[Federal Register Volume 81, Number 119 (Tuesday, June 21, 2016)]
[Rules and Regulations]
[Pages 40158-40160]
[FR Doc No: 2016-14406]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2010-0219; Directorate Identifier 2010-NE-14-AD;
Amendment 39-18556; AD 2016-12-07]
RIN 2120-AA64

Airworthiness Directives; Turbomeca S.A. Turboshaft Engines

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: We are superseding airworthiness directive (AD) 2010-11-10 for
all Turbomeca S.A. Astazou XIV B and XIV H turboshaft engines. AD 2010-
11-10 requires inspection of certain third stage turbine wheels and
removal of any damaged wheel. This AD requires expanding the population
and frequency of repetitive inspections. This AD was prompted by a
report of a third stage turbine wheel crack detected during engine
overhaul. We are issuing this AD to prevent uncontained failure of the
third stage turbine wheel, which could result in damage to the engine
and damage to the helicopter.

DATES: This AD is effective July 26, 2016.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in this AD as of July 26,
2016.

ADDRESSES: For service information identified in this final rule,
contact Turbomeca S.A., 40220 Tarnos, France; phone: (33) 05 59 74 40
00; fax: (33) 05 59 74 45 15. You may view this service information at
the FAA, Engine & Propeller Directorate, 1200 District Avenue,
Burlington, MA. For information on the availability of this material at
the FAA, call<PHONE_NUMBER>. It is also available on the Internet at
http://www.regulations.gov by searching for and locating Docket No.
FAA-2010-0219.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2010-
0219; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this AD, the mandatory continuing airworthiness information,
regulatory evaluation, any comments received, and other information.
The address for the Docket Office (phone:<PHONE_NUMBER>) is Document
Management Facility, U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Brian Kierstead, Aerospace Engineer,
Engine Certification Office, FAA, Engine & Propeller Directorate, 1200
District Avenue, Burlington, MA 01803; phone:<PHONE_NUMBER>, fax: 781-
238-7199; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR

part 39 to supersede AD 2010-11-10, Amendment 39-16315 (75 FR 30270,
June 1, 2010), (``AD 2010-11-10''). AD 2010-11-10 applied to the
specified products. The NPRM published in the Federal Register on March
11, 2016 (81 FR 12843) (``the NPRM''). The NPRM proposed to continue to
require inspection of certain third stage turbine wheels and removal of
any damaged wheel. The NPRM also proposed to expand the population and
frequency of repetitive inspections.

Comments

    We gave the public the opportunity to participate in developing
this AD. We received no comments on the NPRM.

Conclusion

    We reviewed the available data and determined that air safety and
the public interest require adopting this AD as proposed.

Related Service Information Under 1 CFR Part 51

    Turbomeca S.A. has issued Mandatory Service Bulletin (MSB) No. 283
72 0804, Version D, dated July 24, 2015. The MSB describes procedures
for inspecting the third stage turbine wheels.
    Turbomeca S.A. has issued Service Bulletin (SB) No. 283 72 0805,
Version B, dated December 15, 2010. That SB describes optional
terminating action for the inspections.
    This service information is reasonably available because the
interested parties have access to it through their normal course of
business or by the means identified in the ADDRESSES section.

Costs of Compliance

    We estimate that this AD affects seven engines installed on
helicopters of U.S. registry. We also estimate that it would take about
5 hours per engine to comply with this AD. The average labor rate is
$85 per hour. Based on these figures, we estimate the cost of this AD
on U.S. operators to be $2,975.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, Section 106, describes the
authority of the FAA Administrator. Subtitle VII, Aviation Programs,
describes in more detail the scope of the Agency's authority.
    We are issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701, ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under DOT Regulatory Policies and
Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska to the extent
that it justifies making a regulatory distinction, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends part 39 of the Federal Aviation
Regulations (14 CFR part 39) as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by removing airworthiness directive (AD)
2010-11-10, Amendment 39-16315 (75 FR 30270, June 1, 2010), (``AD 2010-
11-10''), and adding the following new AD:

2016-12-07 Turbomeca S.A.: Amendment 39-18556; Docket No. FAA-2010-
0219; Directorate Identifier 2010-NE-14-AD.

(a) Effective Date

    This AD is effective July 26, 2016.

(b) Affected ADs

    This AD supersedes AD 2010-11-10.

