agreement designated as FERC
Gas Tariff, First Revised Volume No. 1, to be effective 8/25/2010.
    Filed Date: 08/25/2010.
    Accession Number: 20100825-5003.
    Comment Date: 5 p.m. Eastern Time on Wednesday, September 15, 2010.

    Docket Numbers: ER10-2377-000.
    Applicants: MATEP Limited Partnership.
    Description: MATEP Limited Partnership submits a Notice of
Cancellation of its Wholesale Power Supply Agreement, Service Agreement
1 file with the Commission.
    Filed Date: 08/24/2010.
    Accession Number: 20100825-0201.
    Comment Date: 5 p.m. Eastern Time on Tuesday, September 14, 2010.

    Docket Numbers: ER10-2378-000; ER10-2379-000.
    Applicants: MATEP Limited Partnership; MATEP LLC.
    Description: Petition of MATEP Limited Partnership et al., for
acceptance of revised market-based rate tariffs and Waiver of Prior
Notice Requirements.
    Filed Date: 08/24/2010.
    Accession Number: 20100825-0202.
    Comment Date: 5 p.m. Eastern Time on Tuesday, September 14, 2010.

    Docket Numbers: ER10-2380-000.
    Applicants: Interstate Power and Light Company.
    Description: Interstate Power and Light Company submits tariff
filing per 35.12: Baseline IPL Agreements to be effective 8/25/2010.
    Filed Date: 08/25/2010.
    Accession Number: 20100825-5025.
    Comment Date: 5 p.m. Eastern Time on Wednesday, September 15, 2010.

    Docket Numbers: ER10-2381-000.
    Applicants: Walnut Creek Energy, LLC.
    Description: Walnut Creek Energy, LLC submits tariff filing per
35.12: Walnut Creek Energy, LLC Baseline Filing to be effective 8/26/
2010.
    Filed Date: 08/25/2010.
    Accession Number: 20100825-5029.
    Comment Date: 5 p.m. Eastern Time on Wednesday, September 15, 2010.

    Docket Numbers: ER10-2382-000.
    Applicants: San Juan Mesa Wind Project, LLC.
    Description: San Juan Mesa Wind Project, LLC submits tariff filing
per 35.12: San Juan Mesa Wind Project, LLC Baseline Filing to be
effective 8/26/2010.
    Filed Date: 08/25/2010.
    Accession Number: 20100825-5034.
    Comment Date: 5 p.m. Eastern Time on Wednesday, September 15, 2010.

    Docket Numbers: ER10-2383-000.
    Applicants: Mountain Wind Power II LLC.
    Description: Mountain Wind Power II LLC submits tariff filing per
35.12: Mountain Wind Power II LLC Baseline Filing to be effective 8/26/
2010.
    Filed Date: 08/25/2010.
    Accession Number: 20100825-5037.
    Comment Date: 5 p.m. Eastern Time on Wednesday, September 15, 2010.

    Docket Numbers: ER10-2384-000.
    Applicants: Mountain Wind Power, LLC.
    Description: Mountain Wind Power, LLC submits tariff filing per
35.12: Mountain Wind Power, LLC Baseline Filing to be effective 8/26/
2010.
    Filed Date: 08/25/2010.
    Accession Number: 20100825-5038.
    Comment Date: 5 p.m. Eastern Time on Wednesday, September 15, 2010.

    Docket Numbers: ER10-2385-000.

    Applicants: Elkhorn Ridge Wind, LLC.
    Description: Elkhorn Ridge Wind, LLC submits tariff filing per
35.12: Elkhorn Ridge Wind, LLC Baseline Filing to be effective 8/26/
2010.
    Filed Date: 08/25/2010.
    Accession Number: 20100825-5039.
    Comment Date: 5 p.m. Eastern Time on Wednesday, September 15, 2010.

    Docket Numbers: ER10-2386-000.
    Applicants: Fairless Energy, LLC.
    Description: Fairless Energy, LLC submits tariff filing per 35.12:
Baseline to be effective 8/25/2010.
    Filed Date: 08/25/2010.
    Accession Number: 20100825-5051.
    Comment Date: 5 p.m. Eastern Time on Wednesday, September 15, 2010.

    Docket Numbers: ER10-2387-000.
    Applicants: Tampa Electric Company.
    Description: Tampa Electric Company submits tariff filing per
35.13(a)(2)(iii): Service Agreement No. 4 With Seminole Electric
Cooperative to be effective 8/26/2010.
    Filed Date: 08/25/2010.
    Accession Number: 20100825-5061.
    Comment Date: 5 p.m. Eastern Time on Wednesday, September 15, 2010.

    Docket Numbers: ER10-2388-000.
    Applicants: Midwest Independent Transmission System Operator, Inc.
    Description: Midwest Independent Transmission System Operator, Inc.
submits tariff filing per 35.12: BREC Attachment RR1 (v2) to be
effective 8/25/2010.
    Filed Date: 08/25/2010.
    Accession Number: 20100825-5070.
    Comment Date: 5 p.m. Eastern Time on Wednesday, September 15, 2010.

    Take notice that the Commission received the following public
utility holding company filings:

    Docket Numbers: PH10-19-000.
    Applicants: Cap Rock Holding Corporation, Cap Rock Energy
Corporation.
    Description: Notice of Material Change in Facts and Termination of
Holding Company Status et al.
    Filed Date: 08/12/2010.
    Accession Number: 20100812-5127.
    Comment Date: 5 p.m. Eastern Time on Thursday, September 02, 2010.

