	UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

 		     WASHINGTON, D.C. 20460

 ADVANCE \d61 			ICE OF PREVENTION,

OFFICE OF PESTICIDES AND TOXIC SUBSTANCES

MEMORANDUM

DATE:		May 18, 2010

SUBJECT:	Application for Experimental-Use Permit and temporary tolerance
exemption for FAL 1800 (Prohydrojasmon)

				EPA Reg. #: 62097-EUP-R

 				Chemical Class: Biochemical

                             PC Code : 028000

CAS Number: 158474-72-7

MRID 47927801-43

FROM:		Miachel Rexrode, Ph.D, Senior Biologist        /S/
05/18/2010

Biochemical Pesticides Branch

Biopesticides & Pollution Prevention Division (7511P)

TO:			Gina Casciano, Regulatory Action Leader     /S/
05/18/2010

Biochemical Pesticides Branch

Biopesticides & Pollution Prevention Division (7511P)

ACTION REQUESTED

The applicant, Fine Agrochemicals Ltd., has submitted a EUP application
and supporting data for FAL 1800, a plant growth regulator to be used to
enhance color formation in apples. The applicant is also requesting a
temporary tolerance exemption.

Executive Summary

Prohydrojasmon is not naturally-occurring but is structurally similar to
jasmonic acid (JA). JA is an intermediate in the pathway to plant
abscisic acid synthesis and has ABA-like activity (i.e. growth
inhibition, senescence, leaf abscission, as well as a role in wound
response and systemic resistance). When plants are attacked by insects
there is a release of JA, which inhibits the insect’s ability to
digest protein.

The toxicological profile of Prohydrojasmon (FAL 1801) shows that this
compound is practically non-toxic with a Toxicological Category IV for
acute oral and acute inhalation and a Toxicology Category III for acute
dermal toxicity. Prohydrojasmon is a slight eye irritant (Toxicity
Category IV) and is not a skin sensitizer or a primary skin irritant
(Toxicology Category IV). Assays for mutagenicity, chromosomal
aberration, developmental toxicity, and subchronic oral did not present
any clinical or toxicologically significant effects. This compound is
relatively unstable in the environment with an aerobic soil half-life of
1.6 – 2.3 hours, and upon consumption breaks down under gastric
condition with a half-life of 0.8 days.

All product chemistry, Tier I toxicology, and Tier I ecotoxicity studies
submitted in support of the EUP for FAL 1800 (ai Prohydrojasmon) in
support of an exemption from the Requirements of Tolerances are
acceptable. There are no data gaps and no additional data are required
at this time. No acute, subchronic, or chronic toxicity endpoints were
identified in Guideline studies that were submitted and reviewed.
Prohydrojasmon is not a sensitizer, not a mutagen or a developmental
toxicant. There are no known endocrine effects via oral, dermal, or
inhalation exposure and no significant exposure via drinking water. A
temporary Tolerance Exemption is appropriate for this compound. There
are no concerns for exposure to non-target organisms (aquatic and
terrestrial species). The Agency has determined a no effect (NE) for
threatened and endangered species when Prohydrojasmon is used in
accordance with EPA-approved labeling. No efficacy data was submitted,
but none were required for this non-public health use product.

RECOMMENDATIONS AND CONCLUSIONS

FATE AND DISTRIBUTION

FAL 1801 Prohydrojasmon (PDJ)

The fate and distribution information (Table 5.0) show that PDJ was
fairly stable in an aquatic environment (pH 9 and 200C half-life was
17.7 days), photodegrades in water in about 58 hours, and degrades
rapidly in soil (1.6 – 2.3 hours). Due to rapid metabolism and
decomposition of PDJ the adsorption constant could not be calculated
(does not bind to soil or sediment).

MRID 47927839: Adsorption/Desorption (OPPTS 835.1230). The laboratory
study was conducted to determine the adsorption and desorption of
prohydrojasmon (PDJ) in four different soils. PDJ was added to the soils
at concentrations of 5, 1, 0.2, and 0.04 mg/L, with a test solution/soil
ratio of 10 mL/2 grams. The soils were incubated at 25°C. After 16
hours, PDJ adsorption in the four soils ranged from 78.1 to 99.3%, and
desorption ranged from 1.0 to 14.9%. The material balance for the four
soils ranged from 13.7 to 71.2%. Due to the rapid metabolism and
decomposition of PDJ and the low material balance percentages, the
adsorption constant for PDJ could not be calculated. The study is
classified as Acceptable.

MRID 47927840: Hydrolysis (OPPTS 835.2120). A laboratory study was
conducted to determine the degradation of prohydrojasmon (PDJ) in water.
Test solutions (2 mg/L) of PDJ were buffered to pH 9 and maintained at
20°C for 24 days or at 40°C for 72 hours. To determine degradation
under gastric conditions, a treatment of pH 1.2 and 37°C for 32 hours
was also included. The half-life of PDJ at pH 9 and 20°C was 17.7 days,
and at pH 9 and 40°C was 2.0 to 2.1 days. Based on these results, the
Arrhenius equation was used to calculate the half-life at pH 9 and 25°C
as 10.7 days. Under gastric conditions, the half-life was 0.8 days. The
major degradation product was dihydrojasmonic acid. The study is
classified as Acceptable.

MRID 47927841: Photodegradation in Water (OPPTS 835.2240). The study
author concluded that in this study, the mean half-life of PDJ under
light-irradiated conditions was 54.0 hours in purified water and 57.8
hours in river water. Under light-shielded conditions, the mean
half-life of PDJ was 685 hours in purified water and 247 hours in river
water. The study is classified as Acceptable.

MRID 47927842: Aerobic soil metabolism (OPPTS 835-4100). The study
author concluded that under aerobic conditions, the elimination of PDJ
was similar in the Ibaraki and Osaka soils, with a half-life of 1.6
hours and 2.3 hours, respectively, and a DT80 of 3.7 hours and 5.3
hours, respectively. The major PDJ metabolite in both soils was DJA,
believed to be the result of de-n-propylation of PDJ, with CO2 generated
as the final product. Under sterile conditions, the half-life of PDJ in
Ibaraki and Osaka soils was extrapolated to be 102 days and 308 days,
respectively. The study is classified as Acceptable.

Table 5.0 Fate and Distribution of FAL 1801(PDJ)

Data Requirement	Results	MRIDs	Study Conclusion

Adsorption/Desorption

OPPTS 835.1230	Due to rapid metabolism and decomposition of PDJ and the
low material percentages, the adsorption constant for PDJ could not be
calculated.

47927839

Acceptable

Hydrolysis

OPPTS 835.2120	Half-life of PDJ at pH 9 (200C) was 10.7 days. Under
gastric conditions the half-life was calculated at 0.8 days.

47927840

Acceptable

Photodegradation in Water

OPPTS 835.2240	Half-life in light-irradiated conditions was 54.0 hours
in purified water 57.8 hours and 57.8 hours in river water.

47927841

Acceptable

Aerobic Soil Metabolism

OPPTS 835.4100	Ibaraki and Osaka soils had half-lives of 1.6 and 2.3
hours, respectively.

47927842

Acceptable

TOXICOLOGY

Test Material: FAL 1800 formulation containing 5.25% PDJ

The toxicological profile of FAL 1800 is summarized in Table 6.0 and
shows that this compound is practically non-toxic mammals with a
Toxicity Category IV as noted for acute oral and acute inhalation
toxicity studies. The acute dermal toxicity study produced an LD50 >
2,000 mg/kg bw  (Toxicity Category III) and the primary eye irritation
study produced acute symptoms after the test material was administered,
but were resolved by day 7 (Toxicity Category III). FAL 1800 is not a
skin sensitizer or a primary skin irritant.

1.	Acute oral toxicity (OPPTS 870.1100): Acute oral toxicity study used
SD rats.  The acute oral LD50 was > 5000 mg/kg bw in both male and
female rats.

2.	Acute dermal toxicity (OPPTS 870.1200): Acute dermal toxicity study
used SD rats.  The acute dermal LD50 was > 2000 mg/kg bw in both male
and female rats.

3.	Acute inhalation toxicity (OPPTS 870.1300): Acute inhalation toxicity
study used rats.  The acute inhalation LC50 was > 5.0 mg/L in both male
and female rats.

4.	Primary eye irritation (OPPTS 870.2400): Primary eye irritation study
used Japanese white rabbits.  Acute symptoms were observed after test
material administration, but were resolved by day 7.  FAL 1800 produces
reversible intense irritation in the eyes.  The maximum average score
for unwashed eyes was 52.0 one hour after test material instillation.
The test material was severely irritating.

5.	Primary skin irritation (OPPTS 870.2500): Primary skin irritation
study used Japanese white rabbits.  No irritation was noted on the skin.

6.	Skin sensitization (OPPTS 870.2600): A skin sensitization study
(Buehler method) used Hartley guinea pigs.  No skin sensitization was
observed.