(c) Applicability

    This AD applies to Turbomeca S.A., Astazou XIV B and XIV H
turboshaft engines with the following part number (P/N) and serial
number (S/N) third stage turbine wheels that incorporate
modification AB 173 (Turbomeca S.A. Service Bulletin (SB) No. 283 72
0091) or modification AB 208 (Turbomeca S.A. SB No. 283 72 0117).
This AD does not apply to third stage turbine wheels that
incorporate Turbomeca S.A. SB No. 283 72 805.
    (1) Third stage turbine wheels, P/N 0 265 25 700 0, all S/Ns;
    (2) Third stage turbine wheels, P/N 0 265 25 702 0, all S/Ns;
    (3) Third stage turbine wheels, P/N 0 265 25 706 0, all S/Ns;
    (4) Third stage turbine wheels, P/N 0 265 25 705 0, with an S/N
listed in Appendix 2.1 of Turbomeca S.A. Mandatory Service Bulletin
(MSB) No. 283 72 0804, Version D, dated July 24, 2015.

(d) Unsafe Condition

    This AD was prompted by a report of a third stage turbine wheel
crack detected during engine overhaul. We are issuing this AD to
prevent uncontained failure of the third stage turbine wheel, which
could result in damage to the engine and damage to the helicopter.

(e) Compliance

    Comply with this AD within the compliance times specified,
unless already done.
    (1) Perform a dye penetrant inspection of the third stage
turbine wheel. Use paragraph <IP_ADDRESS> of Turbomeca S.A. MSB No. 283
72 0804, Version D, dated July 24, 2015, to do the inspection, as
follows:
    (i) Inspect third stage turbine wheels with 300 engine cycles
(EC) or more accumulated since last inspection, or since new, or
since last overhaul, or since repair, within 100 EC after the
effective date of this AD.
    (ii) Inspect third stage turbine wheels with less than 300 EC
accumulated since last inspection, or since new, or since last
overhaul, or since repair, within 400 EC since last inspection, or
since new, or since last overhaul, or since repair.
    (2) Repeat the inspection required by this AD within 400 EC
since last inspection.
    (3) Remove from service any third stage turbine wheels that fail
the inspection required by this AD.

(f) Optional Terminating Action

    Application of Turbomeca S.A. SB No. 283 72 0805, Version B,
dated December 15, 2010 is terminating action for the inspections
required by paragraphs (e)(1) and (2) of this AD.

(g) Alternative Methods of Compliance (AMOCs)

    The Manager, Engine Certification Office, may approve AMOCs for
this AD. Use the procedures found in 14 CFR 39.19 to make your
request. You may email your request to<EMAIL_ADDRESS>
(h) Related Information

    (1) For more information about this AD, contact Brian Kierstead,
Aerospace Engineer,

Engine Certification Office, FAA, Engine & Propeller Directorate,
1200 District Avenue, Burlington, MA 01803; phone:<PHONE_NUMBER>;
fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>    (2) Refer to MCAI EASA AD 2015-0211, dated October 15, 2015, for
related information. You may examine the MCAI in the AD docket on
the Internet at http://www.regulations.gov by searching for and
locating it in Docket No. FAA-2010-0219.

(i) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) Turbomeca S.A. Mandatory Service Bulletin No. 283 72 0804,
Version D, dated July 24, 2015.
    (ii) Turbomeca S.A. Service Bulletin No. 283 72 0805, Version B,
dated December 15, 2010.
    (3) For Turbomeca S.A. service information identified in this
AD, contact Turbomeca S.A., 40220 Tarnos, France; phone: (33) 05 59
74 40 00; fax: (33) 05 59 74 45 15.
    (4) You may view this service information at FAA, Engine &
Propeller Directorate, 1200 District Avenue, Burlington, MA. For
information on the availability of this material at the FAA, call
781-238-7125.
    (5) You may view this service information at the National
Archives and Records Administration (NARA). For information on the
availability of this material at NARA, call<PHONE_NUMBER>, or go to:
http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Burlington, Massachusetts, on June 7, 2016.
Colleen M. D'Alessandro,
Manager, Engine & Propeller Directorate, Aircraft Certification
Service.
[FR Doc. 2016-14406 Filed 6-20-16; 8:45 am]
BILLING CODE 4910-13-P


<EPA BIOPESTICIDES AND POLLUTION PREVENTION DIVISION COMPANY NOTICE OF
FILING FOR PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER

(7/1/2007)>

<EPA Biopesticides and Pollution Prevention Division contact: [Linda
Hollis;<PHONE_NUMBER>]>

<INSTRUCTIONS:  Please utilize this outline in preparing the pesticide
petition.  In cases where the outline element does not apply, please
insert “NA-Remove” and maintain the outline. Please do not change
the margins, font, or format in your pesticide petition. Simply replace
the instructions that appear in green, i.e., “[insert company
name],” with the information specific to your action.>

<SUBMISSION: E-mail the completed template to<EMAIL_ADDRESS>
<TEMPLATE:>

<[Laboratoires Goëmar SA]>

<[Insert petition number]>

<	EPA has received a pesticide petition ([insert petition number]) from
[Laboratoires Goëmar SA c/o SciReg, Inc.], [12733 Director’s Loop,
Woodbridge, VA 22192] 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.>