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

    Docket Numbers: RR10-13-000.
    Applicants: North American Electric Reliability Corporation.
    Description: Request of the North American Electric Reliability
Corporation for Acceptance of its 2011 Business Plan and Budget and the
2011 Business Plans and Budgets of Regional Entities and for Approval
of Proposed Assessments to Fund Budgets.
    Filed Date: 08/24/2010.
    Accession Number: 20100824-5155.
    Comment Date: 5 p.m. Eastern Time on Tuesday, September 14, 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.
    As it relates to any qualifying facility filings, the notices of
self-certification [or self-recertification] listed above, do not
institute a proceeding regarding qualifying facility status. A notice
of self-certification [or self-recertification] simply provides
notification that the entity making the filing has determined the
facility named in the notice meets the applicable criteria to be a
qualifying facility. Intervention and/or protest do not lie in dockets
that are qualifying facility self-certifications or self-
recertifications. Any person seeking to challenge such qualifying
facility status may do so by filing a motion pursuant to 18 CFR
292.207(d)(iii). Intervention and protests may be filed in response to
notices of qualifying facility dockets other than self-certifications
and self-recertifications.
    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 docket(s). For assistance with
any FERC Online service, please e-mail<EMAIL_ADDRESS>or
call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2010-22257 Filed 9-7-10; 8:45 am]
BILLING CODE 6717-01-P


MEMORANDUM

Tetra Tech, Inc.

10306 Eaton Place, Suite 340

Fairfax, VA 22030

phone<PHONE_NUMBER>

fax<PHONE_NUMBER>

TO:			Record

FROM:		Christine Wong, Tetra Tech, Inc.

DATE: 		August 28, 2008

SUBJECT:	Notes from Beaudrey USA teleconferences

To complement existing information on cooling water intake structures
and intake technologies, EPA directed Tetra Tech (Tt) to research and
make contact with intake technology manufacturers, specifically
international intake technology manufacturers.

Tt began by searching the docket records and Internet for intake
technology manufacturers.  A 2007 Power-Technology.com web article
stated that over 90% of French nuclear plants use Beaudrey screens and
the Beaudrey Web site stated that:

Screens equipped with Beaudrey FPSTM will meet and/or exceed the 316b
fish impingement criteria of 80 to 95% mortality reduction in almost all
cases. System operational tests have demonstrated mean survival rates in
excess of 90% across a range of fish species.

Because Beaudrey, a France-based company, also has an American office,
Tt contacted the American office via email to discuss information on
their system operational tests.  On March 4, 2008, Tt spoke with Brian
Hittle, Director of Beaudrey’s USA projects, regarding the company’s
intake screening products and unusually large share of the French intake
technology market.

Tt learned that Beaudrey was founded in France in 1982 to develop
aquatic organism protection technologies for the Electricité de France,
and that there are no national regulation regarding aquatic organism
protection in France, Belgium, or Portugal (the countries where Beaudrey
has worked), or in the European Union.  Mr. Hittle likened the European
aquatic organism protection regulatory framework as similar to the U.S.
before the passage of the 316(b) regulations – site-specific,
locally-driven permits to protect aquatic organisms in specific,
high-value waterbodies.

While over 90% of France’s nuclear power plants use Beaudrey drum
screens, only two facilities use the patented Fish Protection System
(FPS); there are also systems installed at facilities in Belgium and
Portugal.  The company, both in its European and American offices,
remains extremely active in the in the intake technology market.

Tt found that the original Beaudrey screens were Ristroph screens
equipped with fish buckets.  The company’s newest fish protection
technology, the FPS, includes a Hidrostal® fish pumps and backwash
screens and works with all types of Beaudrey traveling screens, drum
screens, and W Intake Protection (WIP) screens.  The FPS also works with
fine mesh screens and can be installed at the same time as the screens
or added/retrofit later.  Fish are impinged for a maximum of one minute,
as the FPS operates at one revolution per minute.  With the FPS/WIP
screen combination (rotating screening wheel with no chains or sprocket
teeth), Beaudrey guarantees no carry-over of debris or fish.  The
company has found that this system works well for high, low, and
mid-range water levels.

Mr. Hittle explained that Beaudrey replaces other company’s screens
when installing its FPS; he did not specify whether the FPS could be
installed on or with other companies’ screens, only indicating that
the Beaudrey doesn’t, preferring instead to do a wholesale
replacement.  He also noted that the Hidrostal® fish pump is the only
technology approved by the U.S. Bureau of Reclamation in California to
move fish; there are many papers available discussing this technology.

Mr. Hittle stated that representatives from Beaudrey have previously met
with Martha Segall (USEPA) to discuss the applicability of Beaudrey’s
technology for 316(b) requirements; the meeting took place after the
Phase II Rule had been promulgated.  Mr. Hittle indicated that the
company has years’ worth of impingement and entrainment data at its
French sites and is willing to share this data upon request.

Mr. Hittle stated that Beaudrey has not had much presence in the U.S.
market, but is working on market penetration.  Beaudrey is currently
running an EPRI-funded pilot study to test its FPS; the pilot test has
been running since fall 2006.  The pilot study has been collecting data
on the effectiveness of the FPS on naturally-occurring fish species; the
pilot test moved on to introduced species in spring 2008.  The data
collection includes both numbers and types of fish impinged.  Mr. Hittle
reported that impingement survival holds steady at about 90% for the
naturally-occurring species, though the pilot study does not account for
fish that were weak or dead prior to impingement.  Beaudrey expects to
have even higher survival rates with the introduced fish.  In follow-up
communications, Mr. Hittle indicated that Beaudrey conducted a series of
native fish sampling events during March and early April, and conducted
the first of a series of hatchery fish introduction experiments (1,500
fish) on April 30th.  Mr. Hittle reported that much of this research is
sponsored or in partnership by/with EPRI, and an EPRI representative
(Doug Dixon) was to be present to observe the introduction experiment.
On May 13, 2008, Mr. Hittle reported on the preliminary mortality study
results from the Beaudrey WIP screen fish introduction test after
holding the fish for 48 hours (Table 1, below) and noted that a full
statistical report will be issued upon completion of the summer warm
water test with more fish.