Table 6.0  Toxicological Data for FAL 1800 (end product)

Data Requirement	LD50	Toxicity Category	MRIDs

Acute Oral Toxicity

OPPTS 870.1100	>5000 mg/kg	IV	47927818, 47927819

Acute Dermal Toxicity

OPPTS 870.1200	>2000 mg/kg	III	47927818, 47927820

Acute Inhalation Toxicity

OPPTS 870.1300	LC50 > 5.0 mg/L	IV	47927818, 47927821

Primary Eye Irritation

OPPTS 870.2400	Acute symptoms were observed after test material was
administered, but resolved by day 7. FAL 1800 produces reversible
intense eye irritation	III	47927818, 47927822

Primary Dermal Irritation

OPPTS 870.2500	No skin irritation.	IV	47927818, 47927823

Dermal Sensitization

OPPTS 870.2600	Not a dermal sensitizer	-	47927818, 47927824

Test Material: FAL 1801 [prohydrojasmon (PDJ)

The toxicological profile of FAL 1801 is summarized in Table 7.0 and
shows that this compound is practically non-toxic mammals with a
Toxicological Category IV as noted for acute oral and acute inhalation
toxicity studies. The acute dermal toxicity study produced an LD50 >
2,000 mg/kg bw (Toxicity Category III). The primary eye irritation study
produced slight acute symptoms after the test material was administered
(Toxicity Category IV) and FAL 1801 proved to not be skin sensitizer or
a primary skin irritant.

1.	Acute oral toxicity (OPPTS 870.1100): Acute oral toxicity study used
SD rats.  The acute oral LD50 was > 5000 mg/kg bw in both male and
female rats.

2.	Acute dermal toxicity (OPPTS 870.1200): Acute dermal toxicity study
used SD rats.  The acute dermal LD50 was > 2000 mg/kg bw in both male
and female rats.

3.	Acute inhalation toxicity (OPPTS 870.1300): Acute inhalation toxicity
study used rats.  The acute inhalation LC50 was > 2.8 mg/L in both male
and female rats.

4.	Primary eye irritation (OPPTS 870.2400): Primary eye irritation study
used Japanese white rabbits.  Slight eye irritation was observed.

5.	Primary skin irritation (OPPTS 870.2500): Primary skin irritation
study used Japanese white rabbits.  No irritation was noted on the skin.

6.	Skin sensitization (OPPTS 870.2600): A skin sensitization study
(Maximization method) used Hartley guinea pigs.  No skin sensitization
was observed.

Comments:   The summary (MRID 47927818) seems to include the study
results of PDJ (MRIDs 47927819 to 47927824) and PDJ Formulation (MRIDs
47927825 to 47927830).

Table 7.0  Toxicological Data for Prohydrojasmon (PDJ) FAL 1801

Guideline #

Test	Results/Toxicity Category	MRIDs	Study Conclusion

Acute Oral Toxicity

OPPTS 870.1100	LD50 > 5000 mg/kg

IV	47927818, 47927825	Acceptable

Acute Dermal Toxicity

OPPTS 870.1200	LD50 > 2000 mg/kg

III	47927818, 47927826	Acceptable

Acute Inhalation Toxicity

OPPTS 870.1300	LC50 > 5.0 mg/L

IV	47927818, 47927827	Acceptable

Primary Eye Irritation

OPPTS 870.2400	 slight eye irritation

IV	47927818, 47927828	Acceptable

Primary Dermal Irritation

OPPTS 870.2500	No skin irritation.

IV	47927818, 47927829	Acceptable

Dermal Sensitization

OPPTS 870.2600	Not a dermal sensitizer	47927818, 47927830	Acceptable

870.3100

90 day Oral Toxicity-Rat	NOEL=566-587 mg/kg/day	47927831

	Acceptable

870.3700

Prenatal Developmental Toxicity Study - Rat 	Maternal NOEL > 500
mg/kg/day

Developmental NOEL > 500 mg/kg/day	47927832	Acceptable

870.5100

Bacterial Reverse Mutation Test	There was no evidence of induced mutant
colonies over background	47927833	Acceptable

 870.5375

In Vitro Mammalian Chromosome Aberration Tests 	There was no evidence of
cells with chromosomal abnormalities	47927834	Acceptable

Classification:  Acceptable; no additional data are required.

TOXICOLOGY STUDIES

FAL 1800 formulation containing 5.25% PDJ

MRID 47927819: Acute Oral Toxicity - Rats (OPPTS 870.1100)

The oral LD50 for males, females, and combined sexes of rats was greater
than 5,000 mg/kg suggesting that PDJ Formulation is a TOXICITY CATEGORY
IV.  This study is classified as Acceptable.

MRID 47927820: Acute Dermal Toxicity - Rats (OPPTS 870.1200)

The acute dermal LD50 for males, females, and combined sexes of rats was
greater than 2000 mg/kg placing PDJ Formulation in TOXICITY CATEGORY
III.  The study is classified as Acceptable.

MRID 47927821: Acute Inhalation Toxicity - Rats (OPPTS 870.1300)

The inhalation LC50 for males, females, and combined sexes of rats was >
5.0 mg/L placing DPJ Formulation in TOXICITY CATEGORY IV.  The study is
classified as Acceptable.

MRID 47927822: Acute Eye Irritation - Rabbits (OPPTS 870.2400)

Eye-unwashed group: Corneal opacity was noted on 6/6 rabbits one hour
after test material instillation with persistence through day 4 with
clearance by day 7.  No iritis was noted on any rabbit during the study.
 Positive conjunctival irritation was noted on 6/6 animals one hour
after test material instillation with clearance by 24 hours.  Eye-washed
group: Corneal opacity was noted on 3/3 rabbits at one hour after test
material instillation with resolution by day 4.  No iritis was noted on
any rabbit during the study.  Positive conjunctival irritation was noted
on 3/3 animals at one hour after test material instillation with
resolution by 24 hours The maximum average score for unwashed eyes was
52.0 at one hour after test material instillation.  The maximum average
score for washed eyes was 40.7 at one and 24 hours after test material
instillation.  PDJ Formulation was severely irritating and is in
TOXICITY CATEGORY III.  This study is classified as Acceptable.

MRID 47927823: Primary Dermal Irritation - Rabbits (OPPTS 870.2500)

Very slight erythema was noted on 3/6 rabbits one hour after patch
removal with clearance on two rabbits by 24 hours and on one rabbit by
48 hours.  The primary irritation index was 0.2 suggesting that the PDJ
formulation was practically not irritating and is in TOXICITY CATEGORY
IV.  The study is classified as Acceptable.

MRID 47927824: Skin Sensitization - Guinea Pigs (OPPTS 870.2600)

After three consecutive weekly inductions, the test animals, control
animals, and controls for positive control animals showed no signs of
reactivity at 24 and 48 hours after challenge and the results for the
DNCB positive control were appropriate.  PDJ Formulation was not a
dermal sensitizer.  The study is classified as Acceptable.

FAL 1801 Prohydrojasmon (PDJ)

MRID 47927825: Acute Oral Toxicity - Rats (OPPTS 870.1100)

The oral LD50 for males, females, and combined sexes of rats was greater
than 5000 mg/kg placing PDJ in TOXICITY CATEGORY IV.  The study is
classified as Acceptable.

MRID 47927826: Acute Dermal Toxicity - Rats (OPPTS 870.1200)

The acute dermal LD50 for males, females, and combined sexes of rats was
greater than 2000 mg/kg placing PDJ in TOXICITY CATEGORY III.  The study
is classified as Acceptable.

MRID 7927827: Acute Inhalation Toxicity - Rats (OPPTS 870.1300)

The inhalation LC50 for males, females, and combined sexes of rats was >
2.8 mg/L placing DPJ in TOXICITY CATEGORY IV. This study is classified
as Acceptable.

MRID 47927828: Acute Eye Irritation - Rabbits (OPPTS 870.2400)

Eye-unwashed group: Corneal opacity was noted on 2/6 rabbits 24 hours
after test material instillation with resolution by 48 hours.  No iritis
or positive conjunctival irritation was noted on any rabbit during the
study.  Eye-washed group: Corneal opacity was noted on 3/3 rabbits at
one hour after test material instillation with resolution on two rabbits
by 24 hours and on another rabbit by 48 hours.  No iritis or positive
conjunctival irritation was noted on any rabbit during the study.  The
maximum average score for unwashed eyes and washed eyes were 5.0 and
11.0, respectively, at one hour after test material instillation.  The
test material PDJ was minimally irritating and is in TOXICITY CATEGORY
IV.  The study is classified as Acceptable.  Note: PDJ Formulation was
severely irritating.

MRID 47927829: Primary Dermal Irritation - Rabbits (OPPTS 870.2500)

No dermal irritation was noted for any rabbit during the study with a
primary irritation index of 0.0.  The test material PDJ was not
irritating and is in TOXICITY CATEGORY IV.  The study is classified as
Acceptable.

MRID 47927830: Skin Sensitization - Guinea Pigs (OPPTS 870.2600) After
intradermal and topical inductions, the test, control, and control for
positive control animals showed no signs of reactivity at 24, 48, and 72
hours after challenge.  The DNCB positive control animals showed
positive reactivity.  The test material PDJ was not a dermal sensitizer.
The study is classified as Acceptable.

MRID 47927831: Subchronic oral – rat (OPPTS 870.3100) No clinically or
toxicologically significant effects were found in any treatment-group.
Therefore, the reviewer establishes the NOAEL as the highest dose,
10,000 ppm (566 mg/kg bw/day for males and 587 mg/kg bw/day for
females).  A LOAEL was not established suggesting that the test animals
could have tolerated a higher dose (protocol calls for a high test level
of at least 1,000 mg/kg). The study is classified as Acceptable although
the LOAEL was not established. The Agency has calculated the possibility
of dietary exposure and concludes that in a worst case scenario (no
degradation) the PDJ residues consumed by a 70 kg person are four orders
of magnitude below NOAEL that was calculated for this compound as noted
in the risk assessment.

MRID 47927832: Prenatal Developmental toxicity – rat (OPPTS 870.3700)

Maternal effects No treatment-related effects were found at necropsy in
maternal animals nor were there effects on copra lutei, number of
implantations, sex ratio, fetal body weight, or preimplantation
embryonic mortality.  The reviewer does not consider the transient
decrease in body weight or food intake as adverse and establishes the
NOAEL for the study as 500 mg/kg bw/day.  A LOAEL was not identified.