<(Options (pick one)>

<	1. by establishing a tolerance for residues of> NA-remove

<	2. to establish an exemption from the requirement of a tolerance for>

<	3. to establish an amendment/expansion of an existing tolerance
exemption for the> NA-remove

<(Options (pick one)>

<	1. microbial pesticide  [NA-remove]>

<	2. biochemical pesticide [Laminarin]>

<	3. plant-pesticide [NA-remove] in or on [NA-remove].>

<	Pursuant to section 408(d)(2)(A)(i) of  FFDCA, as amended,
[Laboratoires Goëmar SA c/o SciReg, Inc.] has submitted the following
summary of information, data, and arguments in support of their
pesticide petition. This summary was prepared by [Laboratoires Goëmar
SA c/o SciReg, Inc.] 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. [Laboratoires Goëmar SA c/o SciReg, Inc.]  Petition Summary>

<	[Insert petition number]>

<A. Product Name and Proposed Use Practices>

<	[The biopesticide, laminarin, is extracted from a brown seaweed,
Laminaria digitata. This brown seaweed grows attached to the bedrock of
the seashore on the sublittoral fringe (uncovered only at spring tides).
In France, it proliferates on the Brittany coastline. Laminaria digitata
is now the most farmed seaweed in France. The harvest is regulated by Le
Ministère de la Mer (French Ministry of the Sea) and La Chambre
Syndicale des Algues (Corporate Union for Algae). L. digitata is also
used in cosmetics as anti-cellulite and anti-obesity treatments. It also
has use in cancer treatment, and treatments against bacterial, viral,
and fungal infections.

Laminarin will be used to elicit the target crops’ self-defense
mechanisms against such disease organisms as gray mold, powdery mildew,
downy mildew, fire blight, and bacterial spot.

For the first laminarin end-use product Goëmar intends to register
(VacciPlant), the concentration of laminarin will be 3.51% with an
application rate of 9.7 – 14.4 fl. oz. per acre in 5-100 gallons of
water. Applications can be made aerially or via standard tractor-mounted
hydraulic sprayer.]>

<B. Product Identity/Chemistry>

<	1. Identity of the pesticide and corresponding residues. [Laminarin is
one of the naturally-occurring glucans from L. digitata. Glucans are
polysaccharides of D-glucose monomers linked by glycosidic bonds.
β-glucans, of which laminarin is one, are found in the bran of cereal
grains, most abundantly in barley and oats and, to a much lesser degree,
in rye and wheat. They are useful in human nutrition as texturing agents
and as soluble fiber supplements. L. digitata is used for sea-vegetable
production in Ireland and France, and is an important food item in
Japan.

Laminarin appears to be a (-(1(3)-linked D-glucan with occasional
(-(1(6) linkage series of molecules, composed of a major M-series
containing 20-30 glucosyl residues linked to a mannitol terminal
residue, and a minor G-series containing 22-28 glucosyl residues. Both
series have a mean degree of polymerisation of 25 glucosyl pure
residues; an approximately 3:1 ratio of M-series to G-series molecules
is maintained across the range of molecular sizes. M-series molecules
contain 0 to 4 branches, with an average of 1.3 branches per molecule;
branched G-series molecules are also detected. This study also showed
that 75% of branches are single glucosyl residues.

Molecular formula: (C6H12O6)n   n = 25 to 30

Molecular mass: 4500 - 5000 g/mol]>

<	2. Magnitude of residues at the time of harvest and method used to
determine the residue. [No magnitude of residue (MOR) studies have been
conducted on laminarin, as it is a naturally-occurring plant extract
(glucans, which are polysaccharides) which cannot be differentiated from
a plant’s other naturally-occurring oligosaccharides. Laminarin is
also toxicologically innocuous (see Toxicological Profile, pages 6-12).
Further, OPPTS Guideline 860.1550 indicates that residue studies “will
be waived for toxicologically-innocuous active ingredients.” As a
tolerance exemption is being sought, no magnitude of the residue studies
or residue analytical methods are being submitted]>

<	3. A statement of why an analytical method of detecting and measuring
the levels of the pesticide residue are not needed. [Laminarin is a
naturally-occurring plant extract (glucans, which are polysaccharides)
which cannot be differentiated from a plant’s other
naturally-occurring oligosaccharides. A tolerance exemption is being
sought for laminarin.]>

<C. Mammalian Toxicological Profile>

<[Acute oral toxicity

		Report No. 20010618 ST

Guideline:	870.1100

Methods:	Groups of five male and five female rats were exposed orally to
2,000 mg/kg of laminarin (91% purity) in a volume of 10 ml/kg as a
suspension in water for injection. A group of control animals under the
same conditions as the test animals was treated with 10 ml/kg of water.
Animals were monitored daily for 14 days after administration of the
compound.