Mr. Hittle conducts power plant inspections up and down the Mississippi
River valley; he commented that a common concern among plant operators
is that a mandate for recirculating cooling towers will permanently
lower water levels in the Mississippi River basin, or possibly, in the
entire U.S., as large volumes of makeup water are taken up and never
returned. Mr. Hittle noted that a facility in Kansas City has dug deep
groundwater wells and begun using groundwater for cooling to avoid 316
intake water implications.

Table 1: Pilot Study Initial Results

Fish Species	Control Group Survival	Test Group Survival

Bluegill

	101 live/101 total = 100.0% survival	197 live/199 total = 99.0%
survival

Fathead Minnows

	81 live/100 total = 81.0% survival	165 live/208 total = 79.3% survival

Channel Catfish

	90 live/100 total = 90.0% survival	220 live/229 total = 96.1% survival


[Federal Register Volume 80, Number 56 (Tuesday, March 24, 2015)]
[Notices]
[Pages 15657-15658]
[FR Doc No: 2015-06473]

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

DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

Hazardous Materials: Notice of Application for Modification of
Special Permit

AGENCY: Office of Hazardous Materials Safety, Pipeline and Hazardous
Materials Safety Administration (PHMSA), DOT.

ACTION: List of application for modification of special permits.

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

SUMMARY: In accordance with the procedures governing the application
for, and the processing of, special permits from the Department of
Transportation's Hazardous Material Regulations (49 CFR part 107,
subpart B), notice is hereby given that the Office of Hazardous
Materials Safety has received the applications described herein. This
notice is abbreviated to expedite docketing and public notice. Because
the sections affected, modes of transportation, and the nature of
application have been shown in earlier Federal Register publications,
they are not repeated here. Requests for modification of special
permits (e.g. to provide for additional hazardous materials, packaging
design changes, additional mode of transportation, etc.) are described
in footnotes to the application number. Application numbers with the
suffix ``M'' denote a modification request. These applications have
been separated from the new application for special permits to
facilitate processing.

DATES: Comments must be received on or before April 8, 2015.
    Address Comments To: Record Center, Pipeline and Hazardous
Materials Safety Administration, U.S. Department of Transportation,
Washington, DC 20590.
    Comments should refer to the application number and be submitted in
triplicate. If confirmation of receipt of comments is desired, include
a self-addressed stamped postcard showing the special permit number.

FOR FURTHER INFORMATION CONTACT: Copies of the applications are
available for inspection in the Records Center, East Building, PHH-30,
1200 New Jersey Avenue Southeast, Washington, DC or at http.//
regulations.gov.
    This notice of receipt of applications for modification of special
permit is published in accordance with Part 107 of the Federal
hazardous materials

transportation law (49 U.S.C. 5117(6); 49 CFR 1.53(b)).

    Issued in Washington, DC, on March 3, 2015.
Donald Burger,
Chief, General Approvals and Permits.

----------------------------------------------------------------------------------------------------------------
                                                                     Regulation(s)      Nature of special permit
    Application No.        Docket No.           Applicant              affected                 thereof
----------------------------------------------------------------------------------------------------------------
                                          MODIFICATION SPECIAL PERMITS
----------------------------------------------------------------------------------------------------------------
14149-M...............  ................  Digital Wave           49 CFR 172.203(a),    To modify the special
                                           Corporation,           172.301(c), and       permit by removing the
                                           Centennial, CO.        180.205.              requirement to check
                                                                                gain control accuracy
                                                                                every six months with
                                                                                calibrated equipment and
                                                                                modify the marking
                                                                                requirements in
                                                                                paragraph 7.h.
14206-M...............  ................  Digital Wave           49 CFR 172.203(a),    To modify the special
                                           Corporation's,         172.301(c), and       permit by removing the
                                           Centennial, CO.        180.205.              requirement to check
                                                                                gain control accuracy
                                                                                every six months with
                                                                                calibrated equipment.
14227-M...............  ................  Aluminum Tank          49 CFR 177.834(h),    To modify the special
                                           Industries, Inc.,      178.700.              permit to authorize the
                                           Winter Haven, FL.                            discharge outlet below
                                                                                the highest point of the
                                                                                tank and allow the tanks
                                                                                to be marked with DOT
                                                                                specifications.
15097-M...............  ................  U.S. Commerce Product  49 CFR 173.56.......  To modify the special
                                           Safety Commission,                           permit to eliminate the
                                           Denver, CO.                                  over-classification of
                                                                                unapproved explosives.
16219-M...............  ................  Structural Composites  49 CFR 173.302a and   To modify the special
                                           Industries (SCI),      173.304a.             permit originally issued
                                           Pomona, CA.                                  on an emergency basis to
                                                                                authorize an additional
                                                                                two years.
16311-M...............  ................  Raytheon Missile       49 CFR Sec.           To modify the special
                                           Systems, Tucson, AR.   172.101 Column        permit originally issued
                                                                  (9B), Sec.            on an emergency basis to
                                                                  172.204(c)(3), Sec.   authorize an additional
                                                                    173.27(b)(2) and    two years.
                                                                  (3).
----------------------------------------------------------------------------------------------------------------

[FR Doc. 2015-06473 Filed 3-23-15; 8:45 am]
BILLING CODE 4909-60-M


[Federal Register Volume 88, Number 147 (Wednesday, August 2, 2023)]
[Notices]
[Pages 50927-50928]
[FR Doc No: 2023-16393]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-98013; File No. SR-NYSEAMER-2023-27]

Self-Regulatory Organizations; NYSE American LLC; Order Granting
Approval of a Proposed Rule Change To Amend Rule 915 (Criteria for
Underlying Securities) To Accelerate the Listing of Options on Certain
IPOs

July 27, 2023.