Developmental effects No treatment-related effects were found on
external examination of the fetuses.  Visceral examination showed a
slight increase in the incidence of thymic remnants; however, the
increase was within the historical background of the performing
laboratory.  Therefore, the Agency does not consider this a
treatment-related effect.  There was also a slight increase in the
incidence of a 14th rib but this was not accompanied by an increased
incidence of abnormal embryos either on external, skeletal, or visceral
examination. Additonally, no increase in the incidence of litters with
this effect was found.  This effect is a common variation in this strain
of rat and is therefore not considered an adverse effect.  Based on the
study results, the NOAEL for the study is the high-dose 500 mg/kg bw/day
but a LOAEL was not identified. The study is classified as Acceptable
although the LOAEL was not established. The Agency has calculated the
possibility of dietary exposure and concludes that in a worst case
scenario (no degradation) the PDJ residues consumed by a 70 kg person
are four orders of magnitude below NOAEL that was calculated for this
compound as noted in the risk assessment.

MRID 47927833: Salmonella/Escherichia/mammalian activation assay (OPPTS
870.5100)

The investigator concluded that PDJ was not mutagenic to the tested
bacterial strains under the conditions used in this study. Using doses
of the test article up to those that were cytotoxic, both without and
with activation, there was no dose that caused at least a 2-fold
increase in the number of revertants compared to the corresponding
solvent control. There was also no test condition which caused any
dose-dependent and reproducible increase in the number of revertants.
All positive controls, without and with activation, gave appropriate.
This is study is classified as Acceptable.

MRID 47927834: In vitro Mammalian Chromosome Aberration Test
(OPPTS 870.5375)

PDJ was tested up to cytotoxic dose levels (80 µg/mL, based on reduced
mitotic activity) without S9 activation, and up to the limit
concentration of 5000 µg/mL with S9 activation. None of the test
concentrations induced a significant increase in the incidence of cells
with chromosomal abnormalities, either in the absence or presence of S9
activation. In both experiments, the fraction of cells with chromosomal
aberrations was below 5%, which indicated a negative response. There was
also no indication of any dose-response effect either without or with
activation. All of the negative, solvent and positive controls gave
appropriate responses.

This study is classified as Acceptable.

ECOTOXICITY STUDIES

FAL 1801 Prohydrojasmon (PDJ)

Ecotoxicity studies (Table 8.0) show that prohydrojasmon (PDJ) is
moderately toxic to fish and aquatic invertebrates (LC50 and EC50 = 3.3
and 9.54 mg/L, respectively) and practically non-toxic to avian species
(LD50 >2,000 mg/kg; LC50 >5,000 ppm). This compound is relatively
unstable in the environment with an aerobic soil half-life of 1.6 –
2.3 hours, and upon consumption breaks down under gastric condition with
a half-life of 0.8 days.

Table 8.0. Ecotoxicity Data for Prohydrojasmon (PDJ)

Guideline #

Test	Results/Toxicology Category	MRID	Study Conclusion

Aquatic Species Testing

850.1010

Acute Toxicity Test, Daphnids 	EC50 = 9.54 mg/L.

Moderately toxic	47927838	Acceptable

850.1075

Acute Toxicity Freshwater Fish

Cyprinus carpio	96 hr LC50 = 3.3 mg/L.

Moderately toxic	47927837	Acceptable

Avian Species Testing

850.2100

Avian Acute Oral Toxicity

Bobwhite (Colinus virginianus) 	LD50 >2000 mg/kg

Practically non-toxic	47927835	Acceptable

850.2200

Avian Dietary Toxicity

Japanese quail (Colinus virginianus)	LC50 >5000 ppm

Practically non-toxic	47927836	Acceptable

FAL 1801 Prohydrojasmon (PDJ)

MRID 47927835: Avian Acute Oral Toxicity (OPPTS 850.2100) The acute
Northern Bobwhite (Colinus virginianus) oral nominal LD50 was >2,000 mg
a.i./kg. The no-mortality concentration and the no-observed-effect
concentration were 2,000 mg a.i./kg. This study is classified as
Acceptable.

MRID 47927836: Avian Dietary Toxicity (OPPTS 850.2200) In a five-day
dietary toxicity test, a group of 10-day-old Japanese quail was
administered prepared diet containing a nominal dose 5000 ppm PDJ (a.i.,
98.08% n-propyl dihydrojasmonate), followed by three days of untreated
basal diet. A control group was fed untreated basal diet only. There
were no treatment-related mortalities, and all birds appeared normal
during the test. Mean body weight, body weight gain, feed intake, and
feed conversion were comparable between the control and test material
groups. The measured concentration of the test material in the prepared
diet was 4721 ± 255.1 ppm, 94.4% of the nominal concentration. The
5-day dietary study produced an LC50 > 5,000 ppm and the NOEC of 5,000
ppm. This study is classified as Acceptable.

MRID 47927837: Fish Acute Toxicity Testing (OPPTS 850.1075) Based on the
mean measured concentrations, the 96-hour LC50 for PDJ Technical in
common carp (Cyprinus carpio) was 3.3 mg a.i./L with the LOEC of 2.76 mg
a.i./L, and the NOEC of 1.42 mg a.i./L. This study is classified as
Acceptable.

MRID 47927838: Aquatic Invertebrate Acute Toxicity Testing (OPPTS
850.1010).

Based on the mean measured concentrations, the 24-hour EC50 was 9.54
mg/L (95% a.i., 7.62-12.0 mg/L), and the 48-hour EC50 was 2.13 mg/L (95%
a.i., 1.64-2.70 mg/L). The study is classified as Acceptable.

Risk Assessment

HUMAN HEALTH

Chronic Exposure and Oncogenicity:

None of the results of the submitted studies triggered the need for
chronic exposure or oncogenicity testing. No morphologic effects (e.g.
hyperplasia or metaplasia) in any organ that could potentially lead to
neoplastic change. Assays for mutagenicity, chromosomal aberration,
developmental toxicity, and subchronic oral did not present any clinical
or toxicologically significant effects.

Effects on the Endocrine System:

No data are available regarding the effects of Prohydrojasmon on
endocrine systems via oral, dermal, or inhalation exposure. No
significant treatment-related effects were observed for prenatal
developmental or maternal testing.

Dose Response Assessment:

No toxicological endpoints were identified; therefore a dose response
assessment was not required.

Dietary Exposure:

The most likely dietary route of exposure of humans to Prohydrojasmon is
via exposure to treated fruit or foliage (e.g. apples). Table 9.0 shows
possible Prohydrojasmon residues on various matrices after one maximum
application of 0.009 lbs ai/A (200 ppm ai/A). The dietary-based
estimated environmental concentrations range from 0.77 to 0.06 ppm on
the day of application and decline to 0.0 by Day 2. This compound is
relatively unstable in the environment with an aerobic soil half-life of
1.6 – 2.3 hours, and upon consumption breaks down under gastric
condition with a half-life of 0.8 days.

The Agency has calculated the possibility of risk to humans through
dietary exposure by using a worst case scenario of maximum application
and no degradation. These calculations (Appendix A) show that the
Prohydrojasmon residues consumed by a 70 kg person are about seven
orders of magnitude below Developmental Toxicity NOAEL  > 500 mg/kg and
about eight orders of magnitude below the Acute Oral toxicity value
(LD50 > 5,000 mg/kg), suggesting no dietary or sublethal risk

Table 9.0 Estimated Prohydrojasmon Residues on Terrestrial Matrices
Using the Terrestrial Exposure Model (T-REX ; USEPA )

Terrestrial Matrix	Dietary-based Estimated Environmental Concentrations
(ppm)

	0 days after application	2 days after first application

Short Grass	0.77	0.0

Tall Grass	0.32	0.0

Broadleaf Plant Foliage	0.41	0.0

Fruits, Pods, and Seeds	0.06	0.0

Drinking Water Exposure and Risk Characterization:

No significant exposure via drinking water is expected when
Prohydrojasmon is used in accordance with EPA-approved product labeling.
The end product is not to be applied directly to water or to areas where
surface water is present. In the unlikely event that exposure via
drinking water did occur, the health risk would be expected to be
minimal, based on low acute oral and dermal toxicity of Prohydrojasmon.

The Agency estimated environmental concentrations (EECs) to an aquatic
site from Prohydrojasmon runoff (spray to apple trees) using the GENeric
Estimated Environmental Concentration model (GENEEC; EPA, 2001). The
model assumed 2 maximum applications of end product at 0.009lbs ai/A (4g
ai/A) at 7 day intervals, a 10.7 day aquatic half-life, a 57.8 hours
photodegradation half-life in water, and a 1.6 – 2.3 hour half-life in
aerobic soil. The peak aquatic EEC was calculated at about 0.00048 ppm
with a decline to 0.000024 ppm after 21 days (Table 10.0). No acute or
subacute endpoints were identified through mammalian testing and the
expected concentrations in surface water are well below (6 to 7 orders
of magnitude) the maximum doses used in laboratory testing (e.g. Acute
Oral Toxicity LD50 > 5,000 mg/kg; Developmental Toxicity NOAEL > 500
mg/kg).