Findings:	No mortalities occurred and no clinical signs were observed
throughout the observation period. No effects on body weight development
were noted. At gross necropsy, no visible lesions were observed.

Conclusion:	The acute oral LD50 of laminarin to rats was determined to
be greater than 2,000 mg/kg, the highest dose level tested.

Acute subcutaneous toxicity

Report No. 970353 ST

Guideline:	None

Methods:	1,000 mg/kg of laminarin (91% purity) was administered
subcutaneously in a volume of 5 ml/kg as a suspension in water to five
male and five female rats. A group of control animals under the same
conditions as the test animals was treated with 5 ml/kg of water.
Animals were monitored daily for 14 days after administration of the
compound.

Findings:	No mortalities occurred, and no clinical signs were observed
throughout the observation period. No effects on body weight development
were noted. At gross necropsy, no visible lesions were observed.

Conclusion:	The acute subcutaneous LD50 of laminarin to rats was
determined to be greater than 1,000 mg/kg, the highest dose level
tested.

Acute dermal toxicity

	Report No. 20000698 ST

Guideline:	870.1200

Methods:	5,000 mg/kg of laminarin (91% purity) was applied to the skin
in the dorsal region of each animal in a volume of 8 ml/kg as a
suspension in water to five male and five female rats. A group of
control animals under the same conditions as the test animals was
treated with 8 ml/kg of water. Animals were monitored daily for 14 days
after administration of the compound.

Findings:	No mortalities occurred and no clinical signs were observed
throughout the observation period. No effects on body weight development
were noted. At gross necropsy, no visible lesions were observed.

Conclusion:	Based on the above, the dermal LD50 of laminarin in rats was
determined to be greater than 5,000 mg/kg, the highest dose level
tested.

4.			Evaluation of acute inhalation toxicity of laminarin in rats

		Report No. 980001 EX

Guideline:	870.1300

Methods:	Groups of five male and five female Charles River Wistar rats
were exposed (nose only) to laminarin (91% purity). The test article was
dissolved in distilled water at 10%, and was administered as an aerosol
of this aqueous solution for 4 hours with the maximum attainable
concentration of 1.02 mg/L. Animals were examined for mortality,
clinical signs, body weight gain, and pathological alterations of organs
at the end of a 14-day observation period.

Findings:	No mortalities were observed. No clinical signs were observed
throughout the observation period. No effects on body weight were noted.
At gross necropsy, no visible lesions were observed.

Conclusion:	The acute inhalation LC50 of laminarin in rats was
determined to be greater than 1.02 mg/L, the maximum attainable
concentration.

5.			Primary eye irritation

		Report No. 20010615 ST

Guideline:	870.2400

Methods:	0.1 g of laminarin (91% purity) was instilled into the
conjunctival sac of the left eye of each of three rabbits.  The
untreated right eye served as a control.

Findings:	The mean indices per parameter (24, 48, 72 h) were zero for
all three rabbits for chemosis, iris and cornea effects, and for one of
the three for redness.  The mean index for redness in the other two
rabbits was 0.33.

Conclusion:	Laminarin is considered non-irritating to the eyes of
rabbits.

6.			Primary dermal irritation

		Report No. 20010617 ST

Guideline: 	870.2500

Methods:	0.5 g of laminarin (91% purity) was applied to the right shaved
flank of each of three rabbits.  Adjacent surfaces of untreated skin of
each animal served as controls. The compound was moistened with 0.5 ml
of water for injection in order to allow good contact between the test
substance and the skin. Semi-occlusive dressings held the compound in
place for 4 hours.

Findings:	The mean indices per parameter (24, 48, 72 h) were zero for
all three rabbits for edema and for two of the three rabbits for
erythema.  The third rabbit had a mean erythema index of 1.00.

Conclusion:	Laminarin is considered non-irritating to the skin of
rabbits.

7. 		Dermal sensitization – Magnusson and Kligman maximization test

Report No. 20010616 ST

Guideline:	870.2600

Methods:	The maximum slight to moderately irritating laminarin (91%
purity) concentration (based on the cutaneous reaction 24 hours after
intradermal administration) and used during the primary induction phase
was 25% (p/v) in water for injection.

The maximum slight to moderately irritating laminarin concentration
(based on the reading of cutaneous reactions 1 hour after removing the
dressing of a 48-hour epicutaneous exposure and used during the second
induction phase and the sensitization phase performed by the topical
route) was 25% (p/v) in water for injection.

The Maximum Non-Irritant Concentration (MNIC) determined by epicutaneous
application (based on reading of cutaneous reactions 24 and 48 hours
after removing the dressing of a 24-hour exposure) and used during the
challenge phase was 25% (p/v) in water for injection.