I. Introduction

    On April 21, 2023, NYSE American LLC (``NYSE American'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\ a
proposed rule change to amend NYSE American Rule 915 (Criteria for
Underlying Securities) to reduce the time to market for the listing and
trading of options on certain covered securities following their
initial public offering (``IPO''). The proposed rule change was
published for comment in the Federal Register on May 1, 2023.\3\ One
comment letter was received on the proposed rule change.\4\
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 97374 (Apr. 25,
2023), 88 FR 26634 (``Notice'').
    \4\ See Letter from Ellen Greene, Managing Director, Equities &
Options Market Structure, SIFMA, to Vanessa Countryman, Secretary,
Commission (May 16, 2023), available at https://www.sec.gov/comments/sr-nyseamer-2023-27/srnyseamer202327.htm.
---------------------------------------------------------------------------

    On June 13, 2023, pursuant to Section 19(b)(2) of the Act,\5\ the
Commission designated a longer period within which to approve the
proposed rule change, disapprove the proposed rule change, or institute
proceedings to determine whether to disapprove the proposed rule
change.\6\ This order grants approval of the proposed rule change.
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78s(b)(2).
    \6\ See Securities Exchange Act Release No. 97717, 88 FR 39895
(June 20, 2023).
---------------------------------------------------------------------------

II. Description of the Proposal

    The Exchange proposes to modify Commentary .01(4)(a) of NYSE
American Rule 915 to reduce the time for it to begin listing and
trading options on certain covered securities following their IPO.\7\
NYSE American Rule 915 establishes requirements that underlying
securities must meet in order for the Exchange to list and trade option
contracts on them. Commentary .01 of that rule sets forth certain
guidelines for the Exchange to consider in evaluating potential
underlying securities.
---------------------------------------------------------------------------

    \7\ See 15 U.S.C. 77r(b)(1)(A) (defining ``covered security'').
---------------------------------------------------------------------------

    One such guideline is a minimum market price per share that an
underlying security must trade at before the Exchange can list options
on it.\8\ Specifically, Commentary .01(4)(a) to NYSE American Rule 915
requires the market price per share of an underlying covered security
to have been at least $3.00 for the previous three consecutive business
days preceding the date on which the Exchange submits a certificate to
The Options Clearing Corporation (``OCC'') to list and trade options on
it (``three-day lookback period'').\9\ Under the current rule, if an
IPO occurs on a Monday, the earliest date the Exchange could submit its
listing certificate to OCC would be Thursday, with the market price
determined by the closing price over the three-day lookback period from
Monday through Wednesday. An option on the security would then be
eligible for trading on the Exchange on Friday (i.e., within four
business days following the IPO inclusive of the day the listing
certificate is submitted to OCC).
---------------------------------------------------------------------------

    \8\ NYSE American Rule 915(a) requires that, for underlying
securities to be eligible for options listing, such securities must
be duly registered and be an ``NMS stock,'' as defined in Rule 600
of Regulation NMS under the Act, and be characterized by having a
substantial number of outstanding shares which are widely held and
actively traded. See NYSE American Rules 915(a)(1) and (2).
    \9\ The Exchange states that the Options Listing Procedures Plan
(``OLPP'') requires that the listing certificate be provided to OCC
no earlier than 12:01 a.m. and no later than 11:00 a.m. (Chicago
time) on the trading day prior to the day on which trading is to
begin. See the OLPP, at p. 3, available at: https://ncuoccblobdev.blob.core.windows.net/media/theocc/media/clearing-services/services/options_listing_procedures_plan.pdf.
---------------------------------------------------------------------------

    The Exchange proposes to waive the three-day lookback period in
Commentary .01(4)(a) for certain covered securities following their IPO
and accelerate the listing of options on such securities by up to two
days.\10\ As proposed, the Exchange would permit options to be listed
and traded on a new IPO with a market capitalization of at least $3
billion based upon its offering price starting on or after the second
business day following the covered security's IPO day (i.e., not
inclusive of the day of the IPO).\11\ For example, under the proposed
rule, if an IPO for a company with a market capitalization of $3
billion (based upon its offering price) occurs on a Monday, the
Exchange could submit a listing certificate to OCC (to allow it to list
and trade options on the IPO security) on Tuesday if all of the
requirements for options listing are satisfied. Options on the IPO
security could then list and begin trading on the Exchange on Wednesday
(i.e., starting on or after the second business day following the IPO
day, not inclusive of the IPO day). In this way, the proposal could
accelerate the listing and trading of options on IPO securities by up
to two days.
---------------------------------------------------------------------------

    \10\ See Notice, supra note 3, 88 FR at 26635.
    \11\ See proposed Commentary .01(4)(a)(ii) to NYSE American Rule
915. The Exchange also proposes a non-substantive change to number
the existing and proposed criteria for covered securities as (i) and
(ii) of paragraph (4)(a). See proposed Commentary .01(4)(a)(i) and
(ii) to NYSE American Rule 915.
---------------------------------------------------------------------------

III. Discussion and Commission's Findings

    After careful review of the proposed rule change, the Commission
finds that the proposal is consistent with the requirements of the Act
and the rules and regulations thereunder that are applicable to a
national securities exchange.\12\ Specifically, the Commission finds
that the proposed rule change is consistent with Section 6(b)(5) of the
Act,\13\ which requires that the rules of a national securities
exchange be designed, among other things, 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.
---------------------------------------------------------------------------