Table 10.0 Generic Estimated Environmental Concentrations (EECs) of
Prohydrojasmon in Aquatic Sites using the GENEEC Model, ver 2.0 (EPA,
2001) in Parts Per Million (ppm)

Peak EEC	Max 4 Day

Avg EEC	Max 21 Day

Avg EEC	Max 60 day

Avg EEC	Max 90 Day

Avg EEC

0.00048	0.00013	0.000024	0.000008	0.000006

Occupational Exposure:

Occupational exposure to Prohydrojasmon is mitigated as long as the
end-use product is used in accordance with EPA-approved labeling.
Occupational exposures are not included under the Federal Food, Drug,
and Cosmetic Act (FFDCA) in the assessment of aggregated exposures for
the purpose of establishing tolerances and exemptions from tolerance.

Residential, school and Day Care Exposure and Risk Characterization:

Significant human exposure to Prohydrojasmon is highly unlikely in
residential, school and day care areas when the end use product is used
in accordance with EPA-approved labeling. The product is only intended
for commercial use as a plant growth regulator on apples.

Aggregated Exposure from Multiple Routes Including Dermal, Oral and
Inhalation:

There is reasonable certainty that no harm to the U.S. population will
result from aggregate exposure to residues of Prohydrojasmon. This
included all exposures for which there is reliable information. The
Agency arrived at this conclusion based on the low toxicity and rapid
break-down of the compound. The risk from aggregate exposure via oral,
dermal, and inhalation are a compilation of three low-risk exposure
scenarios (oral, dermal, and inhalation) and are negligible. Since there
are no threshold effects of concern for this compound, and no known
toxic endpoints, the provision requiring an additional margin of safety
does not apply.

Cumulative Effects:

Residues of Prohydrojasmon will not reach levels that are of
toxicological concern if the compound is used as proposed. Because of
its low toxicity and low level of exposure, cumulative effects with
other substances that share a common mechanism of toxicity are not
expected.

Human Risk Characterization:

The Agency considered human exposure to Prohydrojasmon in light of
relevant safety factors in FQPA and FIFRA. A determination has been made
that no unreasonable adverse effects to the U.S. population in general,
and to infants and children in particular, will result from the use of
Prohydrojasmon when used in accordance with EPA-approved labeling.

Ecological Assessment

ECOTOXICITY RISK

Terrestrial

Prohydrojasmon is not naturally-occurring but is structurally similar to
jasmonic acid (JA). JA is an intermediate in the pathway to plant
abscisic acid synthesis and has ABA-like activity (i.e. growth
inhibition, senescence, leaf abscission, as well as a role in wound
response and systemic resistance). When plants are attacked by insects
there is a release of JA, which inhibits the insect’s ability to
digest protein.

In order to evaluate risk of Prohydrojasmon exposure to terrestrial
species, the Agency has estimated RQ values using the Terrestrial
Residue Exposure Model (T-REX) Version 1.4.1. A terrestrial risk
assessment includes calculated expected residues, as well as, numerous
calculations of dietary exposure for multiple weight class animals
(Appendix B). Expected residues were calculated for avian and mammalian
food items along with dissipation rate of a chemical applied to foliar
surfaces (single or multiple applications) in order to estimate worst
case acute RQs relative to weight class for various sized birds and
mammals. These calculations showed upper bound Kenega values and that
exposure to Prohydrojasmon (0.009lbs ai/A) has a low potential for toxic
impact to birds (RQ = 0.00) and mammals (RQ= 0.00) that may be feeding
in the area of application as noted in Appendix B. The unique
characteristics of this product, Prohydrojasmon, and the non-toxic mode
of action, biodegradability and low potential for exposure will result
in no risk to all non-target terrestrial organisms.

Aquatic

Prohydrojasmon exposure to aquatic species should result in no toxicity
effects. Estimated environmental concentrations (EECs) in aquatic sites
from Prohydrojasmon runoff after application to terrestrial crops were
estimated using the GENeric Estimated Environmental Concentration model
(GENEEC; EPA, 2001). The model assumed 2 maximum applications of end
product at 0.009lbs ai/A (4g ai/A) at 7 day intervals, a 10.7 day
aquatic half-life, a 57.8 hours photodegradation half-life in water, and
a 1.6 – 2.3 hour half-life in aerobic soil. The peak aquatic EEC was
calculated at a peak of about 0.00048 ppm which declined to 0.000024 ppm
after 21 days (Table 10.0). Since the LC50 values for fish and aquatic
invertebrates is 3.3 mg/L and 9.54 mg/L this would result in Risk
Quotients (RQs) of  0.0001 and 0.00005, respectively, which are about
three and four orders of magnitude below the Agency’s levels of
concern (LOCs = 0.1), suggesting no risk concerns for aquatic species.

Endangered Species

The Agency’s Individual Effects Chance Model Version 1.1 was used to
estimate to the chance of risk to endangered/threatened avian and
aquatic species from exposure to Prohydrojasmon. These values (avian
risk at 1 in 294,000 and aquatic risk at 1 in 418,000,000) suggest that
Prohydrojasmon should not cause toxic risk to endangered/threatened
species. In evaluating risk to aquatic endangered species the calculated
RQs are about two and three orders of magnitude below the aquatic
endangered species LOC = 0.05 resulting in no effect (NE) to aquatic
endangered species. The calculated RQ values for terrestrial species are
0.00 resulting in a no effect (NE) to endangered/threatened terrestrial
organisms.

Appendix A Human Toxicity Calculations

Polyhydrojasmon (PDJ) is to be sprayed on red apples in order to promote
fruit color change. The product is to be applied to tree canopies with
1-2 applications of 100-200 ppm at 7-14 day intervals, 7-28 days prior
to anticipated harvest. The active ingredient (PDJ) amounts to 50 grams
per liter of end product (FAL 1800). The maximum amount of FAL 1800 that
can be applied per acre is 52 oz. or 2.73 oz. ai (5.25% ai in product).

Given: 50 g ai/L or 50 g ai/33.8oz;

            52oz of formulation/A or 2.73oz ai/A (5.25 % ai in FAL
1800);

  X     2.73 oz   =   4g ai/A  or 0.009 lbs. ai/A to be sprayed at each
application.

 50g   33.8 oz

Information on apple production:

300 – 400 trees/A (Minnesota) can produce about 300 – 500 bushels of
apples/A1; One bushel = 42 lbs of apples1. Weight of 10 apples is 3.5
lbs., 3.5 lbs. ÷ 10 apples = .35 lbs./apple1. Human consumption is
about 42 lbs. of apples/year or about 120 apples1. Therefore if we
project a worst case scenario (no degradation and maximum application)
this will result in 4g ai/A (0.009 lbs ai/A) and 0.013g ai/bushel x 2
applications = 0.026g ai/bushel of apples (no degradation).

Risk Scenario

In order to evaluate toxic risk to humans the Agency calculated acute
and sublethal chronic effects in combination with an extrapolated
possible exposure scenario. The acute oral toxicity was calculated at >
5,000 mg/kg (MRID 47927825) while a sublethal NOAEL > 500 mg/kg/day
(MRID 47927832).  The worst case scenario of maximum application and no
degradation was used as an exposure component that amounted to 26mg
ai/42lbs apples or about 0.07 mg ai/apple. Therefore, if the average
70kg human consumes about 120apples/year1 the annual body burden of ai
would amount to 8.4mg (120 x 0.07mg = 8.4mg). A 70kg human would have to
consume > 35,000mg ai/day in order to approach the sublethal NOAEL > 500
mg/kg/day or 350,000mg ai to approach the acute oral dietary of
5,000mg/kg.

1http://www.rma.usda.gov/handbooks/25000/2001/0

Appendix B.  TREX Output for Terrestrial Exposure and Risk from
Prohydrojasmon Application to Apples

References

Parker, R.D., R.D. Jones and H.P. Nelson., 1995. GENEEC: A Screening
Model for Pesticide Environmental Exposure Assessment., in Proceedings
of the International Exposure Symposium on Water Quality Modeling;
American Society of Agricultural Engineers, pp. 485-490; Orlando,
Florida.

U.S. EPA.  1998.  Guidance for Ecological Risk Assessment.  Risk
Assessment Forum.  EPA/630/R-95/002F, April 1998.

U.S.EPA  2008. Terrestrial Residue Exposure Model (T-REX) Version 1.4.1.
EFED/OPP/USEPA.

U.S.EPA  2004. Individual Effects Chance Model Version 1.1.
EFED/OPP/USEPA.

U.S. EPA.  2004.  Overview of the Ecological Risk Assessment Process in
the Office of Pesticide Programs.  Office of Prevention, Pesticides, and
Toxic Substances.  Office of Pesticide Programs.  Washington, D.C.
January 23, 2004.