Determination of the degree of allergenicity at 24 and 48 hours was
based upon the percentage of animals in the group showing a reaction,
rather than on its severity.

The sensitivity and the reliability of the experimental method is
verified, at least every six months, using a positive control group in
which animals are treated with dinitrochlorobenzene (DNCB, 1%).

Findings:	100% of the positive control animals were sensitized at 24
hours and 80% at 48 hours.  The laminarin-treated group had no
sensitized animals at either 24 or 48 hours.

Conclusion:	Laminarin is considered a non-sensitizer to guinea pigs.

8.		4-week oral toxicity study in rats

Report No. RTC 7286/T/240/99

Guideline:	870.3050

Methods:	The toxicity of laminarin (97.6% purity), when given by daily
oral administration to rats, was investigated over a period of four
consecutive weeks.

		A single group of 5 male and 5 female Sprague-Dawley rats received the
test substance daily by oral gavage at a dose level of 1,000 mg/kg for
28 consecutive days.  A second similarly-constituted control group
received 0.5% carboxymethylcellulose in distilled water.

Findings:	There were no toxicologically significant findings in
mortality, clinical observations, neurotoxicity assessment, body weight,
food consumption, hematology, clinical chemistry, organ weights, and
macroscopic or microscopic observations.

Conclusion: 	No toxicologically significant findings were observed in
any of the parameters investigated following treatment with laminarin at
a level of 1,000 mg/kg/day.  The NOEL was determined to be 1,000
mg/kg/day.

9.			90-day oral toxicity study in rats

		Report No. 20000389T

Guideline: 	870.3100

Methods:	Laminarin (94.9% purity) was administered daily by the oral
route for 90 consecutive days to one group of Sprague-Dawley rats
treated at the limit dose of 1,000 mg/kg/day.  A group of control
animals was given the vehicle (water) under the same conditions. Each
group included 10 male and 10 female rats.

		Examinations included: mortality, clinical observations of animals,
body weight changes, food and water consumption, clinical pathology,
ophthalmology, macroscopic findings, organ weights, and histopathology.

Findings:	No deaths occurred during the study.

		No treatment-related clinical or macroscopic examination changes were
recorded and there was no change in functional tests/ophthalmology.
Treated animals had similar body weight changes, food and water
consumptions and organ weights to controls.  There was no statistical
difference in hematology, clinical chemistry, or urinalysis.  No
treatment-related histopathological changes were observed.

Conclusion: 	Laminarin administered for 90 consecutive days to male and
female Sprague-Dawley rats at 1,000 mg/kg was well tolerated.

		The NOAEL was determined to be 1,000 mg/kg/day.

10. 			90-day oral toxicity study in dogs

		Report No. 20000390T

Guideline: 	870.3150

Methods:	Laminarin (94.9% purity) was administered daily by the oral
route for 90 consecutive days to one group of Beagle dogs treated at the
limit dose of 1,000 mg/kg/day.  A group of control animals was given the
vehicle (water) under the same conditions.  Each group included 4 male
and 4 female dogs.

		Examinations included: mortality, clinical observations of animals,
body weight changes, food and water consumption, clinical pathology,
ophthalmology, macroscopic findings, organ weights, and histopathology.

Findings:	No treatment-related deaths occurred during the study.  No
treatment-related clinical (except a slight increase of diarrhea and/or
soft stools common in young laboratory dogs in the treated group) or
macroscopic examination changes were recorded. There was no change in
functional tests/ophthalmology.  Treated animals had similar body weight
changes, food and water consumption, and organ weights to controls.
There were no statistical differences in hematology, clinical chemistry,
or urinalysis.  No treatment-related histopathological changes were
observed.

Conclusion:	Laminarin administered for 90 consecutive days to male and
female Beagle dogs at 1,000 mg/kg was well tolerated.

		The NOAEL was determined to be 1,000 mg/kg/day.

11. 		Ames mutagenicity test

Report No. IPL-R 991011/H11

Guideline: 	870.5100

Methods:	Laminarin (97.6% purity) was tested with and without metabolic
activation (S-9) against Salmonella typhimurium: TA 1535, TA 1537, TA
98, TA 100 and Escherichia coli: WP2 (pKM101) and WP2uvrA (pKM101) using
the maximum concentration of 5,000 µg/plate and four lower dilutions
chosen according to a geometric ratio.

Findings:	With and without metabolic activation in two independent
assays, no biologically significant increase in the number of revertants
was noted in the four Salmonella typhimurium and the two Escherichia
coli strains tested, in the presence of the test compound, laminarin.
It is noted that with metabolic activation, a slight, but statistically
significant, increase in the number of revertants was observed at the
maximum dose tested of 5,000 µg/plate in the first assay in E. coli
strains WP2 (pKM101) and WP2uvrA (pKM101) and at the three tested doses
of 150, 1,500 and 5,000 µg/plate in the second assay in the last
strain, WP2uvrA (pKM101). However, this effect was not biologically
significant, not dose-related, and as biological relevance should be
considered first according to OECD’s recommendations, it was not
attributed to mutagenic activity.