    \12\ In approving this proposed rule change, the Commission has
considered the rule's impact on efficiency, competition, and capital
formation. See 15 U.S.C. 78c(f).
    \13\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    As discussed above, the Exchange proposes to reduce the time to
market for the listing and trading of options on underlying covered
securities following their IPO if they have a market capitalization of
at least $3 billion based upon the offering price. By waiving the
three-day lookback period for such covered securities in Commentary
.01(4)(a), the proposed rule change could reduce the time to market of
options on such securities by up to two days, as options on such
securities

would be permitted to be listed and traded starting on or after the
second business day following the IPO (not including the day of the
IPO) once all listing criteria are satisfied.
    The proposed rule change would only waive the three-day lookback
period for covered securities following their IPO if they have a
substantial market capitalization of at least $3 billion based upon
their IPO offering price. According to the Exchange, based upon data
from 2017 to present, all underlying securities with an IPO market
capitalization of $3 billion would have also met the $3.00 market price
per share three-day lookback period requirement.\14\
---------------------------------------------------------------------------

    \14\ See Notice, supra note 3, 88 FR at 26635.
---------------------------------------------------------------------------

    The Commission believes the proposed waiver of the three-day
lookback period requirement is appropriate for underlying covered
securities that have a market capitalization of at least $3 billion
based on the IPO offering price because those securities would likely
satisfy the lookback requirement, in which case the minimum $3.00 price
test would be met. Further, the proposed market capitalization
requirement of $3 billion based on the IPO offering price would ensure
an objective qualification process for the waiver that would prevent
market participants from being able to influence whether an IPO
security qualifies for the waiver through trading in the security,
which could be a concern if the threshold price were based on the
market price of the shares following the IPO. In accelerating the time
to market for options on these types of large, and likely high profile
IPOs, the proposal does not materially change the listing process for
options, nor does it propose to change any other listing criteria.
    In addition, the Exchange represents that trading in IPO securities
is subject to surveillances administered by the Exchange and cross-
market surveillances administered by the Financial Industry Regulatory
Authority (``FINRA'') on behalf of the Exchange that are designed to
detect violations of Exchange rules and applicable federal securities
laws.\15\ The Exchange represents that those surveillances are adequate
to reasonably monitor Exchange trading of IPO securities.\16\ Vigilant
surveillance can help deter and detect violations of Exchange rules and
the federal securities rules and regulations, and in so doing can help
prevent fraudulent and manipulative acts and practices, and, in
general, protect investors and the public interest.\17\
---------------------------------------------------------------------------

    \15\ See id. According to the Exchange, FINRA conducts cross-
market surveillances on behalf of the Exchange pursuant to a
regulatory services agreement. The Exchange is responsible for
FINRA's performance under this regulatory services agreement. See
id. at 26635, n.9.
    \16\ See id. at 26635.
    \17\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The Commission received one comment letter that recommended
approval of the proposed rule change. The commenter asserted that the
proposed rule change would ``benefit both investors and the market by
allowing for increased efficiency in portfolio and risk management
while continuing to provide for investor protection.'' \18\
---------------------------------------------------------------------------

    \18\ See supra note 4, at 2.
---------------------------------------------------------------------------

    The Commission finds that the proposal to accelerate the listing
and trading of options on certain covered securities following their
IPO by up to two days if they have a market capitalization of at least
$3 billion based upon their IPO offering price, without modifying any
other aspect of the options listing process, should facilitate
transactions in securities. Accordingly, the Commission finds that the
proposed rule change is consistent with the requirements of the
Act.\19\
---------------------------------------------------------------------------

    \19\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

IV. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\20\ that the proposed rule change (SR-NYSEAMER-2023-27), be, and
it hereby is, approved.
---------------------------------------------------------------------------

    \20\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\21\
---------------------------------------------------------------------------

    \21\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Sherry R. Haywood,
Assistant Secretary.
[FR Doc. 2023-16393 Filed 8-1-23; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 77, Number 225 (Wednesday, November 21, 2012)]
[Rules and Regulations]
[Page 69761]
[FR Doc No: 2012-28284]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2012-0995]

Drawbridge Operation Regulation; Upper Mississippi River,
Clinton, IA

AGENCY: Coast Guard, DHS.

ACTION: Notice of temporary deviation from regulations.

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

SUMMARY: The Coast Guard has issued a temporary deviation from the
operating schedule that governs the Clinton Railroad Drawbridge across
the Upper Mississippi River, mile 518.0, at Clinton, Iowa. The
deviation is necessary to allow time for performing needed maintenance
and repairs to the bridge. This deviation allows the bridge to open on
signal if at least 24 hours advance notice is given.

DATES: This deviation is effective from 12:01 a.m. December 15, 2012,
until 9 a.m., March 15, 2013.

ADDRESSES: Documents mentioned in this preamble as being available in
the docket are part of docket USCG-2012-0995 and are available online
by going to http://www.regulations.gov, inserting USCG-2012-0995 in the
``Search'' box and then clicking ``Search''. They are also available
for inspection or copying at the Docket Management Facility (M-30),
U.S. Department of Transportation, West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590, between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary deviation, call or email Eric A. Washburn, Bridge
Administrator, Western Rivers, Coast Guard; telephone<PHONE_NUMBER> or
<EMAIL_ADDRESS>If you have questions on viewing the docket,
call Renee V. Wright, Program Manager, Docket Operations, telephone
202-366-9826.