 PAGE

 PAGE   18


45
2_EPA
EPA_OTAQ
  Year  Foss CO2  Defo CO2       CH4       N2O       NOx      VOCs        CO     SO2,1     SO2,2     SO2,3       CF4      C2F6    HFC125   HFC134a   HFC143a  HFC227ea  HFC245ca       SF6
  Year    (Pg C)    (Pg C)      (Tg)    (Tg N)    (Mt N)      (Mt)      (Mt)    (Tg S)    (Tg S)    (Tg S)    (kton)    (kton)    (kton)    (kton)    (kton)    (kton)    (kton)    (kton)
  1990     6.055     1.599   273.903     6.955      37.8   206.246  1040.263         0         0         0    18.929     1.028     0.001         0         0         0         0     6.327
  2000     7.259     1.265   292.239     7.497    38.449   215.385  1075.392    -7.063     5.988     2.197     17.31     1.888     5.167   158.773         0         0    12.076     6.228
  2005     7.861     1.097   301.407     7.767    38.774   219.954  1092.956   -10.595     8.983     3.295      16.5     2.317      7.75   238.159         0         0    18.114     6.179
  2013     9.198     0.888    332.37     8.474    38.353   223.273  1133.059   -14.304     10.55      3.64    14.639     1.862    13.059    339.54         0         0    44.307     5.696
  2014     9.365     0.862    336.24     8.562      38.3   223.687  1138.072   -14.768    10.746     3.683    14.406     1.806    13.723   352.213         0         0    47.581     5.636
  2015     9.533     0.836   340.111      8.65    38.248   224.102  1143.084   -15.231    10.942     3.726    14.174     1.749    14.387   364.886         0         0    50.855     5.576
  2016       9.7      0.81   343.981     8.739    38.195   224.517  1148.097   -15.695    11.138     3.769    13.941     1.692     15.05   377.558         0         0    54.129     5.515
  2017     9.866     0.784   347.849     8.827    38.142   224.931  1153.111   -16.159    11.334     3.812    13.709     1.635    15.714   390.231         0         0    57.403     5.455
  2018    10.032     0.758   351.716     8.915     38.09   225.343  1158.127   -16.623     11.53     3.856    13.476     1.578    16.378   402.903         0         0    60.677     5.395
  2019    10.197     0.732    355.58     9.003    38.037   225.755  1163.143   -17.087    11.726     3.899    13.244     1.521    17.041   415.575         0         0    63.951     5.334
  2020    10.362     0.706   359.442     9.092    37.984   226.165  1168.162   -17.551    11.922     3.942    13.011     1.464    17.705   428.247         0         0    67.225     5.274
  2021    10.552     0.703   362.441     9.162    38.001   227.913  1172.209   -17.767    11.444     3.984     13.13     1.485    18.025   437.117         0         0    67.676     5.378
  2022    10.741     0.701   365.437     9.233    38.018   229.658   1176.26   -17.984    10.966     4.025    13.249     1.507    18.346   445.988         0         0    68.127     5.481
  2023     10.93     0.698    368.43     9.303    38.035   231.403  1180.313     -18.2    10.488     4.067    13.367     1.528    18.666   454.858         0         0    68.578     5.585
  2024    11.117     0.695   371.421     9.374    38.052   233.146  1184.369   -18.417     10.01     4.109    13.486     1.549    18.987   463.729         0         0    69.028     5.688
  2025    11.304     0.693   374.409     9.444    38.069   234.887  1188.428   -18.634     9.532     4.151    13.605      1.57    19.307   472.599         0         0    69.479     5.792
  2026    11.491      0.69   377.397     9.515    38.086   236.629  1192.489   -18.851     9.054     4.193    13.724     1.591    19.628    481.47         0         0     69.93     5.895
  2027    11.678     0.688   380.386     9.585    38.103   238.371  1196.551   -19.068     8.576     4.234    13.842     1.612    19.948   490.341         0         0    70.381     5.999
  2028    11.865     0.685   383.376     9.656     38.12   240.114  1200.615   -19.285     8.098     4.276    13.961     1.633    20.269   499.211         0         0    70.831     6.102
  2029    12.052     0.682   386.366     9.726    38.137   241.857   1204.68   -19.502      7.62     4.318     14.08     1.655    20.589   508.082         0         0    71.282     6.206
  2030     12.24      0.68   389.358     9.797    38.154   243.601  1208.746   -19.718     7.142      4.36    14.199     1.676    20.909   516.953         0         0    71.733     6.309
  2031    12.428     0.677    392.35     9.867    38.172   245.345  1212.812   -19.935     6.664     4.401    14.318     1.697     21.23   525.824         0         0    72.183     6.413
  2032    12.616     0.675   395.343     9.937    38.189    247.09  1216.878   -20.152     6.186     4.443    14.436     1.718     21.55   534.695         0         0    72.634     6.516
  2033    12.805     0.672   398.338    10.008    38.207   248.835  1220.943   -20.368     5.708     4.485    14.555     1.739    21.871   543.566         0         0    73.085      6.62
  2034    12.994     0.669   401.333    10.078    38.224   250.581  1225.007   -20.585     5.229     4.527    14.674      1.76    22.191   552.437         0         0    73.536     6.723
  2035    13.183     0.667   404.329    10.149    38.242   252.327  1229.071   -20.801     4.751     4.569    14.793     1.781    22.512   561.308         0         0    73.986     6.827
  2036    13.343     0.668   406.335    10.185    37.958   251.329  1220.741   -20.973     4.203     4.511     14.89     1.802    22.846   570.453         0         0    74.243     6.912
  2037    13.504     0.669   408.342    10.221    37.675   250.331   1212.41   -21.145     3.654     4.453    14.987     1.822    23.181   579.599         0         0    74.499     6.997
  2038    13.664      0.67    410.35    10.257    37.391   249.334  1204.077   -21.316     3.106     4.396    15.084     1.842    23.516   588.744         0         0    74.756     7.082
  2039    13.825     0.671   412.359    10.294    37.108   248.337  1195.743   -21.488     2.557     4.338    15.182     1.862     23.85    597.89         0         0    75.012     7.167
  2040    13.986     0.672   414.368     10.33    36.824    247.34  1187.408   -21.659     2.008     4.281    15.279     1.882    24.185   607.036         0         0    75.269     7.252
  2041    14.148     0.673   416.378    10.366     36.54   246.344  1179.072   -21.831      1.46     4.223    15.376     1.902     24.52   616.181         0         0    75.525     7.337
  2042    14.309     0.674   418.388    10.402    36.257   245.348  1170.735   -22.002     0.911     4.165    15.473     1.923    24.854   625.327         0         0    75.782     7.422
  2043    14.471     0.675   420.399    10.438    35.973   244.352  1162.397   -22.173     0.362     4.108    15.571     1.943    25.189   634.473         0         0    76.038     7.507
  2044    14.633     0.676   422.411    10.475     35.69   243.356  1154.058   -22.345    -0.186      4.05    15.668     1.963    25.524   643.618         0         0    76.295     7.592
  2045    14.795     0.677   424.422    10.511    35.406   242.361  1145.718   -22.516    -0.735     3.992    15.765     1.983    25.859   652.764         0         0    76.551     7.677
  2046    14.957     0.678   426.434    10.547    35.122   241.365  1137.378   -22.687    -1.284     3.935    15.862     2.003    26.193    661.91         0         0    76.808     7.762
  2047    15.118     0.679   428.446    10.583    34.839    240.37  1129.038   -22.859    -1.832     3.877     15.96     2.023    26.528   671.055         0         0    77.064     7.847
  2048     15.28      0.68   430.457    10.619    34.555   239.374  1120.697    -23.03    -2.381      3.82    16.057     2.044    26.863   680.201         0         0    77.321     7.933
  2049    15.442     0.681   432.469    10.655    34.271   238.379  1112.356   -23.202    -2.929     3.762    16.154     2.064    27.197   689.347         0         0    77.577     8.018
  2050    15.604     0.682   434.481    10.692    33.987   237.384  1104.015   -23.373    -3.478     3.704    16.251     2.084    27.532   698.492         0         0    77.834     8.103
  2065    17.623     0.629   446.587    11.005    29.957   224.101   959.744   -24.007    -7.669     3.875    17.847     2.365    33.962   873.582         0         0    80.517     8.943
  2080    19.708     0.335   443.027    10.938    26.241   188.232   704.846   -24.404   -10.171     2.555    19.463     2.551    42.184  1098.482         0         0    83.552     9.716
  2095     21.26      0.29    446.41    10.823    24.811    172.97   594.138   -24.568   -10.737     0.602    20.983     2.693    50.563  1311.958         0         0     85.08     10.24
  2100     21.26      0.29    446.41    10.823    24.811    172.97   594.138   -24.568   -10.737     0.602    20.983     2.693    50.563  1311.958         0         0     85.08     10.24
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Produced by write_magicc_file.R from ../R/EPA_OTAQ.csv. JGCRI/PNNL, Thu Jun 21 22:05:50 2012


[Federal Register: May 3, 2007 (Volume 72, Number 85)]
[Notices]
[Page 24636-24637]
[DOCID:fr03my07-106]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. IC-27806]

Notice of Applications for Deregistration Under Section 8(f) of
the Investment Company Act of 1940

April 27, 2007.
    The following is a notice of applications for deregistration under
section 8(f) of the Investment Company Act of 1940 for the month of
April, 2007. A copy of each application may be obtained for a fee at
the SEC's Public Reference Branch (tel.<PHONE_NUMBER>). An order
granting each application will be issued unless the SEC orders a
hearing. Interested persons may request a hearing on any application by
writing to the SEC's Secretary at the address below and serving the
relevant applicant with a copy of the request, personally or by mail.
Hearing requests should be received by the SEC by 5:30 p.m. on May 22,
2007, and should be accompanied by proof of service on the applicant,
in the form of an affidavit or, for lawyers, a certificate of service.
Hearing requests should state the nature of the writer's interest, the
reason for the request, and the issues contested. Persons who wish to
be notified of a hearing may request notification by writing to the
Secretary, U.S. Securities and Exchange Commission, 100 F Street,
NE.,Washington, DC 20549-1090.
    For Further Information Contact: Diane L. Titus at<PHONE_NUMBER>,
SEC, Division of Investment Management, Office of Investment Company
Regulation, 100 F Street, NE., Washington, DC 20549-4041.