Conclusion: 	Laminarin did not induce mutagenic activity in the four
Salmonella typhimurium and the two Escherichia coli strains tested.

12. 			In vivo bone marrow micronucleus test

	Report No. 21149 MAS

Guideline: 	870.5395

Methods:	After a preliminary test to define the dose levels, three
groups of five male and five female Swiss ICO: OF1 (IOPS Caw) mice
received two oral treatments of laminarin (94% purity) at 500, 1,000 and
2,000 mg/kg/day, at a 24-hour interval. All dose levels were corrected
for purity (94%). The top dose level for the cytogenetic test was
selected according to the criteria specified in the international
guidelines; since no observable toxic effects were noted in the
preliminary test, the top dose level selected for the definitive test
was 2,000 mg/kg/day. A control group received the vehicle (water) under
the same experimental conditions, and a positive control group received
cyclophosphamide at 50 mg/kg once.

			The animals were sacrificed 24 hours after the last treatment.  Bone
marrow smears were then prepared.

	For each animal, the number of micronucleated polychromatic
erythrocytes (MPE) was counted in 2,000 polychromatic erythrocytes (PE).
 The PE and normochromatic (NE) erythrocyte ratio was established by
scoring a total of 1,000 erythrocytes (PE+NE).

Findings:	The mean values of MPE, as well as the PE/NE ratio for the
vehicle and positive controls, were consistent with the historical data.

		Cyclophosphamide induced a highly significant increase (p < 0.001) in
the frequency of MPE, indicating the sensitivity of the test system
under these experimental conditions.  The study was, therefore,
considered valid.

		For both males and females, the mean values of MPE, as well as the
PE/NE ratio in the groups treated with the test substance, were
equivalent to those of the vehicle group.

Conclusion: 	Laminarin does not induce damage to the chromosomes or the
mitotic apparatus of mice bone marrow cells after two oral
administrations, with a 24-hour interval, at 500, 1,000 or 2,000
mg/kg/day.

13. 	In vitro mammalian cell gene mutation test in L5178Y TK+/- mouse
lymphoma cells

	Report No. 22626 MLY

Guideline:	870.5300

Methods: 	After a preliminary screening assay, laminarin was evaluated
in two independent experiments. Five dose levels of laminarin (312.5,
625, 1250, 2500, and 5000 µg/ml; two cultures/dose level) were tested
in both test with and without metabolic activation (S-9).

Findings:	Except for some sporadic decreases in the relative survival
(RS) or relative total growth (RTG), no noteworthy effects were induced
in either experiment.  The test material did not induce any noteworthy
increases in the mutation frequency, either with or without S-9.

Conclusion:	Laminarin did not show any mutagenic activity in the mouse
lymphoma assay.

14.	Teratogenicity – rat

Report No. 20000387 T

Guideline: 	870.3700

Methods:		SPF (Specific Pathogen Free) Sprague-Dawley rats were used.
The study involved two groups: 1,000 mg/kg/day and a control. The test
substance was administered to 21 pregnant females at 1,000 mg/kg/day by
oral gavage at a volume of 5 ml/kg in sterile water. Control animals (23
pregnant females) were given sterile water under the same conditions.
Doses were prepared daily.

Findings:	No treatment-related deaths occurred during the study. No
treatment-related clinical or macroscopic examination changes were
recorded. Treated animals had similar body weight changes, food and
water consumptions, and uterus weights when compared to controls. There
were no significant reproductive effects or fetal abnormalities.

Conclusion: 	Under the experimental conditions adopted, laminarin
administered to female rats at the limit dose of 1,000 mg/kg/day was
well tolerated.  No major maternal toxicity and no external fetal
abnormalities were reported.

The NOAEL was determined to be 1,000 mg/kg/day.

15. 	Teratogenicity – rabbit

Report No. 20000388 T

Guideline: 	870.3700

Methods:		Albino SPF (Specific Pathogen Free) New-Zealand White rabbits
were used.  The study involved two groups: 1,000 mg/kg/day and a
control. The test substance was administered to 13 pregnant females at
1,000 mg/kg/day by oral gavage at a volume of 5 ml/kg in sterile water.
Control animals (16 pregnant females) were given sterile water under the
same conditions.  Doses were prepared daily.

Findings:	No treatment-related deaths occurred during the study.  No
treatment-related clinical or macroscopic examination changes were
recorded.  There were no statistically treatment-related significant
differences between the treated and control animals with regard to body
weight changes or food consumption.  Treated and control animals had
similar water consumption and uterus weights.  There were no significant
treatment-related reproductive effects or fetal abnormalities.