SUPPLEMENTARY INFORMATION:
    The Union Pacific Railroad Company requested a temporary deviation
for the Clinton Railroad Drawbridge, mile 518.0, at Clinton, Iowa,
across the Upper Mississippi to open on signal if at least 24 hours
advance notice is given in order to facilitate needed bridge
maintenance and repairs. The Clinton Railroad Drawbridge currently
operates in accordance with 33 CFR 117.5, which states the general
requirement that drawbridges shall open promptly and fully for the
passage of vessels when a request to open is given in accordance with
the subpart. In order to facilitate the needed bridge work, the
drawbridge must be kept in the closed-to-navigation position. This
deviation allows the bridge to open on signal if at least 24 hours
advance notice is given from 12:01 a.m. December 15, 2012, until 9
a.m., March 15, 2013.
    There are no alternate routes for vessels transiting this section
of the Upper Mississippi River.
    The Clinton Railroad Drawbridge, in the closed-to-navigation
position, provides a vertical clearance of 18.7 feet above normal pool.
Navigation on the waterway consists primarily of commercial tows and
recreational watercraft. This temporary deviation has been coordinated
with waterway users. No objections were received.
    In accordance with 33 CFR 117.35(e), the drawbridge must return to
its regular operating schedule immediately at the end of the effective
period of this temporary deviation. This deviation from the operating
regulations is authorized under 33 CFR 117.35.

    Dated: November 8, 2012.
Eric A. Washburn,
Bridge Administrator, Western Rivers.
[FR Doc. 2012-28284 Filed 11-20-12; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 81, Number 144 (Wednesday, July 27, 2016)]
[Rules and Regulations]
[Pages 49165-49169]
[FR Doc No: 2016-17786]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2015-0735; FRL-9948-73]

Etoxazole; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes a tolerance for residues of
etoxazole in or on soybean seed. Valent U.S.A. Corporation requested
this tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective July 27, 2016. Objections and
requests for hearings must be received on or before September 26, 2016,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2015-0735, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Susan Lewis, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone
number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2015-0735 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
September 26, 2016. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2015-0735, by one of
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online

instructions for submitting comments. Do not submit electronically any
information you consider to be CBI or other information whose
disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of April 25, 2016 (81 FR 24044) (FRL-9944-
86), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
5F8398) by Valent U.S.A. Corporation, 1600 Riveira Avenue, Suite 200,
Walnut Creek, CA 94596. The petition requested that 40 CFR part 180 be
amended by establishing a tolerance for residues of the insecticide,
etoxazole, 2-(2,6-difluorophenyl)-4-[4-(1,1-dimethylethyl)-2-
ethoxyphenyl]-4,5-dihydrooxazole, in or on soybean at 0.01 parts per
million (ppm). A comment was received on the notice of filing. EPA's
response to this comment is discussed in Unit IV.C.
    Based upon review of the data supporting the petition, EPA has
modified the level at which the tolerance is being established. The
reason for this change is explained in Unit IV.D.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
    Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for etoxazole including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with etoxazole follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children.
    The effects in the etoxazole database show liver toxicity in all
species tested (enzyme release, hepatocellular swelling and
histopathological indicators), and the severity does not appear to
increase with time. In rats only, there were effects on incisors
(elongation, whitening, and partial loss of upper and/or lower
incisors). There is no evidence of neurotoxicity or immunotoxicity. No
toxicity was seen at the limit dose in a 28-day dermal toxicity study
in rats. Etoxazole was not mutagenic.
    No increased quantitative or qualitative susceptibilities were
observed following in utero exposure to rats or rabbits in the
developmental studies; however, offspring toxicity was more severe
(increased pup mortality) than maternal toxicity (increased liver and
adrenal weights) at the same dose (158.7 mg/kg/day) in the rat
reproduction study indicating increased qualitative susceptibility.
Etoxazole is not likely to be carcinogenic based on the lack of
carcinogenicity effects in the database.
    Specific information on the studies received and the nature of the
adverse effects caused by etoxazole as well as the no-observed-adverse-
effect-level (NOAEL) and the lowest-observed-adverse-effect-level
(LOAEL) from the toxicity studies can be found at http://www.regulations.gov on pages 20-23 of the document titled ``Etoxazole:
Human Health Risk Assessment in Support of Proposed Use and Tolerances
for Residues of Etoxazole in/on Soybean Seed'' in docket ID number EPA-
HQ-OPP-2015-0735.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
    A summary of the toxicological endpoints for etoxazole used for
human risk assessment is discussed in Unit III.B. of the final rule
published in the Federal Register of December 2, 2015 (80 FR 75426)
(FRL-9934-60).

 C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to etoxazole, EPA considered exposure under the petitioned-for
tolerances as well as all existing etoxazole tolerances in 40 CFR
180.593. EPA assessed dietary exposures from etoxazole in food as
follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure.
    No such effects were identified in the toxicological studies for
etoxazole;