Stepstone Funds [File No. 811-6192]

    Summary: Applicant seeks an order declaring that it has ceased to
be an investment company. By April 25, 1997, applicant had transferred
all of its assets to HighMark Funds, based on net asset value. Expenses
of $27,400 incurred in connection with the reorganization were paid by
Union Bank of California, N.A., the acquiring fund's investment
adviser.
    Filing Dates: The application was filed on January 31, 2003, and
amended on April 11, 2007, and April 20, 2007.
    Applicant's Address: 2 Oliver St., Boston, MA 02109.

Morgan Stanley Aggressive Equity Fund [File No. 811-8471]

    Summary: Applicant seeks an order declaring that it has ceased to
be an investment company. On December 8, 2006, applicant transferred
its assets to Morgan Stanley Capital Opportunities Trust, based on net
asset value. Expenses of approximately $455,000 incurred in connection
with the reorganization were paid by Morgan Stanley Investment Advisors
Inc., applicant's investment adviser.
    Filing Date: The application was filed on March 30, 2007.
    Applicant's Address: Morgan Stanley Investment Advisors Inc., 1221
Avenue of the Americas, New York, NY 10020.

Morgan Stanley Growth Fund [File No. 811-6551]

    Summary: Applicant seeks an order declaring that it has ceased to
be an investment company. On October 20, 2006, applicant transferred
its assets to Morgan Stanley Focus Growth Fund, based on net asset
value. Expenses of approximately $381,000 incurred in connection with
the reorganization were paid by Morgan Stanley Investment Advisors
Inc., applicant's investment adviser.
    Filing Date: The application was filed on March 28, 2007.
    Applicant's Address: Morgan Stanley Investment Advisors Inc., 1221
Avenue of the Americas, New York, NY 10020.

DCM Series Trust [File No. 811-9527]

    Summary: Applicant seeks an order declaring that it has ceased to
be an investment company. On January 27, 2006, applicant made a
liquidating distribution to its shareholders, based on net asset value.
Expenses of $1,533 incurred in connection with the liquidation were
paid by applicant.
    Filing Date: The application was filed on April 4, 2007.
    Applicant's Address: 7 Wells Ave., Newton, MA 02459.

ING Clarion Investors LLC [File No. 811-21501]

    Summary: Applicant, a closed-end investment company, seeks an order
declaring that it has ceased to be an investment company. Applicant has
never made a public offering of its securities and does not propose to
make a public offering or engage in business of any kind.
    Filing Dates: The application was filed on March 23, 2007, and
amended on April 12, 2007.
    Applicant's Address: 14 East 4th Street, New York, NY 10012.

Rydex Capital Partners Sphinx Equity Long/Short Fund [File No. 811-
21773]

    Summary: Applicant, a closed-end investment company, seeks an order
declaring that it has ceased to be an investment company. Applicant has
never made a public offering of its securities and does not propose to
make a public offering or engage in business of any kind.
    Filing Dates: The application was filed on March 21, 2007, and
amended on April 11, 2007.
    Applicant's Address: 9601 Blackwell Rd., Suite 500, Rockville, MD
20850.

Kobren Insight Funds [File No. 811-7813]

    Summary: Applicant seeks an order declaring that it has ceased to
be an investment company. On November 17, 2006, applicant transferred
its assets to E*TRADE Funds, based on net asset value. Expenses of
$321,385 incurred in connection with the reorganization were paid by
E*TRADE Financial, parent company of the investment adviser for both
applicant and the acquiring fund.
    Filing Dates: The application was filed on March 2, 2007, and
amended on April 5, 2007.
    Applicant's Address: 20 William St., Suite 310, Wellesley Hills, MA
02481.

Kopp Funds, Inc. [File No. 811-8267]

    Summary: Applicant seeks an order declaring that it has ceased to
be an investment company. On February 23, 2007, applicant transferred
its assets to corresponding series of American Century Mutual Funds,
Inc. and American Century Quantitative Equity Funds, Inc., based on net
asset value. Expenses of approximately $450,000 incurred in connection
with the reorganization were paid by Kopp Investment Advisors, LLC and
American Century Investment Management, Inc., applicant's investment
advisers.
    Filing Dates: The application was filed on March 1, 2007, and
amended on April 3, 2007.
    Applicant's Address: 7701 France Ave. South, Suite 500, Edina, MN
55435.

Citigroup Alternative Investments Multi-Adviser Hedge Fund Portfolios
(Series M) LLC [File No. 811-21999]

    Summary: Applicant, a closed-end investment company, seeks an order
declaring that it has ceased to be an investment company. On December
29, 2006, applicant transferred its assets to Citigroup Alternative
Investments Multi-Adviser Hedge Fund Portfolios LLC, based on net asset
value. Expenses of $326,343 incurred in connection with the
reorganization were paid by applicant and Citigroup Alternative
Investments LLC, applicant's investment adviser.
    Filing Dates: The application was filed on January 17, 2007, and
amended on April 5, 2007.
    Applicant's Address: 731 Lexington Ave., 25th Floor, New York, NY
10022.

INTRUST Funds Trust [File No. 811-7505]

    Summary: Applicant seeks an order declaring that it has ceased to
be an investment company. On March 2, 2006, applicant transferred its
assets to American Independence Funds Trust, based on net asset value.
Expenses of $302,860 incurred in connection with the reorganization
were paid by INTRUST Financial Services, Inc., applicant's investment
adviser.
    Filing Dates: The application was filed on February 26, 2007, and
amended on March 28, 2007.
    Applicant's Address: 3435 Stelzer Rd., Columbus, OH 43219.

    For the Commission, by the Division of Investment Management,
pursuant to delegated authority.
Florence E. Harmon,
 Deputy Secretary.
[FR Doc. E7-8426 Filed 5-2-07; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 76, Number 232 (Friday, December 2, 2011)]
[Proposed Rules]
[Pages 75505-75508]
[FR Doc No: 2011-30637]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2011-0959]

Drawbridge Operation Regulation; Gulf Intracoastal Waterway
(Algiers Alternate Route), Belle Chasse, LA

AGENCY: Coast Guard, DHS.

ACTION: Notice of proposed rulemaking.

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SUMMARY: The Coast Guard proposes to change the regulation governing
the operation of the SR 23 bridge across the Gulf Intracoastal Waterway
(Algiers Alternate Route), mile 3.8, at Belle Chasse, Plaquemines
Parish, Louisiana. Due to increased vehicular traffic, the State of
Louisiana requested a change to the operation schedule, allowing the
bridge to open only on the hour during the day from Monday through
Friday, while maintaining morning and afternoon maritime restrictions.

DATES: Comments and related material must reach the Coast Guard on or
before January 31, 2012.

ADDRESSES: You may submit comments identified by docket number USCG-
2011-0959 using any one of the following methods:
    (1) Federal eRulemaking Portal: http://www.regulations.gov.
    (2) Fax:<PHONE_NUMBER>.
    (3) Mail: Docket Management Facility (M-30), U.S. Department of
Transportation, West Building Ground Floor, Room W12-140, 1200 New
Jersey

Avenue SE., Washington, DC 20590-0001.
    (4) Hand delivery: Same as mail address above, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays. The telephone
number is<PHONE_NUMBER>.
    To avoid duplication, please use only one of these four methods.
See ``Public Participation and Request for Comments'' portion of the
SUPPLEMENTARY INFORMATION section below for instructions on submitting
comments.

FOR FURTHER INFORMATION CONTACT: If you have questions on this proposed
rule, call Donna Gagliano, Bridge Administration Branch at (504) 671-
2128, email<EMAIL_ADDRESS>If you have questions on viewing
or submitting material to the docket, call Renee V. Wright, Program
Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Public Participation and Request for Comments

    We encourage you to participate in this rulemaking by submitting
comments and related materials. All comments received will be posted,
without change, to http://www.regulations.gov and will include any
personal information you have provided.

Submitting Comments

    If you submit a comment, please include the docket number for this
rulemaking (USCG-2011-0959), indicate the specific section of this
document to which each comment applies, and provide a reason for each
suggestion or recommendation. You may submit your comments and material
online (http://www.regulations.gov), or by fax, mail or hand delivery,
but please use only one of these means. If you submit a comment online
via http://www.regulations.gov, it will be considered received by the
Coast Guard when you successfully transmit the comment. If you fax,
hand delivery, or mail your comment, it will be considered as having
been received by the Coast Guard when it is received at the Docket
Management Facility. We recommend that you include your name and a
mailing address, an email address, or a phone number in the body of
your document so that we can contact you if we have questions regarding
your submission.
    To submit your comment online, go to http://www.regulations.gov,
click on the ``submit a comment'' box, which will then become
highlighted in blue. In the ``Document Type'' drop down menu select
``Proposed Rules'' and insert ``USCG-2011-0959'' in the ``Keyword''
box. Click ``Search'' then click on the balloon shape in the
``Actions'' column. If you submit your comments by mail or hand
delivery, submit them in an unbound format, no larger than 8\1/2\ by 11
inches, suitable for copying and electronic filing. If you submit them
by mail and would like to know that they reached the Facility, please
enclose a stamped, self-addressed postcard or envelope. We will
consider all comments and material received during the comment period
and may change the rule based on your comment.

Viewing Comments and Documents

    To view comments, as well as documents mentioned in this preamble
as being available in the docket, go to http://www.regulations.gov,
click on the ``read comments'' box, which will then become highlighted
in blue. In the ``Keyword'' box insert ``USCG-2011-0959'' and click
``Search.'' Click the ``Open Docket Folder'' in the ``Actions'' column.
You may also visit the Docket Management Facility in Room W12-140 on
the ground floor of the Department of Transportation West Building,
1200 New Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays. We have an
agreement with the Department of Transportation to use the Docket
Management Facility.