Conclusion: 	Under the experimental conditions adopted, laminarin
administered to female rabbits at the limit dose of 1,000 mg/kg/day was
well tolerated.  No maternal toxicity and no treatment-related fetal
abnormalities were reported.

The NOAEL was determined to be 1,000 mg/kg/day.]>

<D. Aggregate Exposure>

<	1. Dietary exposure. [Considering laminarin’s mode of action, its
demonstrated lack of toxicity, its approval in Ireland, France, and
Japan as a food source, its natural occurrence, and the fact that it
hydrolyses to smaller-sized oligosaccharides and ultimately to glucose,
it is unlikely that exposure to laminarin would have any negative impact
on human health.]>

<	i. Food. [Dietary exposure to laminarin should not be of concern due
to the low toxicity shown in the acute, subchronic, and teratogenicity
studies previously submitted. In addition, laminarin is naturally
occurring in foods. No adverse health issues to man, animals, or plants
have been associated with this compound. Exposure to laminarin from its
pesticidal use is anticipated to be very low to non-existent due to its
hydrolytic conversion to even smaller oligosaccharides and ultimately to
glucose.

During a meeting on October 14, 1997 the “Conseil Supérieur
d’hygiène publique de France” approved the use of laminar algae
(Laminaria digitata and Laminaria saccharina) in human nutrition.
Approval was subject to the following conditions:

For an adult, the recommended daily amount must be less than or equal to
30 mg of dry product (or 210 mg of fresh product).

For a child less than 4 years old, the recommended daily amount must be
less than or equal to 15 mg of dry product (or 105 mg of fresh product).

Pesticidal uses proposed for laminarin by Goëmar are expected to result
in dietary exposure much lower than these.

The iodine and heavy metal limits previously set for laminar algae are
to be applied: arsenic (As: 3 mg/8 kg), cadmium (Cd: 0.5 mg/kg), mercury
(Hg: 0.1 mg/kg), iodine (I: 6,000 mg/kg), lead (Pb: 5 mg/kg), tin (Sn: 5
mg/kg).

The use of these algae must be in the form of food seasoning.]>

<	ii. Drinking water. [Laminaria digitata is a naturally-occurring brown
seaweed. It is not considered to be a risk to drinking water. Hydrolysis
of laminarin to oligosaccharides and then to glucose, percolation
through soil, and municipal treatment of drinking water would reduce or
eliminate the possibility of exposure through drinking water. Typical
agricultural practices are carried out such that spray drift is
minimized. Although possible minimal spray drift may contact drinking
water, natural and water treatment steps would further reduce or
eliminate the possibility of exposure via potable water. The end-use
product, VacciPlant, is prohibited by the label from direct application
to water and, therefore, is not expected to be present at significant
concentrations in aquatic environments.]>

<	2. Non-dietary exposure. [The potential for non-occupational,
non-dietary exposure from laminarin to the general population is not
expected to be significant and is not expected to present any risk of
adverse health effects, especially given the lack of acute and
subchronic toxicity, acute irritation, mutagenic, and teratogenic
effects.

L. digitata is used in the cosmetic industry, mainly in treatments
against cellulite and obesity, either alone or combined with other
extracts to enhance its activity, but also as a skin conditioner and
fragrance ingredient.]>

<E. Cumulative Effects>

<	[VacciPlant (containing 3.51% laminarin) is applied using a standard
tractor-mounted field crop sprayer with hydraulic boom and nozzles.
VacciPlant may also be applied aerially. Only applications to fruiting
vegetables including tomatoes, eggplant, and peppers; cucurbits
including zucchini, cucumbers, watermelon, and melon; grapes;
apples/pears; and strawberries are intended at present.

There are no other products registered for food use that contain
laminarin as the active ingredient. As previously stated, the brown
seaweed from which laminarin is extracted, is used in sea-vegetable
production in Ireland and France, and is an important food item in
Japan. There are currently no known adverse effects associated with
laminarin consumption. Laminaria species are also harvested for the
extraction of alginate and have other medical and cosmetic uses. In
addition, the label will require pesticide applicators and other
handlers to wear personal protective equipment (PPE) to mitigate
exposure.]>

<F. Safety Determination>

<	1. U.S. population. [Laminaria digitata is a naturally-occurring brown
seaweed.  The plant extract, laminarin, has low toxicity as demonstrated
by the acute, subchronic, teratogenicity, and mutagenicity studies
summarized above. Based on these results, the aggregate exposure to
laminarin over a lifetime should not change with the pesticidal
application of laminarin. Thus, there is a reasonable certainty that no
harm will result from aggregate exposure to laminarin.]>

polysaccharides of D-glucose monomers linked by glycosidic bonds.
β-glucans, of which laminarin is one, are found in the bran of cereal
grains, most abundantly in barley and oats and, to a much lesser degree,
in rye and wheat. They are useful in human nutrition as texturing agents
and as soluble fiber supplements.