therefore, a quantitative acute dietary exposure assessment is
unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA National
Health and Nutrition Examination Survey, What We Eat in America
(NHANES/WWEIA; 2003-2008). As to residue levels in food, EPA assumed
tolerance-level residues or tolerance-level residues adjusted to
account for the residues of concern, 100% crop treated (PCT), and in
the absence of empirical data, Dietary Exposure Evaluation Model (DEEM)
(ver 7.81) default processing factors.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that etoxazole does not pose a cancer risk to humans.
Therefore, a dietary exposure assessment for the purpose of assessing
cancer risk is unnecessary.
    iv. Anticipated residue and percent crop treated (PCT) information.
EPA did not use anticipated residue or PCT information in the dietary
assessment for etoxazole. Tolerance level residues and 100 PCT were
assumed for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for etoxazole in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of etoxazole. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    Based on the FQPA Index Reservoir Screening Tool (FIRST) and
Pesticide Root Zone Model Ground Water (PRZM GW) models, the estimated
drinking water concentrations (EDWCs) of etoxazole for chronic
exposures are estimated to be 4.761 parts per billion (ppb) for surface
water and 0.746 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For the chronic dietary risk
assessment, the water concentration of value 4.761 ppb was used to
assess the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets). Etoxazole is not
registered for any specific use patterns that would result in
residential exposure.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
    EPA has not found etoxazole to share a common mechanism of toxicity
with any other substances, and etoxazole does not appear to produce a
toxic metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has assumed that etoxazole does not
have 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 EPA's Web site at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the Food Quality
Protection Act (FQPA) Safety Factor (SF). In applying this provision,
EPA either retains the default value of 10X, or uses a different
additional safety factor when reliable data available to EPA support
the choice of a different factor.
    2. Prenatal and postnatal sensitivity. No increased quantitative or
qualitative susceptibilities were observed following in utero exposure
to rats or rabbits in the developmental studies. There is evidence of
increased qualitative offspring susceptibility in the rat reproduction
study, but the concern is low since: (1) The effects in pups are well-
characterized with a clear NOAEL; (2) the selected endpoints are
protective of the doses where the offspring toxicity is observed; and
(3) offspring effects occur in the presence of parental toxicity. There
are no residual uncertainties for pre-/post-natal toxicity.
    3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1x. That decision is based on the following
findings:
    i. The toxicity database for etoxazole is complete.
    ii. There is no indication that etoxazole is a neurotoxic chemical
and there is no need for a developmental neurotoxicity study or
additional UFs to account for neurotoxicity.
    iii. The observed qualitative postnatal susceptibility is protected
for by the selected endpoints.
    iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100 PCT and tolerance-level residues. EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to etoxazole in drinking water. These assessments
will not underestimate the exposure and risks posed by etoxazole.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
    1. Acute risk. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. No adverse effect resulting from a single oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
etoxazole is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
etoxazole from food and water will utilize 15% of the cPAD for children
1-2 years old, the population group receiving the greatest exposure.
There are no residential uses for etoxazole.
    3. Short- and Intermediate-term risk. Short- and intermediate-term
aggregate exposure takes into account short- and intermedieate-term
residential exposure plus chronic exposure to food and water
(considered to be a background exposure level).

    A short- and intermediate-term adverse effect was identified;
however, etoxazole is not registered for any use patterns that would
result in either short- or intermediate-term residential exposure.
Short- and intermediate-term risk is assessed based on short- or
intermediate-term residential exposure plus chronic dietary exposure.
Because there is no short- or intermediate-term residential exposure
and chronic dietary exposure has already been assessed under the
appropriately protective cPAD (which is at least as protective as the
POD used to assess short- or intermediate-term risk), no further
assessment of short- or intermediate-term risk is necessary, and EPA
relies on the chronic dietary risk assessment for evaluating short- and
intermediate-term risk for etoxazole.
    4. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, etoxazole is not expected to pose a cancer risk to humans.
    5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population or to infants and children from aggregate
exposure to etoxazole residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (gas chromatography/mass-selective
detector (GC/MSD) or GC/nitrogen-phosphorus detector (NPD)) are
available to enforce the tolerance expression.
    The methods may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
    The Codex has not established a MRL for etoxazole in or on soybean
seed.

C. Response to Comments

    A comment was submitted by the Center for Food Safety and was
primarily concerned about environmental risks, including impacts on
pollinators and endangered species, and Agency's assessment of the
pesticide product under the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA). The comment did not raise any specific issues
concerning the safety of etoxazole under the FFDCA. As such, this
comment is not relevant to the Agency's evaluation of safety of the
etoxazole tolerances; section 408 of the FFDCA focuses on potential
harms to human health and does not permit consideration of effects on
the environment.

D. Revisions to Petitioned-For Tolerances

    The proposed tolerance of 0.01 ppm is below the validated limit of
quantification (LOQ) of 0.02 ppm for the analytical method and is
therefore being raised to the LOQ level.

 V. Conclusion

    Therefore, a tolerance is established for residues of etoxazole, 2-
(2,6-difluorophenyl)-4-[4-(1,1-dimethylethyl)-2-ethoxyphenyl]-4,5-
dihydrooxazole, in or on soybean, seed at 0.02 ppm.

VI. Statutory and Executive Order Reviews

    This action establishes a tolerance under FFDCA section 408(d) in
response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
    This action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: July 14, 2016.
 Susan Lewis,
Director, Registration Division, Office of Pesticide Programs.\

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. In Sec.  180.593, add alphabetically the commodity ``Soybean, seed''
to the table in paragraph (a) to read as follows:

Sec.  180.593  Etoxazole; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                            Parts  (per
                        Commodity                            million)
------------------------------------------------------------------------

                                * * * * *
Soybean, seed...........................................            0.02

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

* * * * *
[FR Doc. 2016-17786 Filed 7-26-16; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 88, Number 229 (Thursday, November 30, 2023)]
[Notices]
[Page 83565]
[FR Doc No: 2023-26278]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4724-DR; Docket ID FEMA-2023-0001]

Hawaii; Amendment No. 8 to Notice of a Major Disaster Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Hawaii (FEMA-4724-DR), dated August 10, 2023, and
related determinations.

DATES: This change occurred on October 13, 2023.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Federal Emergency Management Agency
(FEMA) hereby gives notice that pursuant to the authority vested in the
Administrator, under Executive Order 12148, as amended, Thomas J.
Dargan, of FEMA is appointed to act as the Federal Coordinating Officer
for this disaster.
    This action terminates the appointment of Timothy B. Manner as
Federal Coordinating Officer for this disaster.