Privacy Act

    Anyone can search the electronic form of comments received into any
of our dockets by the name of the individual submitting the comment (or
signing the comment, if submitted on behalf of an association,
business, labor union, etc.). You may review a Privacy Act notice
regarding our public dockets in the January 17, 2008, issue of the
Federal Register (73 FR 3316).

Public Meeting

    We do not now plan to hold a public meeting. But you may submit a
request for one using one of the four methods specified under
ADDRESSES. Please explain why a public meeting would be beneficial. If
we determine that one would aid this rulemaking, we will hold one at a
time and place announced by a later notice in the Federal Register.

Basis and Purpose

    The Coast Guard, at the request of the State of Louisiana, proposes
to change the existing operating schedule for the SR 23 vertical lift
bridge across the Gulf Intracoastal Waterway (Algiers Alternate Route),
mile 3.8, at Belle Chasse, Plaquemines Parish, Louisiana. Due to an
increase in vehicle traffic, the State of Louisiana requested a change
to the operation schedule. This change would allow the bridge to open
only on the hour during the day from Monday through Friday, while
maintaining morning and afternoon maritime restrictions. Bridge tender
logs for the past 7-month period showed that approximately 560 vessels
(19% of the vessels that transit under the bridge) requested an opening
between the hours of 6 a.m. and 9 a.m. and between the hours of 3 p.m.
and 6 p.m. Traffic counts were collected beginning September 26, 2011
for a 2-week period, during the average work week, and a 24-hour
summary showed 7354 vehicles (40%) commuted across the bridge during
the same times. Thus, a substantial delay can occur to vehicular
traffic during the morning and afternoon heavy commute periods. The
proposed change would allow for a set schedule of openings for vessels
while minimally disrupting vehicular traffic during the morning and
afternoon rush hours. Also, the proposed schedule would allow
additional time to clear vehicular traffic from the roadways and reduce
traffic backups caused by the bridge openings. It is expected that very
few vessels will be impacted by this change, and reasonable alternative
routes are available for vessels that must avoid delay. All vessels
waiting during the closure will be allowed to pass at scheduled
openings.
    Presently, 33 CFR 117.451(b) states: The draw of the SR 23 Bridge,
Algiers Alternate Route, mile 3.8 at Belle Chasse, shall open on
signal; except that, from 6 a.m. to 8:30 a.m. and from 3:30 p.m. to
5:30 p.m. Monday through Friday, except Federal holidays, the draw need
not be opened for the passage of vessels.

Discussion of Proposed Rule

    The proposed change will allow the bridge to operate as follows:
The bridge shall open on signal between 8 p.m. and 6:30 a.m. for the
passage of vessels. From 6:30 a.m. until 8 p.m. Monday through Friday
the bridge will only open on the hour for the passage of vessel
traffic. However, to facilitate the movement of vehicular traffic
during rush hour this change will continue to allow the bridge to
remain closed to navigation from 6:30 a.m. until 9 a.m. and from 3:30
p.m. until 6 p.m. Monday through Friday, excluding Federal holidays.
Specifically, the draw need not open at 7 a.m., 8 a.m., 4 p.m. and 5
p.m. weekdays, excluding Federal holidays. Hourly openings will allow
the motorist to know when the bridge

may open. At all times on the weekend the bridge will open on signal.
    The vertical clearance of the bridge is 40 feet above mean high
water in the closed-to-navigation position, so only vessels with
vertical clearance requirement of greater than 40 feet will be affected
by the proposed change. An alternate route is available via Harvey
Canal (GIWW), if such vessels do not wish to be delayed.
    A Test Deviation, following the aforementioned operating schedule
under docket number USCG-2011-0959, is being issued in conjunction with
the Notice of Proposed Rulemaking to test the proposed schedules and to
obtain data and public comments. The test period will be in effect from
December 19, 2011 until January 17, 2012. The Coast Guard will review
the logs of the drawbridge and evaluate public comments for this Notice
of Proposed Rulemaking and the above referenced Temporary Deviation to
determine if a permanent special drawbridge operating regulation is
warranted.

Regulatory Analyses

    We developed this proposed rule after considering numerous statutes
and executive orders related to rulemaking. Below we summarize our
analyses based on 13 of these statutes or executive orders.

Regulatory Planning and Review

    This proposed rule is not a ``significant regulatory action'' under
section 3(f) of Executive Order 12866, Regulatory Planning and Review,
as supplemented by Executive Order 13563, Improving Regulation and
Regulatory Review, and does not require an assessment of potential
costs and benefits under section 6(a)(3) of that Order. The Office of
Management and Budget has not reviewed it under that Order.
    We expect the economic impact of this proposed rule to be so
minimal that a full Regulatory Evaluation is unnecessary. Very few
vessels will be impacted or backed up, and those few vessels should be
able to modify their transit times and routes accordingly.

Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered whether this proposed rule would have a significant economic
impact on a substantial number of small entities. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000.
    The Coast Guard certifies under 5 U.S.C. 605(b) that this proposed
rule would not have a significant economic impact on a substantial
number of small entities. This proposed rule would affect the following
entities, some of which might be small entities: the owners or
operators of vessels needing to transit the bridge from 6:30 a.m. until
8 p.m. Monday through Friday. The proposed set schedule for the minimal
time adjustment of each bridge closure would affect a small number of
vessels impacted by the proposed rule.
    This action will not have a significant economic impact on a
substantial number of small entities for the following reasons. Vessels
that can transit under the bridge may do so at any time. Although, the
set closure of the drawbridge will effectively close that section of
the waterway, an alternative route (Harvey Canal, GIWW) is available
with little additional transit time. Before the effective period, we
will issue maritime advisories which will be widely available to users
of the waterway.
    If you think that your business, organization, or governmental
jurisdiction qualifies as a small entity and that this rule would have
a significant economic impact on it, please submit a comment (see
ADDRESSES) explaining why you think it qualifies and how and to what
degree this rule would economically affect it.

Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this proposed rule so that they can better
evaluate its effects on them and participate in the rulemaking. If the
rule would affect your small business, organization, or governmental
jurisdiction and you have questions concerning its provisions or
options for compliance, please contact Donna Gagliano, Bridge
Administration Branch, at<PHONE_NUMBER>. The Coast Guard will not
retaliate against small entities that question or complain about this
rule or any policy or action of the Coast Guard.

Collection of Information

    This proposed rule would call for no new collection of information
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520.).

Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on State or local
governments and would either preempt State law or impose a substantial
direct cost of compliance on them. We have analyzed this proposed rule
under that Order and have determined that it does not have implications
for federalism.

Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or Tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this proposed rule will not
result in such an expenditure, we do discuss the effects of this rule
elsewhere in this preamble.

Taking of Private Property

    This proposed rule would not affect a taking of private property or
otherwise have taking implications under Executive Order 12630,
Governmental Actions and Interference with Constitutionally Protected
Property Rights.

Civil Justice Reform

    This proposed rule meets applicable standards in sections 3(a) and
3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize
litigation, eliminate ambiguity, and reduce burden.

Protection of Children

    We have analyzed this proposed rule under Executive Order 13045,
Protection of Children from Environmental Health Risks and Safety
Risks. This rule is not an economically significant rule and would not
create an environmental risk to health or risk to safety that might
disproportionately affect children.

Indian Tribal Governments

    This proposed rule does not have Tribal implications under
Executive Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it would not have a substantial direct effect on
one or more Indian Tribes, on the relationship between the Federal
Government and Indian Tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian Tribes.

Energy Effects

    We have analyzed this proposed rule under Executive Order 13211,
Actions Concerning Regulations That

Significantly Affect Energy Supply, Distribution, or Use. We have
determined that it is not a ``significant energy action'' under that
order because it is not a ``significant regulatory action'' under
Executive Order 12866 and is not likely to have a significant adverse
effect on the supply, distribution, or use of energy. The Administrator
of the Office of Information and Regulatory Affairs has not designated
it as a significant energy action. Therefore, it does not require a
Statement of Energy Effects under Executive Order 13211.

Technical Standards

    The National Technology Transfer and Advancement Act (NTTAA) (15
U.S.C. 272 note) directs agencies to use voluntary consensus standards
in their regulatory activities unless the agency provides Congress,
through the Office of Management and Budget, with an explanation of why
using these standards would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., specifications of materials, performance, design, or
operation; test methods; sampling procedures; and related management
systems practices) that are developed or adopted by voluntary consensus
standards bodies.
    This proposed rule does not use technical standards. Therefore, we
did not consider the use of voluntary consensus standards.

Environment

    We have analyzed this proposed rule under Department of Homeland
Security Management Directive 023-01, and Commandant Instruction
M16475.lD which guides the Coast Guard in complying with the National
Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and
have made a preliminary determination that this action is one of a
category of actions which do not individually or cumulatively have a
significant effect on the human environment because it simply
promulgates the operating regulations or procedures for drawbridges. We
seek any comments or information that may lead to the discovery of a
significant environmental impact from this proposed rule.

List of Subjects in 33 CFR Part 117

    Bridges.

    For the reasons discussed in the preamble, the Coast Guard proposes
to amend 33 CFR part 117 as follows:

PART 117--DRAWBRIDGE OPERATION REGULATIONS

    1. The authority citation for part 117 continues to read as
follows:

    Authority:  33 U.S.C. 499; 33 CFR 1.05-1; Department of Homeland
Security Delegation No. 0170.1.

    2. Section 117.451(b) is revised to read as follows:

Sec.  117.451  Gulf Intracoastal Waterway.