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䨰"࠼₁There are no known effects on the immune and endocrine
systems, nor are any effects expected. Laminarin is not structurally
related to any known hormones, neurotoxins, or endocrine disruptors.]>

<H. Existing Tolerances>

<	[Laminarin does not have any existing U.S. tolerances.]>

<I. International Tolerances>

<	[There are no Codex Maximum Residue Levels or international tolerance
exemptions for laminarin.]>

 PAGE

 PAGE   12


[Federal Register Volume 76, Number 9 (Thursday, January 13, 2011)]
[Notices]
[Page 2370]
[FR Doc No: 2011-545]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 13863-000]

Mount Storm Hydro, LLC; Notice of Preliminary Permit Application
Accepted for Filing and Soliciting Comments, Motions To Intervene, and
Competing Applications

January 6, 2011.
    On October 14, 2010, Mount Storm Hydro, LLC filed an application
for a preliminary permit, pursuant to section 4(f) of the Federal Power
Act (FPA), proposing to study the feasibility of the Mount Storm Pumped
Storage Project to be located near Maysville, in Grant County, West
Virginia. The sole purpose of a preliminary permit, if issued, is to
grant the permit holder priority to file a license application during
the permit term. A preliminary permit does not authorize the permit
holder to perform any land-disturbing activities or otherwise enter
upon lands or waters owned by others without the owners' express
permission.
    The project would consist of two artificial, lined reservoirs
created by the construction of embankments. Two options for the upper
reservoir site are proposed. The Option A upper reservoir would be
joined with the lower reservoir by approximately 7,600 feet of conduit.
Maximum hydraulic head would be 1,590 feet. Equipment would consist of
one 200-megawatt (MW), one 100-MW, and one 50-MW reversible pump-
turbines, totaling 350 MW of generating capacity, with up to 100 MW of
additional pumping capacity, for a total of 450 MW pumping capacity.
Annual energy production is projected to be approximately 1,073,100
megawatt-hours (MWh).
    The Option B upper reservoir would be joined with the lower
reservoir by approximately 13,870 feet of conduit. Maximum hydraulic
head would be 1,470 feet. Equipment would consist of one 150-MW, one
100-MW, and one 50-MW reversible pump-turbines, totaling 300 MW of
generating capacity, with up to 100 MW of additional pumping capacity,
for a total of 400 MW pumping capacity. Annual energy production is
projected to be approximately 919,800 MWh.
    For either option, the project would interconnect with either of
three possible 500-kilovolt (kV) lines on the Allegheny Power system
via a new, single-circuit 230-kV line about 4 miles in length. These
500-kV lines include the Greenland Gap-Meadow Brook line, the Mt.
Storm-Doubs line, and the planned Trans-Allegheny Interstate line.
    Applicant Contact: Matthew Shapiro, CEO, Gridflex Energy, LLC, 1210
W. Franklin St., Ste. 2, Boise, ID 83702; phone:<PHONE_NUMBER>, e-
mail<EMAIL_ADDRESS>    FERC Contact: John Mudre<PHONE_NUMBER> or<EMAIL_ADDRESS>    Deadline for filing comments, motions to intervene, competing
applications (without notices of intent), or notices of intent to file
competing applications: 60 days from the issuance of this notice.
Competing applications and notices of intent must meet the requirements
of 18 CFR 4.36. Comments, motions to intervene, notices of intent, and
competing applications may be filed electronically via the Internet.
See 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's
Web site http://www.ferc.gov/docs-filing/efiling.asp. Commenters can
submit brief comments up to 6,000 characters, without prior
registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact information
at the end of your comments. For assistance, please contact FERC Online
Support. Although the Commission strongly encourages electronic filing,
documents may also be paper-filed. To paper-file, mail an original and
seven copies to: Kimberly D. Bose, Secretary, Federal Energy Regulatory
Commission, 888 First Street, NE., Washington, DC 20426.
    More information about this project, including a copy of the
application, can be viewed or printed on the ``eLibrary'' link of the
Commission's Web site at http://www.ferc.gov/docs-filing/elibrary.asp.
Enter the docket number (P-13863-000) in the docket number field to
access the document. For assistance, contact FERC Online Support at
<EMAIL_ADDRESS>call toll-free at<PHONE_NUMBER>; or, for
TTY, contact<PHONE_NUMBER>.

Kimberly D. Bose,
Secretary.
[FR Doc. 2011-545 Filed 1-12-11; 8:45 am]
BILLING CODE 6717-01-P