    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households In Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050, Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

Deanne Criswell,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2023-26278 Filed 11-29-23; 8:45 am]
BILLING CODE 9111-23-P


todd. r. hendrickson@ Cummins. com 02/ 07/ 2005 10: 40: 06 AM To: Alan Stout/ AA/ USEPA/ US@ EPA cc: Subject: Re: Follow up on request of EPA: Clarify E3 Cycle is Appropriate for Prop Curve Aux Engines Alan

Thank you for the quick reply! Upon initial review, I believe EPA's proposed language provides the clarity needed. I'll let you know if there are additional concerns.

Thanks again, Todd  Forwarded by Alan Stout/ AA/ USEPA/ US on 02/ 07/ 2005 11: 08 AM

Alan Stout EPA OAR, OTAQ, ASD 02/ 07/ 2005 09: 59: 05 AM To: todd. r. hendrickson@ Cummins. com cc: Subject: Re: Follow up on request of EPA: Clarify E3 Cycle is Appropriate for Prop Curve Aux Engines Todd, We have reviewed this issue internally and have written up the attached modification to 94.105( b) to clarify that propeller law auxiliary marine engines should operate over the E3 cycle for EPA certification. This language clarifies our understanding of the best way to interpret the current regulatory language.

I expect that this change will be part of the final rule for the technical amendments later this year.

Let me know if you have any questions or concerns with this approach.

Alan _____________

( b) General cycle. Propulsion engines that are used with ( or intended to be used with) fixed pitch propellers, propeller law auxiliary engines, and any other engines for which the other duty cycles of this section do not apply, shall be tested using the duty cycle described in the following Table B   1:

todd. r. hendrickson@ Cummins. com 02/ 07/ 2005 09: 36: 10 AM To: Alan Stout/ AA/ USEPA/ US@ EPA cc: Jean Marie Revelt/ AA/ USEPA/ US@ EPA Subject: Follow up on request of EPA: Clarify E3 Cycle is Appropriate for Prop Curve Aux Engines Alan,

Please recall our discussion the afternoon of January 27th regarding Cummins ( and EMA's) request regarding marine auxiliary engines which operate on a prop curve. Per EMA comments to the Technical Amendment Package, we request that Part 94 be clarified. Or, at a minimum, that EPA accept our interpretation that certification to the E3 cycle is acceptable for such engines. IMO regulations are clear on this point, but EPA regulations are not.

Per your request, I have included additional information to support our position. I have included an attachment with Cummins summary of the issue and copied text below which was prepared by Cummins Marine providing application examples and descriptions of operation.

Note that Cummins is now finalizing engine hardware selections for 2007 Tier 2 certification platforms ( turbochargers, injectors, etc.). It is important that we close this issue quickly in order to select the appropriate hardware and avoid a costly redesign.

In summary, this request is appropriate given that: These auxiliary engines operate on a prop curve in use. The E3 cycle better represents the in use operation than the C1 cycle. The engines are not designed to operate in the C1 area. [ Note that Cummins does not allow C1 operation for these engine designs.] C1 8 mode and C1 NTE design and certification is not appropriate. This would compromise engine designs and unnecessarily waste engineering resources. Part 94 clarification provides harmony with IMO.

I would appreciate any feedback on this request given our current situation with Tier 2 product development. Please call me with any questions at 812 377 4235.

Thanks and regards, Todd Todd R. Hendrickson Cummins Inc.

============================================================ Examples of applications and operation provided by Cummins Marine: Cummins Marine engines can be used in variable speed auxiliary applications. These are typically used to drive liquid pumps of some sort, either water, petroleum, hydraulic fluid, or other liquid. Some examples of these engine applications are as follows:

BJ Services builds cement pumper machinery in Texas, for use on offshore drilling rigs. They use a QSK19 engine to drive a cement pump which isused to inject liquid cement into an oil well as it is being drilled, to form a protective core for the drill. BJ Services has provided data which shows that the engine operates at or slightly below our standard 3.0 prop curve at all conditions, with an overall duty cycle of less than 40%. Cummins Southern Plains in Texas sells a number of KTA19 engines as liquid cargo pumps on barges. These may pump petroleum or other liquids out of the barge storage tanks. Cummins China has some KTA50 engines in sand dredges. These engines drive water pumps, which in turn drive ejector pumps which suck a sand/ water mixture from the bottom of a channel. Frank Mohn A. S. in Norway uses KTA19 engines to drive liquid cargo pumps on barges. The engine may drive the cargo pump directly, or may drive a hydraulic pump which in turn drives the cargo pump.

These are typical of variable speed auxiliary applications. Cummins Marine Application Engineering reviews all potential installations to ensure that the engine cannot be loaded above the typical 3.0 propeller curve, since the engine ratings are developed with this loading in mind. C1 type engine loadings are not allowed for Marine engines.

As an example of engine speeds and loads seen during a pumping job with one of these engines, the BJ Services application can be seen as typical. In filling the drilling core with cement, the engine will be run at a low speed ( 800 1000 rpm) at the start of the fill, while the equipment is being adjusted and fine tuned for the pour. Then, the operator will increase the flow to a maximum ( 1800 rpm) to fill the core most of the way. Finally, near the top, flow has to be reduced so as not to overfill, so the engine will be operated at 1000 1400 rpm until the pour is completed.

The characteristic of a liquid pump is that the load used to drive it is proportional to the engine speed cubed. In other words, a plot of horsepower vs. rpm would have a y= x^ 3 shape, which is the same shape as a propeller curve. ================================================================== Summary of Cummins position: ( See attached file: EPA request  E3 vs.