* * * * *
    (b) The draw of the SR 23 Bridge, Algiers Alternate Route, mile 3.8
at Belle Chasse, shall open on signal; except that from 6:30 a.m. until
8 p.m. Monday through Friday, the draw need only open on the hour for
the passage of vessels. The draw need not open at 7 a.m., 8 a.m., 4
p.m. and 5 p.m. Monday through Friday excluding Federal holidays.
* * * * *

    Dated: November 3, 2011.
Roy A. Nash,
Rear Admiral, U.S. Coast Guard, Commander, Eighth Coast Guard District.
[FR Doc. 2011-30637 Filed 12-1-11; 8:45 am]
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Comment Info: =================

General Comment: Dear Mr. Zeller:

I am writing as an individual consumer to request an extension of the comment period for the Food and Drug Administration's ("FDA") Proposed Rule Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking and Prevention and Tobacco Control Act (the "Proposed Rule") published at 79 Fed. Reg. 23,142 and Federal Register No. 2014-09491. On behalf of myself, I am requesting that the comment period for the Proposed Rule be extended by the FDA for an additional 105 days, from its current 75-day period, to 180 days.

The Proposed Rule raises a number of significant issues and questions that are important and relevant to me, as a consumer of products that are proposed for regulation under the Proposed Rule. The Proposed Rule asks about a hundred different questions I might want to respond to. I want to provide my thoughts and comments on many of these issues, but my time to devote to researching and providing thoughtful comments on these important questions is limited. I have already spent many hours researching and dissecting these issues, but they take time. I know that the FDA took many years to even come up with the Proposed Rule, so I do not think it is at all unreasonable to allow the public a mere six months to comment on it. This is our only opportunity, as consumers, to provide our feedback.

I feel very strongly about e-cigarettes as an alternative to combustible cigarettes. Quite simply, I firmly believe that they saved my life. I wish to provide you with my personal story, as well as science- and evidence-based responses to your questions so that you can take my comment into account. I realize that the FDA has the authority under 21 CFR 10.40 to extend this time frame and that the FDA has exercised this authority on numerous occasions in the past. I would therefore ask that you do so here, so that all stakeholders have the opportunity to provide their comments on this proposed regulation.

I appreciate your consideration of my request and am happy to discuss this issue with you further.

There are so many products that should be regulated by the FDA, e-cigarettes and e-juices are not one of them.  The consumers of these products are bettering themselves by having quit smoking with these products.   We are not sure of how many chemicals are actually in cigarettes, are these approved by the FDA?     As a current user of the e-cigarette, please remove your proposed regulations from this product and leave it to the consumers and manufacturers to decide on there own regulations.


                                 Attachment D
     Pesticide Registration Maintenance Fee Filing Form and Instructions:
See web site at: https://www.epa.gov/sites/production/files/2015-10/documents/blank_2016_pesticide_registration_maintenance_fee_filing_form.pdf; and https://www.epa.gov/sites/production/files/2015-12/documents/maintfee_2016_instructions.pdf


[Federal Register: May 12, 2008 (Volume 73, Number 92)]
[Notices]
[Page 26978-26979]
[DOCID:fr12my08-27]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 13090-000; Project No. 13091-000]

KC LLC; Pine Creek Mine LLC; Notice of Competing Applications
Accepted for Filing and Soliciting Comments, Motions To Intervene, and
Protests

May 5, 2008.
    Take notice that the following hydroelectric applications have been
filed with the Commission and are available for public inspection:
    a. Type of Applications: Preliminary Permit (Competing).
    b. Applicants, Project Numbers, and Dates Filed:
    KC LLC, filed the application for Project No. 13090-000 on December
20, 2007.
    Pine Creek Mine LLC, filed the application for Project No. 13091-
000 on December 20, 2007.
    c. Name of the projects is Morgan Creek Project. The projects would
be located on Morgan Creek, in Inyo County, California. The proposed
projects would be located within the Inyo National Forest on lands
under the jurisdiction of the U.S. Forest Service.
    d. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791a-825r.
    e. Applicants Contacts: For KC LLC: Ms. Kelly Sackheim, Principal,
KC LLC, 5096 Cocoa Palm Way, Fair Oaks, CA 95628,<PHONE_NUMBER>. For
Pine Creek Mine LLC: Mr. Fred Springer, Hydropower Policy Advisor,
Troutman Sanders LLP, 401 Ninth Street, NW., Suite 1000, Washington, DC
20004-2134,<PHONE_NUMBER>.
    f. FERC Contact: Henry Woo,<PHONE_NUMBER>.
    g. Deadline for filing comments, protests, and motions to
intervene: 60 days from the issuance date of this notice.
    All documents (original and eight copies) should be filed with:
Secretary, Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426. Comments, protests, and interventions may be
filed electronically via the Internet in lieu of paper; see 18 CFR
385.2001(a)(1)(iii) and the instructions on the Commission's Web site
under the ``eFiling'' link. The Commission strongly encourages
electronic filings. Please include the project number (P-13090-000, or
P-13091-000) on any comments or motions filed.
    The Commission's Rules of Practice and Procedure require all
intervenors filing documents with the Commission to serve a copy of
that document on each person in the official service list for the
project. Further, if an intervenor files comments or documents with the
Commission relating to the merits of an issue that may affect the
responsibilities of a particular resource agency, they must also serve
a copy of the document on that resource agency.
    h. Description of Projects: The project proposed by KC LLC would
consist of: (1) A proposed notched-weir diversion and intake structure,
(2) a proposed 3,500-foot-long penstock, (3) a proposed powerhouse
containing a generating unit having a total installed capacity of 550
kilowatts, (4) a proposed 60-foot-long 12 kilovolt transmission line,
and (5) appurtenant facilities. The project would have an annual
generation of 3.5 gigawatt-hours that would be sold to a local utility.
    The project proposed by Pine Creek Mine LLC would consist of: (1) A
proposed intake system to be determined, (2) a proposed 9,000-foot-long
penstock, (3) a proposed powerhouse containing a generating unit having
a total installed capacity of 1,200 kilowatts, and (4) a proposed 400-
foot-long 4,160 volt transmission line. The project would have an
annual generation of 7,200 megawatt-hours that would be sold to a local
utility.
    i. The filings are available for review at the Commission in the
Public Reference Room or may be viewed on the Commission's Web site at
http://www.ferc.gov using the ``eLibrary'' link. Enter the docket
number excluding the last three digits in the docket number field to
access the document. For assistance, call toll-free 1-866-208-3676 or
e-mail<EMAIL_ADDRESS>For TTY, call<PHONE_NUMBER>. A copy
is also available for inspection and reproduction at the address in
item e above.

    j. Competing Preliminary Permit--Anyone desiring to file a
competing application for preliminary permit for a proposed project
must submit the competing application itself, or a notice of intent to
file such an application, to the Commission on or before the specified
comment date for the particular application (see 18 CFR 4.36).
Submission of a timely notice of intent allows an interested person to
file the competing preliminary permit application no later than 30 days
after the specified comment date for the particular application. A
competing preliminary permit application must conform with 18 CFR 4.30
and 4.36.
    k. Competing Development Application--Any qualified development
applicant desiring to file a competing development application must
submit to the Commission, on or before a specified comment date for the
particular application, either a competing development application or a
notice of intent to file such an application. Submission of a timely
notice of intent to file a development application allows an interested
person to file the competing application no later than 120 days after
the specified comment date for the particular application. A competing
license application must conform with 18 CFR 4.30 and 4.36.
    l. Notice of Intent--A notice of intent must specify the exact
name, business address, and telephone number of the prospective
applicant, and must include an unequivocal statement of intent to
submit, if such an application may be filed, either a preliminary
permit application or a development application (specify which type of
application). A notice of intent must be served on the applicant(s)
named in this public notice.
    m. Proposed Scope of Studies Under Permit--A preliminary permit, if
issued, does not authorize construction. The term of the proposed
preliminary permit would be 36 months. The work proposed under the
preliminary permit would include economic analysis, preparation of
preliminary engineering plans, and a study of environmental impacts.
Based on the results of these studies, the Applicant would decide
whether to proceed with the preparation of a development application to
construct and operate the project.
    n. Comments, Protests, or Motions to Intervene--Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214. In determining the appropriate action to take, the Commission
will consider all protests or other comments filed, but only those who
file a motion to intervene in accordance with the Commission's Rules
may become a party to the proceeding. Any comments, protests, or
motions to intervene must be received on or before the specified
comment date for the particular application.
    o. Filing and Service of Responsive Documents--Any filings must
bear in all capital letters the title ``COMMENTS'', ``NOTICE OF INTENT
TO FILE COMPETING APPLICATION'', ``COMPETING APPLICATION'',
``PROTEST'', and ``MOTION TO INTERVENE'', as applicable, and the
Project Number of the particular application to which the filing
refers. Any of the above-named documents must be filed by providing the
original and the number of copies provided by the Commission's
regulations to: The Secretary, Federal Energy Regulatory Commission,
888 First Street, NE., Washington, DC 20426. An additional copy must be
sent to Director, Division of Hydropower Administration and Compliance,
Federal Energy Regulatory Commission, at the above-mentioned address. A
copy of any notice of intent, competing application or motion to
intervene must also be served upon each representative of the Applicant
specified in the particular application.
    p. Agency Comments--Federal, state, and local agencies are invited
to file comments on the described application. A copy of the
application may be obtained by agencies directly from the Applicant. If
an agency does not file comments within the time specified for filing
comments, it will be presumed to have no comments. One copy of an
agency's comments must also be sent to the Applicant's representatives.

Kimberly D. Bose,
Secretary.
 [FR Doc. E8-10457 Filed 5-9-08; 8:45 am]